Healthy Skepticism Library item: 13467

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Publication type: news

Goldstein J.
Appeals Court Backs Drugmakers in Antidepressant Suicides
The Wall Street Journal Health Blog 2008 Apr 9
http://blogs.wsj.com/health/2008/04/09/appeals-court-backs-drugmakers-in-antidepressant-suicides/

Full text:

A federal appeals court yesterday sided with drugmakers in a case brought by the families of two people who committed suicide while taking antidepressants. The ruling is important because it turns on the concept of preemption, likely to be the most important legal topic in the drug world this year.

In this case, the families sued the drugmakers under state law, arguing that the warning labels on the drugs weren’t strong enough.

But drugmakers have argued that when they follow the rules set by a federal agency (the FDA), they shouldn’t be subject to suits brought under state law. This is a legal doctrine known as “preemption,” based on the argument that regulation established under federal law preempts suits brought under state law.

In a case earlier this year, the Supreme Court ruled that preemption applies broadly for medical devices. Later this year, the court is expected to answer questions about preemption in the drug industry in a case called Wyeth vs. Levine.

In the case decided yesterday, the families of two people who killed themselves while taking antidepressants (Pfizer’s Zoloft in one instance, a generic version of GlaxoSmithKline’s Paxil in the other) had argued that the warning labels on the drugs weren’t strong enough.

The Court of Appeals for the Third Circuit rejected that argument (the ruling is online here), but did so in pretty narrow terms: “Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires,” the majority opinion said.

A lawyer for one of the plaintiffs in the case told the Philly Inquirer that drug companies “are going to try to expand this ruling so that it applies to all drugs,” while a GlaxoSmithKline lawyer said the case was limited to a specific set of facts.

The ruling came from a three-judge panel. One judge dissented, writing that allowing the case to proceed would give the courts a chance to “evaluate – provide a check on – whether the FDA struck the right balance in the precautions and warnings it required for SSRIs.”