Eisai, Inc. Faces Multiple Suits Over Belviq Cancer Risk

Belviq is a weight-loss drug believed to be associated with increased cancer risk. It uses a chemical compound called lorcaserin to promote appetite suppression by activating serotonin 2C receptors in users’ brains, creating a sensation of satiety. Belviq was approved by the FDA for people with a BMI over 30 and those with a BMI over 27 who also have related comorbidities in 2012, but it was recalled by its manufacturer Eisai Inc. in February 2020.

The FDA Recall

Originally, researchers began investigating Belviq to evaluate its potential for causing adverse cardiovascular events. In 2018, the research was completed, but the results were a bit surprising.

Clinical trials showed that participants who took Belviq instead of a placebo were no more likely to experience adverse cardiovascular events. However, they were more likely to be diagnosed with certain types of cancer, including lung, colorectal, and pancreatic cancers. Of those taking the drug, 7.7% of participants developed cancer, versus 7.1% of those taking the placebo.

The FDA warned patients and medical providers of this association in January 2020, but it wasn’t until February 13, 2020, that the agency announced a voluntary recall of both Belviq and Belviq XR. Eisai complied with the recall but immediately released a press release indicating that the company believes it has “a positive benefit-risk profile.”

Belviq Lawsuits

Several Belviq product liability lawsuits since the product recall. Most plaintiffs took the drug for at least six months and were diagnosed with one of the associated forms of cancer within seven years of stopping Belviq. These lawsuits are still in their early stages.

One case, Fuller v. Essai, Inc., is moving forward right now. In this case, the plaintiffs allege that Eisai’s weight loss drug caused Mrs. Fuller to develop breast cancer. She was diagnosed in June 2019, less than a year after stopping Belviq, and filed a suit with her husband in June 2020.

The plaintiffs claim that Eisai breached its warranty of safety by defectively designing and manufacturing the potentially cancer-causing drug. The suit also claims that Belviq was negligent in failing to perform sufficient studies during clinical trials.

Movement to Dismiss the Complaint

In January 2021, a judge in Louisiana agreed to dismiss the part of the complaint that alleged Eisai’s manufacturing defect and breach of warranty. However, Judge Lance M. Africk, USDC, allowed the pending suit to remain in place with respect to the plaintiff’s design defect claim.

Additional Suits Filed

There is a similar pending case in the Eastern District of New York. In Steinman v. Eisai, Inc., the plaintiff alleges that the company concealed the dangers of Belviq. The plaintiff took Belviq from 2014 to 2017 and was diagnosed with cancer of the thyroid in 2018.

According to this case, Eisai conducted preclinical carcinogenicity testing in 2007 on rats and mice that showed the drug’s main ingredient generated an increase in tumor production. Eisai claims that the tumors occurred only in rats and mice with elevated species-specific prolactin levels, so the results could not be generalized to humans. Steinman claims this constitutes a fraudulent misrepresentation of Belviq’s safety.

There is also a class-action lawsuit against Eisai pending in the Southern District of New York. In Zottola v. Eisai, Inc., the plaintiffs are claiming similar causes of action. The class-action lawsuit seeks to incorporate any Americans who purchased Belviq. Though Eisai has moved to dismiss the suit, it remains pending.