Merck Asks Solicitor General To Weigh In On Fosamax Litigation

On March 22, 2017, a federal appeals court revived claims by hundreds of plaintiffs, which accused Merck & Co of failing to warn Fosamax users of the risks surrounding thigh bone fractures and Fosamax use. At the time, Merck said it was reviewing its options, and that they believed a judge, not a jury, should decide the question of preemption. The company representatives said they were confident in Fosamax’s safety and effectiveness. Fosamax, a drug that targets osteoporosis, has been prescribed to treat or prevent bone loss in post-menopausal women for over two decades.

Almost 10 months later, on Monday December 4th, Merck asked the Supreme General to weigh in on their petition to the Supreme Court for a review of the ruling made in March, hoping to end the multidistrict litigation they are facing over Fosamax’s risks.  

Merck will have the opportunity to ask the Solicitor General to explain the government’s position on Merck’s petition and whether appellate courts have been too lenient in pharmaceutical industry lawsuits or not.

Although there was a change of the warnings on the labels in 2011 in order to include femoral fractures, more than 500 patients who had taken Fosamax before 2011 have filed lawsuits against Merck. One of the main discussions has been over why the FDA rejected a proposed warning of stress fractures for Fosamax’s set of warnings in 2009. This is Merck’s main argument when asking the High Court to dismiss the case.

The patients, however, claim that the FDA would have not rejected a properly worded warning. The FDA rejected the proposed warning because it warned about fractures that did not represent the actual injuries sustained by Fosamax users. These arguments are what the Third Circuit agreed with and led to the ruling made in March by the Appeals Court.

The panel has said they need clear evidence the FDA would have not approved of a proper fracture warning, which Merck has not provided. Neither representatives of the patients or Merck have commented on recent events. This case is Merck Sharp & Dohme Corp. v. Doris Albrecht et al., case number 17-290, before the Supreme Court of the United States.

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