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
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
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. ▪