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Drugs & Medical Devices

SCOTUS Denies Cert in Generic Preemption Case

— March 30, 2015

Federal preemption of claims against generic drug manufacturers has prevented (or severely limited) the ability of users of generic drugs from bringing products liability claims premised upon the failure to warn.  Certain state courts have indicated that some state tort law claims may not necessarily be barred by federal preemption, but these “baby steps” potentially chipping away at preemption have not provided much of a foothold for plaintiffs seeking to hold generic manufacturers liable for dangerous drugs and devices and inadequate warnings.

SCOTUS denied a petition for certiorari filed in Pliva, Inc. v. Theresa Huck, case number 14-544,wherein Pliva, a manufacturer of metoclopramide (generic Reglan), sought review of an Iowa Supreme Court ruling which may not have foreclosed a suit under state law imposing a duty to update a warning.  The plaintiff had sued based on a state law duty to amend warning regarding the development of tardive dyskenisia after metoclopramide use.

A denial of cert does not represent an actual crack in the armor of preemption.

Moreover, the FDA continues to examine whether the manufacturers of generic drugs might someday be able to change the warnings on drugs.

With nearly eight in 10 prescriptions filled by generic drugs, according to the FDA, any change in the way that the preemption doctrine is applied to the manufacturers of generic drugs could have a HUGE impact on mass torts and pharmaceutical litigation.  This is why even a denial of cert by SCOTUS dealing only with the potential for survival of a state law claim makes the news.

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