Drug Injuries From Dangerous Side Effects. Federal law does not bar the victims of drug side effects from filing lawsuits against drug makers in state courts, the U.S. Supreme Court has ruled. By a 6-3 vote, the High Court upheld a ruling awarding $6.7 million to a Vermont woman who lost her arm after a botched injection of Wyeth Pharmaceutical’s anti-nausea drug, Phenergan.
In the lawsuit, Wyeth vs. Levine, the plaintiff had argued that Wyeth had failed to adequately warned about the potential dangerous side-effects posed by using the so-called IV Push method to inject the drug. In 2000, the same year the plaintiff sustained her injury, Wyeth changed the label of Phenergan to warn that the drug should not be given in this manner.
Wyeth had argued that the Food and Drug Administration’s (FDA) approval of Phenergan and other drugs protected drug makers from such consumer lawsuits. That stance had also been advocated by the Bush Administration when the case came before the Court last fall.
Consumer groups, on the other hand, argued that it is vital that a consumer’s right to sue over a defective drug be fully upheld. They pointed out that the FDA approval process does not always catch safety problems, and in some instances, drug makers purposely withhold vital information from the agency. An editorial in an August issue of the New England Journal of Medicine pointed out that often litigation is the only way such wrongdoing is ever made public.
In his majority opinion, Justice John Paul Stevens wrote that “Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight.”
The ruling will be a relief to many patient advocates. An earlier Supreme Court ruling regarding medical device lawsuits was not so favorable. Last February, in the case of Riegel vs. Medtronic, Inc., the Supreme Court ruled that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. Since then, hundreds of medical device lawsuits have been dismissed.
The best hope for the victims of medical devices is for Congress to pass a law that would, in effect, overturn the Medtronic ruling. Several Democratic members of the House and Senate have said recently that they plan to introduce a law to restore consumers rights during the current session of Congress.