A cert petition filed earlier in March in the long-running In re Fosamax (Alendronate Sodium) Products Liability Litigation gives the Supreme Court a chance to clarify'for the second time'the Third Circuit's restrictive application of the impossibility preemption defense.
Impossibility Preemption, Wyeth, and Albrecht
Readers of this blog are likely familiar with impossibility preemption. Under the doctrine, state law is preempted where it is "impossible for a private party to comply with both state and federal requirements."1 Pharmaceutical companies can face that impossible situation in mass-tort litigation asserting state-law failure-to-warn claims when new scientific evidence identifies side effects associated with their drugs, and FDA does not or would not accept new warning language on labels.
In Wyeth v. Levine,2 the Supreme Court held that FDA approval of a drug's label did not necessarily preempt state-law failure-to-warn claims because manufacturers can strengthen warnings without prior FDA approval. But it recognized that preemption is appropriate when there is "clear evidence that the FDA would not have approved a change" sought by plaintiffs.3
The Court "elaborate[d]" on Wyeth's "clear evidence" test in Merck Sharp & Dohme Corp. v. Albrecht, holding that impossibility preemption is a question of law, not fact, and that "clear evidence" is not an evidentiary standard, but a description of the test the court should apply to determine "whether the relevant federal and state laws 'irreconcilably conflict[t].'"4 Under the Wyeth-Albrecht test, manufacturers must show that (1) they fully informed FDA of the justifications for the warning, and (2) FDA informed manufacturers that it would not approve the warning.5
In re Fosamax Litigation
The Albrecht decision arose from an appeal of a 2013 ruling in the Fosamax litigation. The plaintiffs in Fosamax allege that the drug, which treats and prevents osteoporosis in postmenopausal women, can increase the risk that everyday "stress fractures" in bones progress to complete breaks, including breaks in the thigh bone called "atypical femoral fractures."6 Merck has argued that the plaintiffs' failure-to-warn claims were preempted because FDA, in a May 2009 "Complete Response Letter," rejected its proposed warnings about "low-energy femoral shaft fractures" and stress fractures on the "precautions" section of the label.7
In 2013, a district court agreed that FDA's rejection was clear evidence that FDA would not have approved the label change.8 The Third Circuit reversed, but the Supreme Court in Albrecht overruled the Third Circuit and remanded. On remand, a newly assigned district judge again agreed with Merck and found the claims preempted. The court recognized that the language in FDA's May 2009 letter "gives rise to competing inferences" about the basis for its rejection,9 but considered extrinsic evidence regarding the "meaning and scope of the" letter and held that FDA was fully informed and would not have approved the warning sought by the plaintiffs.10 This extrinsic evidence included other contemporaneous communications with FDA officials stating the agency's review of the data "did not show an increase in the risk" of atypical femoral fractures and FDA's acceptance of adverse event reports from Merck while nonetheless rejecting Merck's proposed warning.11
Last September, a Third Circuit panel vacated and remanded for a second time, holding that the district court erred "by giving too little weight to the...
