Merck Sharp & Dohme Corp. v. Albrecht

Facts

Merck Sharp & Dohme manufactures Fosamax, a bisphosphonate drug that treats and prevents osteoporosis in postmenopausal women by slowing the breakdown of old bone cells. While this mechanism helps prevent osteoporotic fractures, it may increase the risk of atypical femoral fractures by preventing the healing of stress fractures. The original 1995 FDA-approved label did not warn of this risk. As evidence accumulated linking Fosamax to atypical femoral fractures, Merck received adverse event reports and conducted statistical analyses showing a significant incidence of femur fractures. In 2008, Merck applied to the FDA to add language about “low-energy femoral shaft fracture” to the Adverse Reactions section and a discussion of stress fractures to the Precautions section. The FDA approved the Adverse Reactions addition but rejected the Precautions change, stating that identifying “stress fractures” might not clearly relate to the atypical subtrochanteric fractures reported in literature. In 2010, the FDA ultimately required Merck to add a warning about atypical femoral fractures, specifically rejecting Merck’s continued use of the term “stress fractures.” More than 500 individuals who took Fosamax and suffered atypical femoral fractures between 1999 and 2010 filed lawsuits alleging that Merck failed to adequately warn them and their doctors about these risks.