Patient safety depends on tort litigation to identify a brand-name drug’s undisclosed risks, illuminate flaws in a drug’s design, and raise concerns that a drug requires further study before it is safe for patient use. However, since the U.S. Supreme Court’s landmark decision in Wyeth v. Levine, which permitted the plaintiff to move forward but recognized an in-principle impossibility preemption defense, drug manufacturers have shielded themselves from liability under a range of circumstances. Under this defense, federal law preempts state law tort actions against brand-name drug manufacturers in any court across the country. Yet, the scope of the impossibility preemption defense remains unclear.
On May 20, 2019, the Supreme Court clarified its interpretation of impossibility preemption in Merck Sharp & Dohme Corp. v. Albrecht. This case involved state law claims regarding Merck’s alleged failure to adequately warn patients and physicians of the risks of femoral fractures associated with Fosamax, a drug used to treat osteoporosis in postmenopausal women. In Albrecht, the Supreme Court decided that impossibility preemption is a question of law for judges to decide, rather than a question of fact for a jury. The Court also elaborated on Wyeth’s requirements for a viable impossibility preemption defense. Ultimately, rather than deciding whether or not the plaintiffs’ state law claim in Albrecht was preempted, the Court remanded the case. For now, the future of impossibility preemption defenses is left for lower courts to decide, but Albrecht provides the framework within which they must decide it.
The Supreme Court’s decision in Albrecht marks a step forward in the muddled path the Court has forged in this area. While the Court attempts to provide a simple analytical framework for determining when impossibility preemption defenses succeed, questions remain about the power and applicability of this defense for brand-name drug manufacturers. This Note seeks to provide lower courts deciding impossibility preemption questions with a functional understanding of where the doctrine stands after Albrecht. Given the increasing pace of new brand-name drug approvals and the rise of product liability litigation involving pharmaceuticals, it is crucial that future litigants are aware of the status of the impossibility preemption defense. If this defense still exists after Albrecht, it is also imperative that courts know it when they see it.