Products Liability News
Jewelry from Popular Teen Stores Recalled Over Cadmium About 137,000 pieces of children's jewelry sold at two stores popular with pre-teen girls - Justice and Limited Too - have been recalled for high levels of the toxic metal cadmium. The voluntary recall was announced by the U.S. Consumer Product Safety Commission, and it was the sixth recall of cadmium products since early June, including about 12 million "Shrek" movie-themed drinking glasses distributed at McDonald's. Other recalls targeted jewelry, mostly for children. The latest involved 19 different styles of necklaces, bracelets and earrings distributed by Tween Brands.
FDA Orders Baxter Recall of IV Pumps The Food and Drug Administration has ordered Baxter International to recall all of its Colleague infusion pumps in use and provide a refund or no-cost replacement to United States customers. Electronic infusion pumps that deliver intravenous fluids like medication or nutrients have come under scrutiny by the FDA, which said it would establish additional requirements for manufacturers. "Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague infusion pumps still in use," the FDA said in a letter to the company. The FDA said it gave the final order to Baxter after finding "unacceptable" the company's planned timeline to fix the pump's problems. Baxter told the FDA earlier this year that it planned to begin its next round of corrections to the pumps in 2012 and expected to complete them by 2013. The recall affects about 200,000 pumps, mostly used in hospitals. The FDA ordered a transition plan for the recall that includes the option of replacing Colleague pumps covered by a 2006 consent decree with a replacement pump other than the Colleague model. Baxter stopped selling the Colleague pumps in 2005 after authorities seized more than 6,000 pumps thought to have a defect that could cause them to shut down or deliver the wrong amount of medication.
Guacamole and Salsa Linked to Food Poisoning Contaminated salsa or guacamole were the culprits in nearly 1 out of every 25 foodbourne illness outbreaks linked to food in restaurants between 1998 and 2008, according to new research released by the federal Centers for Disease Control and Prevention. The newly released figures are more than double the rate during the previous decade. Part of the problem is that individual ingredients in salsa - peppers, tomatoes, cilantro - all have been linked to widespread salmonella outbreaks in recent years. Researchers scoured CDC records for salsa- and guacamole-linked outbreaks starting in 1973. They didn't detect any until 1984, and of the 136 dip-related outbreaks they found, 84 percent were tied to restaurants and delis. Between 1984 and 1997, salsa- and guacamole-linked illnesses accounted for about 1.5 percent of all food establishment outbreaks, and from 1998 to 2008, that figure rose to nearly 4 percent. The salsa and guacamole outbreaks sickened some 5,560 people, sent 145 people to the hospital and contributed to three deaths. About a third of the illnesses were caused by salmonella, 18 percent were caused by norovirus and about 15 percent by shigella.
Kentucky Jury Favors Defense in Asbestos Case Turning aside claims for millions of dollars in damages sought by a man who said he was sickened by asbestos brought home on the clothing of his father, a Kentucky jury voted in favor of Union Carbide, the only remaining defendant in a case that began with nearly 30 co-defendants. In 2008, the plaintiff was diagnosed with pleural mesothelioma, a cancer caused by exposure to asbestos fibers that attack the lining of the lungs and other internal organs. He filed suit in 2009 on behalf of himself and his two teenage children, claiming that his father had brought the fibers into their home from work on his clothes in the 1960s and 1970s. The suit named Union Carbide, a subsidiary of Dow Chemical Co., which mined and distributed a joint compound that contained Calidria. Before trial, 26 other corporate defendants reached a confidential settlement with the plaintiff's family. Before the trial, the family submitted a "final itemized damages list" totaling almost $40 million, including $20 million in punitive damages and more than $1 million for each of his children. Union Carbide offered a "seven-figure settlement," but the family declined. After six days, the jury found that the plaintiff's cancer was not caused by exposure to the joint compound and that Union Carbide had not acted with "indifference to or a reckless disregard for the health and safety of others."
New Rules Could Make Eggs Safer The Food and Drug Administration says egg safety rules that just took effect could prevent thousands of cases of salmonella poisoning each year. The new rules were announced by the Obama administration last year and go into effect soon. The FDA says they could reduce the number of salmonella illnesses by nearly 60 percent. The government will now require some egg producers to do more testing for salmonella and large-scale producers will have to constantly refrigerate eggs while they are stored and transported. The FDA said egg safety rules implemented in the 1990s limited the growth of bacteria but didn't prevent contamination in many cases.
Nutritional Value of Fruits and Veggies Dwindling Today's conventionally grown produce isn't as healthful as it was 30 years ago - and it's only getting worse. In 2004, researchers analyzed 43 fruits and vegetables from 1950 to 1999 and reported reductions in vitamins, minerals and protein. Using USDA data, they found that broccoli, for example, had 130 mg of calcium in 1950. Today, that number is only 48 mg. Scientists believe the farming industry's desire to grow bigger vegetables faster using selective breeding and synthetic fertilizers decreases produce's ability to synthesize nutrients or absorb them from the soil. On the other hand, by avoiding synthetic fertilizers, organic farmers put more stress on plants, forcing them to protect themselves by producing phytochemicals. Another study found that organic tomatoes can have as much as 30 percent more phytochemicals than conventional ones.
China Finds More Milk Tainted with Deadly Chemical Chinese officials have found 76 tons of milk powder and dairy products laced with a deadly industrial chemical in at least three provinces that was apparently left over from a milk scandal in 2008 that killed six babies and sickened hundreds of thousands. The discovery shows that toxic milk remains a danger in China despite a crackdown in which dozens of people were arrested and two - a dairy farmer and a milk salesman - were executed for producing or selling toxic milk. State media and food safety experts said the recently seized melamine-tainted powder was probably produced in or before 2008 and stockpiled instead of destroyed. China ordered tens of thousands of tainted milk products burned or buried after more than 300,000 children were sickened and at least six died from the contamination. However, crucially, the government did not carry out the destruction itself. Melamine is added to watered-down milk to make it appear rich in protein in quality tests that measure nitrogen, which is found in both melamine and protein. Health problems from the chemical include kidney stones and kidney damage.
California Aims to Boost Enforcement of Organic Rules The state with the nation's largest organic farming community is launching an effort to improve oversight of an industry many describe as a poorly regulated free-for-all. The California Organic Program is considering new rules to help officials monitor the more than 2,800 organic farms and ranches that bring in about $1.1 billion every year. Among other things, the new rules would allow the state to establish a spot inspection program to ensure California-made products labeled as organic are authentic. The state will target known problem areas, such as farmers markets, where enforcement has been spotty and produce is often passed off as organic when it's not.
California Company Recalls 4,200 Bags of Spinach Ready Pac Foods is recalling some 4,200 bags of spinach salad after federal investigators confirmed the presence of E. coli in a random sample test. No illnesses have yet been reported in connection with the Spinach Temptations line of six-ounce bagged salads. The recall applies to bags sold in California, Washington and Arizona. Food and Drug Administration investigators detected the bacteria in a bag of salad mix taken from a store shelf and informed the company of their findings. Spinach with the Ready Pac label was among dozens of brands pulled from store shelves in 2006 after federal authorities traced a nationwide E. coli outbreak to the processing plant that bags its spinach. Ready Pac also supplied the scallions suspected in an E. coli outbreak linked to Taco Bell that same year.
Pill Maker Declines to Specify Size of Recall When Procter & Gamble announced a recent recall of some Scope mouthwash with defective child-resistant caps, it disclosed the extend of the recall - 35,000 bottles - in a government news release. When a unit of Johnson & Johnson announced an expanded recall of Tylenol and other over-the-counter drugs, however, the manufacturer declined to say how many bottles of pills were involved. The expanded recall involves 21 lots of certain kinds of Tylenol, Motrin and Benadryl made at a plant in Puerto Rico, and the number of bottles in a product lot can vary widely. The lack of specific figures released contrasts sharply with the typical availability of public information related to other consumer product recalls. The Consumer Product Safety Commission, which oversees product recalls, negotiates with companies to make sure that they detail the number of recalled products in releases to the public. Providing recall statistics is important, because consumers often take action depending on the size of a recall. A larger recall that garners wide news coverage often prompts people to scour their homes for defective or unsafe products so they can throw them out or return them for a refund. Since last year, the manufacturers has recalled millions of bottles of Tylenol arthritis caplets, Motrin and other products made at a plant in Puerto Rico. The products may be contaminated with a byproduct of a chemical used to treat wooden transport pallets, causing a moldy odor in the bottles.
FDA: Cepheid Recalls MRSA Blood Culture Assay In response to an increasing number of complaints of false-negative results, Cepheid has recalled all lots of its Xpert methicillin-resistant staphylococcus aureaus blood culture assay products for use with the GeneXpert Dx System. According to Cepheid, the products' potential to generate infrequent rates of false-negative MRSA results could lead to incorrect treatment or delay of care for patients who are actually infected with MRSA. The recall is a corrective action, which means practitioners can continue to use the product and are not required to return it to the company. According to Cepheid, when an MRSA negative result is obtained, the result should be considered "MRSA indeterminate, antimicrobial susceptibility testing pending," with more testing performed with an FDA-cleared, phenotypic antimicrobial susceptibility method on isolated colonies from the blood culture bottle. However, MRSA positive results generated on the assay can still be reported as positive results.
Medtronic Unit Fixing External Defibrillator Issue Medtronic's Physio-Control subsidiary recently launched a field correction effort to fix certain devices used to shock patients in cardiac arrest because it found a potential battery-power problem. The Food and Drug Administration said nearly 43,000 Lifepak 20 and Lifepak 20e defibrillators and monitors could be affected and assigned a "Class 1" recall, which is the agency's most significant recall level. The news came after it appears one patient may have died as a result. Though the company isn't pulling machines from the field, it is urged frequent testing.
Judge Sues Security Firm When a U.S. District Court judge pulled into the parking garage at Philadelphia's federal courthouse in 2008, the last thing she expected was a broken ankle and other injuries. As she was waved through the guard booth, she stopped at the gate and used her key card to gain access to the entry ramp. When the traffic signal turned green and the gate's arm rose, she watched as the security barrier lowered, and she proceeded over it, intending to drive down the ramp into the garage. However, the 18-inch-high hydraulic barricade "suddenly and violently popped up," striking the front end of her car and causing the airbag to deploy. As a result, she sustained a fractured right ankle, a bruised knee, wrists and arms, lacerations to her lip and hip and back pain, according to the lawsuit she and her husband recently filed in federal district court. The lawsuit claims she incurred medical expenses related to medical care, treatment and rehabilitation due to the defendants' actions and inactions. Named as defendants in the lawsuit are the manufacturer of the barrier, who the judge claims knew the barricade was defective and unsafe and "failed to operate properly" before her accident. Before her accident, an Alabama couple sued the same company when a 1,700-pound steel barrier malfunctioned, crushing his right leg and permanently disabling him. The couple is seeking more than $75,000 in damages and other costs.
To Protect Babies, Keep Car Seats in Car To prevent injuries in babies, car seats should stay in the car - which is the new message of a new study, which shows that almost 9,000 infants go to the emergency room every year for car seat-related injuries that happen outside the car. If the seat does have to come out of the car, parents should make sure their babies are always strapped in. Researchers reviewed five years worth of data from a national U.S. surveillance system to find records of babies less than one-year-old that were taken to the ER for car seat injuries. From 2003 to 2007, almost 2,000 babies in the sample - about 43,500 in the entire U.S. - were brought to the ER for a car seat injury. Most of those injuries happened when babies fell out of their car seat or were in the seat when it fell off a table, counter or shopping cart. Head or neck injuries were most common, especially in the youngest babies, who were also more likely to go to the ER. About half of the injuries happened at home. There were only a few car seat-related deaths recorded in the sample, so they weren't able to calculate a national estimate. Part of the reason these injuries are so common is that parents may assume that babies won't be moving around because they haven't developed good coordination yet. Parents commonly leave the baby in a car seat without strapping it in, or set the seat somewhere that puts the child at eye level.
Bison Meat Recalled Over E. Coli Scare A Colorado company has issued a recall of ground bison meat and tenderized bison steaks possibly contaminated with a bacteria that causes food poisoning, the U.S. Agriculture Department said. Rocky Mountain Natural Meats' recall over 66,000 pounds of different ground meat and steak products produced earlier this year with "sell or freeze by" dates in June. The company's ground bison meat has been linked to five cases of E. coli illness in Colorado. The products were sold in retail stores across the United States and food service distributors in Utah and Arizona. One of the steak products went to restaurants. The products were carried in Hannaford, King Soopers, Market Basket, Price Chopper and Whole Foods stores. Symptoms of E. coli include bloody diarrhea, dehydration and severe cramping. In severe cases, the infection can cause kidney failure.
Getting a New Knee or Hip? Do It Right the First Time In the United States in 2007, surgeons performed about 806,000 hip and knee implants - double the number performed a decade earlier. Though these procedures have become routine, they are not fail-safe. Implants must sometimes be replaced, and a study in 2007 found that 7 percent of hips implanted in Medicare patients had to be replaced within seven and a half years. The percentage may sound low, but the finding suggests that thousands of hip patients eventually require a second operation, forcing those patients to endure additional painful recoveries and increased medical expenses. The failure rate should be lower, and experts cite Sweden's failure rate to be a third of that in the United States. While considering replacing a deteriorating knee or hip, choose or request a referral to an experienced surgeon at a busy hospital. Also seek out an experienced physician, as a 2004 study found that patients receiving knee replacements from doctors who performed more than 50 procedures a year had fewer complications than patients whose surgeons did 12 procedures or fewer a year.
More Kid Jewelry Recalled for Toxic Cadmium Federal regulators have found high levels of the toxic metal cadmium in trinkets that were distributed for free to children at some doctor and dentist offices over the past five years. The news came as the Consumer Product Safety Commission announced a recall of nearly 70,000 charm bracelets and rings - the fourth time this year that the federal government has said cheap Chinese-made jewelry was being pulled from shelves because of cadmium, a known carcinogen. What stood out about this recall was that kids got the items in places where they are taken to stay healthy or get better. Cadmium is a naturally occurring metal that, if ingested, can weaken bones and kidneys. The concerns from federal regulators is that kids could be exposed if they bite and suck on - and in rare cases, even swallow - jewelry containing cadmium. The commission said parents should immediately throw away the approximately 66,200 "Children's Happy Charm Bracelets" bracelets and 2,200 rings that have a metal football-shaped charm attached to an adjustable band. The charm bracelets have colored beads and a single metal charm shaped like a butterfly, moon or sun. The items were distributed at doctor and dentist offices nationwide between June 2005 and March 2010.
Oregon Supreme Court Tosses Out $100 Million in Punitives Against Philip Morris The Oregon Supreme Court has ruled that Philip Morris does not have to pay $100 million in punitive damages to the family of a smoker who sued the tobacco giant over its low-tar cigarettes. The case, however, will go to another jury to decide how much the woman's death from lung cancer will cost Philip Morris. The family was originally awarded $150 million in 2002 before the judge reduced it to $100 million. The Oregon Supreme Court vacated the $100 million award and sent the case back to the trial court to reconsider the punitive damages after ruling the judge failed to properly instruct the jury. According to the ruling, the judge should have told the jury it could not punish Philip Morris directly for harm caused to others besides the smoker.
Airline Food Preparation Unsafe, FDA Finds Airline food may be dangerous for your health, according to inspection reports from the Food and Drug Administration. FDA inspectors found the kitchens of three major airline caterers were unsanitary and could cause illness for passengers. The kitchens, which supply U.S. and foreign airlines at U.S. airports with over 100 million meals every year, serve many of the major airlines, including Delta, American, US Airways and Continental. The report found that some kitchens had cockroaches, flies and mice. Many had employees with poor hygiene who used unclean equipment and stored food at improper temperatures.
States Ease Food Safety Rules for Homemade Goods Food-safety laws are designed to keep the public safe, but some lawmakers in Wisconsin and a few other states say it's not reasonable to make people selling a few jars of jam at a farmer's market follow the same rules as big food companies. Wisconsin lawmakers enacted the so-called Pickle Bill earlier this year to allow small vendors to sell high-acid canned foods, such as pickles and salsas, without a license. Health officials, however, say they worry people could get sick from foods made in kitchens that aren't inspected.
Antibiotics in Animals Need Limits, FDA Says Federal food regulators took a tentative step toward banning a common use of penicillin and tetracycline in the water and feed given cattle, chickens and pigs in hopes of slowing the growing scourge of killer bacteria. However, the Food and Drug Administration has tried without success for more than three decades to ban such uses. In the past, Congress has stepped in at the urging of agricultural interests and stopped the agency from acting. The FDA has released a policy document stating that agricultural uses of antibiotics should be limited to assuring animal health, and that veterinarians should be involved in the drugs' uses. While doing nothing to change the present oversight of antibiotics, the document is the first signal in years that the agency intends to rejoin the battle to crack down on agricultural uses of antibiotics that many infectious disease experts oppose.
Kellogg Recalls Cereal for Odor and Flavor The Kellogg Company is voluntarily recalling about 28 million boxes of Apple Jacks, Corn Pops, Froot Loops and Honey Smacks cereals because an unusual smell and flavor from the packages' liners could make people ill. Kellogg said about 20 people have complained about the cereals, including five who reported nausea and vomiting. The lining of the cereals' boxes seem to have produced the waxy smell and flavor, and the company is trying to identify the substance on the liner.
More Than 2 Million Cribs Recalled More than two million cribs from seven companies have been recalled amid concerns that babies can suffocate, become trapped or fall from the cribs. Most of the cribs were drop-sides, which have a side rail that moves up and down so parents can lift children from them more easily. That movable side, however, can malfunction or detach from the crib, creating a dangerous gap where babies' heads can become trapped, leading to suffocation or strangulation. The companies involved in the recall were Evenflo, Delta Enterprises Corp., Child Craft, Jardine Enterprises, LaJobi, Million Dollar Baby and Simmons Juvenile Products Inc. No deaths were associated with the cribs, but there were reports of at least 16 entrapments of infants. In one case, a child was found unconscious and later hospitalized.
Shellfish Poisoning Kills Two in One Week A second person from Alaska has died from a suspected case of paralytic shellfish poisoning in less than a week. The man was flown to the hospital where he was diagnosed with paralytic shellfish poisoning after developing symptoms, including tingling of the lips, numbness in his body, weakness and poor condition. If tests confirm his death is the result of eating a crab, his will be the second death from paralytic shellfish poisoning in less than a week after a woman died from eating clams. There have been five reported cases of suspected paralytic shellfish poisoning in the past two weeks. Three people were sickened earlier this month after eating claims. The higher number of suspected cases could be due to several very low tides that brought out recreational and subsistence clammers and crabbers.
Woman Sues Subway Over Sickening Sandwich A suburban Chicago woman who claims she went to the emergency room after eating a Subway sandwich is suing the restaurant chain following a salmonella outbreak that sickened nearly 100 of its customers across Illinois. The lawsuit accuses Subway of failing to prevent the outbreak, which the Illinois Department of Public Health is investigating. Currently, results show that 97 people became ill after eating at Subway restaurants in 28 counties. The suit says she became ill after eating the sandwich earlier this year and does not specify a dollar amount in damages.
Group May Sue Over Happy Meal Toys A Washington-based consumer advocacy group threatened to file a lawsuit against McDonald's, charging that the fast food chain "unfairly and deceptively" markets toys to children through its Happy Meals. The group, which has filed dozens of lawsuits against food companies in recent years, is hoping the publicity and the threat of a lawsuit will force McDonald's to negotiate with them on the issue. The group announced the lawsuit in a letter to McDonald's 30 days before filing it with the hope that the company will agree to stop selling the toys before a suit is filed. The group believes the toys in Happy Meals violate state consumer protection laws in Massachusetts, Texas, New Jersey and California. The group is hoping its first lawsuit against the mega-chain will have a similar effect as its 2006 lawsuit against Kellogg that prompted the company to agree to a settlement raising the nutritional value of cereals and snacks it markets to children.
FDA Slow to Rule On Tobacco Regulation A year after a new law put tobacco regulation in the hands of the Food and Drug Administration, one thing is clear: It will likely be years before any of the most aggressive steps to reduce deaths from smoking might happen. When President Obama signed the bill into law, anti-tobacco advocates suggested it could lead to a reduction in nicotine levels, a ban on menthol cigarettes and other aggressive moves. However, such moves are still a long way down the road as the FDA takes its time assessing the scientific evidence for what would best improve public health. That leaves the industry and effects on both companies and consumers under a cloud of smoke. But for public health experts, one thing is clear - more needs to be done to snuff out the death and disease caused by cigarettes and other tobacco products, and stop people from using them in the first place.
Florida Jury Finds Domestic Distributor of Chinese Drywall Negligent A Florida jury has awarded $2.46 million to a Miami couple who claimed their house was ruined by gas emitted by imported Chinese drywall in the nation's first trial against a domestic distributor. Jurors concluded that a Miami-based supplier knowingly sold defective wallboard that was installed in the couple's home. The couple asked for $4.4 million in damages for repairs and the inconvenience of temporarily losing access to their $1.66 million home. The jurors found that the company was negligent, knowingly sold defective wallboard, violated Florida's deceptive and unfair trade law, and reduced the home's resale value. The couple's lawsuit is similar to thousands filed nationwide by homeowners with Chinese drywall installed in their homes. Homeowners complain noxious gases released by the wallboard leave homes smelling like rotten eggs and corrode metal pipes and electronics. The case was strengthened by accusations of a cover-up. The company signed a secret deal in 2007 with a Chinese drywall manufacturer. The Chinese company agreed to replace the supplier's tainted supply with U.S.-made board as long as the supplier kept quiet about problems.
FDA Urges Consumers to Avoid Coffee Aphrodisiac The Food and Drug Administration has urged consumers to stop using an instant coffee product that is being marketed as a sexual aphrodisiac, saying it could dangerously lower blood pressure. In a statement, the FDA said Magic Power Coffee contains a chemical that could interact with some prescription drugs to significantly lower blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness. Because it is an instant coffee labeled as "all natural dietary supplement," consumers may assume it is harmless and poses no health risk - when in fact, Magic Power Coffee can cause serious harm. Magic Power Coffee is sold on Internet sites by several independent distributors.
Campbell Soup Recalls 15 Million Pounds of SpaghettiOs Campbell Soup is recalling 15 million pounds of SpaghettiOs with meatballs after a cooker malfunctioned at one of the company's plants in Texas and left the meat undercooked. The Agriculture Department announced the recall, which involves lots manufactured since 2008. Recalled are certain lots of three varieties of the pasta product often consumed by children: SpaghettiOs with Meatballs, SpaghettiOs A to Z with Meatballs, and SpaghettiOs Fun Shapes with Meatballs. The USDA said there have been no reports of illness or customer complaints associated with the product.
Surgeon vs. Knee Maker: Who's Rejecting Whom? Amid the booming use of artificial joints in the United States, experts say a troubling situation is taking root for patients and doctors: When disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices. While producers of implanted heart devices have a voluntary system in which outside panels investigate problems, American makers of orthopedic devices do not. Many artificial joints are cleared under law by the Food and Drug Administration for sale without testing in patients. In addition, no one in the country tracks the long-term performance of artificial hips and knees, a $6.7 billion annual business that surged as baby boomers reached middle age.
FDA Seeks Explanation of Marlboro Marketing When the FDA says "no light" cigarettes, it evidently means it. Days before a new federal ban on making tobacco products using the words "light" or other terms that might imply a safer smoke, federal regulators sent a stern letter to the Altria Group, maker of the cigarettes known as Marlboro Lights. The Food and Drug Administration asked Altria about notes that have been placed on the last packs of Marlboro Lights reading, "Your Marlboro Lights package is changing, but your cigarette stays the same." The notes also say, "In the future, ask for Marlboro in the gold pack." The FDA's letter to said the inserts "may perpetuate the mistaken beliefs associated with your 'light' cigarettes when marketed as Marlboro in the gold pack."
Already Under Scrutiny, Johnson & Johnson Recalls Additional Over-the-Counter Drugs The Johnson & Johnson unit whose recall of liquid children's Tylenol and other pediatric medicines is under Congressional investigation announced that it was recalling additional over-the-counter drugs. McNeil Consumer Healthcare is recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. The company said in a statement that "the products were inadvertently omitted" from an earlier recall - one preceding the children's drug recall - involving medicines made at a company plant in Puerto Rico. Since last year, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the plant in Puerto Rico. The company began the recall after receiving consumer complaints about a moldy odor emanating from some products.
Recall Tied to Moldy-Smelling Tylenol Products Johnson & Johnson is expanding a months-old recall of certain over-the-counter medicines due to complaints about a moldy smell that can cause nausea and sickness. This is the third major recall in eight months, leading to congressional investigations and citations by the Food and Drug Administration. The company is expanding a recall to four lots of Benadryl Allergy Ultratablets and one lot of Extra Strength Tylenol. The odor associated with the products came from a chemical used to treat wooden pallets that transport and store medication packaging materials. Three More E. Coli Cases Linked to Raw Milk in Minnesota Minnesota health officials say the number of E. coli cases linked to raw milk or other dairy products from a farm has grown to eight. The Minnesota Department of Health announced three additional cases have been identified. Two of those cases are school-aged children who consumed milk from a dairy farm. The Health Department says both cases had E. coli with the same DNA fingerprint as five earlier cases associated with dairy products from the farm. The other new case was an infant living in the same household as one of the five earlier cases, but a stool sample was not available for genetic fingerprinting.
More Disputes Over Handling of Drug Recall The feud between Johnson & Johnson and congressional investigators over the company's recent recalls of over-the-counter medicines deepened as they disputed the meaning of company documents turned over to a House committee. The new material sheds light on an incident in 2009 in which McNeil Consumer Healthcare, a unit of Johnson & Johnson, hired private companies to buy certain defective Motrin products from stores. McNeil has said it did nothing wrong in removing the Motrin and that the medicine posed no safety risk. But investigators consider the documents significant because they deepen concerns about whether McNeil, responsible for the recent recall of an estimated 136 million bottles of pediatric medicines, was aboveboard in its handling of various quality-control problems. The chairman of the committee conducting the investigation has suggested that the documents raise the prospect that McNeil conducted a surreptitious Motrin recall in 2009 without the full knowledge of the Food and Drug Administration and has repeatedly referred to it as a "phantom recall."
FDA Faults Companies On Unapproved Genetic Tests The Food and Drug Administration is cracking down on companies that sell genetic tests directly to consumers. The FDA sent letters to five companies involved in that business, saying their tests are medical devices that must receive regulatory approval before they can be marketed. The letters say the companies must apply for approval or discuss with the agency why certain test claims do not require such approval. However, the letters stopped short of saying the tests must be taken off the market until they are approved. The FDA said it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval.
Ikea Recalls 3.4 Million Window Shades Ikea is recalling 3.4 million window blinds and shades after a child nearly strangled on a cord. The recall covers three styles of shades: Roman shades and roll-up blinds sold at Ikea stores nationwide over more than 11 years, from January 1998 to June 2009, and roller blinds from that time period that don't have a tension device attached to the bead chain. The Consumer Product Safety Commission announced the recall after receiving a new report of a one-and-a-half-year-old boy who nearly strangled earlier this year. Ikea has previously recalled hundreds of thousands of other Roman shades and roller blinds in the past two years after a one-year-old girl died and a two-year-old boy had a close call. The recalled blinds are dangerous for young children because their necks can become entangled in the cords.
New Device May Underestimate Blood Pressure Automated blood pressure measuring devices are replacing old-fashioned mercury manometers in doctor's offices and clinics around the world. But a new head-to-head comparison of the two techniques suggests that the newer version isn't necessarily better - and could even be missing some people with high blood pressure who are in need of blood pressure-lowering treatment. Readings were about two points lower with the automated device compared to the mercury-based technique. What's more, discrepancies were larger in people 65 and older. While two points may not seem like much, there's strong evidence that even a 2-point reduction in blood pressure can reduce the risk of heart attack and stroke. The differences were larger for a significant number of patients - and huge for a few of them. For example, seven percent of patients showed a discrepancy of 10 to 15 mm Hg and four percent had a 15 to 20 mm Hg difference; 2 percent had discrepancies of 20 mm Hg or higher. And while about 10 percent of patients younger than 65 showed a discrepancy in blood pressure readings between the two techniques, nearly 30 percent of those 65 and older did.
Drug Maker Seen as Uncooperative On Inquiry A Congressional investigation into a recent recall of children's Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, investigators say, raising the prospect that new measures - like issuing of subpoenas to compel cooperation - could be invoked. The unit of Johnson & Johnson that makes the over-the-counter drugs is already under scrutiny by the Food and Drug Administration for a pattern of violations in manufacturing and quality control practices that have led to a number of recent recalls. The agency said recently that it was considering criminal penalties or other actions against the unit. Now a New York Democrat claims Johnson & Johnson had used delaying tactics in its dealings with the House Committee on Oversight and Government Reform and in some instances had provided misinformation - accusations the company denies. Such conduct has cast Johnson & Johnson in an unusually negative light and might compel the committee to take more aggressive action as it looks into drug quality and safety issues raised by the recall.
Opposing Counsel in Chinese Drywall Trial Spar Over Alleged 'Deal' to Hide Defects Jurors heard opening statements in the nation's first trial involving a domestic distributor of defective Chinese drywall as a Miami couple claimed the supplier covered up problems while making a deal with the manufacturer to replace unsold sheets. The case pits the couple against Banner Supply, a Miami company that provided the Chinese drywall used to build their home in 2007. They blame the company for selling builders drywall that released sulfide gases that damaged their home. About 550 million pounds of Chinese drywall used to finish nearly 60,000 homes was imported from 2004 to 2007. Homeowners are seeking damages from companies along the supply chain for manufacturing or supplying drywall that smells like rotten eggs and eats away at metal inside homes. Speaking to the jury for the first time, one of Banner's attorneys said the company takes responsibility for the damage to the couple's home and is willing to pay for repairs. However, the attorney countered claims that the company attempted to cover up produce defects. The couple alleges a confidential agreement between the manufacturer and Banner - which was kept secret until it was unsealed by a judge - is proof of the corporate attempt to hide drywall problems. According to documents, Banner agreed to get rid of its Chinese drywall inventory and promised to keep silent about any odor or health problems.
Most Cans of Food Contain Controversial BPA BPA, or bisphenol A, seems to be ubiquitous, with just about every food item packaged in a can containing the chemical. The exposure to BPA from canned food is far more extensive than from plastic bottles, and it's particularly concerning when it's lining infant formula cans. BPA is the key compound in epoxy resin linings that keep food fresher longer and prevents it from interacting with metal and altering the taste. It has been linked in some studies of rats and mice to not only cancer but also obesity, diabetes and heart disease. Trade groups for chemicals and can manufacturers say they stand behind the chemical, and point to some studies from governmental health agencies that deem BPA safe and effective for food contact. But the Food and Drug Administration for the first time expressed "some concern" about BPA last year. Propelled in part by recent independent scientific studies and also bowing to mounting concern from the public and consumer groups, the agency announced that it would tap $30 million in federal stimulus funds to study the chemical's potential effects on the human body.
Safety Features Planned for Radiation Machines Manufacturers of radiation therapy equipment said at a patient-safety conference that within the next two years their new equipment and the software that runs it would include fail-safe features to help reduce harmful radiation overdoses and other mistakes. Two associations representing the biggest manufacturers of radiotherapy equipment said their equipment - including linear accelerators, which generate high-powered beams of radiation - will shut down if it does not detect that the treatment plan had been checked, that beam modifying devices were correctly placed and that the patient was properly positioned. Most machines are currently configured so that quality-assurance checks are at the discretion of the user.
Homeowner Frustration Over Chinese Drywall Shift to Suppliers Jury selection has begun in a case pitting a Miami couple against Banner Supply, which imported Chinese drywall for their home in 2006. The couple blame the importer for drywall that allegedly released odorous sulfied gases and damaged their home. The couple received a fraction of the estimated 550 million pounds of Chinese drywall that was imported from 2004 to 2007 - enough to finish nearly 60,000 homes. Some cases over the drywall ended up in federal court and others in state courts with defendants ranging from Chinese manufacturers to foreign and domestic distributors and home builders. All federal cases have been consolidated in multidistrict litigation in New Orleans. In the Miami case, the couple blames Banner Supply for not informing them about the problems with Chinese drywall, which they say released sulfide gases that ate away at metal wiring, damaged electronics and left a rotten smell that remains today. Banner Supply blames the German-Chinese company that supplied the drywall and is accusing several corporations they trusted of failing to sell a safe product.
FDA Changes Driven by Food Outbreaks Small mistakes are often difficult to identify as the sources of food-borne illnesses, a situation that has frustrated health authorities for years. The Food and Drug Administration and other agencies gather information about a contamination outbreak after people have already been sickened, and their investigations into what went wrong come well after the crucial evidence is gone. Few rules are on the books that require preventive steps to make many foods - produce in particular - safer. The FDA now hopes to change that through sweeping rules designed to more closely track how growers, packers, shippers, distributors and retailers handle the produce Americans eat as it courses from the farm to consumers' tables.
FDA Struggles to Keep Food Safe A new report says the Food and Drug Administration is stretched thin and needs to reorganize to better keep the nation's food safe. The report released by the Institute of Medicine and the National Research Council says the agency needs to become more efficient and better target its limited dollars to prevent foodborne illness outbreaks. The 500-page report says the FDA lacks the vision necessary to protect consumers. Researchers say the FDA is too often reactive and not focused enough on prevention. The report recommends the agency focus on preventing outbreaks in the riskiest foods rather than tackling problems on a case-by-case basis.
McDonald's Pulls Shrek Glasses for Cadmium Toxic cadmium has been discovered in the painted design on Shrek-themed drinking glasses being sold nationwide at McDonald's, forcing the fast food company to recall 13.4 million of the collectibles in the U.S. and Canada. The U.S. Consumer Product Safety Commission warned customers to immediately stop using the glasses, and McDonald's said it will post instructions on its Web site regarding refunds. The potential danger to children would be long-term exposure to low levels of cadmium, which could leach from the paint onto a child's hand, then enter the body if the child puts that unwashed hand to his or her mouth.
Infant Death Prompts Baby Sling Recall The death of a 10-day-old boy in Texas has prompted the recall of some handmade baby slings. The Consumer Product Safety Commission urged parents to immediately stop using the infant slings from Sprout Stuff, saying the slings pose a suffocation risk. About 40 Sprout Stuff infant ring slings were sold directly to consumers between 2006 and 2007. Consumers had been previously warned of a suffocation risk for babies in slings, which wrap around parents' chests so they can carry their babies or just "wear" them to stay close. The agency has investigated at least 13 deaths associated with sling-style infant carriers over the last 20 years.
Kellogg to Restrict Ads to Settle Inquiry into Health Claims for Cereal The Kellogg Company has agreed to advertising restrictions to resolve an investigation into its claims about the health benefits of its Rice Krispies cereal, the Federal Trade Commission has announced. The agreement expands on a settlement order that Kellogg agreed to last year over similar claims that another cereal, Frosted Mini-Wheats, was "clinically shown to improve kids' attentiveness by nearly 20 percent." The commission acted against Kellogg as public health researchers and obesity opponents have intensified their challenges to the marketing of sugary foods.
Smoker's $8 Million Award Could Open Door to More Suits A woman who was in her early teens in the 1970s when she began smoking Salem cigarettes has since smoked every day after becoming hooked on nicotine. In 1996, at age 36, she developed larynx cancer, and the following year, she underwent a total laryngectomy. That was followed by radiation and chemotherapy treatments. She can no longer breathe through her mouth or nose, and she instead uses a tube in her throat. Her diet consists of soft foods like pudding and mashed potatoes. Recently, she also became a footnote in legal history when a federal jury in Connecticut awarded her $8 million in what is believed to be the first successful product liability lawsuit in Connecticut by an individual plaintiff against a tobacco company. The total could leap to as much as $24 million if the judge decides to award punitive damages in a subsequent hearing.
Burn Victim's Suit Goes Forward Against Bacardi Over Bartender's Pyrotechnics A woman who claims she was severely burned when a bottle of Bacardi 151 rum caught fire during a restaurant bartender's pyrotechnic display has won her attempt to proceed with a personal injury and products liability action against Bacardi and the restaurant. She alleges Bacardi knew or should have foreseen that its high-proof rum was being widely used for a variety of dangerous, flammable displays. She accused the company of employing a poorly designed flame arrester on top of its bottle that could be easily removed by bartenders. In denying Bacardi's motion to dismiss, a Manhattan Supreme Court justice held that whether consumers would find acceptable a lower-proof rum that was less incendiary and whether the Bacardi 151 bottle had been defectively designed were factual issues.
Four PediaCare Children's Medicines Recalled More children's products associated with the recent children's Tylenol recalls have been added to the list. Blacksmith Brands, Inc. and the Food and Drug Administration issued a voluntary recall of four types of PediaCare over-the-counter children's medicines because they were produced at the McNeil Consumer Healthcare plant, which is where the recently recalled children's Tylenol products were manufactured. That plant has been temporarily shut down because it failed to meet FDA manufacturing standards.
More Cancer-Causing Agents in U.S. Cigarettes Americans inhale more cancer-causing agents with their cigarettes, probably because of the tobacco blend, while smokers in Canada, Britain and Australia get less, researchers have reported. Their unique study also demonstrated that the amounts of these carcinogens in a smoker's cigarette butts directly correlated with tell-tale compounds in the smoker's urine.
Indoor Tanning Linked to Skin Cancer Indoor tanning almost doubles the risk of dangerous melanoma skin cancer, and the more hours spent tanning, the greater the risk, according to a new study. Those who used indoor tanning devices were 1.74 times as likely to develop melanoma as those who did not. Frequent users - who had more than 100 sessions or 50 hours of indoor tanning over 10 years - were at 2.5 times the risk of non-users. Last year, the International Agency for Research on Cancer, part of the World Health Organization, classified tanning beds as carcinogenic to humans, and the United States Food and Drug Administration is considering revising requirements for tanning beds and strengthening warning labels about the risks.
Johnson & Johnson Shakes Up Local Plant Johnson & Johnson has removed at least two top managers at its McNeil Consumer Healthcare plant in Fort Washington since its massive recall of all infant and children's formulations of Tylenol, Benadryl, Motrin and Zyrtec, a top executive told a congressional oversight panel. The Montgomery County plan will remain closed until later this summer when Johnson & Johnson expects to submit a master plan to the Food and Drug Administration for fixing manufacturing and quality controls that led to the recall. Johnson & Johnson has also replaced "a number of key quality and manufacturing individuals" in charge of the plant outside Philadelphia and three other McNeil facilities, which manufacture some of the world's best-known brands of over-the-counter medications.
FDA Weighs Penalties in Drug Recall The Johnson & Johnson unit that recalled millions of bottles of liquid children's Tylenol and other pediatric medicines recently may face criminal penalties, product seizures or other sanctions, the Food and Drug Administration announced. The agency is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson subsidiary, after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls. McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadry and Zyrtec because they may have contained too much of the active ingredient of the drug, metal specks of inactive ingredients that failed testing requirements, the agency said. But McNeil's problems go beyond those related to the recall, including other forms of contamination dating back two years.
Tylenol Plan Under Scrutiny Over Recall A Pennsylvania drug plant plagued by quality-control problems that prompted a nationwide recall of children's Tylenol and dozens of other widely used over-the-counter medicines apparently shrank its work force sharply in recent years, according to local government tax records. Also, a Food and Drug Administration inspection report this year cited failure to properly train contract and temporary employees as part of a lengthy catalogue of quality-control issues at the plant. The performance of Johnson & Johnson and its subsidiary will soon be examined at a congressional hearing into what may rank as the biggest recall of pediatric medicines in U.S. history.
Report: Tobacco Firms Target Women With half of all men in some developing countries already hooked on cigarettes, the tobacco industry is now courting lucrative new customers - young women. About 80 percent of the world's estimated 1 billion smokers are men, but more women are picking up the habit in some countries as flavored products and glossy feminine packaging to cater to them. Nationwide surveys in Bangladesh, Thailand and Uruguay found that females aged 15 to 24 were more aware of tobacco marketing than older women, suggesting that advertising is directed at them. The data were the first batch to be analyzed from the Global Adult Tobacco Survey, a large sampling of 14 developing countries that hopes to provide a clearer picture of how tobacco is used and promoted.
Judge: Lead Companies Must Cover Own Defense Costs Three companies that sold lead-based paint and were sued by the state in a landmark case cannot recover money they spent defending themselves in the lawsuit, a Rhode Island judge has ruled. In 2006, Rhode Island won a jury verdict that could have forced the three companies, including Sherwin-Williams, to spend billions of dollars removing lead paint from homes and buildings in the state. However, the state Supreme Court threw out the verdict in 2008, and the companies asked for the state to reimburse them for legal expenses. A Superior Court judge denied that request, saying the lawsuit was brought in good faith and focused public attention on problems associated with lead-based paint, which can cause reduced intelligence and even brain damage in children who ingest flakes or dust from it and was banned for U.S. residential use in 1978. The judge said ordering the companies to be reimbursed could deter the state from bringing public health lawsuit in the future.
More Kids' Tylenol Problems Reported Federal health regulators are investigating hundreds of consumer complaints involving cold medicines recalled by Johnson & Johnson last month, according to a congressional memo. The Food and Drug Administration has not directly linked any of the reports to flaws with the company's products. Executives from Johnson & Johnson and FDA officials will testify on the massive recall of 40 varieties of children's cold medicines. Those include infant Tylenol, Benadryl and Motrin. The FDA prodded the company to recall the products after finding quality control problems at a plant in Pennsylvania.
Questions for Makers On Defects in Drugs For consumers who turned to drugstore brands after the recall last month of liquid children's Tylenol and other medicines made by a unit of Johnson & Johnson, there is yet more unsettling news. The recall included more than 40 varieties of liquid pediatric Tylenol, Motrin, Bendaryl and Zyrtec that may have contained metal particles, too much of the active drug ingredient or inactive ingredients that did not meet testing requirements. At the time, the FDA recommended that consumers look for generic alternatives to these brand-name over-the-counter frugs. But now, Perrigo, a company that supplies drugstore equivalents of those children's medicines to pharmacy giants like CVS and Walgreens, has received a warning letter from the FDA about significant manufacturing violations of its own - including ibuprofen tablets contaminated with metal shavings. Although the problems cited did not mention children's products, the deficiencies at both Johnson & Johnson and Perrigo raise questions about why some manufacturing plants have shipped defective medicines.
In E. Coli Fight, Some Strains Largely Ignored For nearly two decades, the worst enemy of the food industry and government regulators was a virulent strain of E. Coli bacteria that has killed hundreds of people, sickened thousands and prompted the recall of millions of pounds of hamburger, spinach and other foods. But as everyone focused on controlling that particular bacterium, known as E. coli O157:H7, the six rarer strains of toxic E. coli were largely ignored. Collectively, those other strains are now emerging as a serious threat to food safety. Earlier this year, romaine lettuce tainted with one of them sickened at least 26 people in five states, including three teenagers who suffered kidney failure. Although the federal government and the beef and produce industries have known about the risk posed by these other dangerous bacteria for years, regulators have taken few concrete steps to directly address it or even measure the scope of the problem.
Study Finds Supplements Contain Contaminants Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found. The levels of heavy metals - including mercury, cadmium and arsenic - did not exceed thresholds considered dangerous, the investigators found. However, 16 of the 40 supplements tested contained pesticide residues that appears to exceed legal limits, the investigators found. In some cases, the government has not set allowable levels of these pesticides because of a paucity of scientific research. Investigators found at least nine products that made apparently illegal health claims, including a product containing ginkgo biloba that was labeled as a treatment for Alzheimer's disease and a product containing ginseng labeled as a treatment to prevent diabetes and cancer. They also described a salesperson at a supplement specialty store who claimed that a garlic supplement could be taken instead of blood pressure medication.
Veterans Affairs Compromised by Medical Devices At a recent congressional hearing, the assistant secretary for information and technology at the Department of Veterans Affairs said that during the past 14 months, more than 122 medical devices have been compromised by malware and identified protecting its medical devices from cyber threats a "critical challenge." "The major challenge with securing medical devices is that, because their operation must be certified, the application of operating system patches and malware protection updates is tightly restricted," he said. "This inherent vulnerability can increase the potential for cyber attacks on the VA's trusted network by creating risk to patient safety." The VA defines a medical device as any device used in patient healthcare for diagnoses, treatment or monitoring, or that has gone through the Food and Drug Administration's premarket review process. The VA is the federal government's largest medical care provider and has more than 50,000 networked medical devices. "These infections have the potential to greatly affect the world-class patient care that is expected by our customers. In addition to compromising data and the system, these incidents are also extremely costly to the VA in terms of time and money spent cleansing infected medical devices," he continued.
Insult to Injury: More Kids Hurt by Own Crutches Injuries to young people related to the use of crutches, wheelchairs and walkers are on the rise - up an estimated 8 percent annually between 1991 and 2008, research shows. According to Ohio researchers, the use of these "mobility aids," while intended to help people get around, sent more than 3,000 people aged 19 or younger to the emergency room in 2008 alone. The annual number of injury cases increased 23 percent from 2,500 in 1991 to over 3,000 injuries in 2008, which many claim is an underestimate of the actual number of injuries. Even though crutches are the number one mobility aid used by children and adolescents, 67 percent of the injuries involved wheelchairs, followed by crutches at 25 percent and walkers at 8 percent.
Battery Ingestion a Rising Risk for Kids The rate of severe poisonings from battery ingestion among U.S. children has risen in the past 25 years, along with the growing use of lithium "button" batteries in a wide range of consumer products, new research shows. The number of children who die or suffer serious injuries each year remains quite small, but such severe cases are accounting for a growing proportion of all button-battery poisonings. The findings underscore the importance of keeping the small, disc-shaped batteries out of children's reach. Between 1985 and 2009, U.S. poison-control centers received 59,535 reports of button-battery ingestion. The yearly incidence rates fluctuated, with no pattern of an increase over time. However, the rate of severe poisonings clearly rose.
Labels Urged for Food that Can Choke The American Academy of Pediatrics, the nation's leading pediatricians' group, wants food to be subject to as much scrutiny as toys and is calling on the Food and Drug Administration to require warning labels on foods that are known choking hazards and to evaluate and monitor food for safety. The pediatricians' group began studying the issue nine years ago when 17 children around the world, including several in the United States, choked to death on a gelatinous candy that had to be sucked out of a plastic cup the size of a coffee creamer. The FDA eventually banned its sale. While there are no recent nationwide figures on food choking, about 17,500 children 14 and younger were treated in emergency departments for choking in 2001, and 60 percent of the episodes were caused by food. In 2000, 160 children died from an obstruction of the respiratory tract.
Senator Moves to Ban Drop-Side Cribs At least 32 infants and toddlers since 2000 suffocated or were strangled in a drop-side crib, which has a side that moves up and down to allow parents to lift children from the cribs more easily than cribs with fixed sides. Drop-sides, around for decades and probably slept in by many of today's parents, are suspected in an additional 14 infant fatalities during that time. The Consumer Product Safety Commission, which regulates cribs, has warned about the problem. Its chairman has pledged to ban the manufacture and sale of cribs by the end of the year with a new performance standard that would make fixed-side cribs mandatory. The industry has already started phasing out drop-sides and big retailers such as Babies 'R Us and Wal-Mart have taken them off sale floors. Yet there is still plenty for sale on the Internet, and that's part of the reason Congress is getting involved.
Agent Orange's Catastrophic Legacy Still Lingers Thirty-five years after the end of the Vietnam War, its most contentious remaining legacy is Agent Orange. Eighty-two percent of Vietnamese surveyed in a recent poll said the United States should be doing more to help people suffering from illnesses associated with the herbicide, including children born with birth defects. After President Bush pledged to work on the issue during a visit to Hanoi in 2006, Congress has approved $9 million mostly to address environmental cleanup of Agent Orange. But while the U.S. has provided assistance to Vietnamese with disabilities - regardless of their cause - it maintains that there is no clear link between Agent Orange and health problems. Vietnamese officials say the U.S. needs to make a much bigger financial commitment to adequately address the environmental and health problems unleashed by Agent Orange. Wal-Mart Pulls Toxic Trinkets Wal-Mart is pulling an entire line of Miley Cyrus-brand necklaces and bracelets from its shelves after tests found the jewelry contained high levels of the toxic metal cadmium. Wal-Mart will remove the jewelry, which was made exclusively for the retailer, while it investigates. Wal-Mart had learned of cadmium in the Miley Cyrus jewelry, as well as in an unrelated line of bracelet charms, earlier this year, but had continued selling the items. It said as recently as last month that it would be too difficult to test products already on its shelves. Exactly how many of the items have been sold in unclear.
Pesticides in Kids Linked to ADHD Exposure to pesticides used on common kid-friendly foods - including frozen blueberries, fresh strawberries and celery - appears to boost the chances that children will be diagnosed with attention deficit hyperactivity disorder, or ADHD, new research shows. Youngsters with high levels of pesticide residue in their urine, particularly from widely used types of insecticide such as malathion, were more likely to have ADHA, the behavior disorder that often disrupts school and social life, scientists in the United States and Canada found. Kids with higher-than-average levels of one pesticide marker were nearly twice as likely to be diagnosed with ADHA as children who showed no traces of the poison.
No Answer from Cell Phone Study The frustratingly inconclusive results from the world's biggest study so far into possible links between mobile phone use and cancer are symptomatic of problems that can dog scientific research like this. Campaigners, cancer doctors and mobile phone manufacturers have been waiting for a decade to see if the findings of the study led by the International Agency for Research into Cancer would finally provide an answer. However, it didn't, and experts say the biases and potential errors that rendered the study unreliable are difficult to avoid, yet very hard to adjust for.
Ground Beef in Schools This Fall Will be Safer Students will be eating safer beef in school cafeterias when they return to school in the fall. The Agriculture Department has announced that the government will require higher standards for ground beef purchased for schools starting in July. The standards will force producers to test the beef for contamination more often and will prohibit certain trimmings from being used. USDA, which oversees the school lunch program and coordinates food purchases with schools, will also prohibit the purchase of beef produced on the same day that E. coli O157 or salmonella is found through testing at a plant.
More Toxic Jewelry for Kids Recalled Federal regulators announced another recall of children's jewelry with high levels of the toxic metal cadmium, also saying they've expanded their investigation in an effort to keep dangerous items off store shelves in the first place. The U.S. Consumer Product Safety Commission announced that its inspectors at 10 of the nation's largest ports are now screening children's jewelry - typically imported from China - for cadmium. Word of increased scrutiny came as the agency announced the voluntary recall of about 19,000 "Best Friends" charm bracelet sets made in China and sold exclusively at the jewelry and accessories store Claire's, which has more than 3,000 stores in North America and Europe. While the CPSC does not release its results, independent testing revealed that the bracelets contained up to 91 percent cadmium by weight, and shed alarming amounts during a test that examined how much cadmium children might be exposed to if they accidentally swallow the charms.
Food Poisoning Suspected in Hospital Deaths A health officials says food poisoning perhaps from an ingredient in chicken salad could be what killed three Louisiana mental health hospital patients and sickened 40 others. Officials say patients showed signs of gastrointestinal stress. The three deaths happened a few hours after the symptoms developed.
USDA Tightens Salmonella Standards for Poultry The Department of Agriculture is setting new standards for the levels of salmonella and another pathogen in young chickens and turkeys as part of an effort to strengthen food safety. The new standards would hold poultry slaughterhouses more accountable by decreasing the number of samples allowed to test positive for the pathogens. The USDA said the new standards could help prevent an estimated 39,000 illnesses due to campylobacter and 26,000 illnesses due to salmonella.
Drop-Side Cribs Tied to 32 Child Deaths At least 32 young children have strangled or suffocated in the past nine years due to defects and other problems of drop-side cribs, the government said in another warning about these types of cribs. In the same time period, there were another 14 reported children's deaths in drop-side cribs, although safety officials have not conclusively determined if a drop-side problem caused these deaths, the Consumer Product Safety Commission said. The agency also said there have been hundreds of incidents caused by or related to drop-side detachments in cribs made by various manufacturers. The agency reiterated that drop-side cribs tend to be less structurally sound than cribs with four fixed-sides. The side that moves up and down - the drop side - can break, deform or detach, creating a dangerous gap between the crib mattress and dropped side.
FDA Investigates E. Coli at Arizona Lettuce Farm Federal investigators are looking at a farm in Arizona as a possible source of a widespread E. coli outbreak in romaine lettuce, according to the distributor. Freshway Foods said it recalled lettuce sold in 23 states and the District of Columbia because of a possible link to an E. coli outbreak that has sickened at least 19 people - three with life-threatening illness. College students at the University of Michigan, Ohio State and Daemen College are among those affected. Freshway Foods worked with the Food and Drug Administration to trace the contaminated lettuce to an Arizona grower. The recall only applies to romaine lettuce with a "best if used by" date before or on May 12. The recall also affects "grab and go" salads sold at Kroger, Giant Eagle, Ingles Markets and Marsh grocery stores. The lettuce was sold in Alabama, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia and Wisconsin.
U.S. Panel Criticized as Overstating Cancer Risks A dire government report on cancer risks from chemicals and other hazards in the environment has drawn criticism from the American Cancer Society, which says government experts are overstating their case. The government's report says the proportion of cancer cases caused by environmental exposures has been "grossly underestimated." It warns of "grievous harm" from chemicals and other hazards, and cites "a growing body of evidence linking environmental exposures to cancer." Children are especially vulnerable, the panel says, and it urges that government to strengthen research and regulation, and advises individuals on ways to limit exposure to potential threats like pesticides, industrial chemicals, medical X-rays, vehicle exhaust, plastic food containers and too much sun. Nearly 80,000 chemicals are in use in the United States, and yet only a few hundred have been tested for safety. The cancer society, however, argued that the report was "unbalanced by its implication that pollution is the major cause of cancer" and presented an unproven theory - that environmentally caused cases are grossly underestimated - as if it were a fact. The cancer society estimates that only 6 percent of all cancers in the United States are related to environmental causes.
Cancer Risk from Chemicals 'Underestimated' Americans are being "bombarded" with chemicals, gases and radiation that can cause cancer, and the federal government must do far more to protect them, presidential cancer advisers have announced. Although as many as two-thirds of cancer cases are caused by lifestyle choices like smoking, poor diet and lack of exercise, the panel said many avoidable cancers were also caused by pollution, radon from the soil and medical imaging scans. Since so little is known about the possible risks of cell phones, people would be prudent to wear headsets and make calls quickly, the two members of the panel advised. "The panel was particularly concerned to find that the true burden of environmentally induced cancer has been grossly underestimated," they wrote in their report.
Panel Investigates Johnson & Johnson Recalls Lawmakers presented information from regulators about Johnson & Johnson's recall of Children's Tylenol and other over-the-counter pediatric medicines, saying the company's repeated recalls "point to a major problem" with production. The House Committee on Oversight and Government Reform has opened an investigation after Johnson & Johnson recalled 40 widely used children's pain and allergy medications, saying some might have a higher concentration of their active ingredients, while others might be contaminated. FDA inspectors had found thick dust, grime and contaminated ingredients at the plant that produces Children's Tylenol and dozens of other products.
Agency Told Tylenol Maker of Many Quality Concerns The Johnson & Johnson unit that voluntarily recalled certain lots of children's liquid Tylenol and Motrin had numerous and wide-ranging quality control problems at the plant that made the products, according to a recently released federal inspection report. That unit, McNeil Consumer Healthcare, failed to adequately investigate and correct various deficiencies in its manufacturing and drugs made at its plant. The report, which the agency sent to McNeil before the recall, said the company had used raw materials with known bacterial contamination to make certain lots of infants' and children's liquid Tylenol. Samples of finished products tested negative for bacteria, however, and the risk to consumers was remote. McNeil disagrees with the FDA's account of the bacteria issue, claiming it had not used material that had tested positive for bacteria. The company alleges a supplier had rejected some drums of a material from a master lot after finding bacterial contamination, but the drums sent to McNeil's plant had tested negative for bacteria. The FDA report also said McNeil had not responded properly to several dozen consumer complaints about foreign particles found in certain medications.
Local Children's Tylenol Plant Temporarily Closes McNeil Consumer Healthcare has voluntarily shut down its local Fort Washington plant where it produces Children's Tylenol and dozens of other recalled over-the-counter medications in response to an FDA report that said raw ingredients contaminated with bacteria had been used in some of the infants' and children's products. The Food and Drug Administration said it had so far found no evidence of bacteria in any finished products it tested. Agency officials considered harm to children unlikely from the microorganisms or from previously identified problems with the McNeil medications, including inconsistencies in product potency and other contaminants. FDA officials said parents should substitute generic versions of the medications, none of which are made by McNeil, a Johnson & Johnson subsidiary.
Jury Awards $200 Million in Punitive Damages in Asbestos Case A Los Angeles jury awarded $200 million in punitive damages and $8.8 million in compensatory damages in an asbestos product liability case, but it looks likely to be reduced. After the jury handed down its verdict, the judge asked attorneys from both sides to write briefs on what an appropriate punitive damages award would be. Plaintiffs attorneys argued that their client's mesothelioma was caused by asbestos fibers she breathed while washing her husband's work clothes. Her husband worked for the city's water and power department for 24 years. At trial, the Los Angeles Department of Water and Power only disputed its share of the liability, and the other defendant, which the jury hit with 70 percent of the liability, argued that there was "no constitutional or legal basis for such a grossly excessive award."
Cough Medicine Ingredient to Get Safety Probe Health regulators are concerned about the potential for people to abuse a key ingredient in many cough suppressant medications, calling for a public meeting to weigh the issue. The Food and Drug Administration will call on a panel of outside advisers to look at the potential risks and benefits of the drug dextromethorphan, used in cough medicines made by Pfizer and Procter & Gamble, among others. Cough medicines have been under FDA scrutiny for the last few years, especially their use in children. The agency has said they should not be used in children 2 and younger, while manufacturers have urged against their use in children under 4.
FDA Deal Leads to Recall of Infusion Pumps Baxter International is recalled its Colleague infusion pumps from the American market under an agreement with federal regulators that sought to fix problems like battery failures and software errors. The Food and Drug Administration said that infusion pumps used to administer drugs and liquids were linked to more than 56,000 complaints of injuries, deaths and malfunctions from 2005 to 2009. The Baxter Healthcare Corporation, the company's principal American subsidiary, has been under a consent decree with the FDA since 2006 that allowed the agency to require a recall of the pumps. Baxter says there are just under 200,000 of these pumps in use at hospitals and other medical facilities, while the Colleague pumps, which have not been sold to new customers since 2005, will be phased out.
Don't Get Burned by Sunscreen Claims What many consumers don't realize is that while most sunscreens help prevent sunburn, many don't provide effective protection against skin damage from ultraviolent A rays, which make up 95 percent of the UV spectrum. Some new sunscreen formulas protect against UVA, but there have been some worries abut ingredient safety. So, consumers must sort through a maze of misleading claims and products that vary widely in their effectiveness.
New Study Challenges Benefits of Vitamin A for Women and Babies Giving women vitamin A capsules did not save their lives or the lives of their new babies, according to a surprising new study from Ghana. The results contradicted an earlier study in Nepal that showed a huge drop in deaths among child-bearing women taking Vitamin A, and disappointed experts who hoped pills could be a cheap, easy lifesaver. Scientists did establish in the 1980s that giving Vitamin A to malnourished children prevented stunting and deaths from measles and diarrhea. The 1999 study in Nepal suggested the vitamin also saved young mothers, although that result was regarded skeptically because so many of the women had died of unrelated causes. The new study recruited nearly 208,000 women, half of whom got a weekly low dose of vitamin A while the other half received a placebo. Few in either group died, but the vitamin also did not reduce hospitalizations for childbirth complications. Nor did it reduce stillbirths or deaths of newborns.
Children's Tylenol and Other Drugs Recalled A unit of Johnson & Johnson has voluntarily begun a recall of certain children's over-the-counter liquid medicines because of manufacturing deficiencies. The deficiencies may affect the potency, purity or quality of the products, and the Food and Drug Administration is investigating the plant where the products were made to make sure there were no other problems. Consumers should stop using certain lots of infants' and children's Tylenol, Motrin, Zyrtec and Benadryl products because some of them may contain more of the active drug ingredient than specified. Other products involved in the recall may contain foreign particles or inactive ingredients that may not meet testing requirements.
Thousands of Cribs Recalled The government has recalled thousands of Simplicity and Graco cribs, warning that babies could suffocate or strangle in them. The Consumer Product Safety Commission said the Simplicity recall was linked to at least one death and involved thousands of cribs, possibly hundreds of thousands, though many had previously been recalled for other defects. The agency said about 217,000 Graco dropside cribs were also recalled. The problem with both types of cribs stems from hardware failure.
Relacore Plaintiffs Take Last Stab at Securing Class Action Status for Suit A lawyer for dissatisfied users of the dietary supplement Relacore took his third and probably final shot at getting class action treatment for the suit, which alleges that manufacturer made false claims about the drug's effectiveness in cutting belly fat and stress. Two lower New Jersey courts have held that there are too many possible variables to satisfy the class action requirement that questions of law or fact common to the class predominate over questions affecting only individual members. But the plaintiffs' attorney told the state Supreme Court that both courts were wrong: that the common variable is the manufacturer's fraud on consumers. The suit seeks certification of a class comprised of all New Jersey residents who bought Relacore since it came to market in 2002. The lead plaintiff alleges she bought Relacore in 2004 after seeing an ad that claimed it would reduce belly fat. However, after using it for 90 days - at $39.00 for each month's supply - her waistline actually increased.
Australia Fights Tobacco with Taxes and Plain Packs Australia could become the first nation to ban brand images and colors on cigarette packages under a wide-ranging set of antismoking measures that the government recently unveiled. Starting in 2012, tobacco products would have to be sold in the plainest of packaging with few or no logos, brand images or colors. Promotional text would be restricted to brand and product names in a standard color, position, type style and size, rending them not unlike the bland boxes that carry generic prescription drugs. Restrictions on Internet advertising, a hefty increase in the tax on tobacco products and new antismoking campaigns are also among the initiatives.
Judge Rejects Plea Deal On Guidant Heart Device A federal judge has rejected a plea agreement between the federal government and the Guidant Corporation, saying that the deal did not hold the company sufficiently accountable for an episode in which it sold potentially flawed heart defibrillators. The deal called on Guidant to plead guilty to two misdemeanors and pay a $296 million fine, described as the largest by a medical device company. However, the judge said the provisions of the agreement were "not in the best interest of justice and do not serve the public's interest because they do not adequately address Guidant's history and the criminal conduct at issue." The case results from disclosures in 2005 that Guidant did not alert doctors and patients that some of its defibrillators had a defect that might cause them to fail when needed to interrupt and erratic and possibly fatal heart rhythm. At least six patients who got the devices died.
FDA Steps Up Oversight of Infusion Pumps Federal regulators say they are moving to tighten their oversight of medical devices, including one of the most ubiquitous and problematic pieces of medical equipment - automated pumps that intravenously deliver drugs, food and other solutions to patients. The Food and Drug Administration recently issued preliminary guidelines that will require producers of the devices, known as infusion pumps, to supply the agency with more test data on them before they can be approved for sale. Over the last five years, the agency says it has received reports of 710 patient deaths linked to problems with the devices, though FDA officials say they think the number may be significantly higher. Some of those deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device's software malfunctioned. An estimated two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes. The pumps use a variety of designs to intravenously deliver food, fluids and drugs like pain medications, insulin and cancer treatments.
Throwing Your Dog a Bone Could be Deadly If they only knew, dogs from coast to coast might by howling over this advice from the government. The Food and Drug Administration issued a reminder to consumers to toss out bones from their meals rather than feed them to their pets. The FDA spelled out 10 reasons it's a bad idea to give doggie a real bone. Among them: broken teeth, mouth or tongue injuries, bones or fragments of bones getting stuck in a dog's esophagus or even its stomach, which might require surgery. Bone fragments also can cause constipation. Worse, it could be deadly. Giving your dog a real bone could cause a bacterial infection of the abdomen, called peritonitis, when fragments poke holes in a dog's stomach or intestines. "Your dog needs an emergency visit to your veterinarian because peritonitis can kill your dog," says the caution from the FDA.
When Heart Devices Fail, Who Should be Blamed? It was a landmark episode brought to light by two Minneapolis cardiologists that changed the way the medical device industry deals with the safety of heart implants. Now the doctors, five years later, are raising a fundamental question about medical safety and the law: who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it? The legal case that grew from the doctors' revelations involves heart defibrillators once made by the Guidant Corporation, which is now part of Boston Scientific. Guidant continued to sell the devices, evidence indicates, even after it discovered that some might short-circuit and fail. The defibrillators, intended to protect people from erratic, potentially fatal heart rhythms, have been associated with at least six deaths, including that of a 21-year-old patients of the two cardiologists. A federal judge will soon consider an agreement with Guidant in which the company would plead guilty to two criminal misdemeanors and pay a $296 million fine. The Justice Department is hailing the result, saying the fine would be the largest ever paid by a medical device maker. But the cardiologists are not celebrating. Instead, they have written a letter to the judge urging him to reject the deal.
Tobacco 'Mints' Tied to Kids' Poisoning Smokeless, flavored tobacco products that look like candy and come in packages shaped like cell phones may be contributing in accidental poisonings in very young children, new research suggests. Nicotine-laced pellets, strips and sticks that dissolve completely in the user's mouth - dubbed "tobacco candy" by critics - have joined chewing tobacco and snuff to become the second-largest common cause of unintentional tobacco ingestion in kids younger than 6. Between 2006 and 2008, nearly 1,800 U.S. youngsters - almost 600 a year - accidentally consumed smokeless tobacco products, according to an analysis of 13,705 tobacco-related reports to the nation's poison control centers. That's a fraction of the nearly 3,600 poisonings a year that involved cigarettes and filter tips, but it worries researchers. Potential poisonings add to the growing list of worries from those who fear that tobacco makers thwarted by anti-smoking laws are trying to peddle their addictive products to a new generation of users. Tasty flavors and packaging that resembles Tic Tac mints could be a powerful draw to young users, critics say.
Flavored Tobacco Pellets Denounced as Lure to Young Users A research study and editorial published in the medical journal Pediatrics takes direct aim at a novel tobacco product that some critics say too closely resembles Tic Tac breath mints. R.J. Reynolds Tobacco, the nation's second-largest cigarette maker behind Philip Morris, is test marketing the product, Camel Orbs, along with other dissolvable tobacco products, in three cities. It is part of a broad industry trend to create smokeless products in response to declining cigarette use and the rise of smoke-free air laws. The study says Orbs, pellets made of finely ground tobacco with mint or cinnamon flavoring, are packed with nicotine and can poison children and lure young people to start using tobacco. The pellets dissolve in the mouth, like breath mints. Reynolds says Camel Orbs are marketed only for adults and come in child-resistant containers.
Plaintiffs in Tainted Chinese Drywall Litigation May Win in Court, But Will They Ever Collect? A federal judge in New Orleans recently ruled that a Chinese manufacturer of noxious drywall owes seven Virginia homeowners $2.6 million to completely replace the offending material and all other affected building fixtures. Thousands of similar cases could be on the way, so do Chinese companies need to worry? As a practical matter, probably not. In general, collecting on a U.S. judgment in China is difficult if not impossible. Chinese law only permits the enforcement of foreign judgments through bilateral treaties, but China doesn't actually have any such treaties with other countries. The defendant in the New Orleans suit did not respond to it at all, allowing a default judgment to be entered against it. The drywall at issue, used in homes throughout the United States, is said to emanate sulfuric fumes and corrode pipes and wiring.
Metal Shavings from Swings a Danger to Children with Autism Children with autism are often calmed by riding on a swing; some do it for hours every day. But doctors are warning of a danger that can occur when wear and tear causes small metal fragments to peel from the suspension apparatus and fall into children's eyes. Though medical treatment is required, the source of the foreign body in the eye is often not apparent, according to a recent paper in The Journal of the American Association for Pediatric Ophthalmology and Strabismus. In once case described in the article, a 10-year-old boy came to Cincinnati Children's Hospital with something lodged in his right eye, and the doctor, who had treated him once before for a similar problem, realized this was the child's fourth such incident in three years. It was soon discovered that the boy spent hours each day on a homemade swing. In another case, an 8-year-old boy came in with a metallic fragment in the cornea; he, too, had been in once before.
Jury Awards $30 Million in Three Asbestos Cases A Philadelphia jury has awarded a total of $30 million to plaintiffs in three separate asbestos cases that were tried together, though the plaintiffs' attorneys say their clients will see a fraction of that money because of prior settlements with the bulk of the defendants. In one case, the jury awarded $14.5 million to a woman as the executrix of the estate of her husband, who died at 54 from mesothelioma. The jurors then found all of the 11 defendants listed on the verdict sheet liable for the damages. Only three defendants remained in the case, however. The companeis' shares of the verdict equal $3.95 million. In post-trial motions, plaintiffs' attorneys included a 12th bankrupt defendant that has also settled and asked that the verdict be molded to include the additional defendant and have a portion of its share paid out by the remaining defendants. That situation would have the three companies remaining in the case paying four-twelths of the verdict minus the 12th company's settlement payout, which would come out to about $4.8 million. In another case, the jury awarded $3.5 million to the administrator of the state of a man who died at 62 from mesothelioma. The jurors then found the 20 defendants listed on the verdict sheet liable. Only one company remained in the case and will be responsible for one-twentieth of the verdict, or $175,000. Finally, the jurors awarded the estate of a man $12 million and then found the 15 defendants listed on the verdict sheet liable for the damages. The plaintiffs' lawyer said there is only one defendant left in the case brought on behalf of the 64-year-old man who died of mesothelioma. His main exposure came from his two years as a boiler tender on a destroyer for the Navy, where every day he handled pipe valves that were sealed with the sheet gasket casting made by the company. The company will be responsible for $800,000 of the $12 million verdict. Like in the first case, plaintiffs' attorneys plan on asking that the bankrupt defendant be included in the liability portion and having the company be responsible for that 16th share as well as its initial share. That would bring the damages against the company to about $1.5 million.
Plaintiffs Lawyers Seek New Trial After Contrite Juror E-Mails to Say He Changed His Vote A plaintiff whose $1.3 million asbestos claim was no-caused by a jury has asked for a new trial because a juror confessed he switched his vote at the end of the 10-hour deliberation, saying that otherwise, "we would've never gotten out of there." The New Jersey jury found by a 7-1 vote that the widow of a railroad worker failed to prove that the company's handling of asbestos hazards was negligent and caused his death by lung cancer. The defense blamed the death on his 31 years of smoking. Six days after the verdict, the plaintiff's lawyers received an email from a male juror saying the panel did believe asbestos played a role and that he and others were on the plaintiff's side before he changed his vote in the case. The plaintiff's lawyer used the mail to ask a judge for a new trial. The grounds: the jury did not fulfill its sworn function to base its decision on the facts. A 6-2 vote is insufficient for a verdict under New Jersey law requiring agreement by five-sixths of a civil panel. The plaintiff's lawyer concluded the email supported the idea that extraneous concerns, not the evidence, tainted the deliberations.
FDA Toughens Process for Radiation Equipment The Food and Drug Administration is taking steps to reduce overdoses, underdoses and other errors in radiation therapy by strengthening the agency's approval process for new radiotherapy equipment. In a letter to manufacturers, the FDA said its action was based on a recent analysis of more than 1,000 reports of errors involving these devices that were filed over the last 10 years. The FDA will no longer allow new radiotherapy equipment to enter the market via a streamlined approval process that sometimes involved the use of outside, third-party reviewers. That process was instituted in the 1990s to reduce the agency's workload and speed approval time. Most of the reported problems - 74 percent - involved linear accelerators, computer-controlled machines that generate high-powered beams of radiation that target and destroy cancer cells. Problems with computer softward were most frequently cited as a cause for the errors.
Antibacterial in Soap Comes Under U.S. Scrutiny The U.S. Food and Drug Administration it reviewing the safety of triclosan, a widely used antibacterial agent found in soap, toothpaste and a range of other consumer products. The agency stressed there are no grounds to recommend any changes in the use of triclosan but said some recent studies merited a closer look. The FDA noted that there was no evidence that triclosan could be harmful to people but noted that an animal study showed the chemical may alter hormone regulation and several other lab studies showed that bacteria may be able to evolve resistance to triclosan in a way that can help them also resist antibiotics. Many experts agree that soap containing triclosan does little or nothing extra to remove bacteria that using soap without the ingredient, as washing the hands physically removes the excess bacteria.
Rule On Lead Safety Set to Take Effect After almost two decades of delays, the Environmental Protection Agency is on track to implement a regulation requiring the construction industry to help prevent cases of lead poisoning among children. The agency said it expected more than 125,000 renovation and remodeling contractors to be trained and certified in lead-safe work practices when the new regulation takes effect. Under the rule, workers would have to take steps like containing their work area with plastic and conducting a thorough cleanup of lead paint dust stirred up during construction activity, which federal officials say is partly to blame for about 120,000 cases of elevated lead levels in children younger than 6 each year. Congress passed legislation in 1992 directing the EPA to propose the regulation, but the agency did not finish the rule until 2008, after environmental and public interest groups filed a lawsuit to pressure the agency to issue it. Some environmental groups are now pushing to make the rule tougher, while builders are warning their clients that it will inevitably increase construction costs. The rule applies to work performed in homes and buildings occupied by children, including schools and day care centers built before lead paint was banned in 1978.
Local Spa and Five Others Get FDA Warning The Food and Drug Administration issued warning letters to six spa companies, including one based in King of Prussia, for making false and misleading statements about drugs they contended could eliminate fat. In a procedure known variously as lipodissolve, mesotherapy, lipozap, lipotherapy or injection lipolysis, patients receive a series of fat injections meant to "dissolve and permanently remove small pockets of fat from various parts of the body," the FDA said. The primary ingredients are phosphatidylcholine and deoxycholate, although vitamins and herbs may also be added. The FDA has not evaluated the drugs and says it knows of no "credible scientific evidence" that shows they eliminate fat. It also says that the injections' safety is "unknown." Adverse reactions include scarring, skin deformation and painful knots in treated areas. The spas and a Brazilian company that markets lipodissolve products have 15 days to respond to the FDA or face "legal action."
Pennsylvania Jury Awards Nearly $89 Million in Plane Crash Case A Philadelphia jury has awarded nearly $89 million in damages in a personal injury and products liability case involving a 1999 plane crash in which four people died and another suffered serious injuries. The jury awarded $24.7 million in compensatory damages and found that the defendant's conduct was malicious, wanton, willful or oppressive, allowing for a subsequent punitive damages phase of the trial. After the judge gave the jury a stipulated net worth of the defendant of about $640 million, the jury went back to deliberations and returned with an award of $64 million in punitive damages. The combined award of $88.7 million is the largest out of Philadelphia Common Please Court in the last five years. The plaintiffs argued that the carburetor on the engine died at takeoff, causing power loss that resulted in an unsuccessful emergency landing. The pilot crashed not far from the airport where he was trying to return for the landing. The defense argued there was nothing wrong with the carburetor and that it was pilot error that caused the crash as the pilot overloaded the plane, causing it to stall.
New Jersey Court Affirms Record $30.3 Million Award in Asbestos Exposure Case A New Jersey appeals court has upheld a $30.3 million verdict in an asbestos-exposure mesothelioma case, the largest known award in the state. The defendants lost on every issue, including the standard of causation to be applied in light of the plaintiff's short history of working with asbestos-laden materials. The suit was brought by a woman whose husband died from mesothelioma in 2002, a year after he was diagnosed. In 2008, a jury awarded damages of $8 million for pain and suffering; $2 million for loss of consortium; $9,281,660 for lost earnings; $2,030,544 for loss of services; and $3 million to each of his three daughters for loss of parental care. Dozens of companies were sued, but only two were left by the time of the verdict. Two others settled during trial, while General Motors settled beforehand. The suit combined direct exposure claims characteristic of traditional asbestos litigation with indirect or "take home" exposure. The man was allegedly exposed as a child to asbestos by his father, who handled brakes and clutches containing asbestos working at a GM warehouse and carried the fibers home on his work clothes. He also encountered asbestos directly in the early 1970s, when he was in college and spent summers and winter breaks working at a GM warehouse handling auto parts.
Court Rules Defective Sperm Can't Be Basis for Products Liability Suit Genetic defects in sperm from a sperm bank cannot form the basis for a products liability suit, a federal appeals court has ruled, because allowing such a claim would be tantamount to recognizing a claim of "wrongful life." The ruling upholds a 2009 decision that rejected claims by both a mother and a daughter who suffers from Fragile X syndrome, a mutation known to cause a group of maladies that include mental retardation and behavioral disorders. A judge had initially ruled that, under New York law, the sperm bank could be sued under products liability laws because "the sale of sperm is considered a product and is subject to strict liability." However, two months later, he reversed himself and dismissed the entire case, predicting that the New York Court of Appeals would reject the claim. "I find it more likely than not that it would find that the injuries alleged in plaintiff's strict liability and warranty claims are essentially claims for wrongful life." In both rulings, the judge rejected all claims by the mother on statute of limitations grounds, finding that she waited too long after learning that her daughter's genetic defects were directly connected to the sperm donor. Now, the 3rd Circuit has ruled the judge's second decision was correct in holding that the mother's claims were untimely and that the daughter plaintiff had "no cognizable injury."
Federal Circuit Ruling Sparks Surge of Patent Whistleblower Suits A recent federal appellate decision has unleashed a wave of whistleblower suits accusing companies of falsely labeling their products as covered by patents. Last year, a U.S. Court of Appeals for the Federal Circuit ruling steeply increased the potential fines in so-called "false marking" cases, from a typical $500 for an offense to hundreds of thousands, or even millions of dollars, depending on the number of items sold. Since the ruling, plaintiffs lawyers have filed more than 130 new lawsuits. The lawsuits have targeted companies in a variety of sectors, and plaintiffs lawyers say the suits are justified, because the public is harmed when companies label products or packaging with a U.S. patent number that's expired or does not cover the product's technology. The false-marketing statute allows whistleblower plaintiffs to file suits and calls for fines of up to $500 per offense. Plaintiffs are entitled to one-half of the penalty; the other half goes to the United States.
Makers of Artificial Joints Rarely Offer Warranties When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty - but that is not how the multimillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers. The million or so artificial hips and knees implanted each year in the United States, they say, are normally not guaranteed. Instead, the costs of replacing implants that fail early because of design or mechanical problems - devices that sell for as much as $15,000 each - are largely paid by Medicare, insurance companies and patients. Implants can fail for many reasons, but if only a small percentage of them fail prematurely because they are substandard, the costs to taxpayers, policyholders and patients can run into the tens of millions of dollars each year, health care experts estimate. Orthopedic producers may sometimes even profit from the failures because they sell the replacements at full price.
Researchers Report Progress On E. Coli Test It's not the pathogenic E. coli microbe itself that harms people who eat ground beef or other foods that contain it. Rather, it's the toxins that E. coli produces that do the actual damage. Proper testing of food should look for both, though, since it is possible for one to be present without the other. That usually means two separate tests, but now scientists with the Agricultural Research Service of the United States Department of Agriculture report significant advances toward a single test that can detect both pathogenic E. coli and its toxins. The test uses tiny polystyrene beads that are coated with antibodies for the proteins found on the bacteria and two of the major toxins it produces. The beads are mixed with a sample of ground beef that has been further chopped up in a blender, and then separated from the sample and analyzed. In addition to its two-in-one nature, the test is also quicker than current E. coli tests, with results in less than 24 hours rather than about a week. More work is required, but the plan is to have a commercialized test in a few years that could be used by government and the food industry itself.
Chemical Exposure May Triple Breast Cancer Risk Exposure to certain chemicals and pollutants before a woman reaches her mid-30s could triple her risk of developing breast cancer after menopause, Canadian scientists said. Researchers found that women exposed to synthetic fibers and petrol products during the course of their work appeared to be most at risk. "Occupational exposure to acrylic and nylon fibers, and to polycyclic aromatic hydrocarbons may increase the risk of developing postmenopausal breast cancer," they wrote.
Weak Rules On Toxins and Safety For 14 years until just last month, GlaoSmithKline sold a denture cream called Super Poligrip that contained high levels of zinc. The zinc helped with adhesion and was probably safe so long as people used moderate amounts of cream. Indeed, the human body needs small amounts of zinc to function. But some people ended up using much larger amounts, and they began to develop the kind of nerve damage associated with excess zinc. A North Carolina man, who was using a tube of Poligrip a week, had to quit his job as a car mechanic and now needs a walker to get around his house. Another customer began using a walker in 2007 and died a year later, apparently a result of a copper deficiency from "zinc overload." Last month, GlaxoSmithKline, which also makes Tums, Nicorette and the country's top-selling asthma drug, stopped making the version of Poligrip with zinc, after having previously resisted just such a move. In Japan, responding to regulators' concerns, the company has also recalled from stores any remaining zinc-infused cream.
Panel to Examine Menthol Cigarettes' Impact A new U.S. Food and Drug Administration panel will take a closer look at menthol cigarettes and how the government should regulate them, but most believe an outright ban is unlikely. The tobacco industry is keeping a close eye on the committee's work and its recommendations for menthol, a still-growing part of the shrinking cigarette market. The committee will discuss the scientific research on the public health effects on menthol cigarettes, including among children and certain ethnic groups. The FDA won the authority to regulate tobacco, including banning certain products, limiting nicotine and blocking labels such as "low tar" and "light" that could wrongly imply certain products are less harmful. The law doesn't let the FDA ban nicotine or tobacco entirely.
BPA's Environmental Impact Investigated The Environmental Protection Agency will investigate the impact of the chemical Bisphenol-A on the U.S. water supply and other parts of the environment. Federal regulators have been ramping up their scrutiny of the controversial plastic-hardener at the behest of scientists and activists who say it can interfere with infant growth and development. The EPA said in a statement it will begin measuring levels of BPA in drinking and ground water. More than one million pounds of BPA are released into the environment each year, according to the agency. The EPA will also "look for ways to reduce unnecessary exposures, including assessing substitutes." BPA is found in canned food linings, water bottles, CDs and hundreds of other household items. Earlier this year, the FDA changed its position on the chemical's safety, voicing "some concern" about its effects on children and infants. The agency previously concluded in 2008 that the trace amounts of the chemical that leach out of food containers are safe.
Is Your Breakfast Giving You Cancer? Chances are, you started your day with a generous helping of folic acid. For more than a decade, the government has required enriched grains - most notably white flour and white rice - to be fortified with folic acid, the synthetic form of the B vitamin folate. Many food manufacturers take it further, giving breakfast cereals, nutrition bars and beverages a folic acid boost. The extra nutrient isn't meant for you, though - it's added to protect fetuses from developing rare but tragic birth defects. The fortification effort appears successful: Since 1998, the number of these birth defects dropped by about 19 percent. But for women past the years of having children, as well as for men of any age, unnatural dosages of this nutrient don't seem to be helpful - and may even be harmful. Indeed, many scientists have grown increasingly concerned about mouting research - including a study published last year in the Journal of the American Medical Association - suggesting that all the extra folic acid might increase your odds of developing cancer.
Florida Jury Awards Smoker's Widow $26.6 Million A Florida man could not stop smoking even after he was diagnosed with lung cancer, heart disease and chronic obstructive pulmonary disease. He tried hypnosis, nicotine gum and even attended anti-smoking seminars before succumbing to cancer in 1994. A jury as awarded his widow $26.6 million after finding cigarette manufacturers R.J. Reynolds and Philip Morris liable for causing his lung cancer and death. The jury decided the cigarette maker should pay his widow $10 million each in punitive damages and $6.6 million in compensatory damages. A $10 million jury award was reduced by a finding that her husband was one-third responsible for his illness. Florida smokers filed about 8,000 lawsuits after the Florida Supreme Court threw out a record $145 billion class action award in 2006 but allowed people to sue individually. The smoker's widow filed one of the follow-on suits.
FDA Mulls Teen Tanning Bed Ban Federal health experts say more restrictions are needed to protect teenagers from the cancer risks of tanning beds, including a potential ban for people under 18. A panel of advisers to the Food and Drug Administration recommended that the agency put tighter controls on artificial tanning, ranging from requiring parental consent forms to banning the practice in younger teens. The FDA has regulated sunlamps for more than 20 years, but a recent report by the World Health Organization tied the devices to skin cancer, prompting a call for tougher rules. The WHO analysis showed that the deadliest form of skin cancer increases 75 percent in people who use tanning beds in their teens and 20s. More than 30 states already have tanning salon regulations in place - including a handful that require parental consent - but new FDA requirements would apply nationally. The panel also recommended the FDA add bolder warning labels to tanning beds and change how they are regulated.
Medicines Washing Down the Shower Just by showering or bathing, you may be adding to the growing concentrations of medicines, hormones and other health care products polluting the nation's water supply, a new study shows. Experts have suspected that out drinking water supply was being contaminated by what we flush down the toilet. A variety of prescription drugs can pass through our bodies and then be excreted either in urine or fecal matter. Now researchers have found that medicines and other chemicals may also be flowing into the water while we're bathing and showering - and they might even be slipping through the laundry. Prescription drugs and other health care products that are applied to the skin can just wash off or rub off on clothes, while oral medications, such as steroids and antibiotics can seep through the skin in our sweat, mix with the bathwater and then spiral down the drain.
Federal Judge Declines to Block New York City's Limits on Flavored Tobacco Sales A federal judge has refused to enjoin a New York City law severely restricting the sale of flavored tobacco. The plaintiffs, two manufacturers of so-called smokeless tobacco - better known as chewing tobacco and snuff - set forth several constitutional arguments for blocking the law, including that it is pre-empted by the Family Smoking Prevention and Tobacco Control Act of 2009, which amended federal law by specifically authorizing the Food and Drug Administration to regulate tobacco. Finding the tobacco companies unlikely to ultimately prevail, a judge denied their motion for a preliminary injunction.
More Than One Million Baby Slings Recalled More than one million baby slings made by Infantino have been recalled after claims linking them to three infant deaths. The Consumer Product Safety Commission said babies could suffocate in the soft fabric slings. The agency urged parents to immediately stop using the slings for babies under four months. The recall involves one million Infantino "SlingRider" and "Wendy Bellissimo" slings in the United States and 15,000 in Canada. Officials with the CPSC issued a broad warning about sling-style baby carriers earlier, saying they pose a potential suffocation risk to infants, especially babies under four months. The commission has identified or is investigating at least 14 deaths in the last 20 years. Three of the deaths occurred last year and were linked to Infantino slings.
Lead Found in Indian Spices and Powders Lead has been found in house paint and imported toys, and now it appears Indian spices and ceremonial powders may contain lead at levels that may be hazardous to children. Sindoor, the vermillion powder applied along the hairline or as a dot on the forehead, had the highest contamination levels of some 157 products tested by researchers, with some samples consisting of almost 50 percent lead. Pediatricians and investigators in Boston tested the product after four young children were referred to a hospital with elevated blood lead levels. The source of a three-year-old girl's elevated lead level was traced to a religious powder she ingested regularly, and a one-year-old boy's lead level was traced to spices and herbs.
Florida Court Upholds $24 Million Verdict Against Tobacco Companies A nine-year products liability case produced a major victory over tobacco companies when the 3rd District Court of Appeals upheld a $24.8 million award to a man who died of cancer shortly after trial. The appellate panel offered no legal reasoning in its decision against Philip Morris, Brown & Williamson and Liggett Group. The unanimous opinion is the first appellate ruling upholding a verdict since the Florida Supreme Court dismantled a smoker class action and opened the door to individual trials. With the plaintiff dying, his attorneys sued and pushed for a quick trial in 2002 instead of forcing their cancer-ridden client to wait for the Supreme Court ruling. The jury awarded his widow a total of $37.5 million in 2002, and the award was later reduced to $24.8 million. Tobacco attorneys appealed, challenging trial decisions and insisting smokers trials could not proceed without a Supreme Court directive. The appellate court's decision cited the Supreme Court ruling, which allowed smokers to pursue individual lawsuits and offer the original jury's findings as fact. New juries are advised to accept that smoking causes cancer and other illnesses, cigarettes are addictive and tobacco companies defrauded consumers by misleading them.
Over One Million High Chairs Recalled The government has announced a recall of some 1.2 million high chairs, saying they posed a fall hazard to children. The Consumer Product Safety Commission announced the voluntary recall of the high chairs made by Graco Children's Products, Inc. "Screws holding the front legs of the high chair can loosen and fall out," the regulatory agency said, adding that cracking plastic brackets could also cause the chair to "tip over unexpectedly." The affected models were produced between November 2003 and December 2009 and sold at major retailers nationwide, including Sears, Target and Wal-Mart. The tip-overs resulted in 24 reports of injuries including bumps and bruises to the head, a hairline fracture to the arm and cuts, bumps and bruises and scratches to the body. Graco had received 464 reports of screws loosening or falling out. This is the second recent recall of Graco products. Earlier this year, Graco recalled about 1.5 million strollers after some children's fingertips were amputated by hinges on the products.
Objectors Fail to Block Mattel Lead Paint Settlement A federal judge has approved a class settlement resolving multidistrict litigation involving lead paint in Mattel toys. In approving the deal, the judge rejected claims by objectors that it amounted to a "coupon" recovery contrary to the Class Action Fairness Act of 2005. Objectors also noted that attorney fees of nearly $13 million exceeded the value to the class. The settlement involves millions of toys that were recalled or removed from the market in 2007 by Mattel or its subsidiary Fisher-Price due to excessive lead content. The settlement also involves toys recalled due to small magnets that could come loose. No personal injury claims against Mattel are covered in the deal. The class is estimated to include more than 1.5 million parents or guardians who purchased the recalled toys for their children. Some class members have already returned recalled toys and received a voucher for full value that they can apply toward the purchase of another Mattel product. These plaintiffs would receive checks worth half that value. Class members who return toys now would be entitled to a check or voucher equal to the price of the recalled product. Class members without a proof of purchase could receive vouchers for as many as three toys per household, as long as the total settlement amount for those members does not exceed $10 million. Class members who paid for lead testing of their children within six weeks of the recall announcement can seek reimbursement, as long as the total amount for the class does not exceed $600,000.
Tobacco Rule Proposed in 1995 to Go Into Effect Fifteen years after the Food and Drug Administration first proposed banning the sale and marketing of tobacco products to teenagers, top government officials have announced they would finally put the rule into effect. The rule was hugely controversial when first proposed in 1995 and was never adopted by the agency because of a Supreme Court ruling that legislation was needed to empower the FDA to regulate tobacco products. The tobacco industry adopted most the rules' provisions in 1998 as a result of litigation, and every state bans tobacco sales to minors. The new rule provides consistent enforcement mechanisms across the country. Other provisions not adopted by the industry are still contentious and may end up in court, and even those that are not controversial may lead to changes across the country. For instance, the rule prohibits tobacco companies from using color advertising in store displays, a provision that a federal judge in Kentucky recently found unconstitutional.
Maker of Tylenol Explains Actions Taken to Alleviate Musty Smells of Pills The Johnson & Johnson unit that drew criticism and a federal warning letter in January on the grounds of mishandling quality control problems with Tylenol says it has taken steps to prevent similar incidents in the future, according to documents newly posted on the Web site of the Food and Drug Administration. The company "recognizes the seriousness of this situation and has identified this corrective action plan as our top priority." In January, the FDA sent a warning letter in which officials said the company had failed to thoroughly investigate consumer complaints of a moldy odor from some bottles of Tylenol Arthritis Relief Caplets. In 2008, a number of consumers reported temporary digestive problems after using the products. But after ruling out bacterial contamination, the company did not initially conduct other testing to determine the root cause of the musty smell, the FDA said. The warning letter also said that the company had failed to alert officials about the problem in a timely fashion - waiting more than a year after the first complaints to notify the agency. A related FDA inspection report cited several other quality control issues, including failure to monitor Tylenol Arthritis Caplets for possible impurities or degradation.
Long-Term Safety of Drug-Coated Stents Doubled New research shows more patients who got drug-coated stents right after suffering a heart attack later died from heart-related problems than those who received older, cheaper bare-metal stents. Stents are tiny tubular devices used to prop open diseased heart arteries and have been widely used for almost 20 years. Newer and more expensive versions of the devices are coated with anti-clotting drugs that keep treated arteries from reclogging. Seven years after the first drug-coated stent was approved in the United States, members of the American College of Cardiology debated the issue, saying more research is needed to understand the long-term effects. Danish researchers conducted a trial examining the effectiveness and risks of the two types of stents implants right after heart attack. They found that after three years, patients who got bare-metal stents were more likely to have problems, like requiring more intervention for blockages, while patients with the drug-coated variety were more likely to die from heart-related problems.
Kroger Recalls Two Seasonings Due to Salmonella Kroger Co. said it is recalling two of its seasonings due to an ingredient that may be contaminated with salmonella. The largest U.S. grocery retailer said it would pull its California seasoning blend garlic powder and special seasoning blend lemon pepper from stores in 31 states. No illnesses have been reported.
Defibrillator Sales Halted by a Maker Boston Scientific vowed when it acquired Guidant in 2006 for $27 billion that it would rebuild the troubled producer of implantable heart defibrillators into a new model of industry safety and public transparency. However, Boston Scientific has since halted defibrillator sales, saying it had failed to properly notify the Food and Drug Administration about two recent manufacturing changes to the devices. The company also voluntarily withdrew all of its defibrillators from hospital shelves. Recently, a leading heart device researcher said that the company's devices might pose a potential risk to patients because of the way a component was constructed. The company has rebutted that charge. It is still unclear whether company's failure to notify the FDA involved significant issues or simply paperwork violations, because Boston Scientific did not describe them.
Misleading Food Labels to Get Makeover The aisles of American supermarkets can be bewildering places, lined with dozens of variations of cereals, crackers, chips and other foods, many of which boast of their supposed healthfulness. What claims are the conscientious eater to trust and what foods should they pick to put on their table? This question has become harder and harder for shoppers to answer, as health problems associated with poor diets, such as heart disease and obesity, affect more U.S. residents each year. Meanwhile, studies show that Americans want more and better guidance on what foods to eat. The rising obesity epidemic in the United States, combined with the proliferation of various labeling schemes and the worries about the potentially misleading nature of some of these schemes, has prompted the Food and Drug Administration to conduct a review of so-called front-of-packaging labeling. The aim is to come up with a standard set of regulations that would govern what claims manufacturers can make on these food labels. The FDA and nutrition advocates hope the review will remedy this situation and provide consumers with a standard system of labels they can rely on to make choices about what foods they buy.
Tainted Ingredient Sold After Salmonella Found The company responsible for a ballooning recall of processed foods continued to manufacture and distribute a flavor-enhancing ingredient for a month after tests confirmed it was made with contaminated equipment, according to a Food and Drug Administration report. FDA inspectors said the company, Basic Food Flavors, knew of salmonella contamination on its equipment after it received the results of a private inspection in January. Despite two additional inspections that showed contamination, the company continued to distribute the ingredient, called hydrolyzed vegetable protein until February and continued to manufacture it. The FDA began an investigation o the company in response to a report from one of Basic Food Flavors' customers about salmonella contamination. During several visits to the plant, agency inspectors found "light brown residue" and "dark brown liquid" in and around the paste mixers and inside pipes used to manufacture the ingredient, among other violations. No illnesses have been associated with the recall.
CDC Uses Shopper Card Data to Trace Salmonella As they scrambled recently to trace the source of a salmonella outbreak that had sickened hundreds around the country, investigators from the Centers for Disease Control and Prevention successfully used a new tool for the first time - the shopper cards that millions of Americans swipe every time they buy groceries. With permission from the patients, investigators followed the trail of grocery purchases to a Rhode Island company that makes salami, then zeroed in on the pepper used to season the meat. Never before had the CDC successful mined the mountain of data that supermarket chains compile. At least 254 people in 44 states were sickened in the outbreak, which included 30 in California, 19 in Illinois, 18 in New York and 17 in Washington. Shopper cards have been around for more than a decade, offering customers discounts in exchange for letting supermarkets track their buying habits. The cards are used to build customer loyalty and help stores market their products.
Baby Slings to Get Warning After Deaths The government is preparing a safety warning about baby slings - those popular and fashionable infant carriers that parents strap around their chests to give the little ones a cuddle on the move. The concern: Infants can suffocate, and at least a few have. The head of the Consumer Product Safety Commission announced the agency is getting ready to issue a general warning to the public about the slings. In 2008, Consumer Reports raised concerns about the soft fabric slings and some two dozen serious injuries, mostly when a child fell out of them. Consumer Reports specifically complained about the "SlingRider" by Infantino, which cradles the child in a curved or "C-like" position, nestling the baby below mom's chest or near her belly. It's the "C-like" position that causes safety advocates to shudder. They say the curved position can cause the baby, which has little head and neck control in the early months, to flop its head forward, chin-to-chest - restricting the baby's ability to breathe. Another concern is that the baby can turn its face toward mom's chest or belly and smother in the parents' clothing. The "SlingRider" was recalled in 2007 for problems with the plastic sliders on the sling's strap.
With Warning, Hip Device Withdrawn A unit of Johnson & Johnson, just months after saying it was phasing out an artificial hip implant because of slowing sales, has warned doctors that the device appears to have a high early failure rate in some patients. The action follows more than two years of reports that the hip implant, which is known as the ASR, was failing in patients only a few years after implant, requiring costly and painful replacement operations. Some orthopedic experts have voiced dismay that the company had not halted sales of the device earlier. Some specialists said that they believed the device had a device flaw that made it difficult to implant properly, a claim the company disputes, who had said the product had no safety problems. The director of an implant database in Australia said the data had shown for some time that the ASR had been failing early at a significantly higher rate than some competitors' devices. Last year, the company voluntarily withdrew the ASE from the Australian market. While the ASR is not widely used in the United States, the company said that it had been implanted in thousands of patients worldwide.
Couple Sues Target After Truck Injures Toddler A Pennsylvania couple has filed a lawsuit against Target, claiming that an improperly marketed wicker trunk that they used as a toy chest trapped their 18-month-old daughter's neck, leaving her in a persistent vegetative state. The couple alleges that Target should either have made the chest safe by inserting a lid support in it, or labeled it as inappropriate for use as a child's toy box. The family is seeking putative damages and cites Target's blatant disregard for safety. According to their complaint, the mother was preparing to leave for work when she found the lifeless body of her daughter. Her head was trapped inside the brown, rectangular truck after the lid collapsed on her. She suffered a severe lack of oxygen to the brain, resulting in spastic quadriplegia, severe psychomotor mental retardation and an inability to speak. Included among the claims in the suit are negligence and infliction of emotional distress. The suit also cites several customer reviews on Target's Web site that praise the trunks for being great to hold blankets and toys for young children. The lawsuit also cites statistics from the Consumer Product Safety Commission that show that at least 45 children have died, and others suffered serious brain damage, as a result of trunk lids falling on them or trapping them inside.
Food Products Recalled for Salmonella Thousands of processed food products - from chilis to hot dogs to dips - contain an ingredient that federal food regulators say was contaminated with salmonella, although so far only a few dozen have been recalled because most were cooked before being sold. Basic Food Flavors of Nevada sold its hydrolyzed vegetable protein to food manufacturers across the country. One of the company's customers found salmonella in supplies sent from Basic Food Flavors, and the customer alerted the Food and Drug Administration, which inspected the company's plant. The inspection uncovered salmonella contamination in the company's processing equipment, leading the company to recall its hydrolyzed vegetable protein made since 2009. Food makers who used the product often cooked it again, killing the salmonella. Health officials have yet to identify anyone who has been sickened by the contaminant, but the nation's disease tracking system is poor, so the lack of evidence of a contamination does not mean that no one has been sickened by the contaminated products.
Concerns Over 'Metal On Metal' Hip Implants Some of the nation's leading orthopedic surgeons have reduced or stopped use of a popular category of artificial hips amid concerns that the devices are causing severe tissue and bone damage in some patients, often requiring replacement surgery within a year or two. In recent years, such devices, known as "metal on metal" implants, have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. They are used in conventional hip replacements and in a popular alternative procedure known as resurfacing. The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, became widely used in the belief that they would be more durable than previous types of implants. The cause and scope of the problem are not clear, but studies in recent years indicate that in some cases the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient's body. That situation can touch off inflammatory reactions that cause pain in the groin, death of tissue in the hip joint and loss of surrounding bone. Doctors at leading orthopedic centers say they have treated a number of patients over the last year with problems related to the metal debris.
Food-Borne Illnesses Cost U.S. $152 Billion Food-borne illnesses, such as E. coli and salmonella, not only take a toll on American consumers' health, they cost the United States $152 billion annually in health care and other losses. The report comes as the U.S. Senate considers legislation that would require more government inspections of food manufacturers and give the Food and Drug Administration new authority to order recalls, among other things. The government estimates 76 million people each year are sickened by food-borne illness, hundreds of thousands are hospitalized and about 5,000 die. The financial cost determined in the new report was significantly higher than the $35 billion reported by the Agriculture Department in 1997. In 2008 and 2009, salmonella contamination in peanut butter crackers and peanut paste sickened 714 people in 46 states and prompted the largest recall in history. In just the last few months, contamination fears have sparked numerous recalls, including onion soup mixes, salami, and Nestle raw cookie dough. In addition, the FDA warned Kellogg about tainted Eggo frozen waffles.
Philip Morris Sues Over Counterfeit Marlboros Philip Morris USA, the nation's largest tobacco company, has filed federal lawsuits accusing eight New York and New Jersey retailers of selling counterfeit Marlboro cigarettes. The company said the New York area is fertile for cigarette smugglers because of the combination of high federal, state and local taxes. Over the last few years, increased taxes on cigarettes have given rise to counterfeit or black market cigarettes. In New York City, a pack of Marlboro cigarettes can cost more than $10. Philip Morris is asking the court to ban the retailers from purchasing, distributing or selling counterfeit Marlboro cigarettes. It also is asking for companies to turn over their profits from the illegal cigarettes, along with punitive damages and attorney fees. Philip Morris says it has filed lawsuits against 35 stores in New York and New Jersey since last year.
Salmonella Fears Prompt Onion Soup and Mix Recall Kroger Co. has recalled two onion soup and dip mixes because of possible salmonella contamination. The grocer said an ingredient in its Kroger Onion Soup & Dip Mix and Kroger Beefy Onion Soup & Dip Mix may have been contaminated with the bacteria. No illnesses have been reported in connection with the products, but eating food contaminated with salmonella can cause salmonellosis, a potentially life-threatening bacterial foodborne illness.
Shelled Pecans Recalled Over Salmonella Fears A Texas-based pecan company has recalled plastic bags of its pecan pieces in small, medium and large sizes because they may be contaminated with salmonella. The American Pecan Co. announced that its one-pound bags of shelled pecans were sold to walk-up customers in south-central Texas, as well as to mail-order customers in Texas, New York and Massachusetts. A routine sampling by the Food and Drug Administration found bacteria in the pecans. The company says no illnesses have been reported, but it has stopped producing and distributing the product.
China's Tainted Milk Caused Kidney Damage More than one in 10 Chinese children sickened by contaminated milk showed signs of kidney damage six months afterward, researchers have found, raising concerns about the long-term effects of the country's massive food safety scandal. At least six children died and nearly 300,000 children fell ill two years ago after consuming infant formula deliberately contaminated with the industrial chemical melamine in order to fool inspectors testing for protein. The study's results point to the possibility that as many as 30,000 children could have suffered health complications for months after drinking the contaminated milk. It also shows that the long-term health effects remain little understood, even as China make plodding progress in cleaning up a food supply strewn with tainted products. More milk products contaminated with melamine resurfaced in markets in recent months. Researchers studying ultrasound images of infants who fell ill in the 2008 contamination found that while most children in a rural Chinese area recovered, 12 percent still showed kidney abnormalities six months later.
Choking Warning Urged for Food Labels The American Academy of Pediatrics, the nation's largest pediatricians group, is calling for sweeping changes in the way food is designed and labeled to minimize children's chances for choking. Choking kills more than 100 U.S. children 14 years of age or younger each year and thousands more - 15,000 in 2001 - are treated in emergency rooms. Food, including candy and gum, is among the leading culprits, along with items like coins and balloons. Of the 141 choking deaths in kids in 2006, 61 were food-related. Doctors say high-risk foods, including hot dogs, raw carrots, grapes and apples, should be cut into pea-sized pieces for small children to reduce chances of choking. Some say other risky foods, including hard candies, popcorn, peanuts and marshmallows, shouldn't be given to young children at all. Federal law required choking warning labels on certain toys including small balls, balloons and games with small parts. Unless food makers voluntarily put more warning labels on high-risk foods, there should be a similar mandate for food, the pediatrics academy says.
GlaxoSmithKline to Remove Zinc from Poligrip Denture Adhesive GlaxoSmithKline announced it would stop making and distributing three versions of its popular denture adhesive Poligrip until it removed zinc from the products because of concerns about health risks. The action affects three Poligrip products: Super Poligrip Original, Ultra Fresh and Extra Care. The company plans to reformulate the products, used by an estimated 3.5 million households in the United States, without zinc. In a consumer advisory on its Web site, the company said it had "become aware of potential health problems associated with the long-term excessive use of our zinc-containing denture adhesive products." The company added that the products were safe to use as directed, but that some consumers used excessive amounts. Glaxo said excessive use of the product over several years "may lead to the development of neurological symptoms and blood problems such as anemia. Neurological symptoms may include numbness, tingling or weakness in the arms and legs, and difficulties with walking and balance."
Coded to Obey Law, Lights Become Marlboro Gold When it comes to new rules for marketing so-called light cigarettes, tobacco companies plan to honor the letter of the law - but to shade the truth, critics say. Come June, under the new federal tobacco law, cigarette companies will no longer be allowed to use words like "light" or "mild" on packages to imply that some cigarettes are safer than others. But in a move that critics say simply skirts the new rules, tobacco companies plan to use packaging to make those same distinctions: light colors for light cigarettes. So Marlboro Lights, the nation's best-selling brand, from Philip Morris, will be renamed Marlboro Gold. Anticipating the new rules, R.J. Reynolds has already changed Salem Ultra Lights, which are sold in a silver box, to Silver Box. The Food and Drug Administration has begun a federal review of the color-coding approach, a step that could conceivably lead to further actions against products designated as light.
FDA Warned Kellogg Over Tainted Eggo Waffles U.S. food safety regulators have made public a warning letter to Eggo waffle maker Kellogg Co. in which they said the company had not gone far enough to address food safety violations at its Atlanta froze food plant. An October 2009 Atlanta plant inspection found bacterial contamination and sanitation violations such as improper handling of trash and food and insufficiently sanitized equipment, the FDA said. The FDA's letter comes after the Georgia Department of Agriculture found Listeria bacteria in Eggo Buttermilk Waffles earlier that year. Kellogg's plant had "significant deviations" from the manufacturing practices for food manufacturers and Kellogg's response so far had not addressed the violation, the agency wrote. Kellogg said it has fully addressed all of the violations and that its response to the FDA letter would be filed shortly. FDA inspectors found Listeria on five swabs from around the Atlanta plant. One of those positive swabs came from the wheels of a forklift used in the plant. Listeria is a bacteria that can contaminate food and cause a mild illness or a severe, sometimes life-threatening, illness called invasive listeriosis.
Think Cigars are Safe? Not Quite, Study Shows If you thought it was only cigarettes that were dangerous to smoke, think again. A recent U.S. study shows cigars and pipes also raise the risk of lung disease, defying their image of sophistication and celebration. Researchers found that even if the smoke is not inhaled, people who smoke cigars or pipes have a greater risk of airway damage that could lead to emphysema and other diseases. Cigarette smoking is a well-known risk factor for chronic obstructive pulmonary disease, a group of lung diseases that includes emphysema and chronic bronchitis, but few studies have looked at whether other types of smoking add up to COPD. The research found that among more than 3,500 U.S. adults, those who had ever smoked cigars or pipes were more likely than non-smokers to show obstructed airflow - a hallmark of COPD - during tests of lung function.
E. Coli Fears Spark 4.9 Million Pound Meat Recall A Southern California meatpacking firm has significantly expanded its recall of ground beef and veal that might be contaminated with E. coli. The recall includes approximately 4.9 million pounds of products. The original recall was announced earlier this year and was for only 864,000 pounds of meat. There have been no reports of illnesses associated with consumption of the products, which include ground beef patties, diced beef, veal patties and beef burrito filling mix. The original recall was expanded based on evidence collected in an ongoing criminal investigation. Inspectors found the products were prepared in a manner that did not follow rules to prevent food safety hazards.
Advocates Want More Money for Food and Drug Administration The Food and Drug Administration was sitting pretty, winning a significant budget increase while many other federal agencies faced the prospect of cut or frozen budgets for 2011 as the Obama administration confronted a huge deficit. But a sprawling coalition of public interest advocates, patient groups and health care industry interests regulated by the FDA had a negative message for the White House: It's not enough. Lobbying for more money for a regulatory agency in the face of a projected trillion-dollar deficit may seem counter-intuitive, especially when many of those doing the pushing include food, drug and medical equipment interests that haven't always welcomed FDA oversight. That's because its role in ensuring the safety of food, drugs and medical devices has huge implications for the economy, influencing everything from the price of produce to the marketability of high-tech medical goods.
Chicken-Flavored Pet Food Recalled Nature's Variety is voluntarily recalling packages of its chicken-flavored pet food over concerns of salmonella contamination. The company said in a statement that no pets or humans have been sickened. Included in the recall are three-pound packages of chicken medallions, six-pound packages of chicken patties and two-pound packages of chicken chubs.
Report Points to Diet Supplements Risks A new report on people sickened by a liquid dietary supplement illustrates the real - if rare -risks associated with using these products. In 2008, users of "Total Body Formula" and "Total Body Mega Formula" started losing their hair and began suffering from fatigue, diarrhea, nausea and other symptoms; some doubled their dose of the liquid supplement in response. But the symptoms, first reported by patients of a Florida chiropractor who was selling the products in his office, were subsequently traced to a batch of the supplements carrying up to 200 times the amount of selenium stated on the label. Further investigation found 201 people in ten states who had been sickened by the supplement. While small amounts of selenium are essential for proper nutrition - and people usually get plenty in their diet - excess amounts are toxic, and the effects can persist for months. Researchers found that the median dose of selenium people had consumed was nearly 42,000 micrograms per day; the recommended daily allowance of selenium is 55 micrograms.
USDA Sharpens Rules for Organic Milk and Meat New rules say organic milk and meat must come from livestock grazing on pasture for at least four months of the year, and that 30 percent of their feed must come from grazing. The old rules said only that animals must have "access to pasture." It took years to craft the new regulations, which offer clarity for ranchers, food companies and consumers, who have forked over billions of dollars for organic food without a crystalline standard for livestock. The organic industry's rapid expansion, and the ensuing competition between small- and large-scale farmers and ranchers, has put a premium on defining what it means to be organic. To that end, the Agriculture Department announced the pasture rules are the first step in sharpening that definition.
Florida Ruling to Determine Fate of Thousands of Asbestos Cases Responding to a split between two South Florida appellate panels, the Florida Supreme Court has stepped into a simmering dispute over a law meant to help courts manage a flood of asbestos litigation. The justices heard arguments for the first time on whether retroactive application of the 2005 Florida Asbestos and Silica Compensation Fairness Act impermissibly interfered with pending lawsuits by setting a new medical threshold for people exposed to asbestos. With thousands of claims hanging in the balance, the high court is reviewing the dismissal of 13 cases by a judge for failing to meet the law's requirements. Justices asked attorneys on both sides whether passage of the law, which requires plaintiffs to demonstrate diagnosis of asbestos-related disease, wiped out previously viable claims. If so, the law could run afoul of constitutional due process protections.
'Biggest Loser' Trainer Sued for Diet Supplement Jillian Michaels has been sued for alleged false advertising by a woman who claims she was duped into buying a diet supplement endorsed by the celebrity trainer. The woman is seeking class-action status for a case she filed in California. Michaels is a hard-charging, no-nonsense trainer best-known as one of the stars of NBC's hit reality show, "The Biggest Loser." The woman's lawsuit claims she bought a product called "Jillian Michaels Maximum Strength Calorie Control" and that it has failed to lessen her appetite or cause her to lose weight as advertised. Michaels' picture and endorsement appear on the packaging, touting her as "America's Toughest Trainer." The product and a Web site advertising include the claim, "Two Capsules Before Main Meals and You Lose Weight...That's It!" "Ms. Michaels knows better - taking two pills before eating does not miraculously cause weight loss," the lawsuit states. The Web site and packaging do note that the statements haven't been approved by the U.S. Food and Drug Administration. The woman is also suing the manufacturing and marketing company behind the supplement.
Target Pulls Valentine's Toys Over Lead Concerns Target Corp. announced it is pulling its Valentine's Day "Message Bears" from store shelves after California's attorney general raised concerns that the toys have illegal levels of lead. The response comes a day after a letter sent by the attorney general said testing of the holiday toys revealed lead levels that violate federal law. The products were identified as two of Target's "Message Bears" - one a pink stuffed bear with "XOXO" across the chest and the other a brown stuffed bear with "I Love U" across the chest, with "love" represented by a heart. Investigators from the Center for Environmental Health, a nonprofit watchdog, found that the bears' inflated vinyl letters contained well over federal limits for lead in products for children under the age of 12.
Smoker's $300 Million Award to be Overturned The largest individual award to a former Florida smoker against the tobacco industry will not stand. Calling the $300 million jury verdict "excessive" and "shocking," a judge said he would determine a lower award later against tobacco giant Philip Morris USA. The landmark verdict was reached last year for an emphysema patient who quit smoking in 1993. The jury's decision to award $56.5 million in compensatory damages and $244 million in punitive damages stemmed from anger and went beyond just compensation and punishment, the judge said. Under state law, judges must reduce jury awards found to be excessive. The judge said he would determine a proper reduction based on the evidence.
Turkey Hill Recalls 150 Cartons of Ice Cream Turkey Hill Dairy has recalled a small batch of its chocolate marshmallow ice cream because it may contain almonds. The dairy was able to isolate the problem to fewer than 150 1/2-quart containers sold in central Pennsylvania. The ice cream had been distributed to 205 locations, including Walmart, convenience stores and some grocery stores and are being pulled from the shelves. Turkey Hill issued the recall after a customer alerted the dairy that day that there were almonds in a container of chocolate marshmallow ice cream and that the container did not identify the nut on its list of ingredients. No illnesses have been reported, and Turkey Hill narrowed the problem down to two minutes of production.
170 More Tons of Tainted Milk Found in China A new discovery has punched a 170-ton hole in China's promises to overhaul its food safety system. Officials say they've found yet another case where large amounts of tainted milk powder from the country's 2008 scandal that should have been destroyed were instead repackaged. China ordered tens of thousands of milk products laced with an industrial chemical burned or buried more than 300,000 children were sickened and at least six died from the contamination. But, crucially, the government did not carry out the eradication itself, and this month an emergency crackdown has made it clear that tons of compromised products are still on the market. At least five companies are suspected of reselling tainted products that should have been destroyed. The problem products uncovered in the 10-day emergency crackdown have so far been limited to the domestic market.
Study Links Sugary Sodas to Pancreas Cancer People who drink two or more sweetened soft drinks a week have a much higher risk of pancreatic cancer, an unusual but deadly cancer. People who drank mostly fruit juice instead of sodas did not have the same risk, the study of 60,000 people in Singapore found. Sugar may be to blame but people who drink sweetened sodas regularly often have other poor health habits. The high levels of sugar in soft drinks may be increasing the level of insulin in the body, which may contribute to pancreatic cancer cell growth. Insulin, which helps the body metabolize sugar, is made in the pancreas. Researchers followed 60,524 men and women for 14 years. Over that time, 140 of the volunteers developed pancreatic cancer. Those who drank two or more soft drinks a week had an 87 percent higher risk of being among those who got pancreatic cancer.
FDA May Fix Cereal Servings Seeking a new weapon in the fight against obesity, the Food and Drug Administration wants to encourage manufacturers to post vital nutritional information, including calorie counts, on the front of food packages. The goal is to give people a jolt of reality before they reach for another handful of chips. But the urgency of the message could be muted by a longstanding problem: official serving sizes for many packaged foods are just too small. And that means the calorie counts that go with them are often misleading. So to get ready for front-of-package nutrition labeling, the FDA is now looking at bringing serving sizes for foods like chips, cookies, breakfast cereals and ice cream into line with how Americans really eat. Combined with more prominent labeling, the result could be a greater sense of public caution about unhealthy foods.
FDA Compares Dissolvable Tobacco to Candy The Food and Drug Administration is saying in letters to two tobacco companies that flavored, dissolvable tobacco products - that the agency compares with candy and says contain a lot of nicotine - could be particularly appealing to kids and young adults. The FDA's Center for Tobacco Products wrote to R.J. Reynolds Tobacco Co., maker of Camel cigarettes, and the smaller Star Scientific Inc. voicing concern over smokeless products that are consumed like breath mints but made from finely milled tobacco. "CTP is concerned that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance and easily concealable size of many of these products," the Center for Tobacco Products told the companies. Regulators are worried the products' nicotine content and rapid dissolution could cause nicotine dependence and addiction and be especially dangerous to children and young adults.
FDA Aims to Identify Risky Food and Drug Imports U.S. border inspectors nationwide will soon start using a new computer system to identify risky food and medicine from abroad, the head of the U.S. Food and Drug Administration has announced. The project follows recalls of tainted toothpaste, pet food, seafood and other products from China, as well as a contaminated blood thinner blamed for dozens of deaths in 2008. About 20 million of shipments of food, medicine, medical devices and cosmetics are expected to arrive at U.S. ports this year, which is up from about 6 million a decade ago. With the growing flood of products, inspectors typically examine less than 1 percent. Under the new system, border staff can check products in a computer database that gives a score for the risk level. The score is calculated in part based on whether the maker has a history of recalls and how susceptible the product is to contamination.
Tainted Milk Shows China's Safety Challenges The resurfacing of tainted milk products in China highlights the challenges of policing the food supply in a country where close ties between local authorities and companies hamper regulation while producers are undertrained. The problems have dealt another blow to China's efforts to restore confidence in its dairy supply after a massive contaminated milk scandal in 2008 left at least six babies dead and sickened 300,000 other children. At the time, China promised sweeping changes and punished dozens of officials, dairy executives and farmers. In November, it executed a dairy farmer and a milk salesman. But the penalties failed to deter others, and local governments with close ties to dairy companies often shield them from being punished, leading to the new misdemeanors.
Missouri Firm Recalls Beef on E. Coli Concerns West Missouri Beef is recalling 14,000 pounds of fresh boneless beef because it may be contaminated with E. coli, the U.S. Agriculture Department announced. No illnesses have been linked to the beef, which was distributed to wholesalers in the Chicago area. The meat was produced from October to January, and the recalled beef is in containers marked "EST. 5821." The problem was discovered during a government review at the plant. E. coli is a potentially harmful bacteria that can cause bloody diarrhea, dehydration and in most severe cases kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to food-borne illnesses.
Black Pepper to Blame for Salmonella Outbreak Tests have shown that the same strain of salmonella that sickened more than 200 people in at least 42 states has been found in black pepper, but it's not clear if it's the only source of the outbreak, the state health department has announced. The tests traced the salmonella to closed containers of ground black pepper that would have been used to coat salami at a meat company. The company recalled more than 1 million pounds of salami after many of those who got sick reported they ate it. Meanwhile, about half the people sickened didn't eat any salami. The meat company had two suppliers for the pepper, and the U.S. Department of Agriculture and the U.S. Food and Drug Administration are working to trace its origin and determine if it was distributed anywhere else. The federal Centers for Disease Control reported that at least 203 people had been infected with the same strain of salmonella since July and at least 40 were hospitalized.
Flame Retardant May Affect Fertility A study in the latest issue of Environmental Health Perspectives found that, for each 10-fold increase in PBDE blood concentration, women experience a 30 percent decrease in the odds of getting pregnant each month. PBDEs, or polybrominated diphenyl ethers, are more than just common flame-retardant chemicals - they are also hormone-disrupting pollutants that build up in the blood and tissues.PBDEs have been associated with reproductive and hormonal effects in animals, but this is the first study to examine their association with human fertility. The researchers measured PBDE levels in blood samples from 223 pregnant women enrolled in a long-term study examining environmental exposures and reproductive health. The investigators also asked the women how many months it had taken them to become pregnant. They found that women with the highest blood concentrations of PBDE took the longest to become pregnant - up to 12 months. The study cut off at 13 months. In addition, the 107 women who were actively trying to become pregnant were half as likely to conceive in any given month if they had high levels of PBDE in their blood.
Cadmium Also Found in Adult Jewelry Concern about the heavy metal cadmium in jewelry grew as a California environmental group said new testing of adult necklaces and bracelets bought at three leading retailers, including Saks Fifth Avenue and Aeropostale, detected high levels of the toxic material - as much as 75 percent by weight. One of the pieces was made in China and another was made in India. Labeling on a black-colored link necklace, purchased at Saks for $69.999, did not indicate where it was made. Based on the results of its testing, the Center for Environmental Health said it would seek a ban on cadmium in all jewelry. The center said it began lab testing adult jewelry for cadmium after an investigative report that pieces of cheap children's jewelry imported from China contained levels of cadmium of up to 91 percent of their total content.
Where There's No Smoke, Altria Hopes There's Fire For years, Altria, home to Philip Morris and its popular Marlboro cigarette brand, was a corporate pariah blamed for the deaths of millions of people and sued for hundreds of billions of dollars by attorneys general in every state. After eventually acknowledging, like others in the industry, that cigarette smoking was, indeed, addictive and caused disease, Altria went a step further - it broke from the Big Tobacco pack and began supporting legislation that would ultimately put the company under the regulatory thumb of the Food and Drug Administration. Altria's motives for submitting to strict oversight have long been a mystery. Did the company and its executives, who were internally pursuing a strategy of "societal alignment," suddenly embrace a true partnership on public health? Or was this a case, as its longtime foes and competitors have argued, of Altria seeking to generate good P.R. or lock in its market dominance by cozying up to a regulator that could restrict rivals from marketing new products? Another possible answer was highlighted recently, as the federal government began fine-tuning aspects of a law that President Obama signed last year that gives the government sweeping new powers to regulate the production and marketing of tobacco products. A series of letter that Altria submitted to the FDA as part of that process argues that the government should, effectively, sign off on the notion that smokeless tobacco products are less harmful than cigarettes - and that Altria and other companies should be allowed to market them as such to consumers.
'Princess and Frog' Items Recalled for Cadmium Federal consumer safety regulators have announced the recall of "The Princess and The Frog" pendants sold at Walmart stores because of high levels of the toxic metal cadmium, an unprecedented action that reflects concerns of an emerging threat in children's jewelry. The recall affects two products, about 55,000 items in total, sold exclusively by the world's biggest retailer for $5 each. The action was taken voluntarily by a Rhode Island company. The U.S. Consumer Product Safety Commission, which disclosed the recall, had been testing for cadmium in children's metal jewelry for several weeks in response to an investigative report that revealed high levels of the known carcinogen in the Disney movie-themed pendants and other children's metal jewelry imported from China. The Walt Disney Co. has released a letter to its vendors and licensees that sets a zero-tolerance policy for cadmium in any children's jewelry bearing its brand. That is far stricter than federal regulations, which not only don't require testing for cadmium in children's jewelry but also set no upper limit for home much a product can contain. Disney is now requiring that all products be tested for cadmium, and that a detection means production and distribution of the product should be stopped.
Pepper in Salami May be Source of Salmonella Black pepper used in salami is the possible cause of a salmonella outbreak that sickened people in 40 states, the Rhode Island Department of Health has announced. Tests showed the same strain of salmonella that has sickened at least 189 people since July was also found in two open containers of peppers at a meat company. Thirty-seven people have been hospitalized in the outbreak. Officials are still waiting for results from closed containers of pepper, which are expected soon. The company recalled 1.2 million pounds of pepper-coated salami after officials used the shopping records of people who were sickened to pinpoint the source of the problem.
Lively Arguments in Tobacco Case Center On Preclusive Effect of Factual Findings In a lively and complex argument before a federal appeals court, lawyers for the nation's largest tobacco companies wrangled with attorneys for a woman whose husband died of lung cancer over whether factual findings in a 2006 Florida state case may be applied in some 4,000 federal death and injury suits. The arguments focused primarily on whether plaintiffs going forward with individual suits in federal court would have to relitigate matters decided by the 2006 state court jury in Florida. Some of those findings include: tobacco companies falsified statements and made cigarettes that were dangerous. Another issue for the lawyers was whether a federal district court has the authority to, essentially, overrule the Florida Supreme Court. The primary issue arose from a collateral challenge to the final determination of the Florida Supreme Court in a class action case in which a lower state court jury found in favor of individual plaintiffs and the class as a whole, awarding $145 billion in punitive damages. When the tobacco companies appealed, a Florida court and the state Supreme Court upheld two of the individual verdicts, but found that the $145 billion punitives award had improperly preceded a liability determination. The higher courts prospectively decertified the class on the grounds that individual determinations of specific causation and damages couldn't be established on a classwide basis. Most importantly, the Florida Supreme Court found what it called a "pragmatic solution" to retrying thousands of liability cases. It ruled that Florida common law would permit common findings to be "retained" in follow-on damage actions. In other words, some of the jury's classwide findings would be given preclusive effect in subsequent individual trials of one-time class members. Among those findings were the jury's determination that the tobacco companies marketed cigarettes that were "defective and unreasonably dangerous," concealed or omitted material information about the health and addictive effects of smoking, and failed to exercise the "degree of care" that a "reasonable cigarette manufacturer" would have exercised under similar circumstances.
2 Million Faulty Needles Recalled by FDA Federal health officials have announced the recall of 2 million medical needles because of a risk they can push bits of silicone into patients' bodies. The Food and Drug Administration said the Japanese manufacturer has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009. The needles are used to access injection ports, which are devices implanted beneath the skin of patients who require frequent injections. The ports connect to a vein and allow easy delivery of chemotherapy, antibiotics and other injectable drugs. Huber needles are designed to be non-coring, or to penetrate an injected materials without retaining any of it. However, a monthslong FDA investigation found that the needles can dislodge bits of silicone from the ports, potentially pushing them into the patient's bloodstream. The problem can also damage the ports themselves, resulting in problems delivering drug therapy. An inspection at the manufacturing plant in Japan found that 60 to 72 percent of the company's needles had the design problem.
Studies Link Rare Ailment to Pain Pumps When the first cases popped up in orthopedic journals, they read like medical mysteries. Surgeons around the country reported that several active young patients had suddenly developed chondrolysis, a relatively rare ailment in which joint cartilage dies, leaving bone to grind on bone. Chondrolysis has ended the athletic careers of dozens of high school and college students. In the most severe cases, it has required joint replacements. Many sufferers face lifetimes of pain and disability. Although it is still unknown why chondrolysis develops, several medical studies have concluded that a likely culprit is a pain pump, a postsurgical medical device used to deliver local anesthetics to a specific area through a plastic tube. Whether the pumps cause the chondrolysis - and whether manufacturers should have done more to warn surgeons about the potential risks - is the subject of more than 150 lawsuits working their way through state and federal courts. Recently, an Oregon jury awarded nearly $5.5 million to a chondrolysis patient, and at least a dozen cases are expected to go to trial this year. Lawyers for the patients argue that the manufacturers disregarded safety in their quest to expand into the orthopedic market. But the manufacturers and some medical experts argue that more research is needed to determine whether pain pumps are to blame.
Smoker's Asbestos Claims Fall Short with Jury A Los Angeles jury returned a defense verdict in a multimillion-dollar asbestos case against tobacco company Lorillard, a maker of cigarettes equipped with asbestos filters in the 1950s. The plaintiff was seeking $15 million in economic and non-economic damages. The jury found that the plaintiff, who was diagnosed with mesothelioma in 2008, smoked Lorillard's Kent cigarettes with asbestos-containing filters; however, the jury also concluded that there was no design defect in the product, and that Lorillard wasn't negligent and didn't have a duty to warn him about the dangers of its product. The jury seemed particularly swayed by an expert witness who told the jury about how widely asbestos was used in the 1950s.
More Melamine-Tainted Milk Found in China Melamine-tainted dairy products were pulled from convenience store shelves in southern China more than a year after hundreds of thousands of children had been sickened in a massive milk safety scandal. The announcement calls into question the effectiveness of a crackdown launched by Chinese officials to improve product safety after a number of scandals, including the contamination of baby formula in 2008 and the recent discovery of the toxic metal cadmium in cheap jewelry. Frozen milk products and cartons of milk dating from early 2009 were taken off the shelves after health inspectors tested them and found melamine. The provincial health bureau is checking to see why the products were not pulled from the shelves earlier. Tainted products from three companies were discovered in more than a dozen convenience stores around the province. One of the companies was among those named in the original melamine scandal in 2008, when six children died and 300,000 were sickened after drinking baby formula with melamine, using in the manufacture of plastics and fertilizer.
Huge Range of Salt Found in Processed Foods Many processed foods contain too much salt, and sauces, spreads and processed meats are the top offenders, new research shows. People who consume lots of salt are more likely to see their blood pressure rise as they get older, with a corresponding increase in their heart disease risk. Public health officials are increasingly looking to the food industry collaborations, while New York City has just launched a campaign to cut U.S. salt intake by 25 percent over the next five years. Similar efforts are now underway in Australia, and some companies have begun to reduce the salt content of some of their products. To help guide such efforts, researchers gathered data on the sodium content of 7,221 products in 10 food groups, 33 categories and 90 subcategories. Foods were considered to be high in sodium if they contained more than 500 milligrams of sodium for every 100 grams, while foods with sodium contents below 120 milligrams of sodium for every 100 grams were classified as low sodium. The researchers found dramatic variations in salt content within certain food categories. For example, the saltiest type of hard cheese had six times more sodium than the least salty type, while there was a 14-fold difference in salt content within the sliced meat category and a 100-fold difference within the frozen potato product category.
Giant Eagle Voluntarily Recalls Frozen Hash Browns Giant Eagle Inc. said it voluntarily recalled its Giant Eagle and Food Club brands of frozen loose hash brown potatoes because of the presence of bacteria in non-related products produced at the same independent plant. Giant Eagle, when informed of the possible contamination, said it hired an independent laboratory for testing that confirmed some Giant Eagle products tested positive for a bacteria that can cause serious infection. The Centers for Disease Control has said the risk of an individual developing an infection after consumption of a contaminated product is very small. This particular bacteria affects the elderly, pregnant women, newborns and adults with weakened immune systems. Giant Eagle added that potential health risks are virtually eliminated if the product is cooked as directed.
Guilty Plea in Sale of Products with Steroids VMG Global, a sports nutrition company in California, pleaded guilty to selling products under the guise of dietary supplements that had been illegally spiked with steroids. The Food and Drug Administration has jurisdiction over dietary supplements, defined as products that can offer general health benefits but cannot claim to treat specific diseases or symptoms. Products marketed as dietary supplements that are found to contain undeclared pharmaceutical ingredients like steroids are considered to be illegal, misbranded drugs. Last year, the FDA warned consumers not to buy products marketed as body-building supplements because of concerns that some items might contain undeclared steroids, which can cause serious long-term health problems like acute liver injury. From 2005 through 2009, VMG Global knowingly deceived consumers and the government by marketing two illegal drug products that each contained a synthetic anabolic steroid under the guise of dietary supplements. During this time period, the illegal products, called Tren Xtreme and Mass Xtreme, generated revenue of about $5.6 million. VMG Global pleaded guilty to one charge of introducing unapproved drugs into interstate commerce with the intent to defraud and mislead.
FDA Mulls Tougher Tanning Bed Cancer Warning Just as millions head to tanning beds to prepare for spring break, the Food and Drug Administration will be debating how to toughen warnings that those sunlamps pose a cancer risk. Yes, sunburns are particularly dangerous - but there's increasing scientific consensus that there's no such thing as a safe tan, either. The World Health Organization's cancer division last summer listed tanning beds as definitive cancer-causers, right alongside the ultraviolet radiation that both they and the sun emit. They'd long been considered "probably" carcinogens, but what tipped the scales was an analysis of numerous studies that concluded the risk of melanoma jumps by 75 percent in people who used tanning beds in their teens and 20s. Next comes the FDA, which has long regulated tanning beds as "Class I devices," a category of low-risk medical devices that includes bandages. Tanning beds do bear some warnings about the cancer link, but the FDA recently decided those labels aren't visible enough to consumers and don't fully convey the risk, especially to young people. Later this year, the FDA's scientific advisers will open a public hearing to explore stricter tanning bed regulations, including stiffer warnings and reclassifying them to allow other steps.
Salmonella Warning Issues for Some Dog Treats Consumers should not use certain beef dog treats distributed by Merrick Pet Care because the pet food might be contaminated with salmonella, health authorities have warned. Merrick Beef Filet Squares for dogs were distributed nationwide through retail stores and the Internet. No illnesses linked to the products have been reported, according to the Food and Drug Administration. The FDA warned the contaminated pet food could also infect people if they handled the dog treats and have not thoroughly cleaned their hands. The FDA conducted routine testing of the treats and found evidence for salmonella. Another inspection found deficiencies in the packaging and manufacturing. In pets, salmonella can cause diarrhea, fevers, vomiting, loss of appetite, lethargy and abdominal pain.
Study Sees Parking Lot Dust as a Cancer Risk Chemicals in a cancer-causing substance used to seal pavement, parking lots and driveways across the U.S. are showing up at alarming levels in dust in homes, prompting concerns about the potential health effects of long-term exposure, a new study shows. The substance is coal tar sealant, a waste product of steel manufacturing that is used to protect pavement and asphalt against cracking and water damage, and to impart a nice dark sheen. It is applied most heavily east of the Rockies but is used in all 50 states. But scientists with the U.S. Geological Survey say the sealant - one of two types commonly used in the U.S. - doesn't stay put. It slowly wears off and is tracked into homes on the shoes of residents. The study found high levels of chemicals used in the sealant in house dust and marked the first time researchers have raised alarms about potential health effects for humans - especially young children - from the parking lot coatings. Taken with previous studies indicating that the chemicals contaminate waterways, where they have been shown to harm insects and tadpoles, the finding raises serious questions about the advisability of using coal tar as a sealant.
China to Probe Toxic Metal in Jewelry Exports China's product safety agency will look into findings that dangerous levels of cadmium are being used in exports of children's jewelry, Chinese officials have announced following growing concern in the United States about the products. Attending a toy safety conference in Hong Kong, officials said that the agency had only just learned about a press investigation and would examine the findings on cadmium contamination. Retail giant Wal-Mart pulled products cited in the report from its stores, and the attorney general of Connecticut promised to investigate suspect costume jewelry. A New York state legislator called for a ban on the sale of children's jewelry with cadmium in the state, and a top U.S. consumer safety regulator warned Asian manufacturers that cadmium and other toxins must be kept out of children's charm bracelets, pendants and other baubles. Lab tests conducted on 103 pieces of low-priced children's jewelry on sale in the U.S. found 12 items with raised levels of cadmium, which can hinder brain development in young children and is known to cause cancer.
FDA Launches Consumer Web Site to Explain Itself The Food and Drug Administration is launching a new Web site explaining its operations to consumers as part of a broader effort to rebrand itself as a more accessible agency. The Web site, dubbed "FDA Basics," features short videos about the agency as well as conversations with FDA leaders. The FDA has long operated under strict confidentiality rules because its scientists handle reams of proprietary information from food, drug and device companies. However, the FDA's operating style has come under fire in recent years from critics who have charged that the agency is too slow to disclose drug safety issues.
Calories in Restaurant Food Often More Than Claimed A new study says food at popular chain restaurants and in the frozen food aisles can be more fattening than advertised. A study of meals from 10 restaurant chains including Ruby Tuesday and Wendy's found calorie counts averaging 18 percent more than the values listed by the restaurants. Diet meals made by Lean Cuisine, Weight Watchers, Health Choice and others averaged 8 percent higher than the numbers on the label.
House Not a Product, Says Lawyer Suing Leaky Stucco Manufacturer A case argued recently in front of the New Jersey Supreme Court will determine whether homeowners can lodge product liability suits over housing components that cause damage to the house itself. The plaintiffs were turned away by lower courts in their suit alleging that defectively designed siding allowed water to seep through to the interior of their home, causing severe damage. Other courts cited a provision of the Products Liability Act that defines compensable harm as "physical damage to property, other than the product itself." In this case, the courts found, the product is the house, not the siding. The plaintiffs' lawyer argued that the lower courts misconstrued the law's intent, which was to protect consumers. The plaintiff and his family never dealt with the synthetic stucco company. They bought the house in 2002 and the siding was installed in 1995 when the original owners bought the home. In 2003, the family noticed mold lines. The source of the mold was tracked to moisture that had seeped behind the stucco, causing damage to sheathing, framing, doors, windows and sub flooring. Lower courts ruled the damage was to the house itself and did not constitute "other property" damage so as to allow the plaintiffs to avoid the economic-loss rule, which bars recovery for damage to the product itself, such as cost of repair or replacement, consequential loss of profits and the diminished value of the product as a result of the defect. The company is also arguing that the plaintiffs knew of the damage when they purchased the home; a home inspector had warned them about the risk of water damage associated with the product. They could have purchased a warranty, demanded replacement or walked away from the sale, but they did not.
Even Low Exposure to Lead Poses Risk Recent research shows that lead exposure, long known to be dangerous to children, is also hazardous for adults and even low-level exposure can cause significant health risks. Adult health impacts are occurring at lead exposure levels far below those regulated by the Occupational Safety and Health Administration's standards, and those standards, set in 1978, are no longer protective of human health. As a result, the National Institute of Occupational Safety and Health's Adult Blood Lead Epidemiology and Surveillance Program, the Centers for Disease Control and Prevention, and the Council of State and Territorial Epidemiologists have all reduced the adult blood level considered as "elevated" from 25 to 10 micrograms per deciliter. Studies also have found that the human lead levels revealed by blood tests are of concern at lower levels than previously thought. Even at the lower blood levels, research has found, adults can suffer anemia, hypertension, impaired brain function, kidney disease and cardiovascular disease. Women can experience decreased fertility and reproductive problems, and children of lead-exposed women are at higher risk for birth defects.
Court Tosses $14 Million Verdict Against Whirlpool for Fatal Fire Texas' highest court has nullified a $14 million verdict in favor of a couple who alleged that a defectively designed Whirlpool dryer caused a fire in their trailer that killed their teenage son. The Texas Supreme Court found that testimony by the couple's expert was scientifically unreliable and insufficient to establish that the fire was caused by a design defect in the dryer, finding his opinions to be "subjective, conclusory and not entitled to probative weight." The case involves a used Whirlpool dryer that the couple says they bought from their daughter in 2002. A year after installing the dryer, a fire destroyed the trailer and killed their son. The couple said the fire started in the dryer and sued Whirlpool. The expert claimed that Whirlpool used a corrugated tube in the appliance's air circulation system that was prone to clogging. When the tube became clogged, pieces of lint escaped, were ignited by the unit's heater element and set clothes that were in the dryer on fire. Both the fire marshal and Whirlpool disagreed that the fire was caused by the dryer.
Safety of Beef Processing Method is Questioned Eight years ago, federal officials were struggling to remove potentially deadly E. coli from hamburgers when an entrepreneurial company from South Dakota came up with the idea to inject beef with ammonia. The company had been looking to expand into the hamburger business with a product made from beef that included fatty trimmings the industry once relegated to pet food and cooking oil. The trimmings were particularly susceptible to contamination, but a study commissioned by the company showed that the ammonia process would kill E. coli as well as salmonella. Officials at the United States Department of Agriculture endorsed the company's ammonia treatment, and have said it destroys E. coli "to an undetectable level." They decided it was so effective that in 2007, when the department began routine testing of meat used in hamburger sold to the general public, they exempted all products from the company. With the USDA's stamp of approval, the company's processed beef has become a mainstay in America's hamburgers. But government and industry records show that in testing for the school lunch program, E. coli and salmonella pathogens have been found dozens of times in the company's products, challenging claims by the company and the USDA about the effectiveness of the treatments. Since 2005, E. coli has been found 3 times and salmonella 48 times, including back-to-back incidents in August in which two 27,000-pound batches were found to be contaminated.
FDA to Seek New Standards On Human Test Data The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products. The Center for Devices and Radiological Health announced that the FDA most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met. The same day of the announcement two studies that found shortcomings in some clinical trials accepted by the FDA over the last decade in connection with the approval of high-risk cardiovascular devices. In recent years, the FDA has come under criticism from lawmakers, researchers and patient advocates for the standards it uses in approving medical devices. The issue of FDA oversight has also taken on particular significance because of a recent Supreme Court decision that has shielded makers of high-risk devices from patient lawsuits if their product was approved by the agency. One of the recently released studies found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study. In addition, the study also found that about 25 percent of trials had failed to adequately follow the outcomes of a sufficient number of patients, a level the review defined as 90 percent or more of patients initially enrolled in a trial.
Tylenol Pain Caplets Recalled for Odd Odor Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness. The company has recalled all product lots of the Arthritis Pain Caplet 100-count bottles with the red EZ-Open Cap. Johnson & Johnson had previously recalled five lots of the product after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea. The company said the odor results from trace amounts of a chemical called 2,4,6-traibromoanisole. The chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting, have been "temporary and non-serious," although the health effects of the compound have not been studied.
Studies Say FDA OKs Devices Without Key Info Two new studies find shortfalls in the Food and Drug Administration's approval process for heart devices such as pacemakers and stents. Safety targets often weren't clearly spelled out in the research submitted by device makers and important patient information was missing, according to one study conducted by researchers from the FDA. A separate analysis found heart devices frequently got the FDA's blessing based on research done outside the United States in small groups of patients. Many device studies lacked standards most scientists expect: randomization and a clear goal. The FDA's acting device center director said the agency is taking a close look at its device program and making changes. It wants manufacturers to adhere to tougher research guidelines that will be out in 2010. The FDA, the nation's chief watchdog on device safety, approves products ranging from wrinkle fillers to artificial knees. The new studies cap a year of scrutiny and criticism for the FDA's medical devices division. Earlier this year, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigations saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.
Drug-Resistant Infections Lurk in Meat We Eat More and more Americans - many of them living far from barns and pastures - are at risk from the widespread practice of feeding livestock antibiotics. These animals grow faster, but they can also develop drug-resistant infections that are passed on to people. The issue is now gaining attention because of interest from a new White House administration and a flurry of new research tying antibiotic use in animals to drug resistance in people. Researchers say the overuse of antibiotics in humans and animals has led to a plague of drug-resistant infections that killed more than 65,000 people in the U.S. last year - more than prostate an breast cancer combined. And in a nation that used about 35 million pounds of antibiotics last year, 70 percent of the drugs - 28 million pounds - went to pigs, chickens and cows. Worldwide, it's 50 percent. The rise in the use of antibiotics is part of a growing problem of soaring drug resistance worldwide. As a result, killer diseases like malaria, tuberculosis and staph are resurging in new and more deadly forms. In response, the pressure against the use of antibiotics in agriculture is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health - the Food and Drug Administration, CDC and U.S. Department of Agriculture - declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And the FDA has told Congress that farmers need to stop feeding antibiotics to healthy farm animals. Farm groups and pharmaceutical companies argue that drugs keep animals healthy and meat costs low, and have defeated a series of proposed limits on their use.
How to Avoid Common Cancer-Causing Agents The American Cancer Society recently published its first position statement on environmental cancer-causing agents, calling attention to the need for more research on the full impact of all the chemicals floating around in our environment. People generally associate "environmental factors" that cause cancer with air and water pollutants. However, there are over 100,000 chemicals used in the consumer products that we come in contact with every day, and only a fraction have ever been tested for safety. It's these chemicals the American Cancer Society would like more attention to be paid to, considering that the World Health Organization's International Agency for Research on Cancer has evaluated just 935 chemicals since it started looking at cancer-causing agents in1969. Most of these threats are occupational exposures, which contribute to 2.4 to 4.8 percent of all cancer deaths in this country, but the general population is still exposed at much lower levels. To protect all individuals, the ACS is calling for tighter regulatory standards on both occupational and general exposures, based on sound scientific research that should be better funded, and for greater public disclosure of chemicals being used so that individuals can make informed decisions. The ACS is also calling for more detailed research on a chemical's cumulative-exposure risk, as well as how that risk is influenced by dosing and timing, and for monitoring the accumulation of these chemicals in humans and in the food chain.
U.S. Expands Efforts to Regulate Meds in Water Federal regulators under President Barack Obama have sharply shifted course on long-standing policy toward pharmaceutical residues in the nation's drinking water, taking a critical first step toward regulating some of the contaminants while acknowledging they could threaten human health. A burst of significant announcements in recent weeks reflects an expanded government effort to deal with pharmaceuticals as environmental pollutants. For the first time, the Environmental Protection Agency has listed some pharmaceuticals as candidates for regulation in drinking water. The agency also has launched a survey to check for scores of drugs at water treatment plants across the nation. The Food and Drug Administration has updated its list of waste drugs that should be flushed down the toilet, but the agency has also declared a goal of working toward the return of all unused medicines. The National Toxicology Program is conducting research to clarify how human health may be harmed by drugs at low environmental levels. Last year it was reported that the drinking water of at least 51 million Americans contains minute concentrations of a multitude of drugs. Water utilities have acknowledged the presence of antibiotics, sedatives, sex hormones and dozens of other drugs in their supplies. The research stirred congressional hearings and legislation, more water testing and more disclosure of test results. For example, an Illinois law goes into effect next year banning health care institutions from flushing unused medicine into wastewater systems. The EPA's new study will look for 200 chemical and microbial contaminants at 50 plants that treat drinking water. The list includes 125 pharmaceuticals or related chemicals. This research will help federal water officials decide if regulations are needed.
Some Hazelnuts Recalled for Salmonella Whole Foods Market is recalling organic raw hazelnuts, also known as filberts, that were sold in bulk in stores in California, Colorado, Kansas, New Mexico, Oregon, Utah and Washington. No illnesses have been reported. Mountain Man Nut & Fruit Co. is recalling certain products containing shelled hazelnuts. Certain lot codes and sizes of the following products have been recalled: Filberts, Natural Mixed Nuts, Fancy Mixed Nuts, Choice Mixed Nuts, Dry Roasted Mixed Nuts, Sweet Simplicity Trail Mix, Mountain Jubilee Trail Mix, Cinnamon Almond Appleanche Trail Mix and Fancy Mixed Nut Gift Packs. The recalled products were sold online as well as in the Midwest and Western states.
Maine to Consider Cell Phone Cancer Warning A Maine legislator wants to make the state the first to require cell phones to carry warnings that they can cause brain cancer, although there is no consensus among scientists that they do and industry leaders dispute the claim. The now-ubiquitous devices carry such warnings in some countries, though no U.S. states require them. The legislator said numerous studies point to the cancer risk, and she has persuaded legislative leaders to allow her proposal to come up for discussion during the 2010 session that begins in January, a session usually reserved for emergency and governor's bills. Her bill calls for manufacturers to put labels on phones and packaging warning of the potential for brain cancer associated with electromagnetic radiation. The warnings would recommend that users, especially children and pregnant women, keep the devices away from their head and body. The Federal Communications Commission, which maintains that all cell phones sold in the U.S. are safe, has set a standard for the "specific absorption rate" of radiofrequency energy, but it doesn't require handset makers to divulge radiation levels.
11 Baby Deaths Now Linked to Simplicity Cribs Despite several recalls and warnings, the number of reported baby deaths linked to defective Simplicity Cribs is now up to 11. The most recent death occurred when a 7-month-old child from Kentucky became entrapped in the crib when a part of it broke. The Consumer Product Safety Commission said it's also aware of another 25 incidents involving drop-side parts detaching from Simplicity cribs. The recall of the cribs began in 2005. More than 2 million Simplicity drop-side cribs have been recalled so far because of problems with their plastic hardware. Some of the recalled cribs have the Graco logo and Winnie the Pooh motif. The crib's hardware can break or deform, causing the drop side to detach. This detachment creates a space between the drop side and crib mattress that babies can roll into and become entrapped, leading to suffocation risk. The agency's announcement that 11 babies have died was a big jump from earlier recall announcements that reported only three baby deaths.
50 Million Shades Recalled for Strangulation Risk Government safety regulators and the window-covering industry have recalled all Roman shades and roll-up blinds in homes with small children. The concern is that a child can easily become entangled in the cords and strangle to death. The U.S. Consumer Product Safety Commission announced that about 50 million window coverings need to be repaired to make them safe for kids. About 5 million Roman shades and 3 million roll-up blinds are sold each year. A reported eight children have died and 16 were nearly strangled in window-covering cords since 2001. Strangulations in Roman shades can occur when a child places his neck between the exposed inner cord and the fabric on the backside of the blind or when a child wraps the cord around his neck. With roll-up blinds, the hazard occurs when a child's neck becomes entangled in the lifting loop.
Take Care When Ordering Bear for Dinner There are fewer than 10 cases a year of the parasitic disease trichinosis in the United States, and in recent years, bear meat has accounted for almost all of the nonpork cases, according to a recent report from the Centers for Disease Control and Prevention. Black bear, specifically. Other infections came from walrus meat, deer, wild boar - and one case of cougar. Two patients who became ill said they had eaten raw bear meat while stuffing it into sausage. But most of the meat had been cooked: stir-fried, boiled, broiled, baked, microwaved or cooked over an open fire. In some cases, the meat was both boiled and fried. Trichinosis can be fatal, but none of the recent cases were. It causes stomachache, nausea and diarrhea at first, followed several weeks later by muscle aches, itching, fever, chills and joint pain. Order your bear steak well done will not necessarily do the trick, though. Freezing meat is also not a guarantee, because some wild game are infected with freeze-resistant trichinella. Instead, it should be cooked to an internal temperature of 160 degrees Fahrenheit.
Zhu Zhu Pets Safe, Safety Regulators Say Zhu Zhu Pets - one of the holiday season's hottest toy crazes - do not violate safety standards, federal toy regulators announced after a consumer group raised concerns over the presence of a heavy metal on one model. The toy "is not out of compliance" with a U.S. toy safety law that went into effect this year. The California-based consumer group GoodGuide raised concerns over the presence of a potentially harmful heavy metal in a Mr. Squiggles model of the robotic hamsters. The group said its testing found antimony - a heavy metal that can cause vomiting if eaten, and heart and lung problems in breathed - on the furry toy's hair and nose in levels that exceeded new federal limits. But those claims fell apart when GoodGuide said the way it got its test results - using a special gun that shoots X-rays into a toy and gives a reading for how much lead, antimony or other substances are in the material - is not recognized by the CPSC for judging whether a toy is hazardous. Instead, the CPSC tests how much of a heavy metal would actually seep out if a child sucked or swallowed a toy - not just how much of a potentially dangerous substance a toy contains.
CDC: Pet Frogs Source of Salmonella Outbreak Pet frogs are being blamed for a national salmonella outbreak that sickened at least 48 people. The illnesses occurred from June through November, with reports coming in from 25 states. Health officials investigating the illnesses found that many of the people said they'd been in contact with frogs such as the African dwarf frog. The salmonella strain was found in aquariums with frogs in three homes where illnesses occurred. Pet reptiles have been fingered as a source of salmonella infection before. At least 107 people were sickened in a recent outbreak blamed on turtles.
Feds Probing Chemical Levels in Zhu Zhu Pets The Consumer Product Safety Commission has opened an investigation into the popular Zhu Zhu Pets toy because it may contain higher-than-allowed levels of antimony, a heavy metal which if ingested can make children sick. The CPSC probe came after San Francisco-based GoodGuide named Zhu Zhu Pets hamsters one of the top-selling toys with low ratings after finding the chemical on the hair and nose of one of the toy hamsters called Mr. Squiggles. The group assigned the toy a rating of 5.2 on a 10-point scale. On prolonged exposure, antimony - which is used in textiles and plastics to prevent them from catching fire - can cause lung and heart problems, ulcers and diarrhea. But the toy's maker, St. Louis-based Cepia LLC, insisted in a statement that its Mr. Squiggles toy is "absolutely safe" and has passed rigorous testing. Antimony was measured at 93 parts per million in the hamster's fur and at 106 parts per million in its nose. Both readings exceed the allowable level of 60 parts per million.
FDA Warns of Problems with Sterilization Device Doctors and hospitals should stop using a device from the Steris Corporation to sterilize surgical tools after reports of malfunctions, according to the Food and Drug Administration. Users have reported problems that could result in patients becoming infected from unsterile instruments.
No Cell Phone Brain Tumor Link A very large, 30-year study of just about everyone in Scandinavia shows no link between cell phone use and brain tumors, researchers have reported. Even though mobile telephone use soared in the 1990s and afterward, brain tumors did not become any more common during this time, the researchers reported. Some activist groups and a few researchers have raised concerns about a link between cell phones and several kinds of cancer, including brain tumors, although years of research have failed to establish a connection. Researchers did not detect any clear change in the long-term time trends in the incidence of brain tumors from 1998 to 2003 in any subgroup.
After Delays, Vaccine to Counter Bad Beef Being Tested Thousands of calves are now part of a large-scale test to see whether animal vaccines are an answer to one of the nation's most persistent food-safety problems. The test has been a long time coming. Bureaucratic delays in Washington stalled the arrival of the vaccines for years, even as people continued to become sick and die from eating tainted beef. And now, even if the vaccines prove successful in the ambitious tests that are just getting under way, they face an uncertain future as farmers and feedlot owners worry about who will pick up the extra cost. Scientists are fairly sure that vaccines will not, on their own, wipe out the dangerous strain of E. coli known as O157:H7. But if they prove effective, they could significantly reduce the amount of harmful bacteria that cattle carry into slaughterhouses, which means that safeguards already in place there would have a greater chance of eliminating the remaining germs from the beef supply.
Baby Formula Company Wins Damage and Injunction in Rare False Advertising Trial Earlier this year, PBM Products, which makes store-brand baby formula, failed to enjoin ads that claimed Mead Johnson's more expensive formula provides babies with unique developmental benefits. PBM didn't drop the case, though; instead, it switched counsel and pressed on to an eight-day jury trial. The "rocket docket" jury awarded PBM $13.5 million in damages, and recently, a judge gave PBM the injunction it wanted, barring Mead from advertising claims that parents put their babies' health at risk if they used any formula other than its Enfamil brand. The judge also directed Mead to retrieve already-published ads containing those claims. The ads in dispute, which claimed that only Emfamil's mix of ingredients provided visual and mental benefits to infants, appeared on approximately 1.6 million mailers directed at parents. At trial, PBM was able to prove that their store-brand formula has the same nutritional values as Enfamil.
Recalled Cat Food Sickens 21 Cats A Missouri company has announced its recalled dried cat food has sickened 21 cats. The Diamond Pet Foods product was distributed in multiple states in the South and along the East Coast. The company recalled certain bags of Premium Edge Finicky Adult Cat and Premium Edge Hairball cat food earlier this year because they could lead to gastrointestinal or neurological problems for cats. They do not contain enough thiamine, an essential nutrient for cats. If cats fed these foods have no other source of nutrition, they could develop thiamine deficiency. If untreated, this disorder could result in death. The company has confirmed 21 reports of thiamine deficiency in New York and Pennsylvania. The food was distributed to 18 states.
Stay-Tabs On Cans Aren't Staying Out of Children Soda can manufacturers replaced pull tabs with "stay-tab" because children had a habit of pulling off the tab, throwing it into the drink to avoid throwing it on the sidewalk and then swallowing it when they took a big swig. But it turns out that even stay-tabs are not childproof. Earlier this year, a 7-year-old was taken to a Cincinnati emergency room with a stomachache after swallowing a stay-tab. A radiologist in the hospital looked for other reports of stay-tab swallowing and found 19 such reports from the hospital since 1993. Only four of the tabs could be seen on the X-ray, and though younger children are generally more likely to swallow things accidentally, most of the swallowers were in their teens.
Cancer Concerns in Big Doses of Folic Acid Grains and cereals have been fortified with folic acid in the United States since 1998 as part of an effort to reduce the incidence of neural tube birth defects in babies. However, a recent study has raised safety concerns, linking megadoses of the vitamin to increased cancer rates, particularly lung cancer. Researchers followed 6,261 patients with ischemic heart disease who had participated in two randomized clinical trials set up to assess whether homocysteine-lowering treatment with folic acid and vitamin B12 reduced heart disease. The study found that 10 percent of patients who had been treated with folic acid and vitamin B12 had developed cancer, compared with 8.4 percent of those who had not received the treatment, an increased risk of 21 percent. The analysis indicated that the added risk was associated with high blood levels of folate, rather than vitamin B12.
Baby Crawl Launched to Promote Toxic Chemicals Law Babies and Brockovich are highlighting a new grassroots campaign in favor of federal legislation mandating stronger regulation and testing of more than 80,000 synthetic chemicals found in household goods and cleaning products. The "Million Baby Crawl" campaign asks parents to sign up their children on the Web for a virtual knees-and-hands trek to Washington, D.C. in support of the Kid-Safe Chemicals Act to reform existing toxic chemical rules that, it says, have failed to protect the health of children and adults. Consumer and environmental advocate Erin Brockovich said the new law is needed because the 1976 Toxic Substances Control Act doesn't live up to its name. Since it was enacted, the U.S. Environmental Protection Agency has required testing of 200 of the 80,000 chemical compounds used in consumer products.
Filing Deadline Looms for Homeowners' Litigation Over Chinese Drywall Homeowners who claim problems with defective drywall have until December 2 to file papers for a national class action against Knauf Plasterboard Tianjin. Owners who meet that deadline for filing a claim with proof of Knauf drywall will be covered by a lawsuit to be filed December 9. About 35,000 Florida homes may contain allegedly defective Chinese drywall, and the state is believed to have about 30 percent of the installations nationally. The suspect drywall used primarily in homes built or remodeled from 2004 to 2008 emits corrosive sulfur gas that has been blamed for air conditioners and appliance damage as well as respiratory problems.
Official: Agency Moved Too Slow On Crib Safety The head of the Consumer Product Safety Commission conceded the agency "hasn't been acting as quickly as it should" on crib safety problems. Interviewed on morning news shows in the wake of the largest-ever recall of cribs, the chairman pledged that the CPSC would "firmly but fairly" enforce a law Congress passed last year giving regulators greater authority to police the industry. More than 2.1 million drop-side cribs by Stork Craft Manufacturing on Canada are being recalled following reports of four infant suffocations. The CPSC said the recall involves 1.2 million cribs in the United States and almost 1 million in Canada. Sales of the cribs being recalled go back to 1993 and nearly 150,000 of the cribs carry the Fisher-Price logo.
Largest Crib Recall in U.S. History Announced Government safety regulators say more than 2.1 million drop-side cribs by Stork Craft Manufacturing are being recalled, the biggest crib recall in U.S. history. The Consumer Product Safety Commission says the recall involves 1.2 million cribs in the United States and almost 1 million in Canada, where Stock Craft is based. Nearly 150,000 of the cribs on recall carry the Fisher-Price logo. The agency is aware of four deaths of young children who suffocated in the cribs, which have a side that moves up and down to allow parents to lift children from the cribs more easily. The danger is that a child's head can get caught between the mattress and the side railing, if it separates from the crib.
The Dangers of Taking a Dip in the Hot Tub A hot tub might not seem an especially dangerous place, but over a period of 18 years from 1990 to 2007, more than 80,000 people were injured in hot tubs or whirlpools seriously enough to wind up in an emergency room. Almost 74 percent of the injuries occurred at home. The annual number of emergency room visits has been steadily rising. In 2007, 6,646 people went to emergency rooms after a hot tub injury, compared with 2,549 in 1990. About half the injuries were caused by slipping and falling, but heat overexposure was the problem in 10 percent of the accidents, and near-drowning in about 2.5 percent. Almost 7 percent of the injuries were serious enough to require hospitalization.
Ex-Smoker Wins Against Philip Morris Legal experts predict that thousands of tobacco lawsuits could gain momentum in Florida after a jury ordered Philip Morris to pay $300 million to a former smoker who says she needs a lung transplant. If it survives an appeal, the verdict would be the nation's largest award of damages to an individual suing a tobacco company and could encourage thousands of plaintiffs who have filed similar cases in Florida. A Florida Supreme Court ruling a few years ago made it easier to pursue tobacco lawsuits than in other states. But the tobacco industry, which plans to appeal, appeared unfazed. Tobacco companies have considered product liability suits as little more than a cost of doing business since the seven biggest companies agreed to pay $206 billion in a master settlement agreement with 46 states in 1998. Florida, despite being one of those states, had a major legal ruling in 2006 that lowered a plaintiff's burden of proof against a tobacco company.
Vicks Nasal Spray Recalled After Bacteria Found Proctor & Gamble has recalled some 120,000 bottles of Vicks Sinex nasal spray after the company found bacteria in samples during routine testing. The recall was announced as a precaution after small amounts of the B. cepacia bacteria were found in the over-the-counter product at the German plant where it's made. No illnesses have been reported. The bacteria could harm people with chronic lung problems or weakened immune systems.
Senate Bill Would Require E. Coli Testing Citing public concern that meat companies and federal regulators are not doing enough to make ground beef safe, a Democratic Senator from New York has introduced legislation that would require companies to test for a deadly E. coli strain. The bill, the E. Coli Eradication Act of 2009, is focused on the slaughterhouse and then at grinding facilities before the trimmings are mixed. A few companies already test incoming trimmings at their grinding facilities, but most of the industry relies on slaughterhouses to test their own trim.
Food Agency Delays Ban On Oysters After Outcry THE FDA indefinitely delayed a ban on the sale of raw oysters harvested on the Gulf Coast during warm months in the face of opposition from the oyster industry and legislators from the region. The agency said it would conduct a study of the issue. "It is clear from our discussions to date that there is a need to further examine both the process and timing for large and small oysters harvesters to gain access to processing facilities," the agency said in a statement. The agency announced at a hearing of the quasi-governmental board that oversees the oyster industry that the agency would require by 2011 that all oysters harvested from the Gulf Sea during the warm months be processed to reduce the risk of Vibrio vulnificus, a bacterium that each year kills about 15 people who contract the illness in the United States after eating contaminated raw oysters.
E. Coli Outbreak Traced to Company That Halted Testing of Ground Beef Trimmings A deadly outbreak of E. coli has been traced to a large producer of ground beef that stopped testing its ingredients years ago under pressure from beef suppliers. A facility in New York owned by the company recalled more than 500,000 pounds of ground beef after it was linked to an outbreak that has killed two people and sickened an estimated 500 others. The outbreak has fueled a growing concerns among grocers that not enough is being done to protect their customers. Trader Joe's, an upscale chain, said that it had stopped buying ground beef from the New York plant and was initiating discussions with other suppliers to have grinders test the trimmings they use in making ground beef. Beef trimmings commonly used to make ground beef are more susceptible to contamination because the pathogen thrives in cattle feces that can get smeared on the surfaces of whole cuts of meat.
Chemical in Plastic Bottles Linked to Impotence Male factory workers in China who got very high doses of a chemical that's been widely used in hard plastic bottles had high rates of sexual problems. Heavy exposure to BPA, or bisphenol A, on the job was linked to impotence and lower sexual desire and satisfaction, according to a new study which has added to concerns about BPA's effects on most consumers. The men in the study experienced BPA levels about 50 times higher than those faced by typical American men. BPA is used in a wide variety of consumer products, including some hard plastic bottles and metal food or beverage cans. Several makers of baby bottles recently said they had stopped using the chemical. Some 90 percent of the U.S. population carries detectable levels in their urine.
U.S. Plans Raw Warm-Water Oyster Ban A federal effort to ban the sale of raw oysters harvested during the warm months along the Gulf Coast has kicked up a hurricane of opposition from oystermen and members of Congress and threatened to derails a signature food safety initiative by the Obama administration. At issue is how far the federal government should go to save the lives of 15 people each year who die from eating contaminated raw oysters. A top official at the Food and Drug Administration announced that the agency would ban as of 2011 the sale of raw oysters harvested from the Gulf Coast during the warm water months because they are the source for nearly all the deaths associated with raw oysters each year. The agency said processes like freezing and pasteurization that make the oysters safer are available and do little to alter the taste. But oystermen and some restaurant owners say the difference in taste between raw and processed oysters is so profound that the Gulf Coast oyster industry would be irreparably harmed and a cultural institution destroyed.
D.C. Court of Appeals Resurrects Cell Phone Radiation Cases The D.C. Court of Appeals has revived a series of lawsuits by individuals who say they were harmed by cell phone radiation, reversing a lower court decision that found the claims were blocked by federal law. The six cases at issue, filed in 2001 and 2002, target some of the biggest names in the wireless industry, including Verizon, Motorola, Sprint and Nokia. The plaintiffs allege they suffered illnesses and injuries including brain cancer due to radiation from their mobile phones, and that the wireless companies' marketing misled them into believing their products were completely safe. They also claim that their phones failed to meet Federal Communications Commission regulations limiting the amount of radio frequency radiation they can emit.
Company Recalls Devices After FDA Action A Pennsylvania medical diagnostic company that won a key agreement with the Army to help diagnose brain injuries from roadside bombings must deal with lingering regulatory issues involving the Food and Drug Administration. Neuro Kinetics Inc., developer of devices that help diagnose brain injuries, said it won the arrangement to place its devices at Army installations. The company has been forced to recall 72 of its devices due to questions raised a little over a year ago by the FDA. In a warning letter dated 2008, the FDA said it found evidence the company shipped devices with software that had not yet been reviewed and approved by the agency, a violation of federal law. The company issued a recall in 2009. The company said the required approval was later obtained, but the company must now recall devices that were shipped and remove software the FDA did not approve.
Costs Surge for Medical Devices, But Benefits Opaque When makers of heart defibrillators wanted Medicare to vastly expand the types of patients eligible to receive the devices, which can cost upward of $25,000, agency officials were skeptical. It was not clear how many of those patients would actually need a defibrillator, a device that can deliver a life-saving shock to restore a faltering heart to normal rhythm. So government and industry struck a deal in 2004. Medicare agreed to expand the device's use, nearly doubling the number of patients who qualified for one. The companies, in return, agreed to pay for a study to see which patients really benefited. Five years later, Medicare underwrites more than half of the $4 billion the nation spends annually on defibrillators, but the agency is no closer to knowing how many lives that big investment is saving. That is because the device companies did not finance the study beyond their initial $4 million commitment, and Medicare did not pick up the slack. As a result, researchers still cannot gather data that would identify the types of patients who would most benefit from a defibrillator. So doctors keep implanting costly defibrillators in patients who many not benefit from them. And doctors and patients have no way of knowing whether one producer's model performs better than a competitor's.
Bug Spray Eyed in Death of Infant Bug spray that produces a fog to kill insects is likely to blame for the death of a 10-month-old South Carolina boy and critical injuries to his 2-year-old brother. Authorities say the children's mother had been using foggers in their mobile home because of an insect problem. She called 911 to report her youngest son was having trouble breathing. Paramedics took all three to a hospital, where the youngest was pronounced dead. The mother was coated in chemicals when she arrived at the hospital. She was released and then readmitted with breathing problems. Investigators found seven fogger containers. She told authorities she set off three when she began renting a month ago, then continued using them when the insects wouldn't die. A single fogger is typically used to treat 6,000 cubic feet, and directions call for residents to vacate their homes and open windows and doors. While most people use foggers once a month, the mother was using two to three each week.
E. Coli Kills Two and Sickens Many Two people, one from New Hampshire and another from upstate New York, have died after eating ground beef that may be responsible for an E. coli outbreak linked to illness in more than two dozen people. The suspect beef was produced by a company in western New York which issued a voluntary recall. The products in question are ground beef or packaged beef patties that were made from September 14 through 16 and distributed mostly in the northeast. The products went to retailers in eight states.
Ex-Tomato Supplier Settles with Sheetz A settlement has been reached in a lawsuit filed by Sheetz over how a supplied owed the company for providing it with tainted tomatoes in 2004. A jury was expected to hear the case between Sheetz and its supplier, but the trial was called off after the out-of-court settlement was announced. Though the terms of the settlement were confidential, Sheetz indicated that a conservative estimate of the damages it suffered because of the bad tomatoes was more than $11 million. The supplier admitted its liability in providing tainted tomatoes to many Sheetz stores in Pennsylvania and surrounding states. According to the Pennsylvania Department of Health, more than 425 people were stricken with salmonella poisoning as a result of the bad tomatoes.
Food Labeling Program Halts Over FDA Concern A food industry group is voluntarily halting promotion of its nutrition labeling program after federal regulators said such systems could mislead consumers. Industry leaders launched the "Smart Choices" program earlier this year to identify foods that meet certain nutritional standards and then highlight them for consumers with a green label on package fronts. But the Food and Drug Administration said that there are so many labeling programs with different criteria that they may mislead consumers about the health benefits of certain foods. The agency told manufacturers it will crack down on inaccurate labeling, although it did not name specific products or give a timeline for enforcement. Smart Choices, which includes nine major companies such as Kellogg, Kraft and General Mills, has been criticized for handing its green seal to processed foods that are high in sugar, such as Froot Loops cereal and Crack Jack snack food.
FDA to Clarify Standards for the Front of Food Labels The Food and Drug Administration said that it would seek to clear up the confusion caused by a surge of upbeat nutritional claims - for everything from Froot Loops to mayonnaise - that manufacturers have begun to make on packaged food labels. By early next year, the agency will issue proposed standards that companies must follow in creating nutritional labels that go on the front of food packaging. That could force manufacturers to deliver the bad news with the good, putting an end to a common practice in which manufacturers boast on package fronts about some components, such as vitamins or fiber, while ignoring less appealing ingredients, like added sugar or unhealthy fats. The FDA's move could present a challenge to the Smart Choices program, a nutrition labeling campaign begun this summer with much fanfare by some of the nation's largest food companies. That program has drawn fire because it gives a nutritional seal of approval to many foods, including sugary cereals and high-fat mayonnaise, that many nutritionists consider to be unhealthy.
Sugar Cereals 'Smart Choices'? FDA Not So Sure The FDA said that nutritional logos from food manufacturers may be misleading consumers about the actual health benefits of cereal, crackers and other processed foods. The agency sent a letter to companies saying it will begin cracking down on inaccurate food labeling. U.S. manufacturers, including Kellogg, Kraft Foods and General Mills, rolled out their so-called Smart Choices program last year, amid growing concern about obesity rates. The green labels appear on the front of foods that meet certain standards for calories per serving and fat content. But consumer advocates complain about lax standards for the program, with logos appearing on everything from frozen sweets to sugary cereals.
Consumer Suit Over Cheerios' Health Claims Consolidated Suits by consumers in three states who challenge General Mills' claim that Cheerios can lower cholesterol and cut the risk of cancer, were consolidated in federal court in New Jersey. The court ordered the four cases - three from California and one from New York - be transferred to a New Jersey judge who is overseeing a similar case. The suits, which are putative class actions, peg the amount in controversy as more than $5 million and the class at greater than 100 members. The litigation was prompted by a Food and Drug Administration letter to General Mills that said the claims on boxes of Cheerios Toasted Whole Grain Oat Cereal violate the Food, Drug and Cosmetic Act. The plaintiffs cite General Mills' claims that Cheerios "can lower your cholesterol 4 percent in 6 weeks" and has been "clinically proven to lower cholesterol." Also cited are claims that Cheerios can reduce the risk of cancer of the stomach and colon.
Pet Turtles Sicken Children in 34 States Two girls who swam with pet turtles in a backyard pool were among 107 people sickened in the largest salmonella outbreak blamed on turtles nationwide, researchers report. The 2007-2008 outbreak involved mostly children in 34 states. One-third of all patients had to be hospitalized. In many cases, parents didn't know that turtles can carry salmonella. Despite a 1975 ban on selling small turtles as pets, they continue to be sold illegally. The American Veterinary Medical Association estimates that the number of pet turtles nationwide doubled from 950,000 in 1996 to almost 2 million in 2006.
Fan Manufacturer Ordered to Pay $13.5 Million in Damages A Philadelphia jury ordered Lasko Products, a portable fan manufacturer, to pay $13.5 million after a faulty fan motor sparked a 2005 house fire that killed a 7-year-old Mount Airy boy. The jury deliberated three days before finding that a fan made by Lasko caused the blaze that killed the boy and injured his mother and sister. The jury awarded $4 million to the boy's mother; $2 million to the boy's sister for emotional distress; $7.5 million to his estate; and $10,000 for funeral expenses.
Giving Babies Tylenol May Blunt Vaccine Effects Giving babies Tylenol to prevent fever when they get childhood vaccines may backfire and make the shots a little less effective, surprising new research suggests. It is the first major study to tie reduced immunity to the use of fever-lowering medicines. Although the effect was small and the vast majority of kids still got enough protection from vaccines, the results make "a compelling case" against routinely giving Tylenol right after vaccination, say doctors from the Centers for Disease Control and Prevention. The study was led by military and government scientists in the Czech Republic and was done at 10 medical centers in that Eastern European country. It involved 459 health infants, 9 to 16 weeks old, who were getting vaccines against polio, pneumonia, meningitis, whooping cough, tetanus, hepatitis and other childhood diseases. Half were given three doses of a Tylenol-like brand during the first day after vaccination. The other were given nothing besides the vaccine. Babies given the painkiller were significantly less likely to develop a fever - 42 percent versus 66 percent of the others - and very few in either group developed a high one. However, lower rates of protective antibody levels from several vaccines were seen in the group given the drug. Levels remained significantly lower in this group after booster vaccines, given when the babies were 12 to 15 months old.
FDA Warns Proctor & Gamble for Adding Vitamin C to Nyquil Federal drug regulators warned Procter & Gamble for adding vitamin C to its Vicks cold formulas, a combination not allowed by federal regulations. The Food and Drug Administration said medications like Vicks Nyquil and Dayquil are not permitted to contain the vitamin. According to the agency, a panel of experts found "no study which demonstrated that vitamin C is unequivocally effective for the prevention or treatment of the common cold." P&G advertising for Vicks says the vitamin "can help blunt" the effects of a cold. In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.
Connecticut to Scrutinize Food Labels Raising the stakes in the battle over nutritional claims for packaged foods, the Connecticut attorney general said that he was investigating a national labeling campaign that promotes products like Froot Loops and mayonnaise as nutritionally smart choices. In letters to Kellogg's, General Mills and Pepsi, the attorney general said he was concerned that the program, called Smart Choices, was "overly simplistic, inaccurate and ultimately misleading." The three companies are among several food giants that participate in the program. The Connecticut investigation will seek to determine if the labeling campaign violates the state's consumer protection law, which bars misleading or false product claims.
Meat-Substitute Fungus Blamed for Sickness Quorn Foods should include warnings on its food labels now that more than 1,000 people have reported gastrointestinal reactions to a fungus used as a meat substitute, a Connecticut consumer suit says. The Center for Science in the Public Interest reported that more than 1,400 American and British consumers have filed complaints about the fungus on the CSPI Web site since 2002. An Arizona resident filed the suit in the Connecticut Superior Court on behalf of all U.S. consumers who bought a Quorn product in the last three years. She became sick with stomach-virus-like symptoms after eating the defendant's Chik'n Patties, which contained the chicken-flavored meat-substitute fungus. She says she would not have bought the product if there had been a label warning about the effects of the fungus.
KFC's Grilled Chicken Can Cause Cancer, Docs Say A national doctors' group has sued fast-food giant KFC, alleging its new grilled chicken contains dangerous levels of a cancer-causing chemical. In its complaint, the Physicians Committee for Responsible Medicine says the chain's new menu item contains PhlP, a chemical that can increase the risk of developing cancer "even if consumed in small amounts." Responding to the suit, KFC said its grilled chicken "meets or exceeds all federal and state regulations for food safety." The group says KFC violated California's public health law, known as Proposition 65, by failing to warn consumers that they are being exposed to a substance linked to breast and colon cancer.
Companies Strike Deal On Testing for E. Coli In an expanding effort by the meat industry to make its hamburger safe, officials at the retail giant Costco said that they had struck a new accord on testing for the pathogen E. coli. Costco said it would begin buying beef trimmings for making hamburger from Tyson, one of the largest beef producers, after an agreement reached with Tyson allows Costco to test the trimmings before they are mixed with those from other suppliers. The United States Department of Agriculture has encouraged such testing as a way to make hamburger safer, but some of the largest slaughterhouses have resisted the added scrutiny for fear that one grinder's discovery of E. coli will lead to expanded recalls of beef sent to other grinders.
Bayer Sued Over Health Claims About Multivitamin for Men A nonprofit health advocacy group wants Bayer to swallow yet another bitter legal pill over its marketing techniques - this one involving its Men's One A Day multivitamin. The Center for Science in the Public Interest is suing the German drug giant for allegedly claiming falsely that selenium in the men's multivitamin might reduce the risk of prostate cancer. The lawsuit comes on the heels of several multimillion-dollar settlements that Bayer has paid out to resolve claims about misleading advertising. This year, Bayer agreed to run a $20 million corrective advertising campaign about its birth control pill Yaz. In 2007, it paid a $3.2 million fine over weight loss claims involving its One A Day vitamin as part of a consent decree reached with the Federal Trade Commission and the U.S. Department of Justice and another $8 million resolve allegations, raised by state attorneys general, that it hid safety issues surrounding its cholesterol-lowering drug Baycol. In this case, the plaintiffs allege that Bayer is ignoring the results of the largest-ever prostate cancer prevention trial, which concluded that the mineral selenium was no more effective in reducing the risk of prostate cancer than a placebo. The FDA also released a letter stating that it was "highly unlikely that selenium supplements reduce the risk of prostate cancer."
Illnesses Push USDA and FDA to Write Safety Rules Two federal agencies are teaming up to write new food safety rules for fresh produce, following foodborne illness outbreaks tied to fruits and vegetables in recent years. The U.S. Department of Agriculture announced its fresh produce chief will work with the Food and Drug Administration to develop new produce regulations over the next six months. As part of the process, officials will travel the country to talk with food safety officials and farmers - including small, organic growers - about the impact of the new rules would have on the industry.
Airlines Ordered to Test and Disinfect Onboard Water Federal regulators issued final rules requiring airlines to test and treat the tap water served to passengers and used in plane lavatories. The Environmental Protection Agency rules set out schedules for how frequently airlines must flush and disinfect the water systems on planes and test for coliform bacteria. Coliform are usually not harmful, but they are considered an indicator of the presence of disease-cutting germs. The EPA estimates the cost of the new rules at nearly $7 million a year or about a penny per ticket.
No System Tracks Faulty Medical Devices in U.S. Three years ago, the maker of a surgical clip issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. The clips could dislodge in their bodies with "serious, even life-threatening consequences." Last year, a surgeon in Brooklyn used one of those clips to tie off a man's renal artery when he donated a kidney to his wife. Twelve hours later, the clip popped off and he bled to death internally. Experts say such deaths are the result of a major weakness in the nation's system for recalling thousands of medical devices routinely implanted in people's bodies, ranging from screws and plates to artificial knees and hips. Unlike the auto industry, medical equipment makers have no centralized system for tracking products throughout their life span. That means in some instances manufacturers do not have an easy way of knowing where problematic devices are or which patients got them. Meanwhile, the number of items implanted in people's bodies is soaring, as is the number of recalls. Nearly 2,500 medical devices were recalled for potential safety problems in 2008, which is nearly double the number reported the previous year and a 164 percent increase since 2000.
E.Coli Path Shows Flaw in Beef Inspection Most companies and grocers have been barred from selling ground beef tainted by the virulent strain of E. coli known as O157:H7 since 1994 after an outbreak at Jack in the Box restaurants left four children dead. Yet tens of thousands of people are still sickened annually by this pathogen, federal heath officials estimate, with hamburger being the biggest culprit. Ground beef has been blamed for 16 outbreaks in the last three years alone. This summer, contamination led to the recall of beef from nearly 3,000 grocers in 41 states.
Drinking Water Unsafe at Thousands of Schools Over the last decade, the drinking water at thousands of schools across the country has been found to contain unsafe levels of lead, pesticides and dozens of other toxins. An investigation found that contaminants have surfaced at public and private schools in all 50 states - in small towns and inner cities alike. But the problem has gone largely unmonitored by the federal government, even as the number of water safety violations has multiplied. The contamination is most apparent at schools with wells, which represent 8 to 11 percent of the nation's schools. Roughly one of every five schools with its own water supply violated the Safe Drinking Water Act in the past decade. In California's farm belt, for instance, wells at some schools are so tainted with pesticides that students have taken to stuffing their backpacks with bottled water for fear of getting sick from the drinking fountain.
Tylenol Recalls Some Children's Medications The makers of Tylenol have recalled almost two dozen types of children's and infant's medications as a precaution against possible contamination. The liquid products were being voluntarily pulled from stores and warehouses because bacteria was detected in one of the inactive ingredients. The company said that no bacteria were found in the finished product, and that the likelihood of a serious medical event is remote. But it said it decided after consulting with the FDA that it would recall the products. The company did not announce whether any children had been sickened by the medicines.
U.S. Delayed Telling Schools About Food Recalls The federal government failed to inform schools of recalls of suspected food products, potentially putting millions of schoolchildren at risk of food poisoning over the last two years, a government investigation has concluded. The recalled foods included salmonella-tainted peanut products linked to the deaths of at least nine people. While researchers did not have data on how many children may have been sickened by meals they ate at school, it said it had confirmed that "some affected commodities were served to schoolchildren after holds and recalls were announced." The findings raise "concerns about the safety of foods served in schools and the welfare of schoolchildren, because they are more likely to suffer complications from food-borne illnesses, and in part because they may have less knowledge to make informed choices about the foods they consume."
FDA Medical Device Approvals Get New Review The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs. The Institute of Medicine will conduct a two-year review of the FDA's so-called 510k review procedure, which allows device companies to quickly launch products similar to those already on the market. The procedure was originally intended to speed the approval of simple devices like bandages and wheelchairs, but in recent years it has been used to approve high-risk devices. The Government Accountability Office, Congress' investigative arm, recently identified two-dozen device types that were approved without close scrutiny, including hip replacements and heart implants. Normally, companies have to submit the results of large patient studies before launching such devices. But by arguing that their devices are similar to other FDA-approved products, companies can speed up the approval process. Under the 510k system, manufacturers simply have to give the FDA 90 days notice of their intent to launch their product.
Liggett Settles Lifelong Smoker's Case for $100,000 The good news: A woman accomplished the seemingly impossible when he got a tobacco company to settle with an injured smoker. The bad news: The settlement is worth just $100,000. The amount accepted is peanuts compared with some jury awards starting at $1.2 million in five lawsuits tried this year. Accounting for negligence attributed to smokers, the lower award works out to $600,000. The case stems from the Florida Supreme Court decision tossing a $145 billion class action verdict while allowing smokers to sue individually for damages. Tobacco companies rarely settle. A number of attorneys asked about the settlement said it was the only settlement they were aware of for a former class member. The case was filed by the daughter of a smoker who primarily smoked Liggett cigarettes from 1939 until his death from lung cancer in 1996. If tobacco companies had settled all 350 pending smoker cases in Florida for $100,000, the cost would be about $25 million.
Green Onions Recalled Over Salmonella Fears Two California produce shippers have recalled thousands of cases of green onions supplied by an onion farm in Mexico over fears the onions could be contaminated with salmonella. U.S. Department of Agriculture inspectors found salmonella in a routine test taken in New York last month. No illnesses have been reported. The two companies recalled 1,746 and 3,360 cartons respectively.
USDA Mulls New Food Safety Rules for Spinach Federal food safety officials plan to hold public hearings about a proposal that backers say will help keep bacteria-tainted spinach and lettuce from reaching grocery shelves. The U.S. Department of Agriculture wants to gauge public support for an industry proposal that would enforce standards for producing, handling and inspecting leafy greens nationwide. The proposed voluntary guidelines are an attempt to prevent another disaster like the massive E. coli outbreak in spinach in 2006. That outbreak killed three people, sickened 200 and cost the industry $80 million in lost sales.
3rd Circuit OKs Suit On Snapple Labeling The Food and Drug Administration's policy regarding the use of the word "natural" on food and beverage labeling is not comprehensive or definitive enough to prevent a state from imposing its own standards, a federal appeals court has ruled. The unanimous decision reverses a New Jersey federal court ruling that a consumer's state law claims against Snapple Beverage Corp. were preempted by federal law. A New Jersey woman filed the suit in 2007, seeking to force Snapple to stop using the phrase "all natural" on its labels because the beverages contain high-fructose corn syrup. She claimed that the use of the words "all natural" on a product containing the syrup is a form of deceptive labeling in violation of the New Jersey Consumer Fraud Act. She filed the suit on behalf of all people in the state who bought Snapple and also sought a disgorgement of Snapple's profits from sale of the beverages. Snapple successfully argued that the claims were nationwide, not just in New Jersey, and moved the suit to federal court, where a judge granted the company's motion to dismiss because the consumer claims were preempted by federal labeling regulations.
Lead Illness in Children Linked to Car Seats Lead poisoning in children is usually traced to peeling paint in old homes or lead pipes. But the family car, and the children's car seats, can also become contaminated, especially if parents work in jobs that expose them to lead. When six babies and toddlers in Maine were found to have dangerously high levels of lead in their blood last year, public health workers who tested the children's homes found no traces of lead, except in some deck and outdoor areas where family members left their shoes and dirty clothes. Then they tested the family cars. The parents of several children worked in removing paint from older buildings under renovation; three of them were employed by the same painting contractor, who did not provide workers with showers or places to change clothes before going home, as required, investigators said. Another parent was a self-employed metal recycler.
Court Upholds Chinese Judgment Against American Company Over Helicopter Crash A federal judge in California has enforced a $6.5 million judgment imposed by a Chinese court on an American aircraft manufacturer following a deadly crash of one of the company's helicopters. The ruling is a turning point in a long legal saga pitting two Chinese companies that owned the helicopter against its manufacturer. The verdict represents one of the rare instances in which an American court has enforced the judgment of a Chinese court, possibly opening the door for more Chinese companies to enforce monetary judgments in the U.S. In 1995, the Chinese companies filed suit against the helicopter manufacturer for negligence and breach of implied warranty after a helicopter manufactured by the company crashed on a tour flight. The manufacturer objected to the lawsuit, claiming China was the proper jurisdiction, forcing the Chinese companies to file the suit in China in 2001. But the manufacturer failed to appear for the trial, where a panel ruled against the company in 2004, finding that the crash was the result of manufacturing defects. After a two-day hearing, a federal judge found that the Chinese court's decision lacked impartiality or due process. The decision should be enforced because it was "final, conclusive and enforceable under the laws of the People's Republic of China."
Candlelit Dinners Spark Romance and Toxins Scientists from South Carolina State University tested paraffin-based candles in a specially built chamber and found that burning such candles released toxic chemicals. According to the Centers for Disease Control and Prevention, toluene can affect the nervous system, and if inhaled in high doses by pregnant women, it can create birth defects. Benzene has been linked to cancer, especially leukemia. Scientists found that each time a paraffin candle is burned, it provides chemicals in its emissions. Candles made of vegetable-based wax, however, emitted no toxic chemicals in their tests. The candle industry insists that either type of candle is safe.
FDA Cracks Down On Ibuprofen Gels The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofen. Regulators said the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug. Ibuprofen ointments are often promoted as a safer alternative to pills because they do not carry side effects like stomach ulcers. However, the FDA said there is no research to support that claim.
Enfamil Baby Formula No Better Than Cheaper Brands, Suit Says Baby formula manufacturer Mead Johnson falsely claims that its Enfamil product contains special ingredients beneficial to an infant's development that are not found in less expensive brands, according to a lawsuit filed in California federal court. The suit is the latest of five filed against the company over allegedly false advertising involving Enfamil. Two other formula manufacturers have filed four lawsuits over the last nine years to stop Mead Johnson's alleged false advertising. A California resident also filed suit, alleging Mead Johnson's advertisements falsely lead consumers to believe that Enfamil is the only formula that contains two relatively typical formula ingredients. Enfamil's labeling and advertisements claim that it is the only product that contains a blend of DHA and ARA and that the "scientifically developed formula is not available as a store brand," the complaint says. However, other brands, including cheaper, store-brand formulas, contain the nutrients and are just as beneficial to infants as Enfamil.
Surgeon Tied to Bone Product Inquiry Resigns A former Army surgeon accused of falsifying a study on a bone growth product used on severely injured Iraq war veterans has resigned his teaching post at Washington University. The surgeon was placed on leave earlier this year while the university investigated charges against him. Medtronic, the maker of the bone growth product Infuse, also suspended his consulting contract. The company paid him nearly $800,000 the last few years. An investigation by Walter Reed Army Medical Center, where the surgeon worked before joining the university, concluded that he had falsified parts of a study that claimed greater benefits than other Army surgeons reported for the Medtronic bone growth product. The Army reported its findings to the university and a medical journal the surgeon was also found to have forged the signatures of four listed co-authors, who told Army investigators that they did not approve the study.
Mercury in Fish Widespread No fish can escape mercury pollution. That's the take-home message from a federal study of mercury contamination that tested fish from nearly 300 streams across the country. The toxic substance was found in every fish sampled, a finding that underscores how widespread mercury pollution has become. But while all fish had traces of contamination, only about a quarter had mercury levels exceeding what the Environmental Protection Agency says is safe for people eating average amounts of fish.
Class Certification Denied in Fraud Suit Over Marketing of Relacore A suit alleging that the maker of the dietary supplement Relacore fraudulently marketed it for use in cutting belly fat and stress is not right for class action treatment, a New Jersey appeals court ruled. The judges said that there are too many possible variables to satisfy the requirement that questions of law or fact common to the class predominate over questions affecting only individual members. The marketing campaign for Relacore varied over time. Some advertisements claimed the drug could reduce belly fat while others touted its ability to reduce stress, enhance mood or fight metabolic syndrome. As a result, Relacore users might have bought the product for different reasons and been disappointed in different ways by its alleged failure to measure up to the advertised promises. The lead plaintiff alleges that she bought Relacore in April 2004 based on advertised claims that it would reduce belly fat but that after 90 days of using the product as directed her waistline not only didn't shrink but increased. She sought certification of a class comprised of all New Jersey residents who bought Relacore since its introduction in 2002. Her complaint included claims under the New Jersey Consumer Fraud Act and under common law or fraud, unjust enrichment and breach of express and implied warranty. In 2008, a judge denied certification after identifying 14 individual factors that would necessitate an evidentiary hearing for each class member on the fraud claims. Those factors included the reason for buying Relacore, whether buyers were influenced by a personal recommendation, how the buyers' underlying health might have affected the product's efficacy, how much they paid and whether they sought or obtained a refund.
Lawyers Ask Judge to Lift Ban on Electronic Cigarettes Lawyers for electronic cigarette distributors told a federal judge that their clients do not market their products as a way to quit smoking, and that the Food and Drug Administration was acting like "a dog chasing its own tail" as it tried to explain why it was barring shipments of the device into the United States. Attorneys for Smoking Everywhere and NJoy asked the judge for a preliminary injunction that would lift the FDA's embargo on their products. The companies sued the FDA earlier this year, claiming the agency had erroneously classified e-cigarettes as unapproved drug devices, and banned imports of them into the states. E-cigarettes are small, battery-powered tubes that vaporize liquid nicotine, letting users inhale the chemical without the smoke associated with traditional tobacco cigarettes. The new development in the case is the passage of the Family Smoking Prevention and Tobacco Control Act, which brought cigarettes within the FDA's regulatory reach. Attorneys for e-cigarettes argued that the new law made it clear the FDA was wrong in its embargo because the act created a new regulatory category for tobacco-based products. E-cigarettes couldn't be regulated as drug devices, because the companies did not claim their product improved users' health or affected the body any differently than smoking a normal cigarette.
Cops' Bulletproof Vests Defective, Feds Say The federal government has sued a body armor manufacturer and its founder for allegedly selling defective bulletproof vests to federal agencies and local police forces. The company marketed its Zylon vests to law enforcement agencies as a thinner and more lightweight alternative to other bulletproof vests, according to the U.S. Department of Justice. But prosecutors claim that the company and its founder knew at the time of sale that the products contained "significant manufacturing and degradation problems" in the Zylon fiber that rendered the material unsafe for ballistic use. The government says in the lawsuit that the defendants violated the False Claims Act by supplying federal agencies with the defective products. The act is the government's primary tool for fighting procurement fraud. The lawsuit also accused the founder and his wife of making a fraudulent conveyance for transferring more than $5 million from the company to themselves after learning of the government's investigation into the defective vests. They transferred the assets in order to render the company insolvent and unable to pay the United States for the defective products.
Philip Morris to Appeal $1.9 Million Award to Widower of Smoker A jury awarded $1.93 million to the husband of a woman who smoked two packs of cigarettes a day for more than 40 years. The Florida jury deliberated for more than eight hours before handing down the verdict. The Marlboro smoker started smoking when she was 16 and died from lung cancer in 1996 at 73. Her husband filed suit against Philip Morris, alleging the tobacco company negligently concealed facts about the dangers of smoking. The jury found Philip Morris was liable and decided on damages, awarding total damages of $5.3 million but assiging 63.5 percent of the blame to the smoker. About 8,000 sick smokers are suing statewide in individual spinoffs from a 1994 class action that was disbanded on appeal. The class action named for a Miami Beach pediatrician resulted in a $145 billion verdict, which was overturned.
Court Reinstates Consumer Fraud Class Action Against Snapple In a 30-page ruling, a three-judge panel of the 3rd U.S. Circuit Court of Appeals revived a New Jersey statewide class action against Snapple, finding that federal regulation does not pre-empt consumer fraud claims involving Snapple's "All Natural" labeling. The case began when a New Jersey woman bought two bottles of Snapple in 2007, paying the "premium price" of $1.09 for each. She was apparently surprised and distressed to discover that her Snapple, which was labeled "All Natural," contained high-fructose corn syrup. She filed a class action in New Jersey, alleging consumer fraud and breach of warranty. Snapple's lawyers had the case moved to federal court, where a judge dismissed it, ruling that her claims were pre-empted by FDA regulation of food and beverage labeling. The 3rd Circuit disagreed. The appellate court found that FDA policy left room for state regulation in food and beverage labeling.
Plaintiffs Can Re-File Petland Puppy Mill Suit Pet owners' allegations against Petland for deceptively selling pets from puppy mills are not specific enough to support racketeering charges, an Arizona federal judge has ruled, granting the pet store chain and its primary supplier's motions to dismiss. However, the judge left open the possibility that the consumers could fix the deficiencies in the lawsuit with an amended complaint. Petland, the nation's largest pet store chain, issued a statement on its Web site following the judge's decision stressing its opposition to substandard breeders. Six pet owners filed the lawsuit against the Ohio-based chain and its primary supplier for allegedly conspiring to deceive consumers into paying high prices for dogs from puppy mills that were prone to disease and health problems. The pet owners, including two members of the Humane Society of the United States, filed the lawsuit on behalf of tens of thousands of people nationwide who have bought puppies from Petland since 2004. The lawsuit alleged that the supplier gets its animals from puppy mills and Petland advertised its dogs as the "finest available" even though they allegedly came from mass-breeding establishments. The plaintiffs contended the defendants violated federal mail and wire fraud laws by advertising that Petland's pets were of the highest quality even though they were unhealthy and prone to disease.
Federal Judge Puts Chinese Drywall Cases on 'Rocket Docket' With thousands of homeowners claiming their houses and health are deteriorating from sulfur-emitting Chinese drywall, a federal judge in New Orleans is intent on fast-tracking a handful of cases for trial. The first of these bellwether lawsuits could be tried by the end of the year, a timetable that encourages homeowners to think settlement. In contrast, the drywall maker welcomes home inspections and is investigating "practical solutions" but denies any health effects from its drywall. About 600 tainted Chinese drywall lawsuits have been consolidated into multidistrict litigation for pretrial issues. With the help of plaintiff and defense steering committees, the judge will select five cases to test the waters. Homeowner attorneys see the past as a guide. The judge supervised the $4.85 billion Merck settlement in Vioxx cases, one of the largest pharmaceutical settlements on record. It was reached only after plaintiffs, who claimed the withdrawn painkiller caused heart attacks and strokes, lost a series of trials. The estimated 600 Chinese drywall cases, a number which is bound to grow, are under the same judge's control.
28 Illnesses Linked to Recalled Ground Beef Health officials in three Western states said that at least 28 people had reported illnesses tied to recalled ground beef that might be tainted with salmonella. Last week, Beef Packers Inc. of Fresno recalled nearly 826,000 pounds of ground beef produced from June 5 to 23. The Food Safety and Inspection Service of the Agriculture Department said the beef was sent to retail distribution centers in Arizona, California, Colorado and Utah, with some sold at Safeway Inc. and Sam's Club. The department confirmed that California, Colorado and Wyoming had reported illness linked to the recalled beef. Colorado health officials said 21 people there had been sickened, and all were recovering. California officials said five people had reported feeling sick. Wyoming health officials reported that two people had fallen ill
Quick Tests for Flu Often Inaccurate As the swine flu spreads, many doctors and hospitals are turning to rapid tests that can determine within minutes whether an anxious patient has the flu, and sales of such tests are soaring. However, the tests have a severe limitation: They may fail more than half the time to detect swine flu infections, according to newly published studies and to experts in medical testing. The low sensitivity of the tests is becoming a concern to health authorities because a false negative reading might prompt a doctor not to prescribe antiflu drugs. It is also one of the big issues laboratory directors face as they prepare for what is expected to be a crush of flu testing this fall and winter. Numerous diagnostic companies are hoping to capitalize on demand for influenza testing.
Studies Question Using Cement for Spinal Injuries Two new studies cast serious doubt on a widely used and expensive treatment for painful fractures in the spine. The treatment, vertebroplasty, injects an acrylic cement into bones in the spinal column to ease the pain from cracks caused by osteoporosis, the bone-thinning disorder common in older people. Doctors began performing it in this country in the 1990s, patients swore by it, and it soon caught on, without any rigorous trials to determine whether it really worked. The new studies found the cement no better than a placebo, but it remains to be seen whether the findings will change medical practice, because they defy the common wisdom and challenge a popular treatment that many patients and doctors consider the only hope for a very painful condition.
Two More Dismissals Emerge in Product Liability Cases Thanks to Iqbal Ruling The Supreme Court's ruling in Ashcroft v. Iqbal has quickly become a boon to product liability defenses. Recently, a false-marketing suit involving AstraZeneca's anti-psychotic drug Seroqual was dismissed because it didn't meet the new, tougher standards laid down in Iqbal. Two other recent dismissals against controversial products can be attributed to the Iqbal ruling. A manufacturing and design defect claim where a woman sued Novartis, alleging she developed multi-organ failure after taking its epilepsy drug, was dismissed because her lawyers "failed to allege any facts that would permit the court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of her alleged injuries." A class action was also dismissed against Playtex. The suit alleged excess lead in baby bottle coolers, but the judge cited the Iqbal ruling for dismissal.
U.S. Marshals Seize Skin Sanitizers Strengthening its efforts to keep a deadly strain of E. coli out of meat sold to consumers, the Department of Agriculture said that it would begin regular testing of meat trimmings used to make ground beef. At the same time, the FDA said it was working to develop mandatory standards for growing, harvesting and processing fruits and vegetables, going well beyond the rules currently in place. The announcements were the latest signs that Washington was moving forward with efforts to overhaul the food safety system. The Agriculture Department said it would begin regular testing of "bench trim," the fat and meat trimmed from cuts like steak and roasts as they are prepared in processing plants. Bench trim is normally added to other meat used in ground beef. Government inspectors perform tests for E. coli in the slaughterhouse on most meat used in ground beef, before it goes to the processing plant. But the bench trim had not previously tested by the inspectors, creating a potentially dangerous hole in the government's food safety regimen.
House Approves New Food Safety Laws In a major step toward an overhaul of the nation's food safety system, the House of Representatives passed legislation to require more frequent inspections of processing plants and give the government the authority to order the recall of tainted foods. The legislation seeks to remedy problems in the food safety system that have been discussed for decades. The measure would require the FDA to conduct inspections every six to 12 months at food processing plants that it deems high-risk. These could include plants that have experienced food safety problems in the past or that handle products that spoil easily, like seafood. Lower-risk processing plants would be inspected at least once every three years, and warehouses for packaged foods at least once every five. Backers of the legislation complained that at present, some facilities go a decade or longer between FDA inspections.
Obama Calls Food Safety Bill Major Step The U.S. House of Representatives has passed a far-reaching food safety bill requiring more government inspections and imposing new penalties on those who violate the law, reacting strongly to an outbreak of salmonella in peanuts that killed at least nine people. The legislation would require greater oversight of food manufacturers and give the U.S. Food and Drug Administration new authority to order recalls. It also would require the FDA to develop a system for better tracing food-borne illnesses. Food companies would be required to create detailed food safety plans. President Barack Obama praised the bill soon after it was passed, calling it "a major step forward in modernizing our food safety system." Farm state representatives had argued that the bill would be too invasive on farms.
Supplements for Athletes Draw FDA Alert Federal regulators warned consumers not to use body-building products that are sold as nutritional supplements but may contain steroids or steroid-like substances, citing reports of acute liver injury and kidney failure. The FDA said it issued the warning because of increased reports of medical problems in men who had used such products. But except for naming eight specific supplements sold by a single company, the FDA did not provide much clear guidance to consumers on what other products to avoid. The FDA acknowledged that it did not know how many products its warning affects. Generally, buyers should beware of body-building products that claim to enhance or diminish the effects of hormones like testosterone, estrogen or progestin. In particular, consumers should not buy products labeled with words like "anabolic" and "tren," or phrases like "blocks estrogen" and "minimizes gyno."
FDA Deems Mercury Level in Fillings Safe Silver dental fillings containing mercury are safe for use by adults and children ages 6 and above, the FDA says. Only people who are allergic to mercury should avoid that type of filling. After reviewing more than 200 scientific studies, the agency concluded that mercury vapor released by the filling was not enough to cause brain damage. Still, the agency for the first time classified the fillings as a Class II, or "moderate risk," medical device. The move acknowledges the risk for patients and allows the agency to impose tighter safety controls. The decision is somewhat of a change of heart for the FDA, which settled a lawsuit last year with groups opposed to mercury use by posting a warning on its Web site about the filling's potential risks for fetuses, breast-feeding infants and children younger than 6. The agency said the findings showed that the fillings do not expose those groups to mercury levels considered unsafe by the Environmental Protection Agency, but added that there were few studies on the effects of mercury in fillings on children under 6.
New York City Missed Inspecting 1 of Every 5 Restaurants New York City's health department failed to inspect one in every five restaurants during 2008, according to an audit. Inspectors are supposed to make unannounced annual visits to the city's restaurants, but 22 percent of the restaurants slipped through the cracks last year. The Bureau of Food Safety and Community Sanitation, part of the Department of Health and Mental Hygiene, is responsible for inspecting food service establishments, which include mobile units and cafeterias at schools and senior centers as well as restaurants. If violations are found during a review, inspectors are supposed to return in 14 to 45 days to determine whether the violations have been corrected. In the course of audit, a sample of 62 restaurants failed inspections. In all but two cases, inspectors made follow-up visits, but 20 percent of them were reinspected more than 45 days after the initial inspection.
Family Sues McDonald's for Foodborne Illness An Illinois couple has filed a lawsuit against McDonald's, claiming their son was hospitalized for four days after eating at one of the chain's restaurants. The suit is the first filed on behalf of a McDonald's patron sickened in a recent hepatitis A outbreak. Another lawsuit was filed by a man who got preventive shots after eating at the same McDonald's in Illinois. Attorneys are seeking class action status in that case on behalf of people who got preventive shots recommended by health authorities to diners at the restaurant. Twenty-two people have been sickened with more than 4,500 people receiving preventive shots during a recent hepatitis A outbreak that crossed from Illinois in to Iowa. Two food handlers at the restaurant are among the sick. Both lawsuits name the owner of the franchise as a defendant. He said in a statement that he took immediate action to address concerns raised by county health officials as soon as they identified the problem.
Analysis Finds Toxic Substances in Electronic Cigarettes A preliminary analysis by the FDA has found that electronic cigarettes contain traces of toxic substances and carcinogens. The findings contradict claims by electronic cigarette manufacturers that their products are safe alternatives to tobacco and contain little more than water vapor, nicotine and propylene glycol, which is used to create artificial smoke in theatrical products. When heated, the liquid produces a vapor that users inhale through the battery-powered device. The agency analyzed 19 varieties of cartridges, which hold the liquid, and two cigarettes. The analysis found that several of the cartridges contained detectable levels of nitrosamines, tobacco-specific compounds known to cause cancer. One cartridge was found to contain diethylene glycol, a common ingredient in antifreeze that counterfeiters have substituted for glycerin in toothpaste, killing hundreds worldwide. Electronic cigarettes, which are manufactured in China, are subject to little quality control. The study found the levels of nicotine vary even in cartridges whose labels claim to have the same amount of nicotine. Some of the cartridges that claimed not to contain nicotine actually did. The FDA has called electronic cigarettes drug delivery devices and said they should not be allowed in the country. It has turned away about 50 shipments of the devices at the border, but they still continue to be sold in malls nationwide and online.
At the Beach, Watch Out for Dirty Sand Swimming in water that contains too much bacteria from sewage and other sources is a well-known risk for getting sick, but playing in sand next to that water may be ever riskier. Researchers have found that sand could contain high levels of fecal bacteria, and that people who dig in it could develop gastrointestinal illnesses. Reasearchers contacted more than 25,000 people visiting seven beaches within seven miles of sewage treatment plants. About 10 days later, researchers asked how they had spent their day at the beach and whether they had experienced problems like vomiting and diarrhea since then. Those who dug in the sand were significantly more likely to report having been sick, with those who allowed themselves to be buried in the sand most affected. Children seemed to be at extra risk. Though swimming is temporarily banned when there are high levels of fecal bacteria runoff from cities or animal life, bacteria can continue to live in the sand even after the bacteria in the water has returned to normal levels.
Standards Might Rise on Monitors for Diabetics Federal officials may soon require improvements for the glucose monitors used by more than 11 million diabetics in the United States. The rise in the use of home glucose monitors, even by hospitals, is pushing the action by the Food and Drug Administration, which for decades has followed international standards that allow the devices to be wrong by as much as 20 percent. Such a wide error rate can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma. The FDA has pressed the international group that sets the standards to tighten them. If the group refuses to act, the agency may instead recognize other higher performance standards. A change in the international standards is the easiest and best option. The International Organization for Standardization, which sets the standards, can act quickly and broadly, but the FDA can change the rules itself through a more time-consuming and cumbersome process. Officials said they would keep pushing until monitor accuracy improves.
Concern Growing Over Superbugs in Food Most commonly, MRSA is found in hospitals, where it causes many illnesses. Other encounter different types of the bug in community centers such as the gym, where skin contact occurs and items are shared. In 2008, however, a new source and strain of MRSA emerged in the United States. Two large Midwestern hog farms found the strain in 45 percent of farmers and 49 percent of pigs. The government has yet to put a comprehensive MRSA inspection process in place. Though most people aren't working in meat processing plants, enough handle meat daily. While cooking kills the microbe, MRSA thrives on skin. People can become infected by touching infected raw meat through cuts or nasal passages. Extensive research has found MRSA in many species used for food. Researchers in Louisiana tested 120 cuts of locally purchased meat and found MRSA in 4 percent of the pork and 1 percent of the beef. Though the percentages are small, Americans eat more than 180 million pounds of meat every day.
Wisconsin High Court Rejects Design Defect Claims Over Lead Paint The Wisconsin Supreme Court ruled that a young boy who was exposed to lead paint cannot sue the manufacturers for defectively designing a key ingredient. The Supreme Court dismissed the boy's claims against du Pont and Sherwin-Williams. The case involved a child who alleged that he was exposed to an ingredient in lead paint called white lead carbonate pigment, which existed in paint chips, paint flakes and dust containing paint at his apartment in Milwaukee. The justices ruled that because lead is a characteristic ingredient in of white lead carbonate pigment, the design could not have been defective. The boy may pursue a separate claim that the manufacturers failed to warn him of the ingredient's dangers. More than half a dozen personal injury lawsuits involving lead paint are currently pending in Wisconsin.
Medical School Says Former Army Surgeon Hid Ties to Medtronic A former medical doctor and Medtronic consultant at the center of a research scandal did not tell his medical school employer for a year about his Medtronic ties even as he was conducting company-sponsored research. The new disclosure, which the medical school made in response to a Senate investigation, may intensify the controversy surrounding the physician. The Army has accused him of falsifying a medical journal study about the use of Medtronic bone-growth product on American soldiers with severe leg injuries, reporting more favorable results than other Walter Reed doctors found. The medical documents also shed new light on Medtronic's financial support of the doctor's research on those soldiers, who were treated with the company's bone-growth product, Infuse. Medtronic has denied supporting or knowing about the doctor's study of Infuse at Walter Reed. However, the documents show that for more than a year Medtronic financed a separate, unpublished study by the same doctor while he was teaching that also reviewed the use of Infuse on Walter Reed patients with combat-related leg injuries.
Administration Seeks to Restrict Antibiotics in Livestock The Obama administration will seek to ban many routine uses of antibiotics in farm animals in hopes of reducing the spread of dangerous bacteria in humans. The principal deputy commissioner of food and drugs said feeding antibiotics to health chickens, pigs and cattle, which is done to encourage rapid growth, should cease. He also said that farmers should no longer be able to use antibiotics in animals without the supervision of a veterinarian. Both practices lead to the development of bacteria that are immune to many treatments. A measure has been proposed in the U.S. House of Representatives to ban seven classes of antibiotics important to human health from being used in animals and to restrict other antibiotics to therapeutic and some preventive uses.
Nestle Dough's E. Coli Doesn't Match Outbreak The FDA has found that the strain of E. coli found in a sample of raw cookie dough collected at a Nestle manufacturing plant does not match the strain that has been linked to a 30-state outbreak. The FDA and the federal Centers for Disease Control have been investigating whether the cookie dough was the source of the E. coli outbreak which has sickened at least 69 people. Recently, Nestle voluntarily recalled all Toll House refrigerated cookie dough products made at its Virginia factory after the FDA told Nestle it suspected consumers may have been exposed to E. coli bacteria after eating the dough raw.
Smoke Alarms, Tea Kettles and Basketballs Recalled About 94,000 Kiddie dual sensor smoke alarms have been recalled because an electrostatic discharge can damage the unit, causing it not to warn consumers of a fire. There have been at least two reports of smoke alarm malfunctions involving electrostatic discharge during installation, though no injuries have been reported. About 142,000 Copco Harmony tea kettles have been recalled because the product's lid can come loose during handling, posing a burn hazard. The company is aware of 25 incidents of the lid coming loose and there have been reports of second-degree burns to hands and fingers. About 91,000 packages of DesignWare Sport Balls have been recalled because the basketball's surface coating has high levels of lead, which is toxic if ingested by children. No incidents or injuries have been reported. About 130 Hard Tail girls' hooded jackets and pullover sweat shirts have been recalled because the products have drawstrings through the hoods or waists. This can pose a strangulation hazard to children, though no incidents or injuries have been reported.
Many Pet Supplements Don't Meet Claims Arthritis supplements bought by millions of pet owners for their dogs, cats and horses sometimes skimp on the ingredients the makers claim can help aching pays and aging joints, and some contain high amounts of lead. Four of the six joint supplements for animals tested by ConsumerLab.com lacked the amounts of glucosamine or chrondroitin promised on their labels or had other flaws, such as lead. Wider testing by a trade group of 87 brands found that one-quarter fell short. Over-the-counter dietary supplements for humans do not have to be proven safe or effective before they are sold, and pills for pets get even less scrutiny. Even when these supplements contain what they claim, there is little evidence that they work. A large government study of people with arthritis found that glucosamine and chondroitin did no better than dummy pills in easing mild pain. Testing these supplements on pets is more difficult.
1 Million Play Yards Recalled Due to Faulty Latch About 1 million play yards have been recalled because the side rail can fail to latch properly. A child who pushes against it could fall. The play yards were sold under several brand names and were manufactured in China, Spain and Italy. The company has received 347 reports of play yards' sides collapsing, resulting in 21 injuries, including a concussion, as well as bumps, scrapes and bruises.
Stricter Labeling Urged for Bottled Water Consumers know less about the water they pay dearly for in bottles than what they can drink almost for free from the tap because the two are regulated differently, congressional investigators and nonprofit researchers say in new reports. Both the Government Accountability Office and the Environmental Working Group, a nonprofit research and advocacy organization, recommend in reports that bottled water be labeled with the same level of information municipal water providers must disclose. The researchers urged Americans to make bottled water "a distant second choice" to filtered tap water because there isn't enough information about bottled water. The working group recommends purifying tap water with a commercial filter, however.
Administration Issues New Rules on Egg Safety Researchers discovered during the Reagan administration that contaminated fresh eggs sickened thousands of people, but federal officials squabbled for two decades about how to solve the problem until recently. The Obama administration has released a rule to deal with the nation's egg problem and used the moment to promise a sweeping overhaul of the system to ensure the safety of spinach, lettuce, tomatoes, melons, beef and chicken, all foods that lead to millions of illnesses and thousands of deaths each year. Most of the measures announced are more aspirational than actual. The Agriculture Department promised to develop new standards to reduce salmonella levels in chickens and turkeys by the end of the year. The FDA promised to advise the food industry by the end of the month on how to prevent contamination of tomatoes, melons, spinach and lettuce. And within three months the FDA plans to release advice about how farmers, wholesalers and retailers can build systems to trace contaminated foods quickly from shelf to field.
E. Coli in Beef Linked to 12 Hospitalizations Federal health officials say at least 12 people have been hospitalized in connection with a possible E. coli outbreak in beef and two of them suffered kidney failure. According to the Centers for Disease Control and Prevention, at least 23 people in nine states may have become ill after eating beef produced by JBS Swift Beef Co. of Colorado. The company recalled about 380,000 pounds of beef after some illnesses were reported and a government investigation showed a possible connection to the company's product. That recall expanded an earlier recall of just over 41,000 pounds.
Cookie Dough at Nestle Plant Yields Positive Test for E. Coli The FDA said that a sample of raw cookie dough collected at a Nestle USA manufacturing plant has tested positive for E. coli. Nestle voluntarily recalled all Toll House refrigerated cookie dough products made at the Virginia factory after the FDA told Nestle that it suspected consumers might have been exposed to E. coli bacteria after eating the dough raw. The agency and the Centers for Disease Control and Prevention have been investigating whether the dough was the source of the E. coli outbreak that has sickened 69 people in 29 states.
Nestle Refused FDA Information Inspection reports from a Nestle cookie dough factory show the company refused several times to provide FDA inspectors with complaint logs, pest-control records and other information. Nestle voluntarily recalled all Toll House refrigerated cookie dough products made at the factory after the FDA informed the company it suspected consumers may have been exposed to E. coli bacteria after eating the dough raw. The Centers for Disease Control says 69 people have been sickened in 29 states.
Home Depot Product Liability Suits Advance A federal judge in Atlanta is permitting dozens of product liability suits against Home Depot and the makers of a tile grout cleaner to proceed to trial on negligence claims, but he has stripped away other claims that sought damages for violating federal consumer product safety laws. Ten of those suits, filed by customers who were hospitalized after using Tile Perfect Stand 'n Seal Spray-On Grout Cleaner, were among approximately 50 suits that have been settled. Sickened customers sued Home Depot and five companies tied to the manufacture and distribution of the product. The manufacturer of the grout cleaner had been fielding complaints for more than a month about the potentially devastating health problems associated with its use when the lead plaintiff purchased the cleaner. Two people died and dozens were hospitalized after breathing vapors from the spray. As a result of those injuries, the U.S. Consumer Product Safety Commission issued a recall of 300,000 cans of the product. The lead plaintiff was hospitalized and left with permanent lung damage after inhaling the fumes, which contained Flexipel, a chemical that should not have been produced in aerosol form. More than 100 suits remain active and nearly 50 have been settled. Home Depot continues to vigorously fight the suits, arguing over who bears responsibility for any damages.
3rd Circuit Mulls Pre-Emption of Class Action Over Snapple's Nutrition Claims A panel of the 3rd U.S. Circuit Court of Appeals appears likely to revive a consumer fraud suit that accuses the popular Snapple line of beverages of misleading the public by proclaiming it was "All Natural" even though it was sweetened with high-fructose corn syrup, an ingredient the plaintiffs have labeled as "synthesized" and "unnatural." The judges seem to be leaning towards recent trends of allowing such consumer or products liability suits. A lower court judge had tossed the case in 2007, concluding that such state-law consumer claims were pre-empted by the FDA's labeling regulations. If the suit were revived, it would be pursued on behalf of a class of consumers seeking damages for Snapple's alleged unjust enrichment and fraud on the public during the time that the "All Natural" claim was made.
Medtronic Gets Subpoena Regarding Disputed Study Medtronic disclosed that it had received a Justice Department subpoena seeking information about its ties with a company consultant, a former Army doctor accused of falsifying a favorable medical journal article about a Medtronic bone growth product called infuse. The medical device maker indicated in a filing with the Securities and Exchange Commission that it had received a subpoena in May from the United States attorney in Boston seeking information about its financial ties and other dealings with a former orthopedic surgeon at Walter Reed Army Medical Center in Washington. Recently, Medtronic, at the behest of a senator, disclosed that it had paid about $800,000 in consulting fees over the years to the doctor, with the vast bulk of those funds paid to him in the last three years. It was over that period that the doctor submitted his now-challenged Infuse study to a series of medical journals before it was published in 2008 in a British journal. It claimed Infuse performed "strikingly" better than a traditional bone graft when used to repair serious leg injuries suffered by American soldiers. In an investigation completed last year, the Army accused the orthopedist of forging the name of other military doctors on that Infuse article and citing patient data that did not match Walter Reed records.
Kids' Hoodies Recalled for Strangulation Risk The Consumer Product Safety Commission says Macy's will voluntarily recall about 33,000 hooded children's sweatshirts that pose a strangulation risk. The recall covers boys' and girls' Epic Threads and girls' Greendog sweatshirts in small and medium sizes, that have a drawstring sewn in the base of the hood. They were sold nationwide from July 2008 to March 2009. Consumers can remove the drawstring to eliminate risk, or can return the sweatshirts to Macy's for a full refund.
$788,000 Paid to Doctor Accused of Faking Study Medtronic has announced that it paid nearly $800,000 over an eight-year period to a former military surgeon who has been accused by the Army of falsifying a medical journal study involving one of the company's products. The surgeon claimed in the study that the use of a Medtronic bone growth product called Infuse had proved highly beneficial in treating leg injuries suffered by American soldiers in Iraq. The British medical journal that published the article retracted it after an internal Army investigation found the doctor had forged the names of four other doctors on the study and had cited data that did not match military records. Medtronic has said it was not involved in any way with the challenged report, even though the company is under investigation by the Justice Department and a senator in connection with possibly illegally marketing of Infuse through outside physicians who work for it as consultants. In the last few weeks, Medtronic, which initially declined to say what it had paid the doctor or even if it had hired him, has been under growing pressure to disclose its financial ties to the doctor. It has described the $800,000 paid to the doctor as either reimbursement for travel expenses, payments for speaking or training other doctors on Medtronic's behalf or for consulting.
EPA to Review Safety of Pet Flea and Tick Products Liquid flea and tick treatments for dogs and cats have been on the market for more than a decade, but following a recent increase in reports of adverse reactions among pets, the Environmental Protection Agency has intensified its scrutiny of the products, warning pet owners that the treatments may have serious, even fatal, side effects. Spot-on flea and tick treatments are applied topically, usually between the animal's shoulder blades or along the spine. There have been no recalls of the products, and the agency said that there is no reason to avoid them. But the EPA is investigating a large number of anecdotal reports involving both cats and dogs who received spot-on treatments and suffered problems like skin irritations, hair loss and tremors. The agency is now evaluating all available data on the pesticides, including reports of adverse reactions, the clarity of the directors and label warnings, and the pre-market safety data submitted in support of the products.
Medical Device Maker Accused of Improper Marketing A medical device maker, Synthes Inc., and four of its executives were indicted on federal charges that they improperly promoted a bone filler for purposes not approved by the FDA, including encouraging its use in what prosecutors called "unauthorized" human trials. The indictment is one of the strongest actions taken in recent years against a maker of drugs or medical devices. Prosecutors charged Synthes and Norian Corporation with running an unauthorized trial of the bone filler in spinal procedures known as vertebroplasty and kyphoplasty. Three people died in those procedures, though federal prosecutors said that they could not prove that the Synthes product caused the deaths. Prosecutors estimate that 200 patients had the improper operations. The four executives were charged with criminal misdemeanors involving the shipment of unapproved medical devices. Those charges carry a possible prison sentence of one year.
FDA Chief Makes Produce Safety Early Priority Calling it "a critical time" for food safety, the FDA's new chief said she plans to strengthen steps to prevent contamination of fresh fruit and vegetables. She said the FDA must set and enforce tougher standards for the riskiest products, and a string of recent outbreaks linked to spinach, lettuce, tomatoes and peppers put fresh produce atop her list as she takes over the embattled agency. The FDA, the nation's chief consumer protection agency, has struggled for years to keep up with increasing responsibilities to oversee the nation's complex health industries as well as food, without a budget sufficient to do the job. Its own scientists have charged that their safety concerns were dismissed by leaders too cozy with industry. The new chief has vowed to restore the FDA's credibility by focusing on science-based decisions that shore up public health and put food safety at the top of the list. The FDA has asked Congress for a nearly 20 percent funding increase and new industry user fees to pay for more inspections.
Fewer the Better On the Trampoline On a trampoline, if two is company, three or more may well be a fracture. Researchers who looked at children's trampoline injuries at a Scottish emergency department found that the most common factor was having many people bouncing at the same time. The researchers said three-quarters of the injuries they looked at had involved several people's sharing the trampoline. The number of people bouncing is not the only factor. The comparative weights of the people on the trampoline also make a big difference, and the lightest users often bear the heaviest costs. They are five times as likely to be injured, the study said. A child weighing about 40 pounds sharing the trampoline with an adult weighing 160 pounds experiences forces equivalent to falling almost 11.5 feet.
Chinese Drywall Lawsuits Consolidated A federal panel issued an order consolidating Chinese drywall liability lawsuits before a New Orleans judge. The panel also chose a judge to manage what one attorney estimated could end up being 1,000 homeowner suits nationwide by people who bought homes built by Chinese drywall primarily in the Southeast since 2005. Plaintiffs attorneys say drywall manufactured by Knauf Plasterboard in at least two of its Chinese plants emits sulphur gas that corrodes wiring and ruins appliances such as air conditioning units. Some homeowners also claim they have been forced to leave their homes because of breathing difficulty. Knauf has said there is no evidence that medical problems are caused by the drywall. One attorney, who has filed about 20 drywall cases, said the consolidated litigation will allow plaintiffs attorneys to share information and avoid costly duplicative court costs.
Medtronic Paid Surgeon While in Army Medtronic has acknowledged that it paid a former Army surgeon, who is now accused of falsifying research about one of its products, to give speeches and train other doctors on the company's behalf while he was in the military. The disclosure shows that the financial entanglements between Medtronic and the surgeon were more extensive than previously acknowledged. Army officials have accused the doctor of falsifying research about the benefits of a Medtronic bone growth product called Infuse in treating American soldiers who suffered severe leg injuries in Iraq. Until mid-2006, the doctor, an orthopedic surgeon, worked at Walter Reed Army Medical Center in Washington. Initially, Medtronic officials said that the company had supported some of the doctor's research through grants to a foundation but refused to say when the company had hired him as a consultant. That drew the attention of an Iowa senator, who had already been investigating Medtronic in connection with its marketing of Infuse.
Poultry is No. 1 Source of Outbreaks Poultry was the most commonly identified source of food poisoning in the United States in 2006, followed by leafy vegetables and fruits and nuts, according to a report released by the Centers for Disease Control and Prevention. The report is the first effort by federal researchers to identify how most people in the United States become sickened by contaminated foods. Its findings, while not surprising, were welcomed by food safety advocates. After a concerted campaign by the federal Department of Agriculture to improve the safety of chickens, the number of people sickened by contaminated poultry in 2006 declined compared with an average of the previous five years. But problems persist. Most of the poultry-related illnesses, the centers found, were associated with Clostridium perfringens, a bacterium that commonly causes abdominal cramping and diarrhea usually within 10 to 12 hours after ingestion. The spores from this bacterium often survive cooking, so keeping poultry meat at temperatures low enough to prevent contamination during processing and storage is critical. Researchers counted leafy vegetables, fungi, root vegetables, sprouts and vegetables from vines or stalks as separate categories, because if all of the produce categories were combines, outbreaks associated with vegetables would have far exceeded those in poultry.
Senate Approves Tight Regulation Over Cigarettes More than four decades after the surgeon general declared smoking a health hazard, the Senate cleared the final hurdle to empowering federal officials to regulate cigarettes and other forms of tobacco for the first time. The legislation, which the White House said President Obama would sign as soon as it reached his desk, will enable the FDA to impose potentially strict new controls on the making and marketing of products that eventually kill half their regular users. The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws. The Family Smoking Prevention and Tobacco Control Act, as it is called, stops short of empowering the FDA to outlaw smoking or ban nicotine, strictures that even most antismoking advocates acknowledged were not politically feasible and might drive people addicted to nicotine into a criminal black market. But the law would give the FDA power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke. The law also bans most tobacco flavorings, which are considered a lure to first-time smokers. Menthol, however, was deferred to later studies.
Drywall Safety and Other Recall Bills Before Congress Legislation sponsored by senators from Florida and Louisiana calls for a ban on Chinese-made drywall suspected of emitting sulfur gases and causing the corrosion of household plumbing and wiring. The Drywall Safety Act of 2009 also seeks a recall of Chinese drywall imported between 2004 and 2007. The drywall is made using sulfur products, which can release gases that mix with moisture in the air and result in sulfuric acid. The acid corrodes the coils and wiring of air conditioning and refrigeration systems and copper pipes. The hot, humid weather in Florida and other southern states speeds up the corrosive effect. The acid also emits a rotten-egg smell and affects some residents' eyes, sinuses and breathing, according to numerous lawsuits filed in response to the drywall problems. Plaintiffs in the suits are seeking damages to cover the costs of repairing their homes. Because of increased demand during the housing boom and following Hurricane Katrina and Rita in 2005, thousands of homeowners in Florida and Louisiana and an estimated 100,000 nationwide have installed the defective drywall.
FDA Warns Against Using Some Skin Sanitizers The FDA warned consumers not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection. Clarcon Biological Chemistry Laboratory of Utah issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names. Consumers should not use any Clarcon products and should throw them away. Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage. The FDA said its findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases.
FDA Nears Control Over Tobacco Products A key Senate vote has put Congress in sight of fulfilling a decade-old quest to put the content and marketing of tobacco products under the control of the federal government. The legislation would for the first time give the FDA legal authority to regulate cigarettes and other tobacco products. The 61-30 Senate vote to move forward on the bill sets up possible passage of the measure. The House has already passed a similar bill and resolution of minor differences would send it to President Obama, who supports it. The bill would, for the first time, give the FDA powers to regulate the content of tobacco products, order the removal of hazardous ingredients, restrict the marketing and distribution of cigarettes and smokeless tobacco, clamp down on sales to young people, require stronger warning labels and stop use of characterizations such as "light" or "low tar" that give people the impression of lower health risks. A new officer would be set up in the FDA, with administrative costs paid by a fee on tobacco companies.
Plaintiffs Lawyers Stuck On Denture Cream Lawsuits Plaintiffs law firms are sinking their teeth into product liability lawsuits alleging that denture cream products cause zinc buildup in the body and neurological problems. A dozen cases pending in federal courts in California, Colorado, Florida, New York, Ohio, Oklahoma, Pennsylvania and Tennessee are awaiting the result of a multidistrict litigation panel hearing in Kentucky. The cases target PoliGrip denture adhesive maker GlaxoSmithKline and Procter & Gamble, which manufacture Fixodent. One firm has screened more than 3,000 potential cases and is ready to bite the bullet on about 40. The lawsuits allege that longterm use of the product leads to zinc buildup and neurological problems because copper and zinc compete to bind to receptors and the body then expels the copper that isn't absorbed.
Couple Plead Guilty in Toxic Pet Food Case A Las Vegas company and its owners have agreed to plead guilty in connection with tainted pet food that may have killed thousands of dogs and cats in 2007. An attorney for one of the co-owners of ChemNutra Inc. said his client had reached a plea agreement with prosecutors and would plead guilty. The co-owner's wife and the company also plan to plead guilty. The couple and their company, along with two Chinese companies, were indicted in February 2008 on charges alleging they imported wheat gluten tainted with the chemical melamine, which was then sold to pet food makers. Thousands of cats and dogs reportedly sickened or died after eating the tainted food. ChemNutra and the couple were charged with 13 misdemeanor counts of introduction of adulterated food into interstate commerce, 13 misdemeanor counts of introduction of misbranded food into interstate commerce and one felony county of conspiracy to commit wire fraud. The indictments allege that a Chinese export broker mislabeled 800 metric tons of tainted wheat gluten manufactured by another Chinese company to avoid inspection in China. The contaminated products were then not properly declared when it was shipped to the U.S. as a material to be used in food. ChemNutra then picked up the melamine-tainted product at a port of entry in Kansas City, then sold it to makers of various brands of pet foods. The indictment alleges that the melamine was added to artificially boost the protein content of the gluten to meet the requirements specified in the Chinese company's contract with ChemNutra.
Drug Agency May Reveal More Data On Actions For years, the FDA has withheld information about drugs and medical devices from the public when their makers cite trade secrecy, even in cases where the agency suspects that the products are causing serious illness or death. Now the new leadership of the FDA may change that. The Obama administration plans to announce that it is setting up a task force within the agency to recommend ways to reveal more information about FDA decisions, possibly including the disclosure of now secret data about drugs and devices under study. The task will be complicated. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Changing them would "involve more than one Congressional committee and impact thousands and thousands of companies, and thus would be an extremely difficult legislative path. Still, the goal is to open up a system in which the agency failed to inform the public that widely prescribed heartburn drugs were especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.
A Simple Smooch or Toxic Smack? The debate seems to resurface every few years: Do some lipsticks contain lead? If so, is the amount so negligible that consumers have nothing to be concerned about? Or will all those years of applying lipstick several times a day add up to a worrisome accumulation of a dangerous substance? On one side are advocacy groups and doctors who insist that, over time, those who wear lipstick containing lead are at risk of absorbing high levels of a neurotoxin that may cause behavioral, learning and other problems. On the other side are the FDA and outside experts who say that any traces of lead that do exist are too minute to cause harm. The debate has recently reared its head again when the Campaign for Safe Cosmetics, a coalition of health and environmental groups, issued a plea to the FDA to release information the agency had accumulated on the amount of lead in lipstick. The study was conducted in response to an independent analysis in 2007, paid for by the safe cosmetics group, which found that one-third of 33 lipsticks had lead in excess of 0.1 parts per million, the federal limit for candy. Among the worst offenders were L'Oreal and Cover Girl.
New FDA Chiefs Vow to Fix Lax Food Safety The new chiefs of the FDA expect a "modern food safety system focused on prevention of contamination." Even its defenders acknowledge the FDA, the nation's chief consumer protection agency, is struggling, given increasing responsibilities overseeing ever-more-complex health industries, but not a budget sufficient to do the job. An independent review in 2007 concluded lives were at risk, and morale plummeted as the agency's own scientists charged their safety concerns were dismissed by leaders too cozy with industry. The new heads of the FDA announced that their top priority will be working with the Agriculture Department to improve food safety, following some high-profile crises including the peanut butter outbreak earlier this year that sickened nearly 700 people and is blamed for at least nine deaths. Peanut Corp. of America is under criminal investigation for allegedly shipping peanut butter and another ingredient used in thousands of other products that it knew to be tainted.
FDA: Pistachio Plant Knew Nuts Tainted Food safety inspectors say a California plant at the center of a salmonella scare knew some of its pistachios were tainted by continued shipping nuts for another six months. The FDA issued a sweeping national warning for consumers to avoid eating pistachios after concerns surfaced about nuts from Setton Pistachio of Terra Bella, Inc. In an inspection report that was recently released, FDA officials said Setton first got results in October 2008 showing some of its roasted nuts tested positive for salmonella. But, officials say, it didn't make proper adjustments to its processing procedures and kept shipping out nuts. Officials haven't said whether the company will face sanctions.
Senator Rebukes Medtronic Over List of Consultants The medical device maker Medtronic said that it had suspended its consulting agreement with a former medical doctor accused by the Army of falsifying research involving use of one of the company's products on injured soldiers. The company, which previously declined to disclose many details of its relationship with the physician, also said it had hired him as a consultant in August 2006, the same month he joined the faculty of a medical school. The doctor worked at Walter Reed Army Medical Center, was still on active duty at the time and did not formally retire from the Army until seven months later. Army doctors can accept money to consult for military product companies if they are given approval. Military officials said that they had not found records that the doctor had sought or received such permission. After an Army investigation, a British medical journal retracted an article the doctor had written in which he reported that Infuse had greater success than another technique in healing the shattered legs of American soldiers wounded in Iraq. The Army found that the doctor forged the names of four other Walter Reed doctors he claimed to be his co-authors and presented data that appeared to have been fabricated because it did not match Walter Reed patient records.
Vermont Acts to Make Drug Makers' Gifts Public Cracking down on medical industry payments to doctors, the Vermont legislature has passed a law requiring drug and device makers to publicly disclose all money given to physicians and other health care providers, naming names and listing dollar amounts. The law is believed to be the most stringent state effort to regulate the marketing of medical products to doctors. It would also ban nearly all industry gifts, including meals, to doctors, nurses, medical staff, pharmacists, health plan administrators and health care facilities. In practice, the new law would let Vermont's citizens learn which doctors have been paid, and how much, by the makers of the brand-name drugs for which they wrote prescriptions, or how much money certain surgeons have received from the makers of the stents, pacemakers, artificial knees and such that the doctors implanted. The action by Vermont has been watched around the country, as national legislators and medical groups look for links between industry marketing and health care costs.
FDA Lags in Food Safety Audits The FDA conducted only about half the state food safety audits is promised in the two years before the recent peanut salmonella outbreak, according to new documents the agency sent to Congress. The documents show the agency did not do any of the required audits of state-run food inspections in five states during those states' budget years spanning 2007 and 2008. And the FDA was unable to say whether audits were conducted at all in 11 additional states during that time, including Georgia and Texas, where salmonella was found in two peanut plants during a wide-ranging peanut recall earlier this year. Only 14 states saw 100 percent of the audits completed. The FDA's audits are a key part of the federal government's ability to ensure that food is inspected properly by states that contract the FDA to perform safety checks. The agency turned its records on the audits over to Republicans on the House Energy and Commerce Committee in response to questioning at hearings earlier this year.
Synthetic Turf Fields Kicking Up Safety Concerns Synthetic turf has health experts, activists and parents concerned that children may be exposed to chemicals if they inhale or swallow the rubber granules, known as crumb rubber, that are used as filler between blades of artificial grass. Artificial turf is often made of fake blades of grass with sand or ground tires used as fill to provide a springy cushion. About 25 million used auto tires are recycled into turf each year, and about 4,500 synthetic turf fields are in use throughout the country. Supporters say the artificial turf encourages increased outdoor play, reduces water and herbicide use and provides an even, predictable surface that's more cushioned than old-style Astro Turf. But potential health concerns have led Connecticut and California to conduct their own studies on the health effects of turf. New York City health officials recently commissioned a study to evaluate air quality above synthetic turf and found it didn't show appreciable effects from contaminants in the rubber.
Change in Cigarettes More Dangerous to Lungs? It may be riskier on the lungs to smoke cigarettes today than it was a few decades ago, at least in the U.S., says new research that blames changes in cigarette design for fueling a certain type of lung cancer. Up to half of the nation's lung cancer cases may be due to those changes. It's not the first time that scientists have concluded the 1960s movement for lower-tar cigarettes brought some unexpected consequences. But this study, while preliminary, is among the most in-depth looks. And intriguingly it found the increase in a kind of lung tumor called adenocarcinoma was higher in the U.S. than in Australia even though both countries switched to so-called milder cigarettes at the same time. One difference between the cigarettes is that those sold in Australia contain lower levels of nitrosamines, a known carcinogen, than those sold in the U.S.
Food Companies Placing the Onus for Safety on Consumers Increasingly, corporations that supply Americans with processed foods are unable to guarantee the safety of their ingredients. Many companies do not know who is supplying their ingredients, let alone if those suppliers are screening the items for microbes and other potential dangers, interviews and documents show. Yet the supply chain for ingredients in processed foods, from flavorings to flour to fruits and vegetables, is becoming more complex and global as the drive to keep food costs down intensifies. As a result, almost every element, not just red meat and poultry, is now a potential carrier of pathogens, government and industry officials concede. Many good giants, including ConAgra, Nestle, Swanson and Hungry-Man concede that they cannot ensure the safety of items, and that they are shifting the burden to the consumer. General Mills, which recalled about five million frozen pizzas in 2007 after an E. coli outbreak, now advises consumers to avoid microwaves and cook only with conventional ovens. ConAgra has also added food safety instructions to its frozen meals.
Chicago Bans Bottles with BPA Plastic Chicago's City Council unanimously adopted a measure making Chicago the nation's first city to ban the sale of baby bottles and sippy cups manufactured with a chemical that some studies have linked to disease. Passage was driven by what officials here call federal regulators' failure to take action on a grave public health issue. The chemical, bisphenol-A, or BPA, is commonly employed to harden plastics, among other uses. Over time, it can leach into the contents of a plastic container, particularly one that is used in a microwave oven or cleaned in a dishwasher. Some animal studies have found that BPA apparently accelerates puberty and poses a cancer risk, and, while the issue's focus has been on the safety of children, the chemical has also been tied to an increased risk of heart disease and diabetes in adults. But in a draft risk assessment last year, the FDA said that at levels found in products on the American market, it appeared to be safe.
FDA Takes Issue with Cheerios Health Claims Federal regulators are scolding the maker of Cheerios, saying it made inappropriate claims about the popular cereal's ability to lower cholesterol and treat heart disease. The FDA says in a warning letter to General Mills that language on the Cheerios box suggests the cereal is designed to prevent or treat heart disease. Regulators say that only FDA-approved drugs are allowed to make such claims. Among other claims, the labeling states: "You can lower your cholesterol 4 percent in six weeks." General Mills said the health claims on Cheerios have been approved for 12 years and the FDA's complaints deal with how the language appears on the box. The company said in a statement that the science was not in question.
Doctor Falsified Study on Injured G.I.s, Army Says A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company's product in treating soldiers severely injured in Iraq, the hospital's commander said. An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for. The former Army surgeon reported that a bone-growth product sold by Medtronic, Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced. Army investigators found that he had forged the signatures of four Walter Reed doctors on the article before submitting it to a British medical journal, falsely claiming them as co-authors. He also did not obtain the Army's required permission to conduct the study.
Medical Device Maker Settles Conflict Inquiry in New Jersey The New Jersey attorney general has announced a settlement with a medical device maker accused of failing to disclose financial conflicts of interest among doctors researching its products, and says her office is investigating other similar conflicts in the device industry. "It is outrageous that doctors who are testing, and in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make these devices," the attorney general said. The settlement calls for Synthes, the maker of the ProDisc artificial spinal disk, to disclose any future payments or investments held by doctors involved in researching its products. The company has agreed to make the information publicly available through its Web site. Synthes has also agreed to stop paying doctors who are conducting clinical trials of its products with stock or stock options. The company also agreed to pay $236,000 to reimburse the attorney general's office for its investigation.
Hydroxycut Diet Aids Recalled After Warning Federal drug regulators warned consumers to stop using the popular Hydroxycut line of weight loss products, citing reports of a death due to liver failure and other instances of serious health problems. In all, the FDA said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said. The Hyrdroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, including pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the FDA. The company is voluntarily recalling 14 of the products.
Women Sue Over Device to Stop Urine Leaks More than dozen women are suing the maker of the vaginal sling, called ObTape. The manufacturer stopped selling ObTape in 2006 but says there is nothing wrong with the product, which was cleared for sale by the FDA. The company claims there are risks to any surgical procedure and that doctors should have warned patients. The lawsuits raise new questions about the process by which the FDA reviews new medical devices. While it "approves" drugs, it merely "clears" medical devices with minimal testing if they are deemed "substantially equivalent" to devices already in use. The process has been criticized by the agency's scientists and in a recent Government Accountability Office report concluding that most devices on the market have never been proved safe and effective.
Food Firm Recalls Tainted Lead-Contaminated Lollipops A California-based food distribution company is recalling candy imported from Mexico because it contains high levels of lead. King Maids Inc. said it is warning stores to stop selling Hola Pop, a caramel lollipop with a salted apricot in the center. The candy also comes in other fruit flavors. The company says recent analysis of Hola Pop by the California Department of Public Health found that the candy contained a high level of lead. Pregnant women and parents of children who may have consumed an Hola Pop candy are advised to consult their doctor to determine whether they should undergo medical testing.
Chicken of the Sea Still On Hook in Suit Over Label's Lack of Mercury Warning The U.S. Supreme Court has signaled it's clear sailing ahead for a suit by a New Jersey woman who claims to have suffered mercury poisoning from Chicken of the Sea canned tuna. The denial of certiorari sets that stage for a federal court trial in New Jersey in a putative class action suit, filed under New Jersey's Product Liability Act that faults a cannery company with not putting mercury warnings on the label. The justices without opinion let stand a 3rd U.S. Circuit Court of Appeals ruling last year that the claim in not pre-empted by the FDA's "pervasive regulatory scheme." The appeals court said this is a case where state tort law complements federal regulations, which often lack a compensatory apparatus or a process for gathering information about potential claims. The suit asks for certification of two classes, one in New Jersey and the other nationwide, of people who bought tuna distributed by Tri-Union Seafoods, LLC of San Diego.
Contaminated Spinach Found in Wisconsin Wisconsin officials are recommending residents throw away bags of spinach distributed by a Milwaukee food processor after some tested positive for salmonella. The Wisconsin Department of Agriculture, Trade and Consumer Protection says consumers should discard 10-ounce bags of Kleen-Pak curly-leaf fresh spinach with use-by dates of April 29, April 30 and May 1. It says routine food safety tests of the spinach were positive for salmonella.
Avoid Raw Alfalfa Sprouts Due to Salmonella Risk Government health officials are telling people to avoid eating raw alfalfa sprouts, because they could be contaminated with a strain of salmonella. Officials have received 31 reports of illness associated with eating raw alfalfa sprouts in Michigan, Minnesota, Pennsylvania, South Dakota, Utah and West Virginia. The FDA reports that contaminated sprouts were grown in multiple states. This raises suspicion that the problem stems from the seed for the plants.
3rd Circuit Predicts Change for Pennsylvania Products Liability Law In a potential curtain raiser on the future of Pennsylvania products liability law, the 3rd U.S. Circuit Court of Appeals predicted in a ruling that the Pennsylvania Supreme Court will not import negligence concepts into the strict liability doctrine by adopting portions of a torts legal treatise. The 3rd Circuit panel of judges predicted that, because Pennsylvania's products liability law is a confused affair, the Supreme Court will adopt Sections 1 and 2 of the American Law Institute's Restatement of Torts. The ALI restates common law and distills caselaw in order to propose what form law should take, and courts often use the ALI's work in their rulings. The 3rd Circuit even counted heads in predicting that parts of the Third Restatement will be adopted by the state Supreme Court in regard to design-defect cases. The state Supreme Court is considering whether concepts of negligence should be imported into Pennsylvania's products liability law by the application of Section 2 of the Restatement of Torts in place of Section 402A of the Restatement of Torts. In the case that raised the issued, the court had to consider the permissible scope of bystander recovery for a little girl whose left foot was mangled by a lawn mower driver by her grandfather. One of the judge's ruled that restricting strict products liability claims to "intended users" because of the concern about polluting strict liability claims with the negligence concept of foreseeability does not protect bystanders injured by a defective product.
Alfalfa Sprouts Sold to California Eateries Recalled A Southern California company has recalled alfalfa sprouts that may be contaminated with salmonella. Los Angeles Calco, Inc. announced that it is recalling 4-ounce containers of sprouts that it distributed to three wholesalers in Los Angeles and Costa Mesa. A company official says the sprouts were sold to restaurants but did not go to any retail markets. The company also said that routine testing detected salmonella in some samples but that no illnesses have been reported.
Rare FDA Meeting to Discuss Complaints on Device Approval An unusual internal meeting at the FDA may signal how agency officials intend to handle the many controversies swirling around its embattled device division. The director of the agency's office of device evaluation, sent an e-mail message announcing an "all-hands meeting" to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for two years. Nine dissident scientists signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers. The scientists have sent numerous e-mail messages to the agency's principal deputy commissioner, pleading for his intervention. The commissioner replied to one of the scientists that he was "already burning the candle at both end to keep up with his job," and he asked the scientists to distill their concerns into a single memorandum. In the memorandum sent, scientists charged that the "regulatory review process for medical devices has been severely distorted" and that those who raised concerns about unsafe devices had been retaliated against by agency managers. A Congressional investigation into the scientists' concerns has been opened, and in January the Government Accountability Office released a report that was critical of the device center.
Ill from Food? Investigations Vary by State In just about every major contaminated food scare, Minnesotans become sick by the dozens while few people in Kentucky and other states are counted among the ill. Contaminated peanuts? 42 Minnesotans were reported sick compared with 3 Kentuckians. Jalapeno peppers last year? 31 Minnesotans and 2 in Kentucky become ill. The different numbers arise because health officials in Kentucky and many other states fail to investigate many complaints of food-related sickness while those in Minnesota do so diligently, safeguarding not only Minnesotans but much of the rest of the country, as well. Congress and the Obama administration have said that more inspections and new food production rules are needed to prevent food-related diseases, but far less attention has been paid to fixing the fractured system by which officials detect and stop ongoing outbreaks. Right now, uncovering which foods have been contaminated is left to a patchwork of more than 3,000 federal, state and local health departments that are, for the most part, poorly financed, poorly trained and disconnected, officials say.
Fate of California Smokers' Lawsuit Rests with State High Court A federal appeals court has certified two questions to the California Supreme Court in order to determine whether a woman who developed lung cancer allegedly from years of smoking waited too long to sue tobacco manufacturers. Previously, a federal judge had ruled that the woman's lawsuit was untimely because the limitations period began to run in 1989, when she first was diagnosed with a smoking-related illness. According to the opinion, she smoked cigarettes from 1953 until 1991. She was diagnosed with chronic obstructive pulmonary disease in 1989, periodontal disease in 1990 and lung cancer in 2003. Following her lung cancer diagnosis, she sued various tobacco companies, alleging product liability, misrepresentation, fraud and failure to warn before 1969, when the federal government began requiring health warnings on cigarette packages. The defendants argued that her claims were time-barred, citing a case where it was found that "the dangers of nicotine addiction have been in the public spotlight for many years." The appeals court now must ask the Supreme Court: when can two separate physical injuries stemming from the same wrongdoing be treated as violating two different primary rights and can two separate physical injuries caused by tobacco use by considered "qualitatively different" for determining when the applicable statute of limitations begins to run?
To Fill Food Safety Gap, Processors Pay Inspectors With huge losses from food-poisoning recalls and little oversight from the FDA, some sectors of the food industry are cobbling together their own form of regulation in an attempt to reassure consumers. They are paying government agencies to do what the FDA rarely does: muck through fields and pore over records to make sure food is handled properly. These do-it-yourself programs may provide an enhanced safety level in segments of the industry that have embraced them. But with industry itself footing the bill, some safety advocates worry that the approach could introduce new problems and new conflicts of interest. And they contend that the programs lack the rigor of a well-run federal inspection system. Nonetheless, the approach is spreading.
Spice Recall Expanded due to Salmonella Threat Union International Food Co. is expanding a spice recall to include all Lian How brand and Uncle Chen brand sauces, oil and oil blends in various size packages because the products may be contaminated with salmonella, an organism that can cause serious and sometimes fatal infections, especially in young children, the elderly and those with weakened immune systems. California state health department officials say the salmonella outbreak has sickened 33 people throughout northern and central California, and nine others in Nevada, Oregon and Washington. No deaths have been reported.
Quest to Pay $302 Million in Marketing Case Quest Diagnostics, an operator of medical testing labs, will pay $302 million and one of its business units will plead guilty to misleading marketing practices as part of a settlement with the federal government. The case, involving civil and criminal charges, stemmed from marketing materials for a parathyroid hormone test. The Justice Department said the settlement was one of the largest recoveries in a case involving a medical device. Quest and its subsidiary will pay $262 million plus interest to resolve civil charges for misleading product claims. The government claimed Quest's subsidiary inaccurately marketed unproven advantages to the Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay.
Overseer of Medical Trials, Under FDA Pressure, Agrees to Suspension A Colorado company that approved a make-believe clinical trial run by doctors who did not exist got a dose of reality from the FDA. Under FDA pressure, the company agreed to temporarily suspend approving federally regulated medical studies or enrolling new patients in ones currently under way. Drug and device manufacturers pay companies like Coast to make sure that medical trials are performed ethically and that patient safety is protected. But Coast recently embarrassed itself and then became a Congressional whipping boy. Coast's trouble started when undercover federal investigators prepared plans for a sham medical study involving a make-believe surgical product to see how closely companies like Coast evaluate the studies they are paid to review. Congressional hearings showed that Coast reviewed 356 study proposals over a five-year period and rejected only one of them. Meanwhile, since 2004, the company's revenue more than doubled, to $9.3 million in 2008.
FDA Halts Firm Selling Unapproved Cold Meds Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved couch and cold medicines. The FDA said that Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors. Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved product marketed by Advent and its subsidiary Neilgen Pharmaceuticals include BP Allergy Junior Suspension, RE All 12 Suspension and many others.
Little Progress Against Food Poisoning in 2008 Americans didn't suffer more food poisoning last year despite high-profile outbreaks involving peppers, peanut butter and other foods, according to a government report. Rates of food-borne illnesses have been holding steady for four years. They had been declining from the mid-1990s until the beginning of this decade, due mainly to improvements in the meat and poultry industry, some experts say. But produce-associated food poisonings have been increasing, and the nation is no longer making progress against food-borne disease rates. The report looks at the occurrence of 10 leading food-borne illnesses in 10 states that participate in a federally funded food poisoning monitoring system. Salmonella remained the most common cause of food poisoning, causing more than 7,400 lab-confirmed illnesses in those states. That translates to a rate of about 16 cases for every 100,000 people.
Texas Peanut Plant Fined $14.6 Million A state health agency has levied a $14.6 million fine against the Texas plant owned by a peanut company at the heart of a national salmonella outbreak. The Texas Department of State Health Services said it was fining Plainview Peanut Co. over alleged violations that include unsanitary conditions, product contamination, illnesses linked to peanuts from the plant and operating without a food manufacturers' license. The plant has been closed since February, and its owner, Peanut Corp. of America, is blamed for an outbreak that has sickened nearly 700 people and is said to be the cause of at least nine deaths.
U.S. Food Safety No Longer Improving After decades of steady progress, the safety of the nation's food supply has not improved over the past three years, the government reported. And, it said, in the case of salmonella, the dangerous bacteria recently found in peanuts and pistachios, infections may be creeping upward. The report demonstrated that the nation's food safety system, created when most foods were grown, prepared and consumed locally, needs a thorough overhaul to regulate an increasingly global food industry. The report is likely to deepen tensions between the FDA and the Department of Agriculture, which have long been rivals in overseeing food safety.
FDA to Check Safety of Old Devices Federal regulators said that they would ask makers of some of the riskiest medical devices to prove that their products were safe and effective, a step that critics have said was long overdue. In January, the Government Accountability Office issued a report scolding the FDA for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976. Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law, Congress told the FDA to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which did not. The agency never finished that process, leaving 27 different types of devices unexamined, including artificial lung membranes, external defibrillators and various pacemaker components.
Removing Medtronic Heart Cables a Tough Choice Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous. Consider the Sprint Fidelis, a heart defibrillator cable. In 2007, its maker, Medtronic, stopped selling it after five patients who had the cables died. But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country. In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart. Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed. Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers have performed many of the operations.
Pistachio Recall Signals Tough Stance on Safety As the nation's second-largest processor of pistachios agreed to recall its entire 2008 crop despite no confirmed illnesses, the Obama administration issued a tough warning to all food makers that sloppy manufacturing practices would no longer be tolerated. With the warning, the administration signaled that it was substantially changing the way the government oversees food safety. Food-handling practices that in the past would have resulted in mild warnings may now lead to wide-ranging and expensive recalls, even before anyone becomes ill from contaminated food.
Rocket Fuel Chemical Found in Baby Formula Traces of a chemical used in rocket fuel were found in samples of powdered baby formula and could exceed what's considered a safe dose for adults if mixed with water also contaminated with the ingredient, a government study has found. The study by scientists at the U.S. Centers for Disease Control and Prevention looked for the chemical, perchlorate, in different brands of powdered baby formula. The chemical has turned up in several cities' drinking water supplies. It can occur naturally, but most perchlorate contamination has been tied to defense and aerospace sites. No tests have ever shown the chemical caused health problems, but scientists have said significant amounts of perchlorate can affect thyroid function. However, the extent of the risk is hard to assess. The government requires that formula contain iodine, which counteracts perchlorate's effects. The size of the infant and how much formula they consume are other factors that can influence risk.
Plant at Center of Recall had Salmonella Last Year A company at the heart of a nationwide pistachio recall said that Kraft Foods Inc. detected salmonella in its pistachios more than six months ago but did not inform them until the week of the outbreak. A Kraft spokeswoman said the food products giant did not know until recently that pistachios were the cause of salmonella contamination in a trail mix and promptly informed their nut supplier, Setton Pistachio of Terra Bella, Inc. A production manager for the company confirmed that pistachios tested positive for the bacteria in a Kraft snack mix in September 2008. So far, more than 2 million pounds of roasted nuts have been recalled.
Fake Product Sneaks by Medical Review Board Government investigators looking into lax screening of medical research said they easily won approval from a private review board of a fake product to be used in medical testing on human subjects. The Government Accountability Office also said it was able to register with the Health and Human Services Department a fictitious institutional review board, a panel of doctors and scientists that must approve any medical drug or device to be used in federally funded testing on humans. The president of the fake review board was a dog named Trooper. The GAO said its investigation showed that the system "is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud." Two independent review boards rejected the fake medical protocol, which called for a liter of a fictitious product to be poured into a woman's stomach after surgery. One employee of the boards called it "junk" and another said it was "the riskiest thing I've ever seen on this board." However, another review board approved it unanimously and found the protocol "probably very safe."
Snapple Drinks Not All Natural or Fruity, Consumer Suit Says Snapple Beverage Corp. misrepresents the contents of its products to get consumers to buy drinks they think are healthy, a California federal court lawsuit alleges. The beverages do not contain all natural ingredients or some of the advertised fruit juices despite the company's use of the words "all natural" on its labels and fruit names in the product names, according to the suit. A California resident filed the suit on behalf of consumers in the state who bought Snapple products over the last four years. Although Snapple advertises its drinks as "all natural," they contain artificial ingredients, according to the complaint. The suit seeks an injunction to stop Snapple's allegedly deceptive advertising and direct the company to publish ads correcting the product information. The suit also seeks reimbursement of the money class members spent because of the company's allegedly deceptive practices.
Investigators Find Source of Many Foods Untraceable Most food manufacturers and distributors cannot identify the suppliers or recipients of their products despite federal rules that require them to do so, federal health investigators have found. A quarter of the food facilities contacted by investigators as part of the study were not even aware that they were supposed to be able to trace their suppliers. The report comes as President Obama and a bipartisan chorus of lawmakers have promised major changed to the nation's food safety system. And it may help explain why many small food makers continue to issue peanut-related recalls more than two months after the Peanut Corporation of American was identified as the source of a salmonella scare that has sickened at least 691 people and has been linked to 9 deaths.
Third Time's the Charm for Defense in Florida Smoker Suits Last month, ominous news for the tobacco industry came out of the first individual smoker suits to reach a verdict: A Florida jury awarded a widow $8 million in damages against Altira, the parent company of Philip Morris. With some 8,000 similar suits lined up for trial, can the industry survive the onslaught? Especially now that the second Florida smoker suit has resulted in a $700,000 verdict against Liggett Group. However, tobacco companies got some good news for a change when a jury in Florida delivered a defense verdict for R.J. Reynolds and Altria in a case brought by the widow of a smoker who died of lung cancer. After two weeks of trial, the jury took only 90 minutes to clear the tobacco companies.
24,000 Fisher-Price High Chairs Recalled About 24,000 Fisher-Price high chairs have been recalled because the seat can fall backward from the frame if the release is unlatched while a child is inside. The seat back can also detach if not snapped fully into place. The company has received one report of a detached seat back that resulted in a fractured skull. About 2,900 Baby Necessities pacifiers have been recalled because they failed federal safety tests. The nipples can separate from the base and pose a choking hazard. Weston Pharmaceuticals is recalling one lot of Propafenone HCL tablets sold in 100 count bottles. Some of the tablets may contain higher levels of the active ingredient than specified. Some patients may experience side effects, including irregular heartbeat or low blood pressure. Torres Hillsdale Country Cheese is recalling Asadero and Oaxaca soft Mexican-style cheeses due to possible listeria contamination. Listeria can cause listeriosis, a potentially fatal disease.
Senator Seeks to Halt Sales of "E-Cigarettes" A senator is asking the government to prevent the sale of so-called "electronic cigarettes" until more is known about them. E-cigarettes are marketed as a healthier alternative to smoking and as a way to kick the habit. They are smokeless and battery-powered, releasing a nicotine vapor into the lungs. However, a New Jersey senator has sent the FDA a letter saying that the agency should ensure e-cigarettes are not sold until they've been studied more.
Baxter Recalls Colleague Infusion Pumps Baxter Healthcare Corp. has recalled six models of its Colleague medicine infusion pumps made since 1997, saying battery and software problems could lead to life-threatening failures of the device and a potential risk of fire. Although the company issued an alert about the malfunctions with letters to customers, it re-launched the initiative when the FDA declared the action a "class I" medical device recall. Class I recalls are the most serious of their type because of the probability that use of the device will cause death or serious injury. In its new warning, released in conjunction with the FDA recall declaration, Baxter said it has received reports of an unspecified number of "serious injuries and/or deaths" associated with the pumps. The company says the pumps, which deliver precise levels of medication to a patient through intra-arterial lines, could display failure codes that could cause an alarm to sound and halt delivery of the drug. The pumps could also overheat and cause a fire if improperly cleaned or if there is danger to an insulating layer covering the device's battery harness.
Food Industry Safety Inspections Challenged The food industry's self-policing system failed to catch filthy conditions at a peanut processing plant blamed for a salmonella outbreak in the U.S. The House Energy and Commerce investigations subcommittee released new documents and pictures that attested to long-standing sanitary problems at facilities owned by Peanut Corp. of America. The company is at the center of an outbreak that has sickened nearly 700 people and is being blamed for at least nine deaths. The outbreak was traced to a Peanut Corp. company facility in the state of Georgia. Later, another Peanut Corp. plant in the state of Texas was also found to have serious problems. Peanut Corp. is under criminal investigation. Congress questioned how dozens of food companies that bought peanut paste and other ingredients from Peanut Corp. failed to pick up the problems. Part of the reason is that the companies relied on safety audits by inspectors who were hired by Peanut Corp.
Manufacturers Move to Ban Drop-Side Cribs Crib makers have proposed a ban on drop-side cribs because of concerns over infant deaths, injuries and a series of recalls in recent months. Officials familiar with deliberations of a committee that sets industry standards say the proposal would end production of drop-side cribs, where one side moves up and down. The proposal would require cribs to have four immovable sides. The Consumer Product Safety Commission says at least three children have died in drop-side cribs in the last 18 months. The agency knows of more than two dozen incidents in which drop-sides detached from cribs.
Wal-Mart Cuts Class Off at the Pass in Pet Food Case Lawyers rescued Wal-Mart and a group of pet food manufacturers from a class action that could have led to millions of dollars in damages. A federal judge in Nevada granted a motion by the defense to pre-emptively deny certification to a class of plaintiffs that would have spanned eight states. Typically, plaintiffs try to certify a class only after getting a chance to discover more facts about a case. But courts allow defendants to deny certification early on if the law simply wouldn't support it. A Nevada woman filed a class action in state court against Wal-Mart and a group of food manufacturers in April 2007, alleging that they illegally labeled their pet food "Made in USA," though some ingredients were imported from China. The previous month, the FDA had announced that certain pet food ingredients imported from China were sickening and killing cats and dogs. The defense removed her class action to federal court, where she narrowed her claim to a violation of the Nevada Deceptive Trade Practices Act and similar laws in seven other states. Most recently, a federal judge denied the class certification, ruling that subjective, individual issues made a class action the wrong way to handle the case.
Salmonella Outbreak has Slowed, But Isn't Over New cases of salmonella poisoning linked to tainted peanut products have slowed so much that federal officials will no longer provide weekly updates for one of the nation's largest-ever foodborne outbreaks. But they're stopping short of declaring the danger done. Some 692 people in 46 states and Canada have been sickened in the outbreak since last fall. Salmonella poisoning contributed to nine deaths, and more than 3,400 potentially tainted peanut products have been recalled. The CDC has been reporting between five and 10 new confirmed cases a week for more than a month. Half of the new cases have been reported in people who ate tainted peanut butter crackers manufactured by Kellogg Co.
Group Wants Vintage Kids Books Off the Shelves Could vintage copies of children's books be hazardous to your children? The Consumer Product Safety Commission has raised that possibility in urging the nation's libraries to take children's books printed before 1986 off their shelves while the federal agency investigates whether the ink contains unsafe levels of lead. Few, if any, libraries are complying, and many librarians are ridiculing the recommendation as alarmist. Even the Centers for Disease Control and Prevention say any danger from lead in children's books is slight. However, a federal law passed last year and made effective in February bans lead beyond minute levels in most products intended for children 12 or younger. It was passed after a string of toy recalls. The CPSC is interpreting the law to include books. The CPSC said libraries can safely lend any children's book printed in 1986 and later, by which time a growing body of regulations had removed lead from printer's ink. But the commission still must study the lead content in books printed before 1986. The CPSC delayed until next year the lead testing required as part of the law. Until the testing is down, the nation's more than 116,000 public and school libraries "should take steps to ensure that the children aren't accessing potentially harmful books."
Massachusetts Court Moves "Light" Cigarette Suit Forward The state's highest court ruled that Massachusetts smokers can use a consumer protection law to sue Philip Morris Inc. for the way it marketed Marlboro Lights. The ruling means a class action lawsuit brought by smokers who claim deceptive marketing can move forward. In a similar U.S. Supreme Court case, the justices ruled that smokers may use state consumer protection laws to sue cigarette makers for the way they promote "light" and "low tar" brands. In the class action suit, filed in 1998, the Massachusetts smokers claimed that Philip Morris engaged in deceptive marketing because Marlboro Lights did not deliver lowered tar and nicotine to smokers. Philip Morris, however, argued that the state's consumer protection law is pre-empted by the 1965 Federal Cigarette Labeling and Advertising Act, which prohibits state from regulating any aspect of cigarette advertising that involves smoking and health. The company also claims that the Federal Trade Commission allows the use of terms such as "light" and "lower tar and nicotine" on cigarette packages. The company stopped using the phrase "lower tar and nicotine" on packages in 2003. The state Supreme Court ruled that the FTC had never given express permission to use those descriptors.
Lead Law Throws Young Cyclists Off Course Motorcross as a hobby might not be an option for many youngsters in the wake of new lead standards that took effect in February. Many retailers are unable to sell all-terrain vehicles and motorized bikes designed for children younger than 12. The vehicles might get a reprieve, because the law allows sale of products in which lead is inaccessible and items children cannot absorb lead from. Tire stem valves, engine parts and even handlebar grips could contain lead, which could lead to children absorbing the metal. The Consumer Product Safety Commission plans to rule on the issue soon.
President Promises to Bolster Food Safety Describing the government's failure to inspect 95 percent of food processing plants as "a hazard to the public health," President Obama promised to bolster and reorganize the nation's fractured food safety program. "In the end, food safety is something I take seriously, not just as your president, but as a parent," President Obama said in his weekly radio address. He also announced the creation of a Food Safety Working Group, which will include the secretaries of health and agriculture, to advise him on which laws and regulations need to be changed, to foster coordination across federal agencies, and to ensure that laws are enforced.
Ban on BPA Hailed in Some Quarters Connecticut's Department of Agriculture had learned to live with raw milk, the unpasteurized, unhomogenized milk that enthusiasts believe is good for you but that health officials have long warned can put humans at risk of disease-carrying bacteria. The state's raw milk regulations have been among the most liberal in the nation. But officials proposed stricter regulations after an outbreak of E. coli last summer, which the State Department of Public Health investigators traced to a dairy that has since closed. The department confirmed seven illnesses, including two toddlers who ended up on kidney dialysis, and said there were another seven probably cases. A bill under consideration in the Environment Committee of the General Assembly would restrict raw milk sales to the farm where it is produced and farmers' markets, which would put the state's laws on par with most of the nearly 30 states that allow raw milk sales. The bill would eliminate raw milk sales in stores.
Bill Proposes Restrictions on Raw Milk Sales Bisphenol-A, a hardening agent used in many brands of clear plastic baby bottles and sippy cups, was unanimously banned for such uses recently by the Suffolk County Legislature in New York. BPA was banned because animal studies have linked the substance to a range of health problems. BPA is used to make shatterproof plastic bottles, as a sealant in canned foods and in products ranging from CDs to sunglasses. In a draft risk assessment last year, the FDA said the levels of BPA to which children and adults are exposed do not pose a meaningful risk. Studies with laboratory animals have shown that it appears to accelerate puberty and pose a cancer risk. Most concerns about BPA focus on children, but some recent reports suggest it interferes with chemotherapy, and in adults it has been linked to higher risk of heart disease and diabetes. If the bill in Suffolk County is signed by the County Executive, retailers who sell banned products will be fined $500 for their first offense and $1,000 for their second.
Bipartisan Call for Food Safety Fixes A parade of Democratic and Republican lawmakers promised at a House hearing that they would work to pass a broad array of changes in the nation's food safety system, although they disagreed on crucial details. Among the sharpest areas of disagreement are whether to split the FDA into two agencies and whether to finance increased safety inspections through fees on industry or through general appropriations. The House has held nearly two dozen food safety hearings over the last year, focusing on contamination in jalapeno peppers, peanut butter, pet food, seafood, spinach and tomatoes manufactured in the U.S. and abroad. A panel of experts from consumer groups and the industry largely agreed that broad changes were needed. For industry, the growing number of food poisoning incidents have become enormously expensive.
Peanut Industry: Recall Price Tag Hits $1 Billion The effects of the widespread peanut butter recall could cost rural America's peanut producers $1 billion in lost production and sales. That could be just the beginning, the head of the Georgia Peanut Commission has warned. The recalls, prompted by a salmonella outbreak tied to peanut butter, have severely hurt the nation's peanut producers, weakening pricing and limiting their ability to sell their products. The head also said the recall goes far beyond the source of the outbreak, Peanut Corp. of America, and that the companies that used its peanut butter and peanut paste in their products have had to remove their products from the marketplace. The true cost won't be known until the outbreak is over and the recall complete.
Outbreak Spurs Changes in Georgia Food Inspection Spurred by a deadly salmonella outbreak traced to a Georgia peanut processing plant, the state's lawmakers have sought to toughen food safety standards they say could have stemmed the spread of the illness. The House unanimously adopted a proposal that gives state agricultural officials power to deputize local health inspectors so they can quickly probe potential trouble spots. The state Department of Agriculture complained loudly after the outbreak that its 60 inspectors are stretched thin, trying to monitor some 16,000 sites throughout Georgia. The House plan now goes to the Senate, which has already adopted its own food safety proposal in the wake of the salmonella outbreak. Lawmakers there approved a plan requiring food makers to alert state inspectors within 24 hours if a plant's internal tests show its products are tainted.
Amid Salmonella Fears, Peanut Butter Sales Drop The nation's consumers, worried about the widespread salmonella outbreak, continued to shy away from peanut butter in a recent four-week period, according to new sales numbers. Americans bought 41.8 million pounds of jarred peanut butter in the four-week period ending February 21, which translates to 13.3 percent less than in the same period the previous year. The period's sales were the lowest of any in the three years Nielsen has tracked the U.S. food, drug and mass merchandisers segment. The total retail value of jarred peanut butter sales in the period fell 2.3 percent to $87.2 million, from nearly $89.3 million in the same period last year. The decline came as news continued to arise in this winter's salmonella outbreak tied to peanut butter and peanut butter paste from Peanut Corp. of America. The outbreak has sickened hundreds and may be involved in nine deaths. In one of the largest recalls in U.S. history, companies have recalled more than 2,100 products containing Peanut Corp.'s paste, from ice cream to dog food.
Bill Would Restore Right to Sue Over Medical Devices A day after the Supreme Court decided that federal rules did not protect drug makers from state lawsuits, Democrats in Congress moved to overturn a decision that has shielded medical device companies from similar legal action. Democrats have reintroduced the Medical Device Safety Act, a bill that would allow similar lawsuits against companies that make heart devices, catheters, replacement hips and other apparatus. The device industry's chief lobbying group quickly criticized the effort, saying it would "produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans."
Food Safety Problems Slip Past Private Inspectors When food industry giants like Kellogg want to ensure that American consumers are being protected from contaminated products, they rely on private inspectors. When such a private inspector headed to the Peanut Corporation of America plant in Georgia last year to make sure its chopped nuts, paste and peanut butter were safe to use, the company knew in advance of his visit. The inspector also had less than a day to check the entire plant, which processed several million pounds of peanuts a month. With government inspectors overwhelmed by the task of guarding the nation's food supply, the job of monitoring food plants has in large part fallen to an army of private auditors. An examination of the largest food poisoning outbreaks in recent years show that auditors failed to detect problems at plants whose contaminated products later sickened consumers.
Florida Couple Delays Suit After Drywall Manufacturer Offers Inspection A southwest Florida couple who complained about corrosive gas leaks will wait to file a lawsuit against two U.S. drywall companies after one of them came forward and offered to inspect their home. The couple claims they have experienced the same problem bedeviling homes built in 2006 with Chinese drywall even though they built with an American-made product. They claim their air conditions components, electrical wiring and metal objecst in the home have corroded because of sulphur gas discharged by wallboard that is not 100 percent gypsum. At least 80 percent of their drywall was supplied by National Gysum of Charlotte and the erst was made by Chicago-based USG. USG has said that its subsidiary, L&W Supply, imported a small amount of Chinese drywall in 2006 when supplies were scarce because of the building boom and a series of destructive hurricanes. A federal class action lawsuit has been filed against three Chinese companies operated by Knauf Plasterboard, joining a cavalcade of litigation against the company. Knauf has said it is one of many Chinese manufacturers of drywall.
California Justices Air Standing for Class Actions Against Tobacco Industry Just a few weeks ago, the California Supreme Court ruled that lawsuits under the Consumer Legal Remedies Act can only be filed by individuals who suffer real damage from unlawful business practices. But it still isn't clear where the court stood on applying that same rule to every participant of class actions filed under the state's Unfair Competition law. The outcome is still mostly a mystery, but some predict the justices will reverse the appellate court which upheld class decertification. The underlying suit was filed 12 years ago and accused Philip Morris and five other tobaco manufacturers of violating the UCL and the state's False Advertising Law by allegedly denying links between smoking and serious illnesses. The suit also accused the companies of marketing cigarettes as having no additives and being non-addictive. The suit doesn't seek damages, just injunctive relief and restitution for money plaintiffs spent on cigarettes.
Dirty Syringes Tied to Indian Hepatitis Outbreak Investigators in western India looking into a deadly hepatitis outbreak traced to infected syringes have uncovered a huge operation to illegally recycle hundreds of tons of used medical equipment. Authorities launched the probe two weeks ago after an outbreak of hepatitis B that has killed 56 people and sickened more than 100. The source has been traced to infected syringes. Officials who raided dispensaries, private hospitals and laboratories in the area central to the outbreak found a flourishing black market in reused medical equipment. In the last few days, more than 300 tons of medical waste was discovered in warehouses, much of it packaged for resale.
Study Urges More Oversight of Dietary Items More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. But the FDA does not have enough authority to ensure that the products are safe, and it should seek more oversignt power, according to a government audit. The new report from the federal Government Accountability Office acknowledged that the FDA had taken some steps in the last few years to supervise the supplement industry more closely, but the report said those steps did not go far enough. In the first 10 months of last year, for example, the audit said the FDA received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them. Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations. Even so, the number of problems is underreported. The FDA recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements. The GAO report said, "Consumers remain vulnerable to risks posed by potentially unsafe products."
FDA Warned Syringe Producer of Violations Federal regulators warned a syringe manufacturer of "several significant violations" in its quality control system two years before its needles triggered an outbreak of bacterial infections that prosecutors say led to at least five deaths and hundreds of illnesses. A U.S. Food and Drug Administration warning letter, made public by the agency, cited AM2PAT Inc. in August 2005 for nine serious violations at its factory in Raleigh, where it made syringes of heparin and saline to flush IV lines. Among the problems at the factory, the letter noted poor documentation of sterility tests, insufficient efforts to maintain a sterile environment and unqualified workers. Each of those issues were cited again this month as prosecutors won guilty pleas from two former AM2PAT employees and charged the former CEO.
Bizarre Fish Poisoning Sparks Alarm A broiled grouper featured on the a Texas menu was tainted with a hard-to-detect toxin that produces symptoms so bizarre, they put peanut-linked salmonella infections to shame. Ciguatera fish poisoning is an exotic foodborne illness that health officials say may be dramatically under-recognized in the U.S. The malady afflicts at least 50,000 people a year worldwide, and the real number may be 100 times that many. While ciguatera fish poisoning is largely unknown in most of the U.S., several recent cases have attracted growing concern. Within hours of eating tainted fish, typical food poisoning symptoms set in, including diarrhea, vomiting and fatigue. However, other symptoms include a dangerously slow heart rate and neurological problems that cause hands and feet to tingle painfully and reverses some people's sense of hot and cold. Some patients also say they feel like their teeth are falling out and symptoms can linger for years.
Heart Device Dispute Renews Push for User Registry Conflicting data this week about the failure rate of a critical and widely used Medtronic heart device has set off a debate among researchers who want to understand the discrepancies and the implications for patient care. But some experts say that debate would not be occurring if federal officials, medical device makers and more doctors had thrown their weight more fully behind efforts to develop a national database of patients who get heart devices. The potential of even a small registry in detecting device problems was shown in the case of Medtronic's troubled product, an electrical cable known as the Spirit Fidelis lead that connects a defibrillator to a patient's heart. Using a small registry of patients receiving defibrillators, researchers were able to detect problems with the device.
Common Household Chemicals Tied to Infertility Food packaging, shampoo, clothes and other household products contain chemicals that may make it harder for some women to get pregnant, suggests the first study on the subject. It's still too early to recommend that women who want to conceive try to avoid these products, but the results are concerning enough to warrant further work. The chemicals studied belong to a group called perfluorinated chemicals, or PFCs, which appear in a variety of common products, from upholstery to pesticides. Studies have linked PFCs to toxic effects in the liver, immune system and reproductive system of animals. In people, researchers found that women with many children had lower levels of PFCs than did women with fewer children. Researchers collected blood and surveyed more than 1,200 newly pregnant women who are taking part in the Danish National Birth Cohort. About 30 percent of women tried for more than six months before conceiving. Half of those tried for more than a year. There was an equally big range in chemical levels in the women's blood, with more than 40 times more PFCs in some women than others and more than 16 times more PFCs from the lowest to highest concentrations.
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