In a Long-Awaited Opinion, Federal Court Judge Wolfson Rules in Favor of Merck on Federal Preemption Legal Issue
(Posted by Tom Lamb at Drug Injury Watch)
On March 23, 2022, the federal court product liability lawsuits filed on behalf of women who used Fosamax and suffered femur fractures were dismissed by means of an opinion issued by Judge Freda Wolfson. These Fosamax femur fracture lawsuits had been remanded to the District of New Jersey in late 2019 by the U.S. Court of Appeals for the Third Circuit. That happened after and because the U.S. Supreme Court made a ruling on the federal preemption legal issue in these Fosamax cases in May 2019 (see Merck Sharp & Dohme Corp. v. Doris Albrecht, et al.). As such, the parties to these federal court Fosamax lawsuits had been waiting for this "new" federal preemption ruling by Judge Wolfson for more than two years.
For some analysis of this March 23, 2022 Opinion for the federal court Fosamax MDL lawsuits — captioned In Re Fosamax (Alendronate Sodium) Products Liability Litigation — we turn to this New Jersey Law Journal article, "Ending a 14-Year Battle, Merck Wins Dismissal of Suits Linking Fosamax to Fractured Femurs", by veteran legal reporter Charles Toutant:
The ruling brings an end to roughly 500 suits in litigation that has been ongoing since 2008 and has made a stop at the U.S. Supreme Court. After a ruling in 2013 by the late Judge Joel Pisano that the plaintiff’s failure-to-warn claims were pre-empted by federal law, the U.S. Court of Appeals for the Third Circuit vacated that ruling, finding that preemption should be decided by a jury. Merck then petitioned for certiorari, which was granted by the Supreme Court. In its 2019 decision, the Supreme Court vacated the Third Circuit ruling, finding that the preemption question should be decided by a judge, not a jury. The case landed back at the District Court, which was tasked with deciding if communications between Merck and the FDA were sufficient to give rise to preemption….
On remand, Wolfson said, the question before the court was whether the FDA’s response to Merck’s proposed warning language “prohibited Merck from adding any and all warnings to the drug label that would satisfy state law.”
Merck asserts that federal law preempts the plaintiffs’ state law failure-to-warn claims, citing the FDA’s 2019 communication, rejecting a warning about femoral fractures. Plaintiffs, for their part, asserted that the 2019 FDA communication is not “clear evidence” that the FDA would have approved any and all warnings.
Wolfson said that, as worded, the 2019 FDA communication “gives rise to competing inferences with respect to why the FDA rejected defendant’s wording.” But when viewed along with other FDA correspondence, it “rejected defendant’s precautions warning because the FDA doubted the evidence linking biophosphonate use to atypical femoral fractures in a causal sense,” she wrote.
… Because the FDA rejected the warning due to insufficient evidence of a causal link between Fosamax and femur fractures, the evidence is clear and convincing that the FDA would not have approved a differently worded [warning], no matter how Merck submitted it. The plaintiffs’ state-law failure-to-warn claims are therefore preempted, Wolfson said.
To possibly assist in understanding the above reporting, we point out that after Judge Joel Pisano retired from the District of New Jersey federal court, the federal court Fosamax MDL lawsuits were reassigned to Judge Freda Wolfson.
As regards the women who used Fosamax and suffered femur fractures, their Fosamax lawsuits have been dismissed a second time, now, again as a result of the federal preemption legal defense. For some of those women this will be adding insult to injury, so to speak.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation – Free. Confidential. No Obligation. (Case review is done by attorney Tom Lamb)
Leave a Reply