There are about 500 women who used Fosamax, suffered femur fractures, and then filed a product liability lawsuit against Merck. Their lawsuit had been pending in the federal court Fosamax MDL for ten years or more. In an unfortunate but not altogether unexpected development, in March 2022 their Fosamax lawsuits were dismissed a second time as a result of the federal preemption legal defense asserted by Merck. Understandably, For some of those women this will be adding insult to injury, so to speak.
In more detail, on March 23, 2022, these Fosamax lawsuits were dismissed by means of an opinion issued by Judge Freda Wolfson. Previously, these Fosamax lawsuits had been dismissed in 2013, but that ruling was appealed by the women who were plaintiffs in these femur fracture cases. After several years of legal procedures, these Fosamax lawsuits were remanded to the District of New Jersey in late 2019 by the U.S. Court of Appeals for the Third Circuit. This was the result of a May 2019 Supreme Court ruling in Merck Sharp & Dohme Corp. v. Doris Albrecht, et al., a Fosamax femur fracture case. Given this timeline, the women who filed these federal court Fosamax lawsuits had been waiting for this recent federal preemption ruling by Judge Wolfson for more than two years — only to find out, after that long wait, that Merck had prevailed again.
The March 23, 2022 Opinion for the federal court Fosamax lawsuits pending in the MDL captioned In Re Fosamax (Alendronate Sodium) Products Liability Litigation is lengthy and full of legal reasoning. In essence, however, Judge Wolfson ruled that:
- The FDA rejected a proposed warning submitted by Merck about a causal link between Fosamax and femur fractures because the FDA felt there was insufficient for such a Fosamax drug label change at that time; and,
- The evidence was clear and convincing that the FDA would not have approved a similar but differently worded warning if one had been submitted soon thereafter.
As pointed out above, the outcome of Judge Wolfson’s analysis was that the plaintiffs’ state-law failure-to-warn claims must be dismissed due to federal preemption, which is the ruling made by Judge Wolfson in her recent Fosamax MDL Opinion.[View article at original source]