The Significance of the Medical Device Safety Act in Light of Wyeth v. Levine

Fact Sheet: The Significance of the Medical Device Safety Act in Light of Wyeth v. Levine

The Medical Device Safety Act will restore injured patients’ ability to bring claims for injuries caused by defective medical devices. The bill will also reconcile the legal regime used for device manufacturers with the one used for drug manufacturers, in light of the Supreme Court’s 2009 decision in Wyeth v. Levine. That decision confirmed that Food and Drug Administration (FDA) marketing approval of prescription drugs does not bar patients’ state-law claims seeking damages for harm caused by those products. The Court’s reasoning in Wyeth touches on the core purposes of the Medical Device Safety Act.

The Medical Device Safety Act responds to Riegel v. Medtronic, the Supreme Court’s 2008 decision that held that premarket approval of a medical device by FDA immunizes the device manufacturer from almost all state tort liability through a legal doctrine called preemption. The decision removed a vital and long-standing consumer protection.

In the more recent Wyeth case, the Court rejected the premise that a manufacturer is shielded from state liability simply because the product received FDA’s approval. While the Court specifically addressed drugs, many of its observations, stated below, apply equally to medical devices.