GSK Reaches Major Settlement in Zantac Lawsuit

Pharmaceutical Giant to Pay Up to $2.2 Billion in State Court Cases

GSK, formerly known as GlaxoSmithKline, has agreed to a settlement of up to $2.2 billion to resolve approximately 80,000 lawsuits in U.S. state courts. These lawsuits claim that a discontinued version of the heartburn drug Zantac caused cancer. The settlement significantly develops the ongoing legal battle surrounding the once-popular medication.

5 Key Points

• GSK agrees to settle about 80,000 Zantac lawsuits for up to $2.2 billion.
• The settlement covers 93% of cases pending against GSK in state courts.
• GSK will pay an additional $70 million to settle a related whistleblower lawsuit.
• The company maintains there is no consistent evidence linking Zantac to cancer.
• Other pharmaceutical companies, including Pfizer and Sanofi, face similar lawsuits.

Settlement Details and Company Stance

The agreement, reached with 10 plaintiffs’ law firms, resolves a significant portion of the cases pending against GSK in state courts nationwide. In addition to the main settlement, GSK has agreed to pay $70 million to settle a related whistleblower lawsuit filed by a Connecticut laboratory. Despite the substantial payout, GSK has not admitted to any wrongdoing. The company maintains “no consistent or reliable evidence” that ranitidine, the active ingredient in Zantac, increases cancer risk. However, GSK stated that the settlements were in the company’s best long-term interest to avoid the risk of continuing litigation.

Zantac’s History and Market Withdrawal

Zantac, first approved by U.S. regulators in 1983, became the world’s best-selling medicine in 1988 and was one of the first drugs to surpass $1 billion in annual sales. Over the years, the drug was sold by various pharmaceutical companies, including GSK, Pfizer, Sanofi, and Boehringer Ingelheim. The legal troubles for these companies began after the U.S. Food and Drug Administration (FDA) requested manufacturers to remove Zantac from the market in 2020. The FDA’s decision was based on concerns that ranitidine could degrade into NDMA, a known carcinogen, over time or when exposed to heat.

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Legal Landscape and Other Manufacturers

While GSK’s settlement resolves a significant portion of the Zantac lawsuits, other pharmaceutical companies are still grappling with legal challenges. According to its most recent financial statement, Pfizer has agreed to settle most of the Zantac cases against it in state court. Sanofi announced in April that it was settling about 4,000 cases. Boehringer Ingelheim, which has not announced any major settlements, is currently facing a trial over the drug in Oakland, California state court. The company has denied any wrongdoing.

Ongoing Litigation and Appeals

Despite the settlements, the legal battle surrounding Zantac is far from over. A majority of the remaining state court cases are in Delaware, where a judge in June allowed plaintiffs to present crucial expert testimony that Zantac caused cancer. The drug companies had sought to exclude this testimony, arguing it was not based on sound scientific evidence. The companies are now appealing the judge’s ruling to the Delaware Supreme Court. In a separate development, the companies won a significant victory in 2022 when a Florida federal court judge ruled that about 50,000 cases centralized there could not proceed due to insufficient scientific evidence. Approximately 14,000 of those cases are being appealed and are not part of Wednesday’s settlement.

Current Zantac Product

It’s worth noting that a drug currently sold under the name Zantac 360 uses a different active ingredient and does not contain ranitidine. This new formulation is not implicated in the ongoing lawsuits.