[17-290] Merck Sharp & Dohme Corp. v. Albrecht

Merck Sharp & Dohme Corp. v. Albrecht

Justia (with opinion) · Docket · oyez.org

Argued on Jan 7, 2019.
Decided on May 20, 2019.

Petitioner: Merck Sharp & Dohme Corp..
Respondent: Doris Albrecht, et al..

Advocates:

• Shay Dvoretzky (for the petitioner)
• Malcolm L. Stewart (Deputy Solicitor General, Department of Justice, for the United States, as amicus curiae, supporting the petitioner)
• David C. Frederick (for the respondents)

Facts of the case (from oyez.org)

Beginning in 2010, hundreds of plaintiffs around the country filed personal injury lawsuits against drug manufacturer Merck Sharp & Dohme (“Merck”), claiming that the osteoporosis drug Fosamax had caused them to suffer severe thigh bone fractures. Under state tort law, each plaintiff alleged, among other things, that Merck’s Food and Drug Administration (FDA)-approved drug label failed to include an adequate warning regarding the risk of femur fractures.

In 2011 the cases were consolidated as a multi-district litigation action in the U.S. District Court for the District of New Jersey. The cases subsequently grew to include over 1,000 plaintiffs. After discovery and a bellwether trial, the district court ruled in favor of Merck on a summary judgment motion, dismissing all of the plaintiffs’ claims on the basis that they were preempted by federal law under Wyeth v. Levine, 555 U.S. 555 (2009), which held that state-law failure-to-warn claims are preempted in the event that there is “clear evidence” that the FDA would not have approved the warning that a plaintiff claims was necessary.

The U.S. Court of Appeals for the Third Circuit vacated and remanded the district court’s ruling, holding that preemption was an affirmative defense, and that Merck had not sufficiently proven that it was entitled to that defense as a matter of law. Under Wyeth’s demanding “clear evidence” standard, the appellate court found that the plaintiffs had produced adequate evidence for a reasonable jury to find that the FDA would have approved an appropriately worded warning about the risk of femur fractures, or at least that the chances of FDA rejection were not highly probable. Pursuant to Wyeth and Federal Rule of Civil Procedure 56, this showing was sufficient to defeat summary judgment and move forward to trial.

Question

Is a state-law failure-to-warn claim preempted when the Food and Drug Administration (FDA) rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?

Conclusion

Whether the FDA’s rejection of a proposed drug label preempts state-law failure-to-warn claims requires “clear evidence” that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA informed the drug manufacturer that it would not approve that change and is primarily a legal question that must be resolved by a judge, not a factual question to be resolved by a jury.

Justice Stephen Breyer authored the Opinion of the Court (6-3 in its reasoning, but 9-0 in the judgment). Under the Supremacy Clause of the U.S. Constitution, federal law preempts state law when it is “impossible for a private party to comply with both state and federal requirements.” Here, the state law at issue is state common law or statutes that require drug manufacturers to warn drug consumers of the risks associated with a particular drug. The federal law at issue is the statutory and regulatory scheme by which the FDA regulates the labels of brand-name prescription drugs.

In Wyeth v. Levine, 555 U.S. 555 (2009), the Court held that “absent clear evidence that the FDA would not have approved a change” to the label, the Court could not conclude that it was impossible to comply with both federal and state labeling requirements.” Applied to the facts of that case, that the state-law claims were preempted by federal law only if the drug manufacturer showed it “fully informed” the FDA of the justifications for the warning required by state law, and also that the FDA then informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning. Justice Breyer clarified that “clear evidence” is not a heightened evidentiary standard but a requirement that the court consider “whether the relevant federal and state laws ‘irreconcilably conflic[t].’”

It is not enough that the FDA simply act. It must act pursuant to its congressionally delegated authority, as preemption only occurs when federal law—not all agency action—conflicts with state law. The question whether the FDA’s disapproval of the proposed label is primarily one of law and thus better suited for judges, not juries, to resolve. Judge are “better equipped” than juries “to evaluate the nature and scope of an agency’s determination...and to interpret agency decisions in light of the governing statutory and regulatory context.” Thus, the Third Circuit erred in treating the preemption question as one of fact, not law.

Justice Clarence Thomas joined the majority and wrote separate concurring opinion to explain his understanding of preemption doctrine. Justice Thomas argued that the FDA’s response letter in this case “was not a final agency action with the force of law,” and thus could not preempt under the original meaning of the Supremacy Clause.

Justice Samuel Alito authored an opinion concurring only in the judgment of the Court, in which Chief Justice John Roberts and Justice Brett Kavanaugh joined. Justice Alito agreed with the majority that the question of preemption in this case is a question of law, but he declined to join the majority because of concern that its discussion of the law and facts may be misleading on remand. Justice Alito argued that a standard of proof like “clear evidence” has “no place in the resolution of this question of law” and that notwithstanding the majority’s suggestion to the contrary, there are other ways in which a drug manufacturer may change a label without prior FDA approval.