Makers of Generic Drugs Challenge F.D.A. Plan for Updated Warnings #testosterone / #genericdrugs / #productliability

Testosterone treatment lawsuits are moving forward in the federal multidistrict litigation now pending in U.S. District Court, Northern District of Illinois. According to a Joint Status Report filed by the parties on April 16th, certain generic drug defendants will seek to have claims involving their testosterone products dismissed on the grounds that they are pre-empted by federal law. (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545)

According to court documents, nearly 1,400 testosterone lawsuits have been filed in the Northern District of Illinois on behalf of men who allegedly experienced heart attacks, strokes and other life-threatening cardiovascular events due to name brand or generic testosterone replacement therapies. All of the claims accuse the drugs’ manufacturers of failing to adequately warn patients of these risks, and of wrongly marketing their testosterone therapies as appropriate treatments for low libido, muscle loss, fatigue and other symptoms commonly associated with male aging.

Generic Drug Lawsuits

The U.S. Food & Drug Administration (FDA) currently requires generic medications to carry the same label warnings as their name-brand counterparts, and generic drug makers are barred from altering labels on their own. In 2011, the U.S. Supreme Court ruled in Pliva vs. Mensing that generic manufacturers could not be sued for failing to warn patients about their drugs´ risks, since they have no control over the content of their labels. (Pliva v. Mensing, 131 S. Ct. 2567 (2011)

In 2013, the FDA proposed new regulations that would allow generic manufacturers to make changes to their drugs’ labels when they become aware of new information about potential risks associated with their products. The period for public comment on the proposed rule changes is set to close on April 27, 2015.

This proposed regulation may eliminate the current pre-emption on failure-to-warn claims against generic drug manufacturers. Men who allegedly suffered heart attacks, strokes, deep vein thrombosis, pulmonary embolism or other serious cardiovascular events due to their use of low testosterone therapy may be eligible for compensation for medical bills, lost wages and other injury-related damages.

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