GlaxoSmithKline (GSK) has announced a substantial agreement to resolve approximately 80,000 lawsuits related to its discontinued heartburn medication, Zantac, which is alleged to have caused cancer. The settlement, which could reach as high as $2.2 billion, was revealed by the company on Wednesday and addresses roughly 93% of the pending cases against the British pharmaceutical giant in U.S. state courts.
In addition to the main settlement, GSK has also committed to paying $70 million to settle a related whistleblower lawsuit filed by a laboratory in Connecticut. Despite the financial outlay, GSK has not admitted any wrongdoing. In a statement, the company asserted that there is “no consistent or reliable evidence” indicating that ranitidine, the active ingredient in Zantac, heightens cancer risk. However, GSK emphasized that settling was in the company’s long-term interest to avert the uncertainties and expenses of continued litigation.
Lead attorneys for the plaintiffs, Jennifer Moore and R. Brent Wisner, expressed their satisfaction with the agreement, stating they were “thrilled” with the outcome.
First approved in 1983, Zantac quickly rose to prominence as a leading medication for heartburn, becoming the world’s best-selling drug by 1988 and one of the first to surpass $1 billion in annual sales. Over the years, Zantac was marketed by several pharmaceutical companies, including GSK, Pfizer, Sanofi, and Boehringer Ingelheim.
The wave of lawsuits against these companies began after the U.S. Food and Drug Administration (FDA) requested in 2020 that manufacturers withdraw Zantac from the market. This request stemmed from concerns that ranitidine could break down into N-nitrosodimethylamine (NDMA), a known carcinogen, when exposed to heat or over time.
Pfizer has already settled most of its Zantac cases in state court, while Sanofi announced in April that it would settle around 4,000 cases. Boehringer Ingelheim, however, has not disclosed any significant settlements and is currently facing a trial in Oakland, California, regarding the drug. The company has denied any allegations of wrongdoing.
Moore and Wisner emphasized their commitment to pursuing claims against Boehringer Ingelheim, asserting that they would hold the company accountable for allegedly exposing millions of people to a known carcinogen for over a decade.
Most of the remaining cases are concentrated in Delaware, where a judge recently ruled in favor of plaintiffs, allowing them to present critical expert testimony linking Zantac to cancer. The drug companies had argued against the admissibility of this testimony, claiming it lacked sound scientific basis, and are now appealing the judge’s decision to the Delaware Supreme Court.
In a significant development in 2022, a federal court in Florida ruled against the continuation of around 50,000 Zantac cases, determining that the plaintiffs’ expert testimony was not backed by reliable scientific evidence. Approximately 14,000 of those cases are currently under appeal and are not included in the recent settlement.
It is worth noting that a current iteration of the medication, marketed as Zantac 360, utilizes a different active ingredient and does not contain ranitidine. This new formulation reflects the ongoing evolution of the product in response to safety concerns raised by previous iterations.
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