In February 2020, drug manufacturer Eisai Inc. issued a recall of its weight-loss drugs Belviq and Belviq XR after clinical trials revealed that the tablets were associated with increased risk of cancer. Belviq is the brand name for weight-loss medications containing the active ingredient lorcaserin. Belviq XR is the extended release formulation of this medication. Lorcaserin is a chemical compound designed to promote weight loss through appetite suppression. Belviq works by activating serotonin 2C receptors in the brain, which causes increased feelings of fullness and satiety and thereby decreasing appetite. Belviq was intended to work in conjunction with diet and exercise to promote sustained weight loss.
Belviq is indicated for obese individuals with a body mass index (“BMI”) of 30 or greater, as well as overweight individuals with BMI of 27 to 30 who have at least one other weight-related co-morbidity such as high blood pressure, high cholesterol, or Type 2 diabetes. Initial Belviq testing found that after a year of taking the appetite-suppressant, half of Belviq-takers lost at least 5 percent of their weight and nearly a fourth lost 10 percent.
The U.S. Food and Drug Administration (“FDA”) approved Belviq as a prescription medication in 2012. Upon approval, Eisai was required to conduct a randomized, double-blind clinical trial. The five-year study consisted of approximately 12,000 patients, some of whom took Belviq and some who took a placebo. Of particular concern was the risk of adverse cardiovascular effects typically related to weight loss medications like Belviq.
FDA Recalls Belviq Due to Cancer Risk
In 2018, researchers began wrapping up the clinical trials and releasing their findings. Although no adverse cardiovascular effects were observed, the trials indicated that patients taking Belviq were more likely to be diagnosed with lung, pancreatic, and colorectal cancer than patients taking a placebo. Specifically, 7.7 percent of patients taking Belviq were diagnosed with cancer as compared to 7.1 percent of patients taking a placebo.
In January 2020, the FDA warned that patients should immediately stop taking Belviq, dispose of any remaining tablets in their possession, and speak to medical providers about the increased risk of cancer. The FDA also advised that medical professionals should stop prescribing Belviq, warn patients about the increased cancer risk associated with the medication, and discuss alternative weight loss strategies. The FDA did not suggest cancer screening specifically related to Belviq use, noting that adverse effects were only observed after long-term use of the drug.
On February 13, 2020, the FDA went further and announced that it was calling for the voluntary recall of Belviq and Belviq XR from the market. The FDA announcement reads: “We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety,”
Eisai complied with the FDA’s response by submitting a request to “voluntarily withdraw the drug” soon thereafter. However, in a press release, Eisai maintained “The company’s assessment is that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated,”
Belviq Lawsuits in the Early Stages
Following the recall, several Belviq product liability lawsuits were commenced. Typically, plaintiffs took Belviq for a period of at least six months and were diagnosed with cancer within seven years of their last use of Belviq. Most of the lawsuit arein their early stages and no major decisions or verdicts have been handed down.
There is some early motion practice in one case currently pending in the U.S. District Court for the Eastern District of Louisiana. In Fuller v. Eisai, Inc., Plaintiffs, Stephanie and Robert Fuller, allege that Belviq caused Mrs. Fuller’s breast cancer. Stephanie Fuller took Belviq from August 2018 through October 2018. She was diagnosed with breast cancer in June 2019. She and her husband filed suit in June 2020.
The Fullers claim that Eisai defectively designed and manufactured Belviq, and that Eisai breached an express warranty of safety: “Defendants concealed their knowledge of Belviq’s defects… with the intent of defrauding and deceiving Plaintiff, the public in general, and the medical and healthcare community in particular.” Additionally, “Defendants negligently and improperly failed to perform sufficient tests, if any, on humans using Belviq during clinical trials, forcing Plaintiff, and Plaintiff’s physicians, hospitals, and/or the FDA to rely on safety information that applies to other chronic weight management treatments, which does not entirely and/or necessarily apply to Belviq whatsoever.”
Eisai moved to dismiss the complaint
In January 2021, Judge Lance M. Africk, USDC, Louisiana, agreed in part, finding that Plaintiffs failed to sufficiently allege the Plaintiffs’ manufacturing defect and breach of warranty claims. However, the suit remains pending with respect to the design defect claim.
A similar case is pending in the U.S. District Court for the Eastern District of New York. In Steinman v. Eisai, Inc., Plaintiff, Deborah Steinman, alleges that Eisai concealed cancer-related dangers of Belviq. Steinman took Belviq from November 2014 through February 2017. She was diagnosed with thyroid cancer in 2018.
Steinman claims that Eisai failed to perform sufficient testing of the drugs. Steinman cites preclinical carcinogenicity trials in 2007 conducted on rats and mice, which found that lorcaserin led to an increase in multiple types of tumors. Eisai explained that the tumors were due to elevated prolactin levels which were specific to rats and mice and would not translate to humans. Steinman claims that Eisai fraudulently misrepresented the safety of Belviq to the medical community, the FDA, and the public.
In the Southern District of New York, a Belviq class action suit is currently pending. In Zottola v. Eisai, Inc., Plaintiff asserts similar causes of action including breach of the implied warranty of merchantability, deceptive business practices, false advertising, fraudulent concealment, and fraud. The class is defined broadly, seeking to incorporate “all persons in the United States who purchased Belviq or Belviq XR.” On September 9, 2020, Eisai moved to dismiss the class action suit. The motion remains pending.
About the Authors
Jeff S. Korek joined Gersowitz, Libo and Korek, P.C. in 1992 as partner and senior trial attorney representing victims of medical malpractice and construction accidents. Known for his meticulous preparation and dedication to his clients, he has obtained substantial verdicts. Since 2006, Jeff has been recognized in both Best Lawyers in America and Super Lawyers for personal injury and medical malpractice. In 2016, Jeff was named as Best Lawyers “Lawyer of the Year” for Personal Injury Litigation in New York City. Jeff was also recognized by Best Lawyers as the 2020 “Lawyer of the Year” for Medical Malpractice Law – Plaintiffs in the New York City area.
Justine B. Uy is a Law Graduate and Law Clerk seeking admission in the New York Bar at Gersowitz Libo & Korek. She graduated from Fordham University School of Law in 2020 where she was a member of the Brendan Moore Trial Advocates and the Fordham International Law Journal. She obtained a B.A. from the University of Notre Dame in 2017.
Sources
What is Belviq?
Fuller Suit:
Steinman Suit:
Zottola Class Action:
