Zantac Maker Agrees to $2.2 Billion Settlement

Santa Clara, CAThe drug maker GSK agreed a few weeks ago to pay up to $2.2 billion to resolve Zantac lawsuits. The blockbuster heartburn drug, which was sold over-the-counter, was removed from the market in 2020 after the FDA ordered all ranitidine (the generic name) products withdrawn, citing unacceptable levels of the chemical N-nitroso dimethylamine (NDMA), a probable human carcinogen. 

About 80,000 lawsuits, or about 93 percent of Zantac cases pending against the British drug manufacturer in U.S. state courts, will be settled with this agreement. GSK is expected to settle with the remaining 7 percent of plaintiffs, but said those cases could proceed to trials.

As well, GSK has agreed to pay $70 million to settle a Zantac whistleblower lawsuit filed by Valisure, a Connecticut laboratory. Its testing first rang the alarm that Zantac was linked to cancer. Valisure contended that GSK knew its drug was associated with cancer risk but it chose to keep silent. 

Despite the FDA finding that ranitidine--previously sold under the brand name Zantac, among others--could degrade into NDMA over time or when exposed to heat, GSK has not admitted any wrongdoing: it’s part of the deal. Rather, it said that there was "no consistent or reliable evidence" that ranitidine, Zantac’s active ingredient, increased the risk of cancer.

However, to avoid the risk of continuing litigation, GSK said the settlements were in the best long-term interest of the company. And lead attorneys (from 10 law firms) for the plaintiffs agreed, saying in a joint statement that they were "thrilled" with the deal. GSK wasn’t the only company involved: Pfizer and Sanofi also marketed the heartburn drug, and they too have reached settlements. The German drugmaker Boehringer Ingelheim is continuing with litigation.

According to the U.K.’s Financial Times, a Delaware judge’s decision allowing plaintiffs’ scientists to testify that the drug caused cancer, which left the company exposed to the risk of future US jury trials, hastened settlement discussions. And in August Delaware supreme court judges reviewed that ruling. “That definitely prompted both sides to roll up their sleeves and get it done,” said one of the plaintiffs’ lawyers, adding that the outcome was great “for people who suffered cancer.”

NDMA

N-nitroso dimethylamine is a by-product or waste product of various industrial processes, including the manufacture of rocket fuel. Plaintiff Christopher Montgomery said in his lawsuit that, “NDMA’s lone medical use is to cause cancer in animals for laboratory experimentation,” and that, “Cigarette smoking…has been banned, in part, because it produces NDMA, and animal studies have shown that exposure to NDMA has caused tumors primarily of the liver, respiratory tract, kidney and blood vessels.” Once present in the human body, NDMA further metabolizes into other known carcinogens, including formaldehyde.

Zantac Lawsuits

Plaintiffs alleged that Zantac caused digestive system cancers, including bladder and colon cancer. One plaintiff said that, “Put simply, Zantac is a cancerous poison…When ingested, every tablet (and every dose), produces NDMA…Recent revelations by independent researchers have uncovered what will likely go down as one of the gravest public-health frauds in modern times.” Another plaintiff said in his lawsuit that the link between Zantac and unsafe levels of NDMA goes as far back as 1981, two years before the FDA approved the drug, and this was known or should have been known by manufacturers.

Zantac was first approved for sale in the US in 1983 and within five years it became the world’s best-selling drug, with annual sales reaching $1billion. Sanofi, which bought the marketing rights to Zantac from Boehringer Ingelheim in 2017, released Zantac 360 (Famotidine), which contains no ranitidine. The FDA hasn't found any NDMA contamination in famotidine and has approved it as a safe alternative to the old Zantac.