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Congress Considering Legislation to Eliminate Manufacturers’ Blanket Immunity From Lawsuits Over Faulty Medical Devices Preapproved by FDA

Under the Supreme Court’s 2008 decision in Reigel v. Medtronic making the FDA the final arbiter of medical device safety, if a medical device receives premarket approval from the FDA, the manufacturer cannot be sued for damages by any individuals injured by the device. Following that decision, lower courts threw out 1,400 lawsuits against device manufacturers.

Ironically, drug manufacturers do not enjoy the same immunity. Under the Supreme Court’s March 2009 decision in Wyeth v. Levine, FDA approval of a drug does not shield its manufacturers from lawsuits commenced by injured patients.

Now Congress is considering rectifying that inconsistency with the Medical Devices Safety Act of 2009, which would provide injured parties with legal recourse if they are injured by an implanted medical device.

For arguments for and against the passage of the legislation, see this article recently appearing on MedPage Today.

About the <span>Author</span>

About the Author

Tom D'Amore is the founder of D'Amore Law Group and a trial attorney with over 30 years of experience representing injured people and their families across the West Coast, securing more than $325 million in recoveries. He handles cases involving car accidents, trucking accidents, construction injuries, medical malpractice, and sexual abuse. Licensed in Oregon, Washington, and California, Tom is the only NBTA board-certified truck accident attorney in Oregon. He is a national Board of Governors member, past Executive Committee member, and past Budget and Audit Chair of the American Association for Justice, as well as past President of the Oregon Trial Lawyers Association and an Eagle member of the Washington State Association for Justice.
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