This fall, the Supreme Court will hear arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis. One potential side effect is that it may inhibit bone repair, which could result in an atypical femoral fracture.
The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. The plaintiffs contend that the label should have included such a warning. Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.” Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year and Merck then added a risk of atypical femoral fracture to Fosamax’s label.
Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine 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 instead that: (1) Levine’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, later joined by the Solicitor General, filed a Cert Petition with the Supreme Court asking the following question:
Is a state-law failure to warn claim preempted when the 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?
How the Court answers this question will no doubt shape the drug and device industry for years to come. Levine provided that a drug manufacturer could not be held liable under a failure-to-warn theory if the FDA had previously considered—and rejected—a proposed amendment to the product’s warning label. But Levine did not clearly define when preemption would apply in these circumstances, and as a result, lower courts have struggled to uniformly apply this rule. With Albrecht, the Court now has an opportunity to clear up the ambiguities left in Levine’s wake.
It is difficult to anticipate how the Court will answer the subject question, particularly when its present makeup differs so greatly from that which produced Levine. Justices Scalia, Stevens, Souter, and Kennedy are gone; replaced by Gorsuch, Kagan, Sotomayor, and possibly Kavanaugh. Justice Alito took no part in the consideration or decision of the petition, which creates the potential for a plurality, further complicating the issue.
Nevertheless, given Albrecht’s factual record it seems reasonable that the Court would use this case as an illustration of the appropriate application of conflict preemption in a pharmaceutical failure-to-warn context. At least three court members (Thomas, Gorsuch, and Roberts) appear likely to support preemption under this set of facts, and it would not be unreasonable for Kagan, Ginsburg, and/or Breyer to hold similarly, given that the latter two were both part of the Levine majority, which stated that preemption would apply if there existed “clear evidence that the FDA would not have approved a change[.]” Wyeth v. Levine, 555 U.S. 555, 571 (2009). The odds of a five-justice majority favoring preemption could be buttressed if Kavanaugh is confirmed. Regardless, all one can truly hope for is that the Court avoids a plurality decision, since such an outcome would leave the Third Circuit’s opinion intact and muddy the waters further.
Joe Winebrenner and Elie Biel are with Faegre Baker Daniels in Minneapolis, Minnesota.