Product Liability

Published on: December 9, 2008

Supreme Court to Consider Drug Labeling

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;