Because there is clear evidence that the FDA would not have approved a stronger warning to the precautions section of the Fosamax label prior to plaintiff's fracture, plaintiffs' failure-to-warn action is pre-empted.
July 11, 2013 at 05:10 AM
1 minute read
In re Fosamax (Alendronate Sodium), No. 11-5304, 08-08; U.S. District Court (DNJ); opinion by Pisano, U.S.D.J.; filed June 27, 2013. DDS No. 36-7-xxxx [17 pp.]
Fosamax (Alendronate Sodium) is approved by the U.S. Food and Drug Administration for the treatment and prevention of postmenopausal osteoporosis.
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