AMAG Pharmaceuticals, Inc.

This class action arises out of Defendants’ misrepresentations and omissions made in connection with the sale of a prescription drug known as Makena. Plaintiffs allege that Defendants unlawfully marketed Makena as effective at preventing preterm birth when, in fact, Defendants knew that the drug was worthless. 

Defendants obtained “accelerated approval” for the drug from the FDA based on a single study, which suggested Makena might reduce the risk of recurrent preterm birth, but the study had significant flaws and including that it did not provide conclusive evidence of preterm birth prevention. Therefore, the FDA’s approval of the drug was explicitly conditioned on the completion of a confirmatory study being conducted to demonstrate that Makena is actually effective at preventing preterm birth. 

Defendant AMAG Pharmaceuticals, Inc. (“AMAG”), the owner of the marketing rights to Makena, sponsored the confirmatory study required by the FDA, which was known as PROLONG. While AMAG was well aware that the effectiveness of Makena had not been confirmed, it nonetheless aggressively marketed Makena as effective at preventing preterm birth. In March 2019, the topline results of the PROLONG study were issued, showing Makena was no better than a placebo at preventing preterm birth. While the FDA announced that it would be withdrawing Makena from the market, this was an administrative process that could take years. AMAG capitalized on this time and doubled down on its false claims of Makena’s efficacy. In October 2020, Defendant Covis bought AMAG and attempted to increase sales of Makena at inflated prices, while delaying a final FDA withdrawal decision as long as possible, reaping significant profits from sales of an ineffective drug. 

On October 27, 2023, Kessler Topaz filed a lawsuit against Defendants in the federal District Court of Massachusetts, alleging that Defendants’ conduct caused third-party payors, the entities that make payments on behalf of individuals for the costs of prescription drugs, to pay for a worthless drug that was ineffective at preventing preterm birth—the only condition it was indicated to treat. Plaintiffs assert claims under the Racketeer Influenced and Corrupt Organizations Act (18 U.S.C. § 1962(c), (d)) and state consumer protection laws.