Protecting Patient Safety: S. 2995

In 2011, the Supreme Court ruled in PLIVA v. Mensing that the Food, Drug and Cosmetic Act (“FDCA”) provisions governing the labeling of generic prescription drugs preclude state claims against pharmaceutical companies for failing to adequately warn consumers about health risks. The PLIVA decision created disparate liability schemes for brand name and generic drugs, because the Court had previously ruled in Wyeth v. Levine (2009) that state claims based on inadequate labeling of brand name drugs were permissible.

In response to the injustice of the PLIVA decision, Sen. Leahy (D-VT) recently introduced legislation that would amend the FDCA to allow generic drug manufacturers to change their labeling to warn consumers of newly discovered risks. AFJ and several of its member organizations submitted a letter in support of the legislation. This issue is of particular importance since generics account for more than 75% of drugs prescribed in the United States.

Learn more:

» AFJ's sign on letter (pdf)

» Joint sponsoring senators' press release (pdf)

» Senator Leahy's statement (pdf)

» New York Times: Generic Drugs Proving Resistant to Damage Suits