fosamax 11/6

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

1. PhRMA Backs Merck In 3rd Circ. Over Nixed Fosamax Claims

   Nov 6, 2015 | Law360

   By Joe Van Acker
   
   
   Pharmaceutical Research and Manufacturers of America has asked the Third Circuit to affirm the dismissal of any multidistrict litigation claims over Merck’s osteoporosis drug Fosamax predating a labeling revision by the U.S. Food and Drug Administration, claiming the agency’s previous position clearly barred those claims.

Full Text of Stories Below

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

1. PhRMA Backs Merck In 3rd Circ. Over Nixed Fosamax Claims

   Nov 6, 2015 | Law360

   By Joe Van Acker

   Pharmaceutical Research and Manufacturers of America has asked the Third Circuit to affirm the dismissal of any multidistrict litigation claims over Merck’s osteoporosis drug Fosamax predating a labeling revision by the U.S. Food and Drug Administration, claiming the agency’s previous position clearly barred those claims.
   
   PhRMA, which counts Merck Sharp & Dohme Corp., Pfizer Inc. and other major drug manufacturers as members, told the appellate court on Wednesday that a New Jersey federal judge correctly had dismissed all injury claims from the MDL that came prior to an FDA task force’s report linking femur fractures to bisphosphonates, which include the active ingredient in Fosamax. Many Fosamax users have filed fraud, negligence and other claims against Merck for allegedly failing to warn them that rather than strengthening bones, the drug could actually weaken them and lead to painful fractures.
   
   “The regulatory history for Fosamax ... demonstrates that the FDA had said ‘no,’ continued to say ‘no,’ and did not show any willingness to say ‘yes’ to a labeling change approximating appellants’ theory until September 14, 2010, which, surely, was the first time Merck could have expected a different answer,” PhRMA said. 
   
   After the Fosamax users' cases were consolidated in his court, U.S. District Judge Joel A. Pisano ruled in March 2014 that claims preceding the FDA’s 2010 report were preempted after he reached that same conclusion in a bellwether Fosamax case the previous year.
   
   On Wednesday, PhRMA said that Judge Pisano’s rulings should remain in place, claiming that Merck had actually proposed a stronger warning about the risk of femoral fractures from Fosamax but was rejected by the FDA. The organization said that Fosamax users appealing the preemption decision have raised only semantic arguments by suggesting a variation of the warning Merck proposed, claiming that both warnings would convey “nearly identical information.”
   
   PhRMA also said that Judge Pisano’s decision was procedurally sound because he had gone through three rounds of briefing on the issue of preemption, as well as a trial, before concluding that the plaintiffs didn’t present any evidence to support a different ruling.
   
   With the benefit of hindsight, it’s reasonable to argue that Merck should have issued a stronger warning before it obtained FDA approval, but it’s not reasonable to suggest that the company should have defied the FDA’s rejection of its proposed warning, the trade group said.
   
   “To the contrary, what a responsible manufacturer might be expected to do in such a case is just what Merck did here: continue to recommend a warning to the FDA and cooperate in a task force in consultation with the FDA in order to ascertain what kind of warning the FDA might be willing to approve,” PhRMA said.
   
   Counsel for the parties didn’t respond to requests for comment on Friday.
   
   Merck is represented by Andrew T. Bayman and Chilton D. Varner of King & Spalding LLP, John H. Beisner, Jessica D. Miller, Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP, Karen A. Confoy of Fox Rothschild LLP, Wilfred P. Coronato of Hughes Hubbard & Reed LLP, James C. Fraser, David J. Heubeck, Stephen E. Marshall and Paul F. Strain ofVenable LLP.
   
   Doris Albrecht is represented by Edward Braniff and Michael E. Pederson of Weitz & Luxenberg PC, Donald A. Ecklund of Carella Byrne Cecchi Olstein Brody & Agnello PC and David C. Frederick of Kellogg Huber Hansen Todd Evans & Figel PLLC.
   
   PhRMA is represented by Alfred W. Putnam Jr., Todd N. Hutchison and Carol F. Trevey ofDrinker Biddle & Reath LLP.
   
   The case is In Re: Fosamax, case number 14-1900, in the U.S. Court of Appeals for the Third Circuit.
   

   Return to headline | Return to top

Full Text of Stories Below