A Dallas law firm is part of a team taking on some of the biggest drug-makers in a nationwide lawsuit that alleges that over-the-counter heartburn medication Zantac causes cancer.
In April 2020, the Food and Drug Administration recalled ranitidine, the generic version of Zantac. The recall was part of an ongoing investigation into the medication, suspected of converting N-Nitrosodimethylamine (NDMA), a known carcinogen when the drug was exposed to more than room-temperature heat. NDMA can cause several types of cancer; the lawsuit is focusing on cases of prostate, pancreatic, esophageal, gastric, liver, bladder, and breast cancer.
Zantac was developed in the 1980s and was among the first drugs to hit $1 billion in annual sales. It was offered over-the-counter and prescription in various forms. The medicine was developed in 1976 by GlaxoSmithKline in the UK; a number of companies have manufactured it over the years and under different brands as the patents ran out.
In 2019, an independent lab’s experiment found that NDMA in ranitidine at levels above what is considered safe (NDMA is found in small amounts in food and water). After later testing, the FDA found dangerous levels of NDMA in ranitidine even at normal storage conditions. There are numerous opportunities for temperatures to rise and convert the medicine into NDMA. The manufacturing process involves high heat, storage in trucks and warehouses can be at high temperatures, and consumption can cause the medicine to heat up. These are all opportunities for the drug to develop NDMA, plaintiffs claim.
The claim is more than 1,000 pages, but in essence, manufacturers, distributors, and retailers should have known that their product would cause cancer when stored at high temperatures, as early studies showed the dangers of the drug and NDMA. It includes gross negligence (they should have known and didn’t) and fraud, as reviews say the drug should not have been used over a long time. “They were telling in advertising that this was safe for long-term use,” says Nicholas Gibson, an attorney at Fears Nachawati. “There was a study saying that if you do take it, it should be short-term use. So there’s a lot of contradicting statements and advertisements that have been misleading.”
When the drug was recalled, Dallas plaintiff’s firm Fears Nachawati began recruiting and accepting clients who may have developed cancer because of their use of Zantac. If someone has one of the cancers listed in the lawsuit and took Zantac at least daily for one year or more significant, they could become a claimant in the case. The suit is multidistrict litigation (MDL), which is similar to a class-action lawsuit but allows for new plaintiffs to be added as they are discovered. The case is being ruled in the federal Southern District of Florida.
One issue will be proving the plaintiffs took the drug they claimed. Because it was mostly purchased over the counter, it won’t be easy to track. Retailers have offered to release purchase data for the lawsuit, and medical records may show patients were taking the medication if they told their doctors. In addition, NDMA can be found in cigarettes, alcohol, or other chemicals that may have been present on the worksite. Plaintiffs will have to prove that the NDMA came from Zantac.
The case is still early in the process, and the firm is advertising to attract clients who have the appropriate types of cancer and consistent use of the drug. It is also accepting referrals from other firms that don’t operate in the healthcare space. They are collecting the medical records, reviewing the candidate’s strength, and tracking the 150 different manufacturers of ranitidine over the years.
Over the last several years, some studies show different levels of NDMA conversion in the drug, but the most recent studies were enough to have firms jump on board and take the case. “We weren’t sure if this a good case to take forward if all these different studies are contradicting each other,” Gibson said. “But two months ago, the big plaintiff’s firms determined that this is a valid claim.”
A trial date has not been set, but Gibson estimates that it will be the end of 2022 or 2023.