Eisai Inc. and Arena Pharmaceuticals Inc. failed to get design defect claims dismissed in a lawsuit that alleges the weight loss drug Belviq caused a woman’s breast cancer, according to a court document.
Plaintiffs Stephanie and Robert Fuller claimed Eisai and Arena defectively designed and defectively manufactured Belviq, also known as lorcaserin. Plaintiffs also claimed that manufacturers represented Belviq as safe even if it was not, thereby breaching their express warranty.
“Defendants negligently and/or fraudulently represented to the medical and healthcare community, the Food and Drug Administration … to Plaintiff, and the public in general, that Belviq had been tested and was found to be safe and/or effective for its indicated use,” according to the complaint. “Defendants concealed their knowledge of Belviq’s defects, from Plaintiff, the FDA, the public in general, and/or the medical community specifically.”
Judge Lance M. Africk found the Fullers did not sufficiently allege their manufacturing defect or breach of warranty claim. Based on this, the court granted Eisai and Arena’s motion to dismiss the manufacturing defect and breach of warranty claims on Jan. 15, 2021.
However, this case will continue in the Eastern District of Louisiana with the design defect claim. Attorneys expect more people to file lawsuits across the country.
Belviq Withdrawn from Market for Cancer Risk
The FDA first approved Belviq in 2012 to treat obesity along with diet and exercise. It’s also available in an extended release formula called Belviq XR.
On Feb. 13, 2020, the FDA requested that the drug’s manufacturers voluntarily withdraw the weight-loss medication because clinical trial data showed an increased occurrence of cancer among people who took the drug.
“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,” the FDA said on its website.
During its review of clinical trial data from the CAMELLIA-TIMI 61 trial, the FDA found that several types of cancer occurred more frequently among patients who took Belviq, including pancreatic, colorectal and lung cancer.
Eisai: Belviq Has ‘Positive Risk-Benefit’ Profile
Eisai Inc. complied with the FDA’s withdrawal request and respects its decision but disagreed with the agency’s interpretation of study data.
“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. However, based on the change in FDA’s risk-benefit assessment and as requested by the Agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market,” the company said in a February 2020 statement.
Eisai stressed that Belviq has been evaluated in more than 22,000 patients in more than 30 trials. The company stands by the drug’s safety.
As of February 2020, the company has stopped selling Belviq and Belviq XR in the United States.
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