Preemption Victory on Motion to Dismiss for ANDA-Approved Product in TRT Litigation

November 10, 2015

Kaye Scholer Secures Preemption Victory on Motion to Dismiss for ANDA-Approved Product in Testosterone Replacement Therapy Litigation

Kaye Scholer litigators achieved a significant win for Auxilium Pharmaceuticals Inc., now an affiliate of Endo Pharmaceuticals Inc., when it successfully secured a motion to dismiss all claims related to branded, generic testosterone replacement therapy (TRT) products pending in the TRT MDL approved under the federal government’s abbreviated new drug applications (ANDA) process, including TESTOPEL®, the only TRT product available in a testosterone pellet. 

In an MDL involving over 2,500 plaintiffs, plaintiffs alleged that the use of all TRT products has led to heart attacks and thromboembolic clotting injuries.  Endo and Auxilium and the other major pharmaceutical manufacturers of TRT products are defendants in the MDL. 

In a November 9, 2015 decision, the United States District Court of the Northern District of Illinois–Eastern Division agreed with our preemption arguments that since TESTOPEL® and Depo-Testosterone® (another branded, generic TRT product sold by Pfizer) were approved pursuant to the ANDA process, even though the FDA has designated both drugs as the “reference listed drugs,”  federal law prevents the defendants from unilaterally making changes to the products’ warning labels and thus plaintiffs’ state law claims concerning the content of the labels are preempted, including plaintiffs’ strict liability claims based on design defect and failure to warn, negligence, negligent misrepresentation, breach of implied warranty of merchantability, breach of express warranty, and fraud.  As noted by the court, TESTOPEL® and Depo-Testosterone® are “generic” drugs in the sense that neither was the pioneer drug and they were approved pursuant to the ANDA process, but both drugs are marketed and sold under their branded names.

Along with granting our motion to dismiss all claims involving branded, generic drugs that were approved pursuant to the ANDA process, the court also denied plaintiffs’ request for discovery related to the preemption issue. 

Product Liability Litigation partner Andrew K. Solow led the Kaye Scholer team for this client success, which also included counsels Robert Grass and Julie du Pont, and associates Daniel Meyers, Cara Spencer and Jennifer Rovelli. Kaye Scholer filed the brief along with Pfizer’s counsel from DLA Piper.

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