An appellate court decision in April has shielded the makers of sertraline
and paroxetine from a product liability lawsuit alleging that the companies
failed to warn the public adequately of the increased risk of suicidality in
the product labeling.
The decision was issued for the combination of two cases, Colacicco v.
Apotex Inc. et al. and McNellis v. Pfizer Inc., brought by the
families of two adult patients with depression who committed suicide after
taking these drugs. The plaintiffs argued that the drug companies did not
sufficiently disclose the risk that these antidepressants entail and were thus
responsible for the deaths. The drug companies argued that the Food and Drug
Administration's (FDA) approval and regulation of the products' labeling
supersedes liability claims in the state court.
The preemption argument has been used as a key defense by pharmaceutical
companies in many liability suits, including a class-action suit against
Johnson and Johnson over the Ortho Evra birth-control patch, according to an
April 6 New York Times report. In 2006 the FDA announced its current
official position that agreed with the industry and insisted that its approval
of drug labeling trumps state liability laws and court actions.
The decision by the U.S. Court of Appeals for the 3rd Circuit, located in
Philadelphia, was based primarily on the FDA's review and determination that
there is no convincing evidence to connect antidepressants and increased risk
of suicidal tendencies in adults. The court concluded in a 2-1 vote that the
failure-to-warn claims "conflict with, and are therefore preempted by,
the FDA's regulatory actions," Chief Judge Dolores Sloviter wrote. Thus,
the companies were deemed not liable.
The ruling does not establish a precedent for most liability suits against
pharmaceutical companies based on state law, however. Sloviter was careful to
note that this decision is "limited to circumstances in which the FDA
has publicly rejected the need for a warning that plaintiffs argue state law
Various court decisions in recent years have been inconsistent and
sometimes contradictory regarding pharmaceutical liability claims and on the
question of whether FDA regulation preempts all state liability actions. The
U.S. Supreme Court recently voted 4-4 in the Warner-Lambert v. Kent
case in which the plaintiff claimed to be harmed by the drug company's
deception of the FDA. That decision allowed the case to go forward in state
court (Psychiatric News, April 4). The federal preemption debate over
liability of pharmaceutical companies is expected to be more clearly defined
in a pending Supreme Court decision in Wyeth v. Levine.