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THE PRODUCTS LIABILITY AND BREACH OF WARRANTY CAUSES OF ACTION ALLEGING THE FAILURE OF AN IMPLANTED MEDICAL DEVICE WHICH ASSISTS THE HEART WERE PREEMPTED BY FEDERAL LAW; THE CAUSES OF ACTION ALLEGING NEGLIGENCE ON THE PART OF THE ENGINEERS WHO REPLACED THE LEAD TO THE DEVICE WERE NOT PREEMPTED (SECOND DEPT).

The Second Department, reversing (modifying) Supreme Court, determined the products liability and breach of warranty causes action alleging decedent’s death was caused by an implanted medical device which assisted the heart were preempted by the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976 (MDA). But the causes of action alleging negligence of the engineers who replaced a lead on the device were not preempted by the MDA:

The MDA … includes an express preemption provision, prohibiting state requirements “with respect to a device intended for human use” (21 USC 360k[a]) which are “different from, or in addition to, any requirement” … applicable under federal law and which “relate[ ] to the safety or effectiveness of the device” … . Pursuant to this provision, it has been held that common-law causes of action which “challenge the safety and effectiveness of a medical device and seek to impose requirements that are ‘different from, or in addition to,’ federal requirements,” such as those sounding in products liability and breach of warranty, are preempted … .

… [P]laintiff  … claims in her first and fifth causes of action that negligent acts or omissions of the engineers … , allegedly committed during the course of their replacement of the lead in the decedent’s LVAD, were a proximate cause of his death. Those claims in those causes of action do not “challenge the safety and effectiveness of a medical device and seek to impose requirements” different or additional to federal law … . Accordingly, they are not preempted. Arnold v Lanier, 2021 NY Slip Op 06666, Second Dept 12-1-21

 

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