Devices

Medical Device Safety Act Reintroduced

Reps Rosa DeLauro (D-CT), Jan Schakowsky (D-IL), and Brian Fitzpatrick (R-PA) have reintroduced the Medical Device Safety Act, a bill to increase access to legal recourse for victims of unsafe devices. The bill comes on the heels of a New York Times editorial on changes FDA should make to improve the safety of medical devices.

This bill would amend the federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by the federal prohibition on state or local requirements regarding medical devices. This bill is retroactively effective and applies to pending civil actions.

“Unsafe medical devices have led to the injury or death of millions of patients,” DeLauro says. “However, under current law, the manufacturer cannot be held liable for their deaths or the harm and suffering the device has inflicted. The Medical Device Safety Act resolves this injustice by giving victims and their families the pathway to seek legal recourse for injuries or deaths from devices that received premarket approval from the Food and Drug Administration (FDA)... The United States has a systemic problem with medical device oversight, and the FDA is not living up to its mission as a regulatory agency.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome