In Kreifall v. Excell, Excell’s “Preemption argument” was tried and soundly rejected by the Wisconsin State Supreme Court and then was denied review by the US Supreme Court in Kreifall v. Excell (Cargill subsidiary).  See online version.

Guest Blogger – Andy Weisbecker

In the Deborah Fellner v. Tri-Union Seafoods d/b/a Chicken of the Sea opinion, issued by the US Court of Appeals, Third Circuit, on August 19, 2008, the court protected the right of the consumer plaintiff to pursue her claim against the manufacturer of contaminated tuna products. The defendant tuna producer had argued that the federal regulatory approach by the US Food and Drug Administration (FDA) related to the risk of mercury in tuna products had preempted the consumer’s right to proceed with her claim for damages against the producer based on New Jersey’s product liability laws. The Court of Appeals however, found that the FDA’s related activity was not sufficient to warrant the preemption of the state personal injury claims, and allowed the consumer to proceed with her action against the producer.

The consumer, Deborah Fellner, had alleged in her complaint that she was harmed as a result of her consumption of methylmercury and other harmful compounds contained in the producer Tri-Union’s Chicken of the Sea tuna fish products. She sought recovery under the New Jersey Product Liability Act, based on the producer’s failure to warn of the risks incurred in consuming its products.

The lower US district court initially found that Ms. Fellner’s claims were preempted by the FDA’s regulatory approach to the risks posed by mercury compounds in tuna fish. The court found that Ms. Fellner’s state law claims were preempted due to the Supremacy Clause of the US Constitution. The district court based its finding of a comprehensive FDA regulatory approach on an FDA consumer advisory, a "backgrounder," a section of the FDA’s compliance policy guide, and a letter written by the Commissioner of the FDA. Ms. Fellner appealed that decision.

In reversing and remanding the district court’s decision, the US Court of Appeals held instead that the FDA had promulgated no regulation concerning the risk posed by mercury in fish or warnings for that risk, had adopted no rule precluding states from imposing a duty to warn, and had taken no action establishing mercury warnings as misbranding under federal law or as contrary to federal law in any other respect. The court found that none of the documents cited by Tri-Union constituted a federal legal standard or binding regulatory action on the subject of mercury compounds in tuna which could have given rise to a conflict with state laws.

The Court of Appeals decision re-asserted that the states are independent sovereigns in the federal system, and that therefore courts have long presumed that Congress does not cavalierly preempt state-law causes of action. In all preemption cases, and particularly in those in which Congress has legislated in a field which the states have traditionally occupied, courts start with the assumption that the historic police powers of the states were not superseded by the federal act unless that was the clear and manifest purpose of Congress.

The court found that this was a situation in which the FDA had promulgated no regulation concerning the risk posed by mercury in fish or warnings for that risk, had adopted no rule precluding states from imposing a duty to warn, and had taken no action establishing mercury warnings as misbranding under federal law or as contrary to federal law in any other respect. The court ruled that Fellner’s lawsuit did 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 had not regulated the matter.

The court declined 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. It found that courts with good reason are wary of affording preemptive force to actions taken under more informal circumstances. Regularity of procedure ensures that state law will be preempted only by federal "law," as the US Constitution provides. It also imposes a degree of accountability on decisions which will have the profound effect of displacing state laws, and it affords some protection to the states that will have their laws displaced and to citizens who may hold rights or expectations under those laws.

The court found in this case no federal law with which the alleged state duty to warn conflicts. 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. The court ruled that neither of these agency acts constituted a federal legal standard or binding regulatory action on the subject which could give rise to a conflict, and that neither expressed a policy or viewpoint or approach inherently inconsistent with Fellner’s lawsuit.

The Supremacy Clause provides that state laws will give way when they actually conflict with federal law. This court properly affirmed, however, that such federal preemption of a consumer’s important state law right to assert her product liability claim cannot simply be based on an agency’s effort to preempt such rights by informal means.