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THE DUE PROCESS PRONG OF LONG-ARM JURISDICTION WAS NOT DEMONSTRATED WITH RESPECT THE GERMAN MANUFACTURER; IN ADDITION THE FAILURE TO WARN CAUSE OF ACTION WAS PREEMPTED BY THE FEDERAL MEDICAL DEVICE AMENDMENTS TO THE FDA REGULATIONS (FOURTH DEPT).

The Fourth Department, reversing Supreme Court, determined the due process prong of long-arm jurisdiction was not satisfied and the failure to warn allegation was preempted by Federal Drug Administration (FDA) regulations under the Medical Device Amendments (MDA). The medical device was not described in the decision but it apparently involves treatment of the eye:

Plaintiff has not shown a regular flow of Morcher’s [the German manufacturer’s] goods into New York, advertising directed at New York, the delivery of Morcher’s goods into the stream of commerce with the expectation of purchase in New York, or any other facts that may arguably have established jurisdiction … . …

It is undisputed that the device in question is a class III medical device with respect to which the federal government has established requirements. Thus, we must determine whether plaintiff’s “common-law claims are based upon New York requirements with respect to the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety and effectiveness” … . If so, those claims are preempted by the MDA … . If, on the other hand, the common-law claims provide a damages remedy and are premised on a violation of the regulations of the Food and Drug Administration (FDA), they ” ‘parallel,’ rather than add to, federal requirements” and are not preempted … . … Plaintiff … fails to identify any federal statute or regulation that requires defendants to provide warnings to consumers or their physicians … . Barone v Bausch & Lomb, Inc., 2021 NY Slip Op 00745, Fourth Dept 2-5-21

 

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