Class Action Claims Against Tri-Union Seafoods (dba Chicken of the Sea) not Preempted by FDA Regulations or Opinions Expressed by FDA Commissioner in Letter to State Attorney General Third Circuit Holds
Plaintiff filed a class action lawsuit in New Jersey state court against Tri-Union Seafoods, doing business as Chicken of the Sea, “seeking damages for harm she allegedly sustained as a result of her consumption of methylmercury and other harmful compounds contained in Tri-Union’s tuna fish products.” Fellner v. Tri-Union Seafoods, LLC, ___ F.3d ___ (3rd Cir. August 19, 2008) [Slip Opn, at 3]. Specifically, the class action complaint alleged that defendant’s tuna products contained chemicals that could cause mercury poisoning and that plaintiff suffered mercury poisoning from consuming defendant’s tuna, and alleged negligence and violations of New Jersey’s Products Liability Act based on defendant’s alleged “failure to warn of the risks incurred in consuming its products.” Id., at 3-4. Defense attorneys removed the class action to federal court and then filed a motion to dismiss the class action complaint on the ground that the regulatory actions of the Food and Drug Administration preempt the class action’s claims. Id., at 3. In part, the defense relied on a letter sent by the FDA Commissioner to California’s Attorney General in connection with a 2004 “Proposition 65” lawsuit (see Cal. Health & Safety Code § 25249.6) that the State of California brought against Tri-Union and other defendants and that sought an injunction and civil penalties based on for defendants’ “failure to warn consumers that their tuna products contain dangerous mercury compounds.” Id., at 4. The Commissioner’s letter opinion that the State’s lawsuit was preempted by prior regulatory actions taken by the FDA. Id. The letter stated in part that the State’s lawsuit would “frustrate the [FDA’s] carefully considered federal approach” to the issue of mercury in fish. Id., at 5 (citing People v. Tri-Union Seafoods, 2006 WL 1544377 (Cal. Super. Ct. May 12, 2006)). The California court ultimately ruled that the State’s lawsuit was preempted. Id., at 5. (citation omitted). The New Jersey district court granted defendant’s motion to dismiss the class action, also ruling that the class action claims “are preempted by the FDA’s ‘regulatory approach’ to the risks posed by mercury compounds in tuna fish.” Id., at 3. The Third Circuit reversed.
The Circuit Court explained that “[t]he sole question presented in this appeal is whether [plaintiff’s] state claim for damages is preempted by federal law.” Fellner, at 6. In support of the district court’s ruling, defense attorneys advanced three preemption arguments: “(1) that the FDA has adopted a ‘pervasive regulatory approach’ – embodied in the FDA’s Advisory, backgrounder and internal enforcement guideline – with which Fellner’s state lawsuit actually conflicts; (2) that the FDA has ‘reject[ed] the use of warning labels’ in favor of a more ‘nuanced’ approach – that is, that the FDA has reached a decision that warnings should not be regulated, a decision which preempts the state from entertaining a claim based on a duty to warn theory; and (3) that the FDA would have rejected any warning as ‘misbranding,’ a determination which preempts Fellner’s failure-to-warn claim.” Id., at 6-7. After reviewing the doctrine of federal preemption, the Third Circuit explained that defendant does not assert either express preemption or field preemption, and that “[i]f preemption exists in this case it must be conflict preemption. Id., at 8-9. This issue, as in all preemption cases, turns on Congressional intent, id., at 9 (citation omitted).
The Third Circuit found that the Commissioner’s letter was not entitled to the great weight urged by the defense, see Fellner, at 13-14, concluding that it “simply [did] not find the letter’s reasoning persuasive,” id., at 23-26. Indeed, the Circuit Court stated at page 21, “it is hard to imagine a field more squarely within the realm of traditional state regulation than a state tort-like action seeking damages for an alleged failure to warn consumers of dangers arising from the use of a product.” (Citation omitted.) Based on the Court’s detailed analysis, see id., at 26-36, the Third Circuit concluded that the district court erred in dismissing the class action because the state claims were not preempted by federal law, id., at 36-38. Specifically, the Circuit Court held that (1) “the FDA has regulated neither the risk of mercury in tuna nor the permissible warnings regarding that risk in a manner that conflicts with [the class action] lawsuit,” id., at 31; (2) while the FDA has “studied the risks of mercury in fish,” it has not made a “conclusive determination” in connection with those studies “of the sort which will preempt state law – neither that mercury in fish poses no adverse health consequences, nor to prohibit some or all warnings,” and state laws are not preempted merely because an agency has “studied” or “considered” an issue, id., at 32-33; and (3) (3) “[t]he FDA has taken no misbranding action pertaining to the risk of mercury in tuna whatsoever,” id., at 35, and, for preemption to apply, “the FDA must actually exercise its authority in a manner in fact establishing the state warning as false or misleading under federal law” so the “informal views” contained in the Commissioner’s letter are insufficient to support preemption, id., at 36. The Third Circuit therefore reversed the district court order and remanded the class action for further proceedings.