Since 2008, parties to pharmaceutical product liability cases have struggled with the “clear evidence” implied preemption standard articulated by the U.S. Supreme Court in Wyeth v. Levine.1 In cases of allegedly inadequate warnings about FDA approved prescription drugs, Levine rejected the contention that FDA approval did not, by itself, preempt state-law warning-based claims. Preemption could occur, Levine held, if “clear evidence” showed that “the FDA would not have approved” the label that the plaintiff claim state law required, so that simultaneous compliance with state and federal law would be “impossible.”2 Following Levine, courts varied in the rigor that they applied the “would not have approved” standard set by the Supreme Court. However, in those situations where FDA had actually rejected the warning being advocated by the plaintiff, they held that the warning claim was preempted.3 Another area of general agreement was that preemption generally, and the question of what FDA “would have” done in particular, was a question of law for courts to determine.4
The Third Circuit departed from both of these points of post-Levine consensus in In re Fosamax (Alendronate Sodium) Products Liability Litigation,5 and imposed a standard for impossibility preemption that is literally almost impossible to meet. For this result, and because of the likelihood of further review by the Supreme Court, Fosamax makes this year’s list.
Fosamax is an FDA approved prescription drug made by defendant Merck Sharp & Dohme Corp. (Merck). It is FDA approved for prevention and treatment of osteoporosis in postmenopausal women.6 Fosamax is one of a class of drugs, called bisphosphonates, whose chemical properties allow them to retard the resorption of calcium in post-menopausal women’s bones, thereby maintaining bone strength and mass. Retarding calcium loss unfortunately has some drawbacks, or so it is alleged, that over the long term, it can lead to “microcracks” that increase the otherwise very low risk of “atypical” femoral fractures (AFF).7 That risk is what the Fosamax litigation is about. This risk of AFF from long-term Fosamax use has also been the subject of FDA review, which gives rise to Merck’s preemption defense. The initial labeling for Fosamax, following FDA approval “in the 1990s”8 did not mention AFF. In March 2008, Merck submitted a safety update addressing AFF and, based on some recent medical articles, suggested there might be an association between long-term bisphosphonate use and AFF. FDA saw the information as a “developing safety signal,” and wanted more information.
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