May 22, 2019Client Alert

Supreme Court Empowers Judges to Resolve Preemption Defenses in Failure-to-Warn Drug Labeling Cases

On Monday, May 20, the Supreme Court of the United States issued a significant decision that should inform products liability defense strategies. In Merck Sharp & Dohme Corp. v. Albrecht, the Court held that the issue of whether a state law failure-to-warn claim is preempted by FDA’s review of a defendant’s brand-name drug label is a legal question for a judge, not a jury, to decide. At the same time, the Court suggested the preemption defense might have limited availability to brand-name drug manufacturers.

The Albrecht case involves the prescription drug Fosamax, an FDA-approved treatment for osteoporosis in post-menopausal women. The plaintiffs suffered atypical femoral fractures allegedly caused by use of Fosamax. Atypical femoral fractures occur when ordinary stress fractures propagate and fracture the femur. FDA originally approved Fosamax in 1995. The original label did not disclose “the risk of atypical femoral fractures” despite the fact Merck researchers were aware “of at least a theoretical risk” of those fractures in the early 1990’s. The fact that Fosamax might cause femoral fractures was before FDA when Merck submitted Fosamax for regulatory approval, but the agency did not require any disclosure of those risks in the drug’s initial, FDA-approved labeling.

 After FDA approved Fosamax, evidence that patients were experiencing atypical femoral fractures started to mount. Those reports led Merck to ask for FDA’s permission to list stress fractures as a risk of using Fosamax. The agency denied Merck’s request, asserting that the warning was inadequate in view of the fractures being reported in the literature. Merck went through the changes being effected or “CBE” process (a FDA regulatory procedure that, in contrast to the post-approval supplement or “PAS” process, does not require FDA preapproval) to revise Fosamax’s labeling to identify stress fractures in the Adverse Reactions section of the label. Merck did not include any statement regarding atypical femoral fractures in the warnings or precautions section. In 2011, around two years after Merck’s CBE revision went into effect, FDA ultimately required Merck to include language about atypical femoral fractures in the warning and precautions section of Fosamax’s labeling.

The Albrecht plaintiffs suffered atypical femoral fractures before the FDA-mandated warning went into effect. The plaintiffs brought suit under state law, alleging that Merck failed to provide adequate warnings of the risk of atypical femoral fractures from using Fosamax. Merck raised a preemption defense. Relying on the Supreme Court’s 2009 decision in Wyeth v. Levine, Merck argued that FDA had rejected its attempt to include a warning about stress fractures, and that FDA would have also rejected any attempt by Merck to include such a warning using the CBE process. The district court accepted this argument and granted summary judgment in favor of Merck. The Third Circuit Court of Appeals reversed, noting in passing that it would be helpful if the Supreme Court explicated Wyeth’s preemption rule.

The Supreme Court’s analysis started with a review of Wyeth. That case involved a state law failure-to-warn claim directed at an antinausea medication called Phenergan. Wyeth, the defendant in that case, argued that the claim was preempted “because it was impossible for Wyeth to comply with both state law duties and federal labeling obligations.”  The Supreme Court rejected Wyeth’s defense, noting that Wyeth could have changed Phenergan’s labeling via the CBE process. Absent “clear evidence” that FDA would have ultimately rejected such a change after Merck made it, the Court held it was possible for Wyeth to satisfy both the federal and state standards.  The claim in Wyeth survived preemption.

The Court next elaborated on the “clear evidence” standard. There, the Court explained, the critical question is “whether the relevant federal and state laws irreconcilably conflict.”  The fact that a drug label may contain sufficient disclosures in FDA’s view may not bar state tort law from imposing a more exacting standard. The Court noted that, given a pharmaceutical manufacturer’s ability to make changes to a drug label under the CBE process, “a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.”  In other words, a successful preemption defense in the brand-name drug context will likely be the exception, not the rule.

Finally, the Court addressed the question of whether the preemption defense is for a judge or a jury to decide. The Court held the matter is a question of law for a judge, not a factual determination for a jury. The Court noted judges’ experience with administrative law and in construing written instruments. In effect, this “should produce greater uniformity among courts.”  The Court reversed and remanded to the Third Circuit for application of the “clear evidence” standard to Merck’s defense.

This decision presents implications for drug manufacturers and other potential products liability defendants. The Supreme Court’s ruling that the preemption defense in Albrecht is a question of law for a judge allows defendants to insist that preemption issues be resolved early on in litigation. That said, given the availability of the CBE process, preemption may be available to brand-name drug manufacturers in theory, but not in fact. That could be the case even if FDA was aware of a drug’s risk and declined to mandate a warning.         

Regardless, defendants might still be able to use FDA’s inaction as part of their defense strategy. Chief Justice Roberts and Justices Alito and Kavanaugh concurred in judgment only, agreeing with the majority that the claim in Albrecht was not preempted. Justice Alito did note though that “for years the FDA was: aware of [the atypical femoral fracture] issue, communicating with drug manufacturers, studying all relevant information, and instructing healthcare professionals and patients alike to continue to use Fosamax as directed.”  Despite all of that, FDA determined that a warning should not be included on the drug’s labeling. At the very least, nothing in Albrecht prevents a defendant like Merck from putting on evidence of FDA’s inaction to support a claim that the warnings included on the drug’s label were in fact adequate and reasonable under the circumstances.

Defendants in other FDA-regulated industries may have more success in the preemption arena. Defendants that make other FDA-regulated products or products subject to regulation by the Environmental Protection Agency, the Consumer Products Safety Commission, or any other federal agency should look to use Albrecht early on to dispose of cases where a viable preemption strategy presents itself. And of course nothing in Albrecht prevents brand-name drug manufacturers or other potential products liability defendants from pursuing tort reform at their state legislature.

back to top