Merck Sharp & Dohme Corp. v. Albrecht

PREEMPTION OF FAILURE-TO-WARN CLAIMS

Merck argues that a manufacturer cannot be penalized for failing to warn about a disclosed risk when the FDA has rejected the manufacturer’s proposed warning about that risk. . Merck points to the Supremacy Clause, which states that where federal and state law conflict, federal law takes precedence. Merck asserts that such a conflict exists if it is “impossible for a private party to comply with both state and federal requirements.” Merck further asserts that because the FDA did not permit it to warn about the risk of atypical femoral fractures, penalizing Merck would be punishing them for not taking an action that was forbidden under federal law. Thus, Merck concludes that the conflict at issue falls within the scope of the Supremacy Clause, and that the state law claim should be preempted.

Merck cites existing Supreme Court case law to further support this position. In the past, Merck notes, the Court has held that if federal law had prevented a manufacturer from updating a label on one of its products, then a state law failure-to-warn claim would have been preempted. Merck asserts that the Court has also held that where it is “impossible” for a manufacturer to comply with both state and federal regulations, conjecture about ways in which the parties could act to reconcile the conflicting state and federal duties will not defeat a preemption defense. According to Merck, the case law also establishes that state law failure-to-warn claims are preempted if the manufacturer can prove that the FDA would have rejected a proposed warning. Merck posits that the FDA actually did reject Merck’s request to include a warning after Merck informed the FDA about the potential risks associated with the product. Merck therefore maintains that this rejection should have preemptive effect.

Albrecht contends that federal law does not typically preempt failure-to-warn claims arising under state law against prescription drug manufacturers. Albrecht asserts that in any preemption case, “the purpose of Congress is the ultimate touchstone.” Accordingly, Albrecht claims that when Congress passes a statute containing an explicit preemption clause, the state law covered by that clause is preempted. Albrecht further explains that Congress has never enacted a preemption clause concerning prescription drugs. According to Albrecht, the lack of an express preemption clause, coupled with Congress’ awareness of existing drug litigation in state courts, provides strong evidence that Congress did not intend for an FDA rejection of a proposed warning to preempt state law claims.

Albrecht also argues that Merck could have complied with both state and federal requirements. Albrecht asserts that nothing prohibited Merck from updating its FDA-approved label to meet state law warning requirements, after which it could have used the updated label without waiting for FDA approval. Additionally, Albrecht points to the Supreme Court’s statement in prior cases that the impossibility defense does not apply “absent clear evidence that the FDA would not have approved a change to [the] label.” Albrecht claims that Merck has offered no such clear evidence and that, to the contrary, the Food and Drug Administration Amendments Act confers discretionary authority on the FDA which it can use to require changes to warning labels. As such, Albrecht maintains that Merck’s duty to use adequate, up-to-date warning labels did not end with the FDA’s rejection of one proposed warning, and that this single rejection does not preempt state law claims resulting from Merck’s failure to warn.

MEANING AND EFFECT OF THE FDA’S DECISION

Merck claims that the Third Circuit incorrectly treated the FDA’s rejection of the proposed warning as a single factor in determining whether Merck still had an obligation to rephrase its warning or to propose different warnings. In fact, Merck asserts that the FDA’s rejection was dispositive on this issue and that there is no need for a counterfactual analysis in light of the fact that the FDA handed down an actual decision. Merck contends that the Third Circuit’s finding that the FDA may have accepted an alternative wording of the proposed warning constitutes an impermissible “second-guess[ing]” of the FDA’s conduct. Merck posits that the Court has previously held that a presumption of regularity attaches to the actions of federal agencies, which should be presumed to have properly carried out their duties unless there is “clear evidence” suggesting otherwise. Merck maintains that no clear evidence exists in the present case. Additionally, Merck contends that this second-guessing constitutes the kind of conjecture that the Court prohibited in previous cases.

Merck further argues that if the Third Circuit is correct in holding that a counterfactual inquiry should be made into what the FDA might have done if presented with an alternative warning, the meaning and effect of what the FDA actually did is still a question of law for a judge— rather than a jury—to decide. Merck claims that questions about the meaning of an agency’s action are “classic questions of law,” and the Court has previously assessed the preemptive effect of an agency’s action as a question of law. Merck contends that the Third Circuit’s decision lays out an inappropriate standard of proof by requiring it to prove through clear and convincing evidence that the FDA would have rejected an alternate warning. Because such evidentiary standards do not apply to questions of law, Merck asserts that the Third Circuit’s conclusion is misguided.

Finally, Merck posits that even if the Court were to reject all of its prior arguments, it would still prevail under the Third Circuit’s framework because the FDA stated that it would not have authorized a proposed warning from Merck until October 2010. As such, Merck maintains that no jury could conclude that the FDA would have accepted any alternative warnings at an earlier time. Merck argues that to believe otherwise, a jury would have to conclude that the FDA either mislead the Court or misunderstood the reasons for its own actions, and that this kind of speculation runs contrary to the presumption of regularity that attaches to federal agency actions.

Albrecht counters that Merck never proposed an adequate warning addressing atypical femoral fractures to the FDA. Thus, Albrecht claims that the Third Circuit was correct in considering how the FDA might have responded to such a warning. Albrecht notes that Merck proposed a warning focusing on “stress fractures” rather than atypical femoral fractures, and the FDA exercised its discretionary authority to reject that warning. Albrecht contends that both the FDA and Merck have acknowledged the distinction between atypical femoral fractures and stress fractures and that instead of precluding a warning addressing atypical femoral fractures, the FDA’s response “invited” Merck to add such a warning. Accordingly, Albrecht argues that a counterfactual analysis is proper here because the warning that the FDA rejected did not actually address the risk that gave rise to the state law failure-to-warn claim.

Albrecht argues that the question of whether the FDA would have rejected an adequate warning is a question of fact rather than a question of law and is therefore appropriate for a jury to decide. Albrecht cites the traditional rule that juries decide factual or mixed-fact questions in common-law tort suits, and asserts that this rule is no less applicable to factual issues arising out of a preemption claim. Albrecht claims that the traditional rule applies despite the fact that the question at hand involves evaluating the actions of a federal agency. According to Albrecht, this is true because the question calls for analysis of what the agency might have done, not of what it actually did. Albrecht also maintains that federal drug regulations do not articulate a rationale for preventing factual questions relevant to drug regulation from going before a jury. Thus, Albrecht argues that the “clear evidence” standard for questions of fact is appropriate.

Finally, Albrecht contends that the statement by the government in its amicus brief that the FDA would not have approved a proposed warning until October 2010 is a legal argument, not a factual representation. Albrecht asserts that the government clearly indicated in its amicus brief which of its representations were factual and, in contrast, described the FDA’s claim concerning approval as an interpretation of the FDA’s response to Merck. Albrecht argues that government litigation briefs are not entitled to deference, as the Court has previously given only “some weight” to the government’s conclusions regarding an agency’s objectives and positions.