Preemption Does Not Shield Companies
On March 4 the U.S. Supreme Court, in a 6-3 vote, rejected the argument that federal approval of prescription medications by the Food and Drug Administration (FDA) preempts state laws and thus prevents consumers from suing pharmaceutical companies in state courts, setting a potentially important precedent in liability suits against the drug industry.
The decision upheld a previous ruling by a Vermont jury in the case of Wyeth Pharmaceuticals v. Levine. The plaintiff, Diana Levine, a musician and music teacher, suffered gangrene that resulted in the amputation of a forearm after she received promethazine (Phenergan) injection via intravenous (IV) push, which was accidentally injected into an artery.
The lawsuit claimed that the maker of the drug, Wyeth Pharmaceuticals, failed to include a strong warning to physicians and patients in its labeling about this serious adverse effect. The jury agreed and awarded her $6.7 million.
Wyeth appealed the decision on the grounds that because the drug labeling was approved and regulated by the FDA, a federal agency, the state court had no standing to deem the label information inadequate.
The case has drawn much attention in various sectors because the federal preemption argument has been increasingly used by pharmaceutical and medical-device companies in liability suits. The argument that products under federal agency regulation are shielded from state laws was backed by the Bush administration and has drawn inconsistent rulings in lower courts.
In two earlier cases, though ones with narrower scope than the Wyeth case, the Supreme Court was deadlocked in Warner-Lambert v. Kent, but ruled in favor of the device company in Riegel v. Medtronic (Psychiatric News, April 4, 2008). Last month's ruling may have a signficant impact on a large number of liability lawsuits on the state level.
The majority opinion, written by Justice John Paul Stevens, said that Wyeth was aware of the potential adverse effect of IV push and could have“ unilaterally strengthened its warning” without being directed to do so by the FDA. He stated as well that in passing the federal Food, Drug, and Cosmetics Act there was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” He also cited the “limited resources” available to the FDA to oversee the thousands of drugs to which it has granted marketing approval.
Wyeth attorney Burt Rein said in a statement after the verdict that the company did not think it had the authority to change medication warning labels as the Vermont trial court had suggested. Pfizer is in the process of buying Wyeth for $68 billion. ▪
