STORY FROM: Drugs & Medical Devices

Md. Federal Judge Dismisses Medtronic LVAD Case on Preemption Grounds

November 20, 2019

BALTIMORE — A Maryland federal judge has dismissed an action involving an allegedly defective Medtronic left ventricular assistive device (LVAD), ruling that the claims are preempted because the plaintiffs failed to allege violations of state law requirements which parallel federal law.

In a Nov. 15 order, Judge Paula Xinis of the U.S. District Court for the District of Maryland said merely stating that Medtronic generally violated some non-specific FDA “standards” is insufficient for the court to infer that the claims are parallel, and not in addition, to FDA regulations.

In August 2014, John Winkler underwent implantation of HeartWare Inc.’s LVAD ...

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