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A Florida couple has filed a product liability lawsuit over a breast cancer diagnosis allegedly caused by Belviq, a diet drug recalled last year after data suggested users experience an increased incidence of various cancers.
Mary Milana, and her husband, Victor, filed the complaint (PDF) in the U.S. District Court for the Middle District of Florida on April 7, indicating Eisai Inc. and Arena Pharmaceuticals, Inc., failed to properly test the drug before marketing the controversial weight-loss treatment.
Belviq (lorcaserin) was introduced in 2012, as the first new diet pill approved in years, following a steady stream of recalls and problems with other weight loss medications. However, in February 2020, the FDA required the drug makers to issue a Belviq recall, after identifying an increased incidence of cancer among users of the medication in post-marketing study data.
The lawsuit indicates Milana began using Belviq in August 2013, and continued to take the diet drug through early 2020, even after she was diagnosed with breast cancer in November 2017. However, she did not make the connection between Belviq and her breast cancer, since the drug makers failed to provide any warnings or information for consumers and the medical community, the lawsuit claims.
“The Belviq designed, researched, manufactured, tested, advertised, promoted, marketed, sold and distributed by Defendants was defective due to inadequate warnings or instructions as the Defendants knew or should have known that the product created a risk of serious and dangerous side effects including cancer, as well as other severe and personal injuries which are permanent and lasting in nature and the Defendants failed to adequately warn of said risk,” the lawsuit states. “The Belviq designed, researched manufactured, tested, advertised, promoted, marketed, sold and distributed by Defendants was defective due to inadequate warnings and/or inadequate testing.”
Belviq Cancer Risk
After an FDA advisory panel decided to approve the medication in April 2012, the consumer watchdog group Public Citizen warned there would be problems with Belviq, predicting the diet drug would eventually be removed from the market like a number of other previously-approved weight-loss treatments.
In July 2019, an expert analysis of the CAMEILLIA-TIMI 61 Trial was published by the American College of Cardiology. The study 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.
Even before then, at the time the medication was first approved, the FDA required the drug makers to conduct a five year follow up study involving about 12,000 participants to evaluate the potential heart risks associated with the medication. However, researchers identified at least 462 individuals treated with Belviq who were diagnosed with 520 different primary cancers over a median follow up time of three years and three months.
Milana’s lawsuit joins a number of Belviq lawsuits filed over the last year by former users who allege that cancer diagnosed in recent years was a result of the medication.
In addition to individual cancer diagnosis lawsuits over Belviq, a number of class action claims have also been filed on behalf of former users who paid about $300 per month for the diet drug, and now face continuing health risks that require medical monitoring.
Since the strongest sales for Belviq have come over the past few years, it is widely expected that additional lawsuits will be filed in the coming months and years, as former users may be diagnosed with cases of breast cancer, pancreatic cancer, colorectal cancer, lung cancer and other injuries.