Articles Posted in Product Liability

In the days since we were first informed that the nationwide salmonella food poisoning outbreak originated at a Peanut Corporation of America plant in Blakely, Georgia, the death toll from the outbreak has reached 9, the number of people sickened from salmonella tainted products has risen to 19,000 and food poisoning lawsuits have been filed.

Last week, Stewart Parnell, president of Peanut Corporation of America was summoned to Washington to testify at a congressional hearing. Meanwhile, skeletons have been tumbling at the PCA.Former employees at the Blakely plant have come forward to sing like canaries about the abhorrent sanitation practices at the plant. According to one employee, he once found baby mice inside a packet of peanuts. The same employee also claims that he has been witness to the practice of pasting new stickers on jars of old peanut paste, and has seen holes drilled by rats in sacks of peanuts. A new FDA report also indicates that management at the Georgia plant continued to ship out products that they knew had tested positive for salmonella contamination. According to the report, the company continued to retest its products until test results showed findings that were more to its liking – that the peanut butter was salmonella free.

The concern over products from the Georgia plant is so intense that the FDA has asked consumers to throw out any peanut butter products made at the plant over the past 2 years.

A new report underscores the importance of car seats in saving infant and toddler lives in the event of an automobile accident. New research by a California group indicates that the chances of toddlers and infants dying in an accident drop by as much as 75 percent when they are strapped into these safety seats.

Of course we’ve always known that car safety seats are very effective at reducing fatality rates in children who tend to be the most vulnerable victims in the event of a collision, but this study manages to hit home just how important these seats can be to protect their occupants.The two researchers who conducted the study, Thomas Rice and Craig Anderson, analyzed data from nearly 6000 accidents between 1995 and 2006, and compared the information to arrive at some startling statistics. In the case of babies below the age of one year, the odds of dying in a crash declined by as much as 73 percent, while in the 1-2 year age group, the odds of dying went down by 76 percent. 2-3 years olds had a reduced risk of fatality that was close to 60 percent if they were properly restrained in a car seat.

Of course, it goes without saying that these benefits are only valid if the car seats are of high quality, and meet all safety standards for children’s products.There’s no point in having a child strapped in a seat with improper buckles that can snap open in the event of a collision, or one that has defective clips that can slip open, releasing the child from the safety of the seat.Child seats also need to be made of safe materials with sufficient padding that can actually cushion a child from the force of impact during a collision.Stricter standards and demands for more safety features by parents have led manufacturers to design and create safer car seats, but safety issues continue to crop up every year. The unfortunate fact is that these issues come to light only when there is an unfortunate accident that exposes the instability of a defective car seat.

The Georgia peanut butter plant at the center of the salmonella food poisoning crisis has a poor sanitation record, and has frequently been cited for health and sanitation violations, the NY Times (via Tort Deform) reports.Judging by the condition of the plant in our very own Blakely, Georgia, the media and food poisoning lawyers should not even be surprised that a nationwide outbreak of deadly salmonella poisoning has originated from this facility.

The Peanut Corporation of America plant has been cited several times since 2006 for health violations. Inspectors have frequently found the facility full of large gaping holes in its food security mechanisms. These include grease accumulation inside the facility, doors with large holes that a rat could easily squeeze through, and dirt and grime everywhere.The plant had areas caked with rust that could easily disperse and fall into food products, and poor sanitization of surfaces meant for food processing.Peanut butter packets were left lying around uncovered. These violations continued even till 2008, when inspection reports continued to mention numerous violations.

Dirty and unsanitary conditions breed rodents and insects.Animal feces are just one of the ways that the salmonellum bacterium spreads.The risk of infectious disease is the reason why food processing and preparation plants and establishments that serve food like restaurants, are put though numerous safety inspections.From the report in the Times, it seems like that the plant was a salmonellosis time bomb waiting to go off.

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues. We await the United States Supreme Court’s decision on this issue. Meanwhile, the FDA is having to answer to these problems.

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."

The year 2000 was the year of several dangerous toy recalls, many of which were the focus of product liability lawsuits around the country.This list of the 10 most dangerous toys of 2008 includes toys that pose hazards of choking and aspiration, lead contaminated toys as well as those that are prone to fire and burn hazards.

It isn’t clear if the list is in any particular order of danger or number of injuries caused, but it kicks off with Air Hogs RC Helicopters that came with the danger of exploding lithium-powered batteries.Many of the toy related scares of 2008 – and there were plenty of them – were linked to children being able to remove the detachable magnets from toys, and swallow these. Several dozen children were rushed to emergency rooms with perforated intestines, after swallowing magnets that later began to stick to each other through intestinal walls. Most of these injuries required surgery.The toys that came with magnets attached included earrings that contained a small magnet inside, and these make it to the list too. Other noteworthy defective playthings include backpacks containing off-the-chart levels of lead contamination, balloon sets, Dora the Explorer Lamps (which are actually electrical items and not really play things, but try explaining that to kids who see their favorite Dora on the lamp, and want to play with her), and high decibel High School Musical Rockerz.

Also on the list are children’s toys containing phthalates, a chemical compound that is often mixed with plastic to make it softer. These have been found connected to reproductive problems in male children, including a drop in testosterone levels, as well as genital abnormalities.Linking phthalates to these disorders has been the easy part – the challenge lies in finding out what products contain these chemicals, present as they are in a variety of consumer products, from air fresheners to teething rings.Phthalates are never mentioned in the list of ingredients, which means that most of us who use these cosmetics, perfumes, cleaners, and toys risk being exposed to them every day.Expect to hear more reports of injuries and illnesses associated with phthalates use in toys in 2009.

Seattlepi.com has an interesting story about how well we can expect our federal agencies to ensure that the food that makes it to our tables is safe to eat. The focus of the story is but naturally, the salmonella food poisoning crisis that has engulfed the country with 6 deaths connected to the epidemic so far.

The biggest source of concern to American consumers in this latest crisis, the report says is the manner in which the Food and Drug Administration dragged its feet for more than three months before confirming an outbreak. The latest crisis that has involved the agency’s food safety protocol has had consumer safety advocates, food poisoning lawyers as well as the public, wondering how the FDA which found out weeks ago that the Georgia plant of Peanut Corporation of America was the source of the particular strain of Salmonella found in the contaminated peanut butter, could have waited so long before they even confirmed the source. The FDA continued to mouth the same line – that the peanut butter in question was only sold to restaurants, nursing homes and food companies, but they still have not released a list of all Peanut Corporation of America clients who may have received the contaminated butter. The FDA’s outdated practices mean that manufacturers are rarely forced to recall their products. The agency prefers to rely on voluntary recalls by companies, and in many cases, these are too late to prevent severe illnesses.

More companies meanwhile are queuing up to announce recalls of their products that contain peanut butter. General Mills has recalled 2 varieties of snack bars because butter used in the snacks came from the Peanut Corporation of America. Other companies including Perry’s Ice cream Company, Food Lion Cookie, Hy-Vee Inc, have all removed their products containing peanut butter from store shelves as a precautionary measure because of the fear that these could contain traces of the contaminated butter.

Eli Lilly & Co. has agreed to a settlement with federal regulators that will include a fine of $615 million to settle criminal lawsuits, and a further $800 million to resolve civil litigation related to injuries caused by its anti psychotic drug Zyprexa.That makes the total fine amount to close to $1.5 billion, said to be the largest criminal fine for an American company. The company will plead guilty to one misdemeanor charge, and will not plead guilty to wrongdoing in any civil case.

The punishment is for the company’s indulgence of off-label use of its Zyprexa medication. Off-label use is the promotion of a drug by a company for purposes other than that for which it has been approved.It’s not prohibited for doctors to prescribe drugs for purposes other than that for which it was specified, but pharmaceutical companies are expressly forbidden from promoting such off label use of the drug.

Zyprexa is an anti psychotic drug that is meant for use by patients who suffer from schizophrenia or bipolar mania, but that didn’t stop Eli Lily from promoting the product as a sleep medication for elderly dementia patients. Between 1999 and 2003, thousands of Eli Lilly representatives were urged to promote use of Zyprexa for use in dementia patients.Documents produced in court have shown that the company greedily pushed Zyprexa to treat a variety of disorders that it was never approved for, including aggression, dementia and dementia related to Alzheimer’s Disease.The company began promoting the medication in assisted living facilities and long term care nursing homes. Effects of the medication like weight gain were already becoming evident, but Eli Lilly’s representatives pooh poohed these, saying these were part of the benefits of taking the medication.Representatives were urged to market the drug for symptomatic treatment, even in cases where the drug had not been approved. Incidences of patients dying from heart attacks and infections after using the drug began to surface, and finally in 2006, the FDA ordered the company to have strong warning labels that cautioned patients of the drug’s risk for elderly patients. Since then, the company has paid out $1.2 billion in settlement of at least 32,000 injury claims that were brought against it.This new settlement is in addition to the previous one.

According to the Department of Public Health, five cases of the salmonella food poisoning that have been reported across the country have been found in Georgia.A few days ago, the Centers for Disease Prevention and Control announced an outbreak of salmonella poisoning in 42 states.The outbreak apparently occurred between October to December, and has sickened close to 400 people.One elderly woman who died during the period had been infected at the time of her death, but it hasn’t been confirmed if she died because of the poisoning.

Now, fresh reports confirm that a brand of peanut butter has been traced as the source of the contamination. Batches of King Nut and Parnell’s Pride peanut butter that were distributed by King Nut Cos, and supplied to schools, nursing homes and restaurants, have been recalled.The batches were only sold to institutions, and were not available directly to the public.The company apparently only distributed the product which is manufactured by Peanut Corporation of America.The link was traced when tests conducted by the Minnesota Department of Agriculture and Health on the peanut butter batches revealed a match with the strain of salmonella Typhirium type that has been responsible for the outbreak.

Symptoms of salmonella poisoning include abdominal cramps, fever and diarrhea. In cases of serious infection, hospitalization may be required. The symptoms are particularly acute in the case of children, elderly or those who have weakened immune systems.In serious cases, the infection may spread to other parts of the body, and death can result.

The United States Supreme Court heard oral argument in November in a case called Wyeth vs. Levine.The case comes out of a Vermont Supreme Court decision.Diane Levine was a musician who suffered from migraine headaches.A physician’s assistant administered the drug Phenergan during a “push-IV” injection.The PA accidentally injected the drug into Levine’s artery instead of a vein.This caused tissue necrosis, gangrene, and the eventual amputation of her hand and forearm.

The drug Phenergan, manufactured by Wyeth, had a warning label that warned of this risk if the drug was injected into an artery.The Federal Drug Administration (FDA) had approved the label.Levine warned that the label did not warn of the risks associated with hitting an artery during a push-IV. A Vermont jury awarded Levine $6.8 million against Wyeth.Wyeth argued that the approval by the FDA constituted pre-emption by federal law of state law tort claims.The Vermont appellate courts upheld the verdict, and Wyeth appealed at the federal level.

The United States Supreme Court is now considering whether federal law supersedes state law in drug labeling cases.Currently, state law could supercede federal requirements if new information became available about the drug or the FDA failed to disclose certain risks. In this case, however, Wyeth knew of the risk of harm and did in fact warn of the risk.The risk of harm caused by injecting into an artery is a 1 in 20 million chance of a gangrene adverse reaction. Levine argues the warning should have been stronger, specifically that the push-IV method increased the risk of hitting an artery.

Drug manufacturer GlaxoSmithKline won a significant ruling this week in the Third Circuit of the United States Court of Appeals in Colaccio vs. Apotex.SmithKline, the manufacturer of the anti-depressants Paxil and Zoloft, defended two separate state tort claims that the manufacturer failed to warn of the risk of suicide from taking the drug.Plaintiffs product liability suits failed.

In a split decision, the Third Circuit ruled that federal regulatory law pre-empted state tort law claims in cases against manufacturers of anti-depressants for failure to warn of the risk of suicide.

Anti-depressants are drugs known as selective serotonin re-upate inhibitors (SSRIs).The drugs block the re-absorption of serotonin into the brain.Serotonin is a natural body chemical that regulates mood, sleep and appetite.By blocking the re-absorption the brain cells get an extra dose of a feel-good chemical.Some experts believe that the increase in serotonin causes a drop in the natural chemical dopamine. Dopamine regulates cognition and behavior.