N.J. Federal Judge Allows Design Defect, Warning Claims to Proceed in Truvada Action

NEWARK, N.J. — A design defect claim in a case involving the HIV drug Truvada are not preempted because the plaintiff has adequately pled that Gilead Sciences Inc. could have developed and sought FDA approval for a different, safer drug, a New Jersey federal judge has ruled.

In a March 26 order, Judge Kevin McNulty of the U.S. District Court for the District of New Jersey further ruled that the plaintiff’s failure-to-warn claim is not preempted because Gilead was not barred from seeking FDA approval for an enhanced warning before Truvada went to market and could have used the Changes …