Belviq Recall Class Action Lawsuit Alleges Cancer Risk Outweighed Any Weight Loss Benefit

Manufacturers knew about the risk of cancer caused by Belvic since at least 2012, but continued to sell the recalled diet drug, according to lawsuit

Eisai Inc. and Arena Pharmaceuticals face another class action lawsuit over the Belviq cancer risk, indicating that any weight loss benefits provided by the recalled diet drug are clearly outweighed by the potential side effects.

Amy Gibriano filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on November 11, claiming that the drug makers knowingly exposed users to an increased risk of cancer from Belviq in order to increase profits by marketing a weight loss pill. The lawsuit seeks class action status to pursue damages for all individuals who used the drug.

Belviq was approved by the FDA in 2012, as the first new diet pill allowed on the market in the United States in years. Although the medication was introduced after a series of recalls and problems were associated with other weight-loss medications, the lawsuit indicates the drug makers did not disclose that they failed to properly test or study Belviq for cancer side effects, rendering warnings provided with the medication inadequate.

In February 2020, the FDA required a Belviq recall, after identifying an increased incidence of cancer among users of the medication in post-marketing study data. However, Gibriano’s lawsuit claims just pulling Belviq from the market was not enough.

“While Defendants withdrew [Belviq] from the market and instructed users to stop taking the medication (because it was unmerchantable and not fit for use), Defendants have not refunded or provided restitution to Plaintiff or Class members to reimburse them for the money they paid out of pocket for these defective Products,” Gibriano’s lawsuit states. “Worse is that Defendants Eisai and Arena knew, from the early stages of research and development of these medications that they exposed users to high rates of cancer.”

The lawsuit notes that Eisai was aware Belviq caused cancer as far back as 2012, but continued to aggressively market the drug. Gibriano’s lawsuit notes that by the time Belviq was pulled from the market, a significant amount of damage may have already been done.

The decision to allow Belviq on the market was controversial, and the consumer watchdog group Public Citizen warned in 2012 there would likely be problems with Belviq, predicting the diet drug would eventually be discontinued and removed from the market, like a number of other previously-approved weight-loss treatments.

In July 2019, an expert analysis of clinical trial data was published by the American College of Cardiology, which looked at the effectiveness and side effects of Belviq, including the largest concern at the time: cardiovascular risks.

While not publicly announced until months later, the data contained concerning indications about a potential link between Belviq and pancreatic cancer, colorectal cancer and lung cancer. However, the FDA did not issue Belviq cancer warnings until January 2020, and several weeks later it was determined the weight loss drug needed to be removed from the market.

Gibriano’s case joins hundreds of similar Belvic recall lawsuits filed over the past two years, most involving claims by former users diagnosed with pancreatic cancer, colorectal cancer, breast cancer or other injuries blamed on side effects of the medication.

Since the strongest sales for Belviq came over the last few years the drug was on the market, it is widely expected that additional lawsuits will be filed in the coming months and years, as former users continue to develop injuries and learn that the problems may have been caused by their prior use of Belviq.