The Alabama Supreme Court ruled on Friday in Wyeth v. Weeks that a patient who took a generic version of a drug may sue a brand-name drug manufacturer for failing to warn about a drug’s risks. In June 2011, the U.S. Supreme Court held in Pliva v. Mensing that injured patients' state-law failure-to-warn claims against generic-drug manufacturers are preempted by federal law because the Food and Drug Administration requires those manufacturers to use labeling that is the same as the brand-name labeling. Therefore, a suit against the brand-name company may be a patient's only avenue to seek compensation for injuries. Although most courts have held that a patient who took the generic drug cannot sue the brand-name company because that company owes no duty to an individual who was not its customer, the issue is a state-law question, and the answer may vary from state to state.
On a related issue, the opening brief in the U.S. Supreme Court is due this week in Mutual Pharmacuetical Co. v. Bartlett. The Court will consider in that case whether a design-defect claim brought under New Hampshire law against a generic-drug manufacturer is impliedly preempted by federal law.