As part of the continuing fallout from a recent Supreme Court decision that prevents consumers from holding generic drug makers responsible for dangerous and defective medications they sell, all federal lawsuits over femur fractures caused by Fosamax generic equivalents will be dismissed.
U.S. District Court Judge Joel Pisano has issued an ordered that will result in the dismissal of all claims against generic defendants, including Teva Pharmaceuticals, Barr Pharmaceuticals, Mylan Pharmaceuticals, Apotex Corporation, Sun Pharmaceuticals, Caraco Pharmaceuticals Laboratories and Cobalt Laboratories.
A similar order dismissing Watson Pharmaceuticals from generic Fosamax lawsuits over femur fractures was issued earlier this year by Judge Pisano.
All of the cases involve allegations that generic version of Fosamax (alendronate sodium) caused users to suffer sudden femur fractures, which typically occur with little or no trauma. Plaintiffs allege that the generic drug makers knew or should have known about the femur fracture side effects of Fosamax, but failed to adequately warn consumers or the medical community.
Most of the lawsuits were filed after the FDA forced drug makers to add new warnings in October 2010, providing consumers with information about the risk of sudden femur fractures and urging them to seek immediate medical attention if they experience new groin pain or thigh pain while taking the popular osteoporosis drug, which can be symptoms that occur weeks or months before a complete femur fracture from Fosamax.
The dismissals comes as consequence of a June 2011 decision by the U.S. Supreme Court in PLIVA v. Mensing, which allows generic drug makers to avoid liability for failure to warn about harmful or even deadly side effects of medications they make, since FDA regulations require that their products must carry the same warnings as the name-brand versions.
According to the order, all cases filed on or before January 31, 2012 are dismissed as to any generic drug makers. For all cases filed since February 1, 2012, plaintiffs have 30 days to file a petition for exception to show why their case should be exempt from the dismissal.
The dismissals do not apply to lawsuits against Merck & Co., which makes the name brand version of the drug.