In a significant blow to plaintiffs suing over the HPV vaccine Gardasil, a federal judge on Tuesday sided with Merck & Co. Inc. on its implied preemption defense.
More than 200 lawsuits demand warnings on Gardasil labels about an autoimmune disease called Postural Orthostatic Tachycardia Syndrome, or POTS, and Primary Ovarian Insufficiency, or POI, which is ovarian failure. But U.S. District Judge Kenneth Bell, who is overseeing the Gardasil multidistrict litigation in the Western District of North Carolina, concluded the scientific evidence was lacking, especially for Merck to add a warning on the Gardasil label without approval from the U.S. Food and Drug Administration.