Wednesday, July 2, 2014

The Gaynors' Fosamax® Femur Complaint May Not Properly Sound Against Merck -- But It Does, Against SOME-one.

A few weeks ago, the very able federal trial court Judge Joel Pisano dismissed a Fosmax® femur fracture case, on summary motions. It was to be one of the "femur" bellwether cases.

The case was brought by Barbara Gaynor. Merck was let out of the case because at about the time Mrs. Gaynor sustained her femur injury, Merck had by then made very substantial, and ongoing efforts -- at FDA -- to revise its warnings related to the drug, specifically about femur fractures. But to greatly oversimplify the applicable law here, and as the FDA rules are designed to work -- Merck was not allowed to make the label change (at least not the ones the Gaynors' lawyers were advocating would have changed her outcome) -- until cleared by the agency. So it cannot be that Merck was at fault for failing to warn Mrs. Gaynor, Judge Pisano rightly ruled -- as FDA was at that moment effectively preventing Merck from doing so.

I am interested, though -- by this bit, from the published opinion, in USDC NJ Case No. 12-1492:

. . . .Mrs. Gaynor began taking Fosamax in 1996 and was prescribed the drug by seven (7) different physicians until September 20, 2011, when she sustained a right spontaneous atypical femur fracture. . . .

. . .[T]he Gaynor Plaintiffs’ expert, Dr. Charles Cornell opined that ". . .even if Mrs. Gaynor had been taken off Fosamax by February 2011, she still would have had severely compromised femoral bone due to her pre-2011 prolonged Fosamax use.” See Declaration of Edward Braniff, at Ex. 1 ¶ 20. . . .

It is not clear from the record, but it seems that Mrs. Gaynor was either never prescribed a drug holiday -- or if so, it was less frequent than once every five years, for a period spanning over 15 years. The literature on advisablity of Fosamax drug holidays was well-developed by 2009 if memory serves. So my hunch is that her claim still remains quite viable -- against one or more of the prescribing physicians. Just my hunch.

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