STORY FROM: Drugs & Medical Devices
7th Cir. Refuses to Reinstate 1,000 Testosterone Replacement Drug Cases, Says Claims Preempted
January 22, 2018
CHICAGO - A federal appeals court has refused to reinstate the claims of more than 1,000 plaintiffs against Pfizer Inc. in connection with its Depo-T testosterone replacement drug, finding they are preempted because they would require the drug maker to add additional warnings to its label in contravention of federal law.
In a Jan. 19 opinion, the 7th Circuit U.S. Court of Appeals affirmed that federal law bars reference listed drug (RLD) abbreviated new drug application holders from unilaterally changing their warning labels. The court further held that like all other ANDA holders, Pfizer must match the labeling for the ...