Deborah Fellner must have really, really liked tuna. Between 1999 and 2004, Chicken of the Sea canned tuna was almost all she ate.

After five years of a nearly all-tuna diet, Fellner developed severe mercury poisoning, which caused "extreme physical and emotional injuries," according to the lawsuit she subsequently filed.

Fellner sued Tri-Union Seafoods, which owns Chicken of the Sea, claiming that the company failed to warn consumers that excessive consumption of tuna could lead to mercury poisoning. The U.S. District Court in New Jersey dismissed the case, finding that Food and Drug Administration (FDA) warnings about the dangers of mercury in seafood pre-empted state law. However, in August the 3rd Circuit revived Fellner v. Tri-Union Seafoods. The appeals court found that the lower court had improperly dismissed the class action lawsuit.

According to the unanimous ruling from the 3rd Circuit, the FDA's issuance of four documents warning consumers of potential mercury poisoning did not rise to the level of "binding regulatory action on the subject," and therefore there was no federal law in place to pre-empt the state law under which Fellner filed her suit.

"The federal government has done so little in this area," says Adina H. Rosenbaum, a staff attorney at the Public Citizen Litigation Group in Washington, D.C. Rosenbaum argued the case before the 3rd Circuit on behalf of Fellner.

The appeals court remanded the case back to the lower court for rehearing in light of its findings. According to Amanda Rozier, a spokeswoman for San Diego-based Tri-Union, the company has filed a petition for an en banc hearing before the 3rd Circuit. A decision on the appeal had not been issued at press time.

Level of Law
Initially, Fellner sued Tri-Union in the Superior Court of New Jersey, seeking damages for harm she allegedly sustained by consuming methylmercury and other harmful substances found in Chicken of the Sea. Tri-Union had the case removed to federal court, where it filed a motion to dismiss, claiming the FDA's warnings pre-empted New Jersey law.

In that motion to dismiss, Tri-Union pointed to several actions the FDA had taken that the company argued constituted federal regulation. Those included an FDA consumer advisory published in 2004 regarding the risks of mercury in fish; a "backgrounder" for the FDA's 2004 advisory, which provided further information about those risks; and Section 504.0600 of the FDA's Compliance Policy Guide, which is a guideline recommending that the FDA initiate enforcement action if the concentration of mercury in fish exceeds one part-per-million. The fourth action it cited was a 2004 letter that the commissioner of the FDA sent to the California attorney general, who was suing Tri-Union and several other companies for failure to warn consumers that their tuna products contained dangerous mercury compounds.

The District Court agreed with Tri-Union's pre-emption arguments and dismissed Fellner's case.

In reversing the lower court's decision, 3rd Circuit Senior Judge Walter K. Stapleton said the issue came down to whether the four FDA documents actually constituted federal law. In this case, the FDA's actions did not rise to the level of law, the court found.

Judge Stapleton wrote, "State law is not pre-empted whenever an agency has merely 'studied' or 'considered' an issue; state law is pre-empted when federal law conflicts with state law."

Proper Context
Ricardo Carvajal, of counsel with Hyman, Phelps & McNamara in Washington, D.C., points out that not every action by a federal agency constitutes a regulation. When considering whether a federal agency's actions could have the weight of law and pre-empt state law, it's important to examine the specific actions the federal agency took regarding the matter, he says.

For example, the FDA-issued guidance, which was presented in the lawsuit, was not binding on either the seafood industry or on the FDA itself. "This was just something the FDA wrote to inform its decisions [into whether to pursue regulatory actions against violators]," Carvajal says.

He also points to the 2005 letter cited in the lawsuit that then-FDA Commissioner Lester Crawford wrote to Bill Lockyer, the California attorney general who filed People v. Tri-Union. In that letter, Crawford cited several reasons why the FDA believed that California state law "is pre-empted by federal law with respect to the proposed warnings concerning mercury and mercury compounds in tuna."

In People v. Tri-Union, the California Superior Court agreed with the pre-emption argument. But when Fellner came before the 3rd Circuit, the court reached the opposite conclusion. In doing so, the court examined the manner in which the FDA presented its pre-emption viewpoint to Lockyer.

The FDA commissioner wrote a letter, but the agency did not submit an amicus curiae brief as part of the lawsuit, Carvajal says. To file an amicus brief, the FDA would have to go through the Department of Justice to write the brief, and the DOJ would have to work on that brief in cooperation with the Department of Health and Human Services, which oversees the FDA. By involving so many federal agencies, the submission of an amicus brief has a built-in system of checks and balances--unlike sending a letter as Crawford did. "This was not that formal--it was just a letter," Carvajal says.

"It's important to keep pre-emption cases in context," he says.