A New York state appeals court has revived a woman’s lawsuit against Abbott Laboratories over an allegedly negligent heart valve replacement surgery that caused her husband’s death, finding that not all of her claims were preempted by federal regulations.
The lower court correctly determined that Arlene Arnold’s state law claims of breach of warranty and product liability for the device, a battery-powered mechanical heart pump designed and manufactured by Abbott and St. Jude Medical LLC, were voided by the 1976 Medical Device Amendment to the Food, Drug, and Cosmetic Act, but it erroneously released Abbott out of all claims.
Arnold’s lawsuit claims that her husband, Jaja Arnold, died of a cardiac arrest on Dec. 20, 2017, caused by the failure of the device, known as a HeartMate II Left Ventricular Assist System. The day before, two engineers employed by Abbott participated in the replacement of the device. She’s accused these employees of negligence.
The case was dismissed before “substantive discovery” began, so Arnold claims to not know who those employees are or what exactly they did beyond “performing replacement of the HeartMate II LVAD percutaneous lead.”
While the MDA is supposed to prevent additional regulations covering medical devices from being added to state laws, Arnold argued that there isn’t a federal interest in protecting two engineers from Abbott from state tort claims arising from their negligence.
The panel agreed that Arnold can pursue these claims.