State-level Medical Device Cases, post-Wyeth v. Levine



How has the Supreme Court’s decision in favor of Diana Levine, a Vermont woman who lost her arm after being injected with an anti-nausea drug, changed the future of state-level tort suits?

Brian Wolfman, director of Public Citizen Litigation Group in Washington, says the ruling “reaffirms that preemption is the exception and not the rule”.

Justice John Paul Stevens of the US Supreme Court wrote for the majority when the Court upheld the state verdict in favor of Diana Levine. “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”

This affirmation is going to serve several tort litigation cases immediately, but it will also have an impact on laws and suits regarding medical devices. The day after the decision was handed down, The Medical Device Safety Act of 2009 (MDSA) was introduced to both houses of Congress.

Lawmakers have been encouraged by the Court’s ruling to think that medical device manufacturers could be held to the same determination, despite the Court’s previous ruling in Riegel v. Medtronic. In this case from 2008, the Court decided that state law tort claims regarding FDA pre-approved medical devices are preempted.

The Medical Device Safety Act of 2009 would allow for state-level tort suits. The purpose of the bill would be to give consumers recourse to remedy their injuries within the state court system without totally undermining the FDA’s authority.

As recently as January of this year, federal judges citing the Reigel decision dismissed 1,496 cases. Michael E. Seelie currently represents plaintiffs in pharmaceutical litigation in Jacksonville, Florida.

Michael E. Seelie, PA has represented people in Jacksonville, Florida and the surrounding communities of Orange Park, St. Augustine, Green Cove Springs, Callahan, Palatka, Fernandina Beach, Gainesville, and Lake City in injury cases since 1978.