Expert Advocacy

House Investigates Defective Medical Device Protections

Earlier this year, the United States Supreme Court held in Riegel v. Medtronic that lawsuits based upon state tort law were preempted (barred) by federal law IF the FDA had granted the alleged defective product “pre-market approval” as a medical device.

The protections given to medical device manufacturers in Riegel may be extended to pharmaceutical drug manufacturers when the Supreme Court hears Wyeth v. Levine later this year.

However, Congress is looking at legislatively reversing the Supreme Court’s ruling. Beginning tomorrow, hearings will be held in the House Committee on Oversight and Government Reform to discuss the effect of the Riegel decision and the effect an extension in Wyeth may have.

Write your Congressman and Senators and tell them that legislative reform is needed to provide protections to victims of defectively designed medical devices. If a medical product is defective, a manufacturer should not escape liability simply because the FDA signed off on it–perhaps before the actual defect is discovered after long-term human use.