More bad news on the FDA preemption front

Proving once again that the federal courts are the most effective agents of tort “reform,” the U.S. Court of Appeals for the Third Circuit decided Colacicco v. Apotex, Inc. (pdf, 58 pages) last week. Colacicco involved state law wrongful death cases in which the plaintiffs challenged the sufficiency of manufacturer-issued warnings regarding two Selective Seratonin Reuptake Inhibitor (“SSRI”) drugs, GlaxoSmithKline’s Paxil and Pfizer’s Zoloft. In each case the plaintiff’s decedent took one of the drugs for treatment of depression and later committed suicide. The plaintiffs sued, asserting state law tort claims based on the manufacturers’ failure to provide adequate warnings about the increased risk of suicide inherent in using the drugs.

Preemption arises from Article VI of the U.S. Constitution, which provides in relevant part that federal law is “the supreme Law of the Land.” A federal law can preempt (i.e., nullify) state law in one of three ways. First, Congress can come right out and say that state laws are preempted. That’s called express preemption, which was the issue in the Supreme Court’s recent medical devices case, discussed here. Second, a state law is unenforceable if it conflicts with federal law. That, not surprisingly, is called conflict preemption. Third, there’s “field preemption,” a doctrine under which courts will find state law preempted even without a direct conflict or an express preemption clause if Congress enacts a regulatory scheme so comprehensive that preemption of state law addressing the same subject can be inferred.

The cases before the Third Circuit in Colacicco involved conflict preemption. I’ll leave it to you, the reader, to slog through the forty-one page majority opinion. These cases have grown more than a little depressing and tiring for me. Suffice it to say the court found plaintiffs’ state law failure-to-warn claims preempted by virtue of the Food and Drug Administration’s repeated refusal to require stronger risk-of-suicide warnings for SSDIs such as Paxil and Zoloft.

(For reasons I can’t begin to fathom, a judge of the U.S. Court of International Trade sat on the panel. What the hell. Federal courts of appeals regularly use judges from other courts to round out appellate panels, but c’mon. There wasn’t a single Article III judge anywhere in the Third Circuit who could take this assignment?!)

The dissenting judge does a fine job detailing both why the presumption against federal preemption applies in this case and why the FDA’s view of the preemptive effect of its own regulations isn’t entitled to much weight. The dissent also does a fine job showing the lack of anything resembling a real conflict between state tort law and the FDA’s labeling regulations.

This may well be a case that would attract SCOTUS’s interest. Given the way these cases are going, however, I’m not exactly giddy with excitement over that prospect.

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