When one thinks about federal racketeering, Al Capone and the mafia conjure up images of organized crime more so than antacid drugs.
But a new slew of Zantac (ranitidine) lawsuits, filed on behalf of 230 plaintiffs accuses pharmaceutical-drug manufacturers and distributors of knowingly selling a dangerous product while concealing the risks of ranitidine in marketing literature.
Used as both an antihistamine and an antacid, ranitidine is a histamine-2 blocker that reduces stomach acid. Zantac, the most popular ranitidine remedy has been linked to several types of cancers.
The drug contains a carcinogenic substance, N-nitrosodimethylamine (NDMA). Testing by both the FDA and independent laboratories revealed the impurity.
It is believed that NDMA accumulates because of the high heat the product is exposed to during shipping and storage. Over time, levels of the cancer-causing chemical can increase.
The lawsuit accuses the pharmaceutical companies who manufactured ranitidine, such as GlaxoSmithKline, of engaging in activities that meet the definition of the Racketeer Influenced and Corrupt Organizations Act, or RICO Act.
Concealing the risks of the drug, failing to adhere to good manufacturing practices (GMPs), and engaging in deceptive marketing practices to maximize profits meets the definition of organized crime, the lawsuit suggests.
In September 2019, manufacturers of the drug voluntarily removed their products. However, by then, the damage was done.
Before the FDA requested the removal of Zantac from the market, approximately 15 million Americans were using ranitidine prescription drugs; it’s likely that several million more were using over-the-counter heartburn drugs.
In addition to cancer, there are other potential side effects of ranitidine drugs, such as confusion, pneumonia, and digestive problems.
In 2018 certain blood pressure medications-valsartan, losartan, or irbesartan—were recalled by the FDA because of NDMA contamination.
The new class action lawsuit was filed in the Southern District of Florida and names over 50 defendants.
Additionally, a federal probe by the U.S. Department of Justice has recently been launched, investigating whether Sanofi and GlaxoSmithKline may have known about NDMA but failed to reveal that information with the federal government. Ranitidine was introduced to the market in 1981. GlaxoSmithKline was the first manufacturer of Zantac. By 1988, Zantac became the best-selling drug, earning sales of over $1 billion. In 1997, Glaxo’s ranitidine patent expired. Sanofi later acquired the Zantac brand.