Third Circuit rules FDA regulations do not bar state claim for mercury poisoning

[JURIST] The US Court of Appeals for the Third Circuit [official website] ruled [opinion, PDF] on Tuesday that existing US Food and Drug Association (FDA) [official website] regulations do not preempt a New Jersey woman's state claim that she was poisoned by the mercury in canned tuna. The suit alleges that Tri-Union, producers of Chicken-of-the-Sea [company website] brand tuna, failed to warn consumers about the potential danger of mercury poisoning that resulted from the consumption of its products. The Third Circuit rejected Tri-Union's argument that her claim was preempted by the FDA's regulatory scheme regarding the presence of mercury in fish:

This is a situation in which the FDA has promulgated no regulation concerning the risk posed by mercury in fish or warnings for that risk, has adopted no rule precluding states from imposing a duty to warn, and has taken no action establishing mercury warnings as misbranding under federal law or as contrary to federal law in any other respect. [The] lawsuit does not conflict with the FDA’s “regulatory scheme” for the risks posed by mercury in fish or the warnings appropriate for that risk because the FDA simply has not regulated the matter.

The FDA has only issued a consumer advisory regarding the risks posed by mercury in fish and established a guideline regarding mercury concentrations to guide its enforcement decisions. Neither of these agency acts constitutes a federal legal standard or binding regulatory action on the subject which could give rise to a conflict, and indeed neither expresses a policy or viewpoint or approach inherently inconsistent with [the] lawsuit. In the final analysis, this case involves an agency effort to preempt an area of law traditionally within the states’ police powers
The case was remanded for further proceedings consistent with the court's opinion.

In dismissing the claim, the district court relied on a letter [text] sent by the FDA to then-California Attorney General Bill Lockyer [official profile] after he filed a state suit against a number of tuna canners, including Tri-Union, for their failure to warn consumers that their tuna products contained dangerous mercury compounds in June 2004. The letter, signed by then-Commissioner of the FDA Lester Crawford [official profile], warned that Lockyer's suit would “frustrate the [FDA’s] carefully considered federal approach” regarding the regulation of mercury in fish. The Superior Court of California ultimately found that Lockyer's suit was preempted by federal law [San Francisco Chronicle report] in May 2006.


 

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