Monday, August 18, 2014

Merck Moves To Dismiss All Remaining Femur Fracture Fosamax® Cases -- Claiming Preemption/FDA Warning Label Adequacy

In the aftermath of the Supreme Court's Wyeth v. Levine decision, we will likely see more of this sort of argument. [And one of my many earlier 2014 backgrounders.]

Merck's lawyers -- as of last Friday -- formally moved to dismiss all remaining Fosamax® femur claims by suggesting that prior to 2011, Merck was prohibited from changing an older warning/FDA label, by then applicable law, without FDA's prior written approval. And it could not get FDA approval for the change, at the time. Then, over a year later, the FDA approved Merck's changes, and Merck made the changes -- essentially pre-empting all remaining warning claims, under the Supreme Court's reasoning (if not actual holding) in Levine. Here is the full 36 page PDF filing, from Merck's trial counsel.

What I imagine this leaves for the injured plaintiffs, should Merck prevail here -- is a claim against the prescribing doctor, only. A smaller pot. True enough, in the end, the doctor ought to be responsible for keeping up with the evolving literature showing increasing risk of "brittle bones" injuries on long term Fosamax therapy, I suppose. We will track the progress of this motion in the New Jersey federal District Courts. A tough Monday, all the way around.

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