In a recent development, GSK plc has announced its intention to seek dismissal of an upcoming Zantac case in Florida. This decision comes in the wake of a favorable court ruling on August 15, 2024, which excluded expert testimony linking ranitidine, the active ingredient in Zantac, to prostate cancer.
The Florida court's decision aligns with a previous federal court ruling from December 2022, which rejected expert evidence and dismissed multidistrict litigation cases alleging various types of cancer, including bladder, esophageal, gastric, liver, and pancreatic cancers.
Zantac, first marketed in 1981 by Glaxo Holdings Ltd (now part of GSK), became the world's best-selling drug in 1988. It belongs to a class of drugs called H2 blockers, which work by reducing stomach acid production. The medication was used to treat and prevent ulcers, gastroesophageal reflux disease (GERD), and other related conditions.
However, the landscape changed dramatically when, approximately five years ago, the U.S. Food and Drug Administration (FDA) requested manufacturers to remove Zantac from the market. This decision was based on concerns that ranitidine could degrade into N-nitrosodimethylamine (NDMA), a probable human carcinogen, over time or when exposed to heat. The FDA has set an acceptable daily intake limit for NDMA at 96 nanograms.
The Zantac litigation has become one of the largest mass tort cases in U.S. history, involving multiple pharmaceutical companies. Other defendants in the cases include Boehringer Ingelheim, Pfizer Inc, and Sanofi SA, which sold the drug at different times.
In June 2024, a Delaware court ruling permitted over 70,000 lawsuits to proceed, allowing plaintiffs to present expert testimony suggesting that Zantac causes cancer. GSK is currently appealing this decision. The majority of the more than 74,000 Zantac cases are in Delaware, with only four in Florida.
The ongoing litigation has had a significant impact on GSK's stock performance, with shares falling nearly 10% since the Delaware decision in June. Analysts have estimated potential total settlement costs for the company at around $5 billion.
It's worth noting that alternatives to Zantac include other H2 blockers like famotidine and proton pump inhibitors. The European Medicines Agency also recommended the suspension of ranitidine medicines in the EU in 2020, further highlighting the global impact of the Zantac controversy.
As the legal battles continue, the pharmaceutical industry and consumers alike are closely watching the outcomes of these cases, which may have far-reaching implications for drug safety and corporate liability.
"The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity."