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May 31, 2019 Practice Points

SCOTUS Doesn’t Clarify Application of Pharmaceutical Conflict Preemption

Whether a drug manufacturer should be held liable under a state-based failure-to-warn theory if the FDA had previously rejected a proposed amendment to the product’s warning label is no clearer.

By Elie Biel

On May 21, 2019, the U.S. Supreme Court (SCOTUS) issued its decision in Merck Sharp & Dohme Corp. v. Doris Albrecht, et al., a closely watched case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. The hope was that this case would clarify and build upon the Court’s decision in Wyeth v. Levine, which used preemption principles to hold that a drug manufacturer could not be held liable under a state-based failure-to-warn theory if the FDA had previously considered—and rejected—a proposed amendment to the product’s warning label. Unfortunately, the Court’s decision does not appear to have provided the degree of clarity that many observers had hoped for.

By way of background, the subject litigation concerns Fosamax, a drug widely used to treat osteoporosis in postmenopausal women. Osteoporosis is a condition in which a patient develops weak or brittle bones due to a progressive loss of bone cells, and Fosamax combats the effects of osteoporosis by slowing a patient’s rate of bone cell loss, allowing the body time to replace lost bone cells, thereby decreasing the risk of osteoporotic fractures. Like all medications, however, taking Fosamax is not without risk—one potential symptom of long-term Fosamax use is that the patient may develop an atypical femoral fracture. 

When the Food and Drug Administration (FDA) first approved Fosamax in 1995, Fosamax’s warning label did not warn of the risk of an atypical femoral fracture. Over time, however, evidence began to accumulate about the potential injury. As a result, in 2008 Merck applied to the FDA for preapproval to add language to the Adverse Reactions and Precautions sections of the Fosamax label; namely, by referencing the risk of a “low-energy femoral shaft fracture” in the Adverse Reactions section and discussing the risk of “stress fractures” in the Precautions section. The FDA approved Merck’s proposed Adverse Reactions language but rejected the proposed Precautions language, asserting that Merck’s justification for the proposed Precautions language was “inadequate.” Thereafter, Merck changed Fosamax’s Adverse Reactions section. It made no change to the Precautions section. (FDA continued to examine the issue and in 2011 ultimately instructed Merck to add a risk of “atypical femoral fractures” to Fosamax’s label.)

The plaintiffs (individuals who took Fosamax and suffered atypical femoral fractures between 1999 and 2010) brought state-based failure to warn claims against Merck, asserting that the company had failed to warn about the risk of atypical femoral fractures. Relying on Wyeth, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change. The District Court agreed, but the Third Circuit did not, holding that (1) Wyeth’s reference to “‘clear evidence’ referr[ed] solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury. Merck then appealed the decision to the Supreme Court.

In deciding Albrecht, SCOTUS rejected both prongs of the Third Circuit’s decision. First, the Court refused to characterize or define Wyeth’s use of the phrase “clear evidence” in terms of evidentiary standards, holding instead that the simple question for a judge is “whether the relevant federal and state laws irreconcilably conflict.” 587 U.S. ___ (2019) (Opinion, p. 14) (internal quotes and formatting omitted). And second, SCOTUS held that whether the FDA would have rejected the proposed label change is not a fact question for the jury but a legal question for the judge, as “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination.” Id. at 16. Much to the chagrin of many observers, the Court chose not to analyze or decide the ultimate question as to whether preemption barred the failure-to-warn claims brought against Merck. 

On its face, the Court’s holding appears narrow; however, the opinion’s analysis and dicta contains some particularly important takeaways. First and foremost, this decision underscores the difficulty faced by defendants in asserting pre-emption as a means of defeating state-based failure-to-warn claims. Indeed, the Court pointedly noted that preemption only occurs if “federal law prohibit[s] the drug manufacturer from adding a warning” and that under the FDA’s Changes Being Effected (CBE) regulation a drug manufacturer may, without prior FDA approval, unilaterally change a label “‘to reflect newly acquired information’ if the changes ‘add or strengthen a . . . warning’ for which there is ‘evidence of a causal association[.]’” Id. at 13-14.  The implication being that preemption may only be available if a drug manufacturer tries to make a label change pursuant to the CBE regulation, but is then thwarted from doing so by the FDA. See id. at 14 (“the CBE regulation permits changes, so 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.”). Secondarily, though the issue was neither before the Court nor decided, the opinion appears to suggest that only formal FDA actions, or similar agency actions carrying the force of law, matter to a preemption analysis, i.e. informal communications between the FDA and a drug manufacturer regarding a proposed label change may not be of significant value. Id. at 13-15. This may yet prove to be a significant issue in the Fosamax litigation, as the factual record presented in Justice Alito’s concurrence makes clear. See Alito, J., concurring p. 4-6 (describing how up until October 2010, FDA personnel effectively told Merck to “hold off” on modifying Fosamax’s Precautions section).

Ultimately, the true fallout from Albrecht will not be known for months, if not years. Until then, those in the drug and device industry will just have watch and wait.

Elie Biel is an associate at Faegre Baker Daniels in Minneapolis, Minnesota.

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