Wednesday, August 20, 2008

Chicken of the Sea is Sunk

Yesterday, the Third Circuit decided Fellner v. Tri-Union Seafoods LLC, No. 07-1238, slip op. (3d Cir. Aug. 19, 2008) (link here).

The case involves our favorite subject: tuna fish.

Aaah, no, we're just kidding. The case involves preemption.

The FDA has authority to regulate the field of food safety. The Agency can set standards of food quality and set tolerance levels for poisonous substances in food. And the Agency has enforcement authority to enforce the FDCA's ban on selling adulterated or misbranded food. Id. at 26.

The FDA has issued no regulations governing the level of mercury in tuna fish. But the FDA has issued a consumer advisory and a backgrounder about those risks, and the FDA included in its internal Compliance Guide "a provision recommending that the agency initiate enforcement action if mercury concentrations in fish exceed a specified level." Id. at 27. The FDA also sent a letter to the Attorney General of California saying that the FDA believed that its regulatory actions preempted certain state law claims. Id.

On those facts, the Third Circuit unanimously found that a plaintiff's claims that she suffered mercury poisoning as a result of ingesting tuna were not preempted.

That's not why this case interests us. We like food, but we're not food lawyers.

The Third Circuit of course decided Colacicco v. Apotex, 521 F.3d 253 (3d Cir. 2008), the leading federal appellate case on the issue of preemption of claims brought against drug manufacturers. (We posted about that here, among many other places.) And Judge Sloviter, who wrote the majority in Colacicco, was on the panel in Fellner. What does Fellner tell us about Colacicco?

Only good things. You'll find the Third Circuit's discussion of Colacicco at pages 11 and 12 of Fellner. We reproduce that paragraph here, for your convenience:


"In Colacicco, the plaintiffs’ alleged claims for failure to warn that a family of drugs used to treat anxiety and depression caused an increased risk of suicidality. The FDCA conferred jurisdiction upon the FDA to regulate drug labeling. Regulations authorized by the FDCA predicated the marketing of drugs on FDA approval of the drugs’ labeling both at the time the drugs were initially marketed and on an ongoing basis thereafter. Defendants’ labels had received FDA approval both before and after the suicides at issue. The plaintiffs pointed out, however, that the regulations required that the labeling be revised by the manufacturer unilaterally “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” 21 C.F.R. § 201.57(c) (2003). Plaintiffs argued that this meant the defendants could have complied with both the federal regulations and the state duty to warn, and thus no conflict existed. We rejected this argument because, although the regulations allowed a manufacturer to amend warnings unilaterally, all such amendments remained contingent on the manufacturer ultimately receiving FDA approval, and the FDA in a number of different agency proceedings had previously considered the scientific evidence relied upon by plaintiffs and had exercised its prerogative under the regulations to reject suicidality warnings based on that evidence. The FDA had “clearly and publicly stated its position [regarding the propriety of the warning in the pertinent circumstances] prior to the prescriptions and deaths at issue. . . .” Colacicco, 521 F.3d at 271. Although defendants had not been shown to be participants in those proceedings, we concluded that a conflict existed because, much like agency quasi-judicial proceedings, see Security and Exchange Commission v. Chenery Corp., 332 U.S. 194, 201-03 (1947), the FDA’s actions in those proceedings established a policy against the sought-after warnings applicable not only to the immediate participants but also to others in like circumstances, such as the defendants. Thus, defendants could not have complied with the requirements of both federal and state law."

Needless to say, the Third Circuit's later discussion of why preemption does not apply to the levels of mercury in tuna stands as a counterpoint to why the FDA's regulation of SSRIs do preempt claims against antidepressant manufacturers.

(Fellner does apply the "traditional presumption" against preemption in the food context, "until the Supreme Court provides guidance to the contrary." Id. at. 23. The presumption against preemption is another topic that we've wrestled with repeatedly, including here. And you'll find a fair amount in Fellner about the degree of deference a court owes to the letter in which the
FDA "informally' expressed its belief that certain claims are preempted.)

From the defense side, Fellner is unhappy news for the food industry, but continued good news for pharmaceuticals.

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