Pennsylvania Appeals Court Affirms Preemption of State Law Claims Based on Off-Label Marketing

Last week, the Superior Court of Pennsylvania struck a blow to Appellant Joseph Caltagirone’s wrongful death and survival claims against drug manufacturers Cephalon, Inc. and Teva Pharmaceuticals, USA, Inc. The Superior Court’s non-precedential decision relied on federal preemption principles to affirm the trial court’s dismissal of Appellant’s second amended complaint with prejudice.

Appellant brought wrongful death and survival claims individually and on behalf of his deceased son, who died in 2014 from methadone toxicity. From 2005-2011, a physician prescribed the son Cephalon’s ACTIQ, a fentanyl product approved for treatment of cancer pain of opioid-tolerant patients, to treat his migraines. The product contained an FDA-mandated “Black Box” warning label, advising of serious adverse health risks and specifically warning against the use of ACTIQ for any condition (including migraines) other than cancer pain. The physician nevertheless prescribed the drug for off-label use until moving the son to other opioids.

After his son’s death, Appellant brought suit against Cephalon and its now-parent company Teva, claiming that the companies had engaged in negligence, misrepresentation, fraud, and violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law through off-label promotion of ACTIQ. However, the trial court found that the state law claims were “explicitly premised on violation or disregard of [the FDC Act] and FDA regulation,” and that the claims “could not exist in the absence of federal laws and regulations.” Slip Op. at 6. As such, the trial court dismissed the claims as preempted by federal law.

The Superior Court affirmed that decision, explaining the “general rule” that “there is no private right to enforce the law and regulations of the [FDC Act].” Id. at 7 (citing FDC Act § 310(a)). Citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001) (“State-law fraud-on-the-FDA claims inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.”), the Superior Court explained that because Appellant’s claims were based solely on violations of FDA’s off-label restrictions, those claims were preempted by the FDC Act. Id. at 7.

It is important to note that plaintiffs, like Mr. Caltagirone, still maintain the right to bring state law malpractice claims against physicians in such cases. However, the Superior Court’s decision is another holding by a state court that helps to reinforce the shield of federal preemption available to FDA-regulated companies, an issue that is also being debated in current state opioid litigation against drug manufacturers.