In September of 2019, the U.S. Food and Drug Administration issued a press release, advising the public that bottles of the popular over-the-counter heartburn medication Zantac was found to contain an industrial chemical known as N-nitrosodimethylamine (NDMA). This chemical, a known carcinogen, is classified by the Environmental Protection Agency as “extremely hazardous.” Legally, companies as well as individuals who manufacture, use or store NDMA are required to file reports with the agency.
At the time, the Connecticut-based pharmaceutical lab that first discovered the contamination issued a petition to the FDA to recall the product. Some manufacturers of the drug, including Sanofi and a number of generic drugmakers, voluntarily recalled the product shortly after the information was made public, but an official FDA recall was not issued until six months later. While the FDA attempted to reassure the public that contamination levels were “low,” they remained up to 26,000 times the levels scientifically considered “safe.”
Current Zantac lawsuits allege that drug companies knew, or should have known that Zantac contained a carcinogenic industrial chemical and failed to take measures to protect patients. If you or a family member have developed cancer after taking Zantac, you may be entitled to recover damages.
What Is Zantac?
Zantac, known generically as ranitidine, is classified in pharmacology as a histamine H2 antagonist, or H2 receptor blocker. Although available over the counter at most drug stores and pharmacies, they are often prescribed for the treatment of acid reflux disease, heartburn and ulcers of the stomach and duodenum (upper section of the small intestine).
Histamines are a product of the immune system. You may be familiar with antihistamines, which are medications that suppress the symptoms of allergic reactions such as hay fever. Histamines essentially assist the human body to rid itself of substances that the immune system identifies as potentially harmful, such as pollen and dust. Histamines are the reason people sneeze and get runny noses in the presence of these substances.
In addition to the sinuses and respiratory systems, histamines are also present in the digestive tract. There, they serve the same function, protecting the body from certain foods, non-beneficial bacteria, parasites and other potentially harmful substances. In people with healthy digestive systems, these histamines quickly break down in the presence of an enzyme known as diamine oxidase, or DAO. However, some people are unable to produce DAO in sufficient quantities. The result is high histamine levels, which can cause diarrhea, stomach pain and acid reflux. Others may be able to produce healthy amounts of DAO, but certain foods trigger histamine overload because of underlying conditions.
H2 blockers such as Zantac can relieve the symptoms of occasional acid reflux in most cases. However, if acid reflux happens frequently, it is more important to have a physician identify the underlying cause. It may be as simple as a food allergy, a lifestyle issue such as tobacco use, eating too close to bedtime or the side effect of another medication.
What is NDMA?
The full scientific name for NDMA is N-Nitrosodimethylamine. Not only has this chemical been found to cause cancer, it is also highly toxic to the liver. Trace levels of NDMA are present in many foods such as cured and smoked meats, fish, ale and beer and other foods preserved with sodium nitrate as well as tobacco products. It can also be a by-product of chlorination and wastewater treatment. At one time, NDMA was used in the manufacture of rocket and jet aircraft fuel, antioxidants, industrial lubricants and the production of some types of plastic. Although it no longer commercially produced or used in the US, NDMA can be a byproduct of chemical reactions during the production of pesticides, rubber products, leather, dyes and certain kinds of soap.
In addition to ranitidine, scientists have discovered NDMA contamination in valsartan, an angiotensin II receptor blocker used to lower blood pressure, and metformin hydrochloride, a first-line treatment for type-2 diabetes. In 2021, a study published in the journal Scientific Reports found that NDMA interferes with the repair of damaged DNA—which can lead to the development of malignant tumors. The US Environmental Protection Agency has classified NDMA as a B2 carcinogen, meaning the exposure is likely to cause cancer.
What Did Drug Companies Know?
Ranitidine was first produced and sold by GlaxoSmith-Kline in 1981. After the patent expired, generic forms of the drug were manufactured by Pfizer, Boerhinger-Ingelheim and Sanofi. Scientific journals have been warning of potential problems for several years, so it is likely that these drug companies and others were aware of possible dangers. If they were not, they should have known of the problems, since information was available to the public.
The FDA pulled ranitidine off the market in April, 2020. Approximately one year later, Sanofi introduced a new version, which was called Zantac 360. This version replaces the active ingredient ranitidine with famotidine, which does not pose a cancer risk.
What if I Took Ranitidine?
Scientific research has found at least 20 different forms of cancer that are likely to be caused by ranitidine. These cancers can affect the following:
Most current lawsuits focus on these particular cancers, though there may be additional forms related to NDMA contamination.
If you have ever taken Zantac with ranitidine in the past and have contracted one of the aforementioned forms of cancer, you may be entitled to recover damages from the drug manufacturer.
Drug litigation goes to product liability, so chances are that the number of plaintiffs can number in the hundreds or thousands. The first Zantac lawsuits were filed in a California federal court in September of 2019 against Boehringer-Ingelheim and Sanofi. Plaintiffs alleged that these drug makers were negligent in their failure to warn patients about the product’s dangers and that the drug itself was inherently defective. Within six months, the number of plaintiffs had grown to over 100.
Since that time, tens of thousands of plaintiffs have filed injury lawsuits against drug companies involved in the manufacture of Zantac. In February of 2020, the Judicial Panel for Multidistrict Litigation formed MDL No. 2924. The first bellwether trials are scheduled to begin in early 2023. If these early trials are decided in favor of the plaintiffs, the defendants will likely offer a global settlement to resolve the remaining cases by establishing a fund against which victims can file their claims.
What Damages Can I Recover?
You may receive compensation for the following costs:
- medical procedures
- treatments and rehabilitation
- ongoing medical monitoring
- in-home care and medical equipment
- loss of wages, salary and earning capacity
Non-monetary damages you may be able to recover include:
- pain and suffering
- psychological and emotional distress
- loss of consortium
- wrongful death
Keep in mind that the state of Utah has a four-year statute of limitation on personal injury cases. For a Zantac lawsuit, this means four years from the time your cancer was diagnosed.
What Does it Cost?
Your initial consultation with one of our dangerous drug attorneys costs you nothing. Clients we represent pay nothing out of pocket; we collect our fees only if we win a settlement, amounting to approximately one-third (the standard percentage in the legal industry). This means we are motivated to win your case, so contact our offices today.