More than 1,000 people alleging Pfizer Inc., failed to warn that its Depo-Testosterone treatment could cause cardiovascular events, asked the Seventh Circuit to let them sue the drug maker. The plaintiffs were part of a multidistrict litigation (MDL) in Illinois federal court naming several testosterone replacement therapy makers.
But, U.S. District Judge Matthew Kennelly dismissed their lawsuits after finding that the failure-to-warm claims against Pfizer for its Depo-Testosterone were preempted by the Food, Drug and Cosmetic Act and Food and Drug Administration (FDA) regulations, which bar generic drug manufacturers from altering their products’ labels once they’re approved.
Plaintiffs argued that the rules that block label changes don’t apply to Depo-Testosterone or the drugs the generic product’s labels are based on. And while Depo-Testosterone may be a generic drug, it is the referenced listed drug, which means Pfizer was free to update the safety label to include new warnings, they say.
Plaintiffs are hoping to rejoin the multidistrict litigation of about 6,000 cases charging testosterone makers with not adequately warning that use of the testosterone treatment can increase the risk for heart attacks, strokes, blood clots and death. The lawsuits name more than nine different testosterone therapies.
AbbVie has faced two trials regarding its testosterone treatment AndroGel, and was slapped with $190 million in verdicts. Jurors primarily took issue with the drug companies’ aggressive marketing directly to consumers for uses they claim were off-label.
Other manufacturers are scheduled to face trial in the coming months.