Another Federal Court Supports Preemption

August 24, 2007

In a 2 to 1 ruling on Aug. 17, the U.S. Third Circuit Court of Appeals provided additional support for the validity of the FDA preemption doctrine. In short, preemption describes the agency’s position that because federal law has constitutional supremacy over state law, FDA regulations and actions taken in compliance with them “preempt conflicting or contrary state law, regulations or decisions of a court of law for purposes of product liability litigation.” As we’ve written elsewhere, the preemption doctrine provides a vitally important defense against a potential deluge of state lawsuits.

Most preemption cases have revolved around whether FDA labeling preempts state product liability laws. This one involved alleged deceptive advertising under the Delaware Consumer Fraud Act (DCFA) as well as violations of consumer protection statutes in other states. In a class action lawsuit, a group of consumers alleged that AstraZeneca engaged in deceptive practices by claiming that Nexium was superior to Prilosec. According the Third Circuit’s majority opinion (emphasis added):

“Although the DCFA exemption does not bar the plaintiffs’ suit, their state consumer fraud claims are preempted by federal law. By specifically excluding advertisements covered by 21 U.S.C. § 352(n) and the regulations promulgated there under from the scope of 15 U.S.C. § 52, Congress signaled its intent to give the FDA exclusive authority to regulate prescription drug advertising. The FDA has established specific regulations regarding such advertising. To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress’s and the FDA’s objectives in protecting the nation’s prescription drug users. Accordingly, the state consumer fraud laws are preempted by the extensive federal legislative and regulatory framework. We will affirm the judgment of the District Court.”

Ruling in early July in one of the Vioxx liability lawsuits, a district judge found preemption “utterly unpersuasive.” However, appeals courts have generally ruled in favor the doctrine. The U.S. Supreme Court agreed to hear the Medtronic case in its next session and which means we will likely have a resolution on this contentious matter in the near future

The Delaware ruling as well as the dissenting judge’s opinion may be found at www.ca3.uscourts.gov/opinarch/055340p.pdf.