In recent years, FDA has studiously avoided taking any broad regulatory action on the issue of whether, and under what circumstances, the presence of methylmercury in fish renders that fish adulterated. FDA recognized that the scientific evidence that addresses the potential risks posed by methylmercury in fish left a number of questions unanswered, while evidence addressing the benefits of fish consumption continued to mount. In fact, FDA’s public advisory on methylmercury in fish (issued in tandem with EPA) had evolved to give greater recognition to the benefits of eating fish.
FDA’s public advisory is just that – a public advisory. It is carefully worded so as not to be a guidance document subject to the requirements of the agency’s Good Guidance Practices regulation in 21 C.F.R. § 10.115 (i.e., it does not purport to be either an interpretation of statutory or regulatory requirements, or a statement of policy). Thus, it was a source of dismay to more than a few agency insiders when then-Commissioner Dr. Lester Crawford sent a letter to California’s Attorney General claiming that the public advisory was part of a “carefully considered federal approach to advising consumers” constituting federal law that preempted California’s lawsuit aimed at requiring Proposition 65 warnings on canned tuna.
FDA’s letter initially hit its mark. In People v. Tri-Union Seafoods, the Superior Court of California held that California’s lawsuit was preempted by federal law under the theory of conflict preemption advanced in FDA’s letter, and cited FDA’s letter in support of its ruling. Shortly thereafter, in Fellner v. Tri-Union Seafoods, the U.S. District Court for the District of New Jersey granted Tri-Union’s motion to dismiss in a lawsuit contending that Tri-Union was guilty of negligence under New Jersey law for failing to warn consumers of the risks posed by methylmercury in its canned tuna products. But, earlier this month, the U.S. Court of Appeals for the Third Circuit reversed – and what a reversal it is.
For starters, the appellate court thoroughly disparages FDA’s letter, concluding that “it merits a particularly low level of deference” because it is not “the product of an agency proceeding.” Footnote 8 dryly observes that the letter “follows, and bears a striking resemblance to, a letter… sent to the agency’s chief counsel” by counsel apparently representing the tuna industry in the California litigation, and that the views in the letter “apparently were formulated without the benefit of exposure to conflicting views or critiques.”
The court’s rejection of the significance of FDA’s letter, and of the views espoused therein, is central to the court’s holding that there is “no federal law with which the alleged state duty to warn conflicts.” With respect to FDA’s public advisory, the court concludes that it simply gives advice to consumers and promulgates no legal standard with which the state law claim conflicts. With respect to FDA’s contention that the use of warning labels would frustrate its approach to advising consumers of the benefits and risks of eating fish, the court finds that there has been no “authoritative federal determination that the area [of health warnings] is best left unregulated.” And with respect to FDA’s view that the requirement of a warning would render canned tuna misbranded under federal law, the court observes that “FDA has taken no misbranding action pertaining to the risk of mercury in tuna whatsoever.” On the basis of those conclusions (and Tri-Union’s failure to identify an actual conflict between the state law claims and FDA’s actions), the court rejected all of the conflict preemption arguments advanced by Tri-Union.
The Third Circuit’s decision in Fellner stands as a counterpoint to the court’s April 2008 decision in Colacicco v. Apotex, Inc. As we previously reported, the plaintiffs in Colacicco alleged claims for failure-to-warn against two drug manufacturers (Apotex and Pfizer) with respect to two selective serotonin reuptake inhibitors (paroxetine HCl and sertraline HCl) that they caused an increased risk of suicidality. The court ruled that the failure-to-warn claims conflict with (and are therefore preempted by) FDA’s regulatory actions with respect to such drugs. In Fellner, however, the court states that “[t]his does not mean . . . that federal law capable of preempting state law is created every time someone acting on behalf of an agency makes a statement or takes an action within the agency’s jurisdiction . . . We decline to afford preemptive effect to less formal measures lacking the ‘fairness and deliberation’ which would suggest that Congress intended the agency’s action to be a binding and exclusive application of federal law.”
All of this is not to say that FDA’s approach to the issue of methylmercury in seafood lacks merit, or that lawsuits such as the one against Tri-Union are a positive development. As FDA points out, the public health consequences of warning consumers away from seafood are likely to be negative.