In re: Fosmax (Alendronate Sodium)

In 1995 the FDA approved Fosamax® to treat or prevent osteoporosis and Paget’s Disease. Teva developed alendronate sodium, a generic form of the branded drug, and obtained FDA approval on its abbreviated new drug application in 2008. Other generic manufacturers subsequently obtained approval for formulations. The drugs act by inhibiting bone resorption or absorption and suppressing bone turnover; they also inhibit primary mineralization, which is involved in the formation of new bone. Meanwhile, secondary mineralization of existing bone continues, which increases the bone’s mineral content and results in higher bone mineral density. According to the plaintiffs, higher bone mineral density does not necessarily correspond with reduction of fracture risk but can make bone highly mineralized, homogenous, brittle, and more susceptible to fracture. According to some studies, the effects of alendronate sodium linger, with one study reporting that bone turnover may be inhibited by 50% five years after discontinuing treatment. The district court granted judgment on the pleadings in favor of the generic manufacturer defendants finding that state-law strict liability claims were pre-empted by federal law. The Seventh Circuit affirmed. Manufacturers have no control over the design or labeling of generic drugs; the plaintiffs failed to identify anything the generic defendants could do to reconcile their conflicting duties under state and federal law.View "In re: Fosmax (Alendronate Sodium)" on Justia Law