Fosamax 12/23

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

1. Fosamax Users Rip Merck's Fracture Warnings In 3rd Circ.

   Dec 22, 2015 | Law360

   By Joe Van Acker
   
   
   Osteoporosis sufferers pushing the Third Circuit to revive allegations that Merck failed to warn of painful leg fractures linked to its drug Fosamax disputed on Monday that the company had proposed stronger warnings only to be rebuffed by federal regulators.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

1. Fosamax Users Rip Merck's Fracture Warnings In 3rd Circ.

   Dec 22, 2015 | Law360

   By Joe Van Acker

   Osteoporosis sufferers pushing the Third Circuit to revive allegations that Merck failed to warn of painful leg fractures linked to its drug Fosamax disputed on Monday that the company had proposed stronger warnings only to be rebuffed by federal regulators.
   
   The Fosamax users told the court that, contrary to claims by Merck Sharp & Dohme Corp. and the Pharmaceutical Research and Manufacturers of America, the drugmaker had in fact suggested alterations to its labels that the U.S. Food and Drug Administration found to be inadequate.
   
   “Merck proposed warning language the FDA repeatedly criticized for conflating atypical femoral fractures with less serious stress fractures, creating the potential to confuse or mislead doctors,” they said. “Merck believes that the flaws in its proposed language were inconsequential to the FDA’s decision, even though the FDA cited only those flaws in officially rejecting Merck’s proposal.”
   
   U.S. District Judge Joel A. Pisano dismissed the labeling claims from multidistrict litigation over the osteoporosis drug in 2014 after finding they were preempted by federal law, but the Fosamax users have since argued that the preemption issue boils down to whether or not Merck proposed “a clear and accurate warning” to the FDA.
   
   They said Monday that Merck incorrectly interpreted the FDA’s rejection of its proposed warning to mean that the agency wouldn’t accept any warnings about femoral fractures, and argued that the company wasn’t entitled to summary judgment because the FDA had a “longstanding concern” about those fractures.
   
   “Although the FDA was not absolutely certain that Fosamax causes atypical femoral fractures, even at the time it required the warning, such certainty was not compelled,” the Fosamax users said Monday. “The applicable regulatory standard requires only reasonable evidence of a causal association.”
   
   PhRMA, a trade organization that counts Merck as a member, threw its weight behind the company in November, claiming in an amicus brief that the FDA repeatedly rejected warnings approximating the risk that the Fosamax users have alleged.
   
   The organization said it wouldn’t have been reasonable for Merck to “defy” the agency by putting a rejected warning on its labels, but the Fosamax users said that the company was free to add stronger warnings and remove them later if the FDA complained.
   
   Aside from accusing Merck of providing inadequate warnings, the plaintiffs have also brought design-defect and negligence claims against the company, and said that those claims weren’t preempted either.
   
   Judge Pisano lumped those claims in with the failure-to-warn claims, and the Fosamax Users said that was an error because he never considered the evidence...

   For full story:

   http://www.law360.com/articles/740840/fosamax-users-rip-merck-s-fracture-warnings-in-3rd-circ-
   

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