Zantac (ranitidine), first approved in 1983, is one of the most popular heartburn drugs in the world and has a ubiquitous presence in the medicine cabinets of the vast majority of American households. It became the first ever “blockbuster drug” after break $1 billion in sales in 1986. After an April 2020 FDA request to remove all ranitidine drugs from the market due to new reports of increased risk of the development of bladder, esophageal, liver, and pancreatic cancers.

Zantac belongs to a class of drugs known as H2 (histamine-2) blocker, which also includes Tagamet and Pepcid AC. In addition to heartburn, it is commonly used to treat acid reflux, indigestion, stomach ulcers, and gastroesophageal reflux disease (GERD). Similar to Valsartan, this litigation is not related to the efficacy of the drug itself.

FDA Warning

In September 2019, the FDA issued a warning stating that dangerous levels of N-nitrosodimethylamine (NMDA), which is highly hepatoxic and a known carcinogen used to induce cancer in lab animals, were found in some ranitidine medicines. An online pharmacy, Valisure, using the same testing methods as the FDA, detected 2,511,469 nanograms (ng) of NMDA per 150mg tablet of Zantac. The FDA’s permissible limit is 96ng of NMDA per day, meaning that the Zantac tablets contained more than 26,000 times the admissible amount. The presence of NMDA in the tablets puts the consumer at a heightened risk of developing cancer anywhere along the digestive tract. The FDA issued a statement with respect to the Valisure findings in November 2019. Following their finding, Valisure filed a recall petition with the FDA. This led to a series of ranitidine-based heartburn drug recalls, culminating in April 2020, when the FDA requested the removal of all ranitidine products from the market.

Whistleblower Lawsuit Against GSK

May 2024 an independent laboratory in Connecticut, Valisure,  filed suit in Philadelphia against GlaxoSmithKline saying the manufacturer violated the federal False Claims Act, defrauding the U.S. government and taxpayers by concealing the cancer risk of Zantac. The lawsuit alleges that GSK knowingly hid the risks for nearly four decades during which time Medicare, Medicaid and numerous health insurers and prescription programs covered billions of dollars in prescriptions.

Current Status Of Litigation

The Zantac litigation has moved very quickly due to the recall. Cases were consolidated for pretrial coordination in MDL #2924 and transferred Southern District of Florida under the purview of Judge Robin L. Rosenberg. There are currently more than 100,000 lawsuits filed and the first bellwether trials are expected to move forward in 2023. In December of 2022 Judge Rosenberg gave an extremely unexpected ruling, striking all of the plaintiffs experts, leaving the MDL in peril.  Another litigation beachhead is also occurring in the state court of California via JCCP #5150. These cases will be managed in Alameda County Superior Court by Judge Winfred Y. Smith. Judge Smith previously presided over the Essure JCCP, which was successfully resolved in 2020. Consolidated state court filings in Delaware and New York are also moving forward. In March 2024 Judge Smith decided that plaintiffs experts were sufficiently reliable for the Kelly-Frye standard applied there, paving the way for ‘bellwethers’ trials to move forward later this year.

Update:

While several cases moving forward through California state court have now settled before trial, on April 5, 2024, Sanofi announced that it had resolved 4,000 Zantac lawsuits pending in state courts reportedly for $100 million. The following month Pfizer announced on May 15, 2024 that it has offered $250 million to resolve another 10,000 lawsuits according to a filing in Delaware state court. The first trial got underway in early May in Chicago, which ended in a defense verdict. On May 31, 2024, Delaware Superior Court judge Vivian Medinilla ruled that more than 75,000 lawsuits could move forward.

Links:

1. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
2. https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impurities-ranitidine-drugs
3. https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf
4. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
5. https://www.cnn.com/2020/04/01/health/zantac-fda-remove-from-market-bn/index.html
6. https://www.fiercepharma.com/pharma/sanofis-zantac-settlement-was-100m-or-25k-claimant-bloomberg-report
7. https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-offers-up-250-mln-settle-thousands-zantac-cancer-lawsuits-ft-reports-2024-05-16/
8. https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-faces-whistleblower-lawsuit-over-zantac-cancer-risk-2024-05-20/
9. https://www.medicalbrief.co.za/zantac-did-not-cause-cancer-jury-says-in-first-trial-over-drug/
10. https://www.investopedia.com/gsk-stock-dives-after-judge-allows-zantac-cancer-lawsuits-to-go-forward-8657308