STORY FROM: Drugs & Medical Devices

Lawsuit Targeting Gilead’s HIV Drugs to Proceed in Calif. Federal Court

SAN FRANCISCO — A California federal judge has refused to dismiss a lawsuit targeting Gilead Sciences Inc.’s HIV drugs, ruling that the design defect claims are not preempted because the drug maker failed to show that the FDA would not have approved allegedly safer versions of the drugs.

On May 10, Judge Jon S. Tigar of the U.S. District Court for the Northern District of California further held that the failure-to-warn claims concerning the three pre-2008 drugs are not preempted because Gilead could have made a labeling change via the Changes Being Effected regulation regardless of the existence of “newly ...

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