Product Liability

Published on: January 16, 2009

Eli Lilly Agrees To $1.42 Billion Fine to Settle Zyprexa Litigation

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.

Published on: January 13, 2009

Georgia Affected by Peanut Butter Salmonella Outbreak

by Robert N. Katz, Esq.

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.

Published on: December 9, 2008

Supreme Court to Consider Drug Labeling

by Robert N. Katz, Esq.

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.

Published on: April 11, 2008

Product Liability Suit Fails Against Anti-Depressant Manufacturer

by Robert N. Katz, Esq.

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.

Published on: January 29, 2008

Product Defects Evident in 2007 Automobile Recalls

by Robert N. Katz, Esq.

Former Mitsubishi President, Katsuhiko Kawasoe, was sentenced in Japan last week for professional negligence for his role in covering up defects in Mitsubishi trucks in cars over a three-year period from 1997 to 2000. Apparently, the auto manufacturer hid defects in its clutch system on several models of trucks and cars. The defect caused the brakes to fail. In some cases, occupants were killed in collisions caused by the faulty system. Wrongful death suits arising from these collisions uncovered the scandal.

Mitsubishi hid reports of defects, choosing to secretly repair the cars when brought into dealerships rather than issue a product recall that would have protected consumers. When news of the cover-up came out, sales plummeted, and company officials were forced out in disgrace. Subsequently, those officials were charged with professional negligence and criminal violations for falsifying reports and failing to take proper recall measures.

In the United States, the National Highway Transportation Safety Association (NHTSA) has issued its 2007 recall report. Automobile recalls increased in 2007 by thirty percent from the previous year. Manufacturers issued 588 recalls, affecting almost 15 million vehicles.

Published on: October 4, 2007

Faulty Seatbelts and Air Bags

by Robert N. Katz, Esq.

In Georgia there is a doctrine known as Res Ipsa Loquitur, which translated means “the thing speaks for itself.” Some things are so manifestly the result of someone’s negligence that a jury can infer negligence on the part of the defendant. In other words, the evidence proves the point. For example, a scalpel left in the stomach of a surgery patient infers the negligence of the doctor. Also, a barrel of flour falling out a second story window infers the shopkeeper’s negligence.When applied, this doctrine creates an inference of negligence that the defendant must affirmatively disprove.

To apply this doctrine in a negligence case, the plaintiff must usually show:

That harm would not have occurred without someone’s negligence;