Florida resident Mary Milana first started using the chronic weight-management drug Belviq in 2013 and continued its use through early 2020. In April 2021, she and her husband, Victor Milana, filed a complaint against Eisai, Inc. and Arena Pharmaceuticals, the makers of Belviq, after Mary was diagnosed with breast cancer.
About the Lawsuit
Mary’s complaint, filed in the United States District Court Middle District of Florida, states that Belviq was prescribed to her by her primary care physician and his colleague.
The plaintiff alleges that the defendants knew or should have known that the drug had not been properly tested and was not safe and failed to warn the public accordingly. Rather, the defendants hid their knowledge of the drug’s defects with the intent of defrauding and deceiving the public and the medical community, the complaint alleges. Plaintiffs also accuse Eisai and Arena of negligence in failing to perform sufficient tests on humans during clinical trials.
The claim further states that because of the defendants’ negligence and her use of Belviq, Mary suffers from, among other things, breast cancer and other severe and permanent injuries. Along with these injuries, the plaintiff is claiming physical pain, mental anguish, diminished enjoyment of life, lifelong medical treatment, medications, monitoring, and other damages.
Mary’s husband, Victor, is seeking compensation for loss of consortium, claiming he was deprived of the “comfort and enjoyment of the services and society of his spouse.”
Belviq, also known as lorcaserin hydrochloride, was designed, researched, manufactured, tested, promoted, advertised, marketed, sold and/or distributed by the defendants named in the claim.
In 2009, Arena sought U.S. Food and Drug Administration (FDA) approval to market and sell the drug for chronic weight management—as an adjunct to a reduced-calorie diet and increased physical activity. The FDA came through with its approval in June 2012. Later that year, Arena and Eisai jointly launched Belviq in the U.S.
According to the complaint, defendants performed carcinogenicity tests on rats during the preclinical trial program. The study revealed that lorcaserin induced multiple tumors (primarily mammary tumors). This, combined with a two-year mouse study that also showed an increase in cancerous effects in subjects, should have alerted the defendants that their drug was a carcinogen and/or prompted additional testing.
FDA Safety Communication
In January 2020, the FDA released an alert about a possible increased risk of cancer with Belviq use, based on clinical trial results. About one year later, Eisai submitted a request to voluntarily withdraw Belviq from the market. According to the FDA’s statement, 7.7 percent of Belviq patients were diagnosed with 520 primary cancers. The agency stated that the efficacy of Belviq is not outweighed by its safety risks and instructed all health care professionals to cease prescribing Belviq, let their patients know of the increased risk of cancer, and request that they cease administering the drug.