After years of limited guidance, the Supreme Court has finally provided direction to lower courts on the issue of preemption when they delivered their opinion in Merck v. Albrecht. “Preemption” is a common defense used by defendants in pharmaceutical mass tort litigation. Through this defense, pharmaceutical companies argue that the state law causes of action are preempted by the Food and Drug Administration’s (FDA) control over drug and medical device approval and labeling.
The Preemption Defense
The Merck v. Albrecht case centers the drug, Fosamax, as a focal point in the mass tort litigation. Fosamax is pharmaceutical used for osteoporosis treatment and the case revolves around atypical femur fractures caused by use of the osteoporosis drug. Merck, the maker of Fosamax, asserted the preemption defense. Merck argued that it was the state’s failure to warn consumers of the drug’s risk and causes of action could not be brought against Merck because the FDA rejected its proposed warning label change in 2008. When Merck began to receive reports of atypical femur fractures in the early 2000s, it submitted a proposed label change to the FDA in 2008 and included a warning for fractures. The FDA rejected this labeling change, therefore Merck argues it cannot be sued for “failure to warn” because its attempt to warn was rejected by the FDA. The plaintiffs argue that the proposed label change was rejected because it incorrectly referred to the fractures as stress fractures, rather than atypical femur fractures. In 2011, the FDA requested and changed the label to warn of atypical femur fractures.