A former FDA regulatory consultant says Merck failed to adequately warn the public that its Gardasil HPV vaccine could be linked to postural orthostatic tachycardia syndrome (POTS) and other autoimmune-related conditions, according to a public court filing. The expert report, released after Merck settled hundreds of Gardasil lawsuits, alleges the company had sufficient evidence to strengthen the vaccine's safety warnings years earlier but chose not to do so.

A pharmaceutical regulatory expert says Merck failed to adequately warn the public that its Gardasil HPV vaccine could be linked to postural orthostatic tachycardia syndrome (POTS) and other autoimmune-related conditions, according to a public court filing.

The expert report, released after Merck settled hundreds of Gardasil lawsuits, alleges the company had sufficient evidence to strengthen the vaccine's safety warnings years earlier but chose not to do so.

Since Merck's highly profitable Gardasil vaccine first came on the market in 2006, the list of side effects on the label has grown.