The 3rd U.S. Circuit Court of Appeals has revived a class action suit against the manufacturer of Chicken-of-the-Sea brand tuna brought by consumers who say they were never warned that excessive consumption could lead to mercury poisoning.
The unanimous three-judge panel found that a lower court improperly dismissed the suit on the grounds that it was pre-empted by U.S. Food & Drug Administration regulations.
"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," Senior U.S. Circuit Judge Walter K. Stapleton wrote in Fellner v. Tri-Union Seafoods.
Stapleton, in an opinion joined by Judges Dolores K. Sloviter and D. Brooks Smith, concluded that Deborah Fellner's lawsuit does not conflict with the FDA's regulatory scheme for the risks posed by mercury in fish "because the FDA simply has not regulated the matter."
Defense lawyers argued that Fellner's duty-to-warn claim conflicted with the FDA's decision to forego any warnings in order to avoid scaring consumers away from a useful product.
Attorney John A. Kiernan of Bonner Kiernan Trebach & Crociata argued that the FDA would deem any warning false and misleading because it would not "balance out the negative ... information with positive information about the numerous healthy attributes of canned tuna."
Stapleton disagreed, saying "the FDA took no action to preclude state warnings -- at least, no binding action via ordinary regulatory procedures."
The ruling is a victory for attorneys Adina H. Rosenbaum and Brian Wolfman of the Public Citizen Litigation Group in Washington, D.C., who represented Fellner in the appeal along with attorneys William O. Crutchlow and Khalid Elhassan of Eichen Levinson & Crutchlow in Edison, N.J.
It reverses a decision by U.S. District Judge Dennis M. Cavanaugh of the District of New Jersey that dismissed the suit on the grounds that all of Fellner's claims were pre-empted by the FDA's "regulatory approach" to the risks posed by mercury compounds in tuna.
Cavanaugh, in a January 2007 decision, found that "the FDA's regulatory scheme is the result of over 10 years of data collection and study," and that the plaintiffs were effectively asking the court to disregard the FDA's "deliberately nuanced response" to the issue of mercury in seafood.
But the 3rd Circuit found that Cavanaugh had improperly equated the FDA's decision to issue a consumer advisory with actual regulation.
Stapleton noted that, in the advisory, the FDA offered advice to women who are or may become pregnant about selecting and eating fish.
In doing so, Stapleton said, the FDA did not "specifically regulate" anything, but instead gave "non-binding advice to a class of consumers."
As a result, Stapleton said, the FDA advisory did not "promulgate a federal legal standard" with which Fellner's state law claims could potentially conflict.
"The mere fact that the FDA chose to warn only certain 'at risk' consumers, rather than all consumers, does not create a conflict," Stapleton wrote. "The advisory does recommend continued fish consumption within certain parameters, but that recommendation is clearly not inconsistent with a warning against excess consumption."
Fellner originally filed the suit in the Superior Court of New Jersey, alleging that her diet consisted almost exclusively of Chicken-of-the-Sea tuna for five years, causing her to contract severe mercury poisoning, and that Tri-Union Seafood had failed to warn consumers of the risk of excessive tuna consumption.
Tri-Union removed the suit to federal court and sought dismissal on federal pre-emption grounds, citing a California court's decision to dismiss a consumer suit brought by former California Attorney General Bill Lockyer.
While the California suit was pending, the FDA sent a letter to Lockyer that said the FDA's prior regulatory actions pre-empt the state's suit because tuna canning companies would be unable to comply both with the FDA's approach and state law.
The letter warned Lockyer that his suit would "frustrate the FDA's carefully considered federal approach" to the issue of mercury in fish.
In May 2006, the California Superior Court agreed with the FDA and found the suit was pre-empted by federal law.
Now the 3rd Circuit has issued a ruling that directly conflicts with the California court's decision, finding that the FDA's opinion that such suits are pre-empted is not entitled to deference from the courts because the agency has never truly regulated mercury levels in fish.
"While the FDA may well have the authority to promulgate a regulatory scheme which would preclude any state duty to warn consumers of the risks of mercury in tuna, it simply has not done so," Stapleton wrote.
The FDA's letter to Lockyer doesn't qualify as proof of the agency's regulatory action, Stapleton said, because "courts have declined to permit agencies to promulgate express pre-emption decisions by informal letter."
Stapleton said he had "no reason to doubt that the FDA has studied the risks of mercury in fish," but that the agency "made no 'conclusive determination' of the sort which will pre-empt state law -- neither that mercury in fish poses no adverse health consequences, nor to prohibit some or all warnings."
State law, Stapleton said, "is not pre-empted whenever an agency has merely 'studied' or 'considered' an issue."
Instead, he said, state law is pre-empted only when federal law conflicts with state law.
"The cases leave no doubt that a mere decision not to regulate -- in this case, a decision not to require a federal methylmercury warning -- alone will not pre-empt state law."
Neither Rosenbaum nor Wolfman could be reached for comment.
Kiernan declined to make any immediate comment, saying he had not yet fully reviewed the decision nor discussed it with Tri-Union.