STORY FROM: Drugs & Medical Devices

Claims that Heart Valve Maker Failed to Update FDA of Risks Not Preempted, Mass. Federal Judge Says

BOSTON — Federal law does not preempt claims that the maker of an artificial heart valve failed to provide the FDA with updated information as to the device’s risks, because they allege violations of state law that parallel federal regulations, a Massachusetts federal judge has ruled.

On March 29, Judge Allison D. Burroughs of the U.S. District Court for the District of Massachusetts refused to dismiss the plaintiffs’ claims based on Sorin Group USA Inc.’s alleged duty to report post-approval information and incidents to the FDA.

Allison Plourde was born with DiGeorge syndrome and later diagnosed with aortic arch ...

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