Four years ago, tens of thousands of American consumers filed similar lawsuits against a host of corporate defendants: Boehringer Ingelheim, Sanofi, Pfizer, and GlaxoSmithKline. All of these are major pharmaceutical companies with extensive histories and significant roles in the development, manufacturing, and distribution of medications – and one in particular: ranitidine. You might recognize it better as Zantac.
These companies have been facing legal action for their roles in the development, marketing, and distribution of Zantac, which the plaintiff alleges led to his cancer. Now, years later, it looks like the cases are settling.
Ranitidine 101
Zantac (chemically, ranitidine) is a popular antacid medication used by millions of people to treat gastrointestinal issues such as ulcers, heartburn, and acid indigestion. It’s a type of drug called an H2 blocker, which decreases the amount of acid the stomach produces.
Zantac was developed in 1976 and approved for prescription use by the U.S. Food and Drug Administration (FDA) in 1983. GlaxoSmithKline and its predecessors were responsible for developing, patenting, and commercializing the ranitidine molecule. They controlled the New Drug Application (NDA) for prescription Zantac between 1983 and 2009. Since then, the ownership of the drug has changed hands many times.
Ranitidine became available over-the-counter in 1996 and has been widely used since then.
Pfizer controlled the NDA for Zantac from 1997 until December 2006. It was responsible for manufacturing and distributing the drug in the U.S. during that period. Then Boehringer Ingelheim took over control of the NDA until 2017. After 2017, Sanofi took over.
Adverse Effects and Recall
The problem? Findings in the past decade have shown that when Zantac is ingested, it can lead to the production of N-Nitrosodimethylamine (NDMA), a potent carcinogen. Independent researchers discovered that a single dose of Zantac could contain NDMA levels far exceeding the FDA's allowable daily limit of 96 nanograms. In some cases, the NDMA levels were found to be over 3 million nanograms per dose.
This, of course, raised significant health concerns and led to widespread recalls and regulatory scrutiny. The FDA and other global regulators began reviewing the safety of ranitidine. Pharmacies, including CVS, Walgreens, Rite Aid, and Walmart, stopped selling Zantac and generic ranitidine products.
In October 2019, the FDA ordered all manufacturers of Zantac and ranitidine products to conduct testing for NDMA, with preliminary results indicating unacceptable levels of the carcinogen. Sanofi, the current controller of the Zantac NDAs, voluntarily recalled all brand-name over-the-counter Zantac in the country.
A Flood of Lawsuits
Virgil Beck is a good example of a typical plaintiff in the tidal wave of legal complaints against the Zantac companies. He took ranitidine for approximately 26 years. He was diagnosed with prostate cancer in 2018.
Beck claimed that the ingestion of Zantac led to the production of NDMA within his body. Since this is now known to be a potent carcinogen, he claims that this ultimately caused his cancer. His diagnosis was apparently attributed to the long-term exposure to NDMA formed by the breakdown of the ranitidine molecule in Zantac.
He thus took the pharma companies to court, seeking damages for the harm he has suffered due to their alleged negligence and failure to warn about the risks associated with Zantac. And he was far from the only one. Literally tens of thousands of similar suits were filed, in various parts of the country, both in federal and state courts.
In addition to swarms of individual lawsuits, GSK also got slapped with a lawsuit under the False Claims Act from an independent Connecticut laboratory called Valisure. The lab claimed the pharma company defrauded the U.S. government and taxpayers by concealing cancer risks associated with Zantac. Valisure claims that its 2019 testing revealed Zantac could form a carcinogen known as NMDA, making it unfit for human consumption. Valisure claimed that GSK knew his and hid this information from the FDA (the federal government declined to join the lawsuit).
Some Suits Dismissed, Others Not
New lawsuits were popping up more quickly than the defendants attorneys could handle, as they scrambled to get the cases dismissed. In 2022, a federal district judge in Florida dismissed approximately 50,000 of these suits, ruling that the claims were not supported by sound science. This decision impacted similar federal court cases, but not the tens of thousands of similar cases pending in state courts.
Various trials in Illinois also mostly favored the defense. Sanofi and Pfizer settled thousands of cases over the years, but had many remaining in Delaware. There, plaintiffs were allowed to present expert testimony on the cancer link. The pharma companies claimed that the testimony lacked scientific validity, and appealed to a higher court to get over 70,000 lawsuits dismissed over bad evidence. But the Delaware judge did not dismiss the suits, ruling that expert witnesses can testify that the drug may cause cancer. So, the lawsuits were allowed to proceed.
Settlements to Come
Now, GSK has agreed to pay up to $2.2 billion to settle approximately 80,000 lawsuits in U.S. state courts. This settlement resolves 93% of the cases against GSK. Additionally, GSK will pay $70 million to settle the suit from Valisure.
GSK still has not admitted wrongdoing, citing a lack of consistent evidence linking ranitidine to cancer. Pfizer and Sanofi are also settling their respective Zantac cases. Boehringer Ingelheim faces ongoing litigation, while also denying any wrongdoing.
Related Resources:
- Dangerous Drug Laws and Recalls (FindLaw's Learn About the Law)
- Pharmaceutical Drug Liability FAQ (FindLaw's Learn About the Law)
- How to Get Your Slice of the Class Action Pie (FindLaw's Consumer Protection)
