The Zantac Recall - In 1983 Glaxo Holdings (now GlaxoSmithKline, PLC) received approval from the FDA to sell prescription Zantac for the short-term treatment of ulcers, after 31 other companies had already approved Zantac. Five short years later, Zantac was the world’s best-selling drug, used to treat ulcers, heartburn, and GERD. A 1996 study found that Glaxo’s marketing strategies were directly related to the success of Zantac, including public service announcements, consumer-awareness bulletins, celebrity media tours, and physician education.
By 1997, the patent obtained by Glaxo for ranitidine (the active ingredient in Zantac) expired, prompting many competitors to launch generic alternatives to Zantac. By 2004, Pfizer had garnered FDA approval to sell OTC versions of Zantac in the U.S., leading to a deal with Sanofi, the current manufacturer of Zantac in the U.S. Other companies that sold Zantac and ranitidine in the United States included J & J, Boehringer, Novartis AG, and Ingelheim Pharmaceuticals.
By 2019, the FDA had been alerted regarding the amounts of NDMA found in ranitidine products. While the FDA alerted the American public, they took no action as far as asking that the manufacturers of ranitidine and Zantac pull the products from the market. Days after news regarding the NDMA impurities came to light, Novartis AG stopped distribution of its generic versions of Zantac, and by the end of September 2019, CVS, Walgreens, Walmart, and Rite Aid had pulled ranitidine products from their shelves.
By the end of October 2019, many manufacturers had stopped distributing their products or recalled them altogether, however, it was not until April 1, 2020, that the FDA made their official request for all ranitidine and Zantac products to be recalled. This FDA Zantac recall warned consumers to stop taking Zantac and ranitidine, due to high levels of NDMA. These levels of NDMA have been found to cause cancer in animals and are carcinogenic to humans as well.
Pending Litigation Against Zantac and Ranitidine Manufacturers - Lawsuits against the manufacturers of Zantac and ranitidine are ongoing, and it is expected that the number of lawsuits will increase dramatically over the next few months. Some of the pending lawsuits against Zantac and ranitidine manufacturers include:
- A California federal class-action lawsuit alleged the manufacturers of Zantac failed to warn users the drug contained NDMA; the Zantac class-action lawsuit, alleges the levels of NDMA in a single Zantac pill far exceeds the acceptable threshold for daily NDMA intake. This ranitidine class action lawsuit states that NDMA is a known cause of liver damage, internal bleeding, and even death.
- A Florida man filed a lawsuit against Sanofi after taking Zantac for nine years and subsequently developing breast cancer. Breast cancer in men is very rare; this lawsuit alleges the manufacturers of the drug had an obligation to consumers yet failed to advise consumers or the medical community of any potential harm from Zantac or ranitidine.
- Sanofi and other manufacturers are facing a lawsuit filed by a plaintiff who claims he took Zantac for eleven years, then was diagnosed with bladder cancer. The man claims his bladder cancer was a direct result of NDMA exposure from contaminated Zantac. This particular plaintiff is alleging that a single dose of Zantac contains over 3 million nanograms of NDMA—considerably more than the daily allowable limit of 96 nanograms.
- Plaintiffs Douglas and Anna Maria R. filed a Zantac class-action lawsuit against Sanofi, GlaxoSmithKline, and Boehringer Ingelheim, accusing the Zantac manufacturers of knowingly misrepresenting Zantac as safe, despite knowing the drug produced a toxic carcinogen when ingested. Douglas R. states in his lawsuit that he took Zantac four to five times per week for five years, beginning in 2014. Douglas then developed bladder cancer and underwent multiple surgeries to treat the cancer. Douglas and his wife claim the drug manufacturers put profits ahead of patient health and are asking for $75,000.
- A Georgia man has filed a federal lawsuit against Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals, alleging Zantac caused his stage III colon cancer.
- A Pennsylvania man filed a Zantac cancer lawsuit, alleging Zantac, contaminated with NDMA, caused his bladder cancer. Kenneth M. began using OTC Zantac in the late 1990s, continuing to use the drug through 2018, when he was diagnosed with bladder cancer. The plaintiff has said in his lawsuit that if he had been aware of the NDMA in Zantac, and been warned about the risks of NDMA, he never would have taken the drug. This plaintiff has named Boehringer Ingelheim Pharmaceuticals, Sanofi, Chattem, Pfizer, and GlaxoSmithKline in his lawsuit, and is claiming design defect, failure to warn, breach of express warranty, and breach of implied warranty. Kenneth’s wife has filed on loss of consortium.
- A Rhode Island man filed a lawsuit against GlaxoSmithKline, Boehringer Ingelheim Pharmaceuticals, Sanofi, Pfizer, and Chattem, claiming he was not properly warned regarding the link between Zantac and bladder cancer. The plaintiff began using a generic version of Zantac in 2014, taking a pill at least five times per week until 2019, when he was diagnosed with bladder cancer. This plaintiff believes his cancer diagnosis is directly related to the NDMA found in Zantac and ranitidine.
- A more recent Zantac class action lawsuit/ranitidine class action lawsuit was filed, claiming the manufacturers of Zantac negligently allowed their products to become contaminated. Plaintiff Dana Viola took Zantac from 2000 through 2016 and is naming Sanofi, the current manufacturer, as well as Pfizer, who held the original patent. Viola claims she and other consumers relied on the representation by Pfizer, which held the heartburn medication was safe and free of defects, however, it contained dangerously high levels of NDMA, making it unfit for human consumption.
- A New Jersey man is claiming his prostate cancer is the result of taking Zantac three times per week for more than five years. Plaintiff William M has filed his Zantac lawsuit against manufacturers Boehringer Ingelheim, Chattem, Sanofi-Aventis, and Sanofi. This plaintiff has claimed that the manufacturers were aware of the fact the drug contained dangerous levels of NDMA yet continued to sell to consumers without a warning. According to this Zantac lawsuit, the NDMA levels in each dose of Zantac are thousands of times higher than the FDA’s maximum daily safe level.
- Plaintiff, Steven K., is suing Sanofi-Aventis, after taking Zantac and developing kidney cancer. This plaintiff’s Zantac lawsuit states he used Zantac from the 1980s through 2019, taking the drug up to five times per week. The plaintiff states he was never informed about any potential hazards associated with the drug and with NDMA. This lawsuit claims Zantac posed a higher risk even than the drugs named in the Valsartan recall due to the extremely high levels of NDMA found in Zantac and ranitidine.
- Connecticut and Florida plaintiffs have filed a class-action lawsuit against Zantac manufacturers Sanofi, and Boehringer Ingelheim, stating the manufacturer concealed information regarding Zantac NDMA contamination.
Getting Help with a Zantac Cancer Lawsuit from an Experienced Zantac Lawyer - If you or a loved one took Zantac or ranitidine prior to the Zantac recall, you could be entitled to file a Zantac lawsuit or a ranitidine lawsuit or might choose to take part in a Zantac class action lawsuit or a ranitidine class-action lawsuit. There are many ranitidine cancer risks due to the NDMA found in Zantac. In short, Zantac and ranitidine cause cancer. If you took Zantac or ranitidine and have been diagnosed with cancer, you could benefit from speaking to a Sullo & Sullo Houston Zantac attorney. You could be entitled to past and future medical expenses resulting from your injuries, past and future lost wages, past and future pain and suffering resulting from the injuries, past and future loss of enjoyment of life, and punitive damages, when appropriate.