Studies dating back decades have found that when ranitidine breaks down in a patient’s stomach, the chemical reaction produces NDMA as a byproduct. If too much NDMA is produced through this process in the human body, it could possibly lead to health complications.
The first Zantac lawsuit was filed after NDMA — a cancer-causing substance — was released by the heartburn drug during lab testing. As more information surfaces about the link between Zantac and this carcinogenic substance, as well as the subsequent cancer risk for patients, the number of Zantac lawsuits is expected to rise.Considering a Zantac lawsuit? Get a Free, No-Obligation Case Review Today
Why Are People Filing Zantac Lawsuits?
During a routine test, the online pharmaceutical company Valisure found traces of the probable carcinogen N-nitrosodimethylamine (NDMA) in batches of brand name and generic Zantac (ranitidine). According to Valisure, the levels of NDMA found through various testing methods were more than 3,000 times the recommended limit set by the U.S. Food and Drug Administration (FDA).
FDA testing did not find the same high levels of NDMA in ranitidine products. However, in a public alert statement, the agency did acknowledge the presence of the contaminant at “unacceptable” levels. Additionally, the FDA asked manufacturers to conduct internal tests as a matter of precaution. The agency did not recommend patients discontinue their ranitidine prescription, but concerned patients may consult their doctor about alternative treatment options.
The link between ranitidine medications and NDMA is not a typical case of drug contamination. Although the FDA is still investigating how the process works, essentially, NDMA is released within the body as the ranitidine medication reacts with stomach fluids.
On November 1, 2019, the FDA released a summary of testing results from their ongoing investigation. The agency found levels of NDMA in most recalled ranitidine products were no higher than what can be found in “common foods like grilled or smoked meats.” However, the agency also noted some products tested higher than the FDA’s acceptable limit for NDMA.
Is Zantac (ranitidine) Linked to Cancer?
Since the first FDA public statement, several voluntary recalls of ranitidine products have been issued. The cancer risk for patients taking Zantac has yet to be determined. However, patients have begun filing ranitidine lawsuits against Zantac’s current manufacturer, Sanofi, and a previous manufacturer, Boehringer Ingelheim.
What Is Zantac?
Zantac (ranitidine) is an H2 (or histamine-2) blocker that the FDA approved in 1993. By 1998, Zantac was considered one of the world’s best-selling drugs and was the first drug to exceed $1 billion in annual revenue for its original manufacturer, Glaxo Holdings Ltd. Currently, Sanofi holds the rights to the brand-name drug, and generic ranitidine is sold by multiple companies.
The drug comes in OTC (over-the-counter) and prescription strength. OTC ranitidine is often used to treat or reduce the symptoms of heartburn. Prescription-strength ranitidine may be used to treat more serious gastrointestinal problems, including stomach ulcers and gastroesophageal reflux disease (GERD).
The U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) — a part of the World Health Organization (WHO) — classify NDMA as a probable human carcinogen. NDMA, which is considered an environmental contaminant, is found in water and some food products. It is also a byproduct of several manufacturing processes. It was formerly used to make rocket fuel, but the EPA has stated that the substance is only used for research purposes in the United States today.
Studies have shown a positive correlation between high NDMA exposure and cancers of the stomach and colon. Additionally, overexposure may cause a host of health complications in humans, including liver damage.
NDMA has also been named in the recalls of some blood pressure medications in the last two years.
Despite the FDA’s assurance that only low levels of NDMA were found in their testing, many recalls and actions have been issued regarding ranitidine products. The main recalls and FDA actions are detailed below.
- June 2019 – Valisure notified the FDA of its findings regarding high levels of NDMA in Zantac and other ranitidine-containing drugs.
- September 2019 – Valisure filed a citizen petition asking the FDA to issue a ranitidine recall.
- September 13, 2019 – The FDA issued a public statement announcing that some ranitidine products may contain NDMA.
- September 23, 2019 – Sandoz Inc issued a voluntary recall of ranitidine hydrochloride capsules in varying doses — 150mg and 300mg — due to levels of NDMA above the FDA’s recommended limit.
- September 25, 2019 – As a precautionary measure, Apotex Corp. issued a voluntary recall of ranitidine tablets in several doses —75mg and 150mg — at the retail level.
- September 28, 2019 – Walgreens and CVS suspended all sales of Zantac-brand and CVS-Health-brand ranitidine products.
- October 8, 2019 – As a precautionary measure, GlaxoSmithKline recalled prescription Zantac medications.
- October 18, 2019 – As a precautionary measure, Sanofi issued a recall of all Zantac OTC in the United States and Canada.
- October 23, 2019 – Dr. Reddy’s Laboratories Ltd. issued a nationwide voluntary recall of their ranitidine heartburn medications.
- November 6, 2019 – Aurobindo Pharma USA, Inc. initiated a voluntary recall of ranitidine tablets, capsules and syrup after detecting traces of NDMA in the finished product.
- November 8, 2019 – American Health Packaging recalled eight lots of ranitidine syrup after detecting traces of NDMA in the finished product.
- November 12, 2019 – Amneal Pharmaceuticals recalled lots of ranitidine tablets and syrup due to the potential presence of NDMA above the FDA’s accepted threshold.
- November 15, 2019 – Golden State Medical Supply, Inc. issued a nationwide voluntary recall of ranitidine hydrochloride capsules (manufactured by Novitium Pharma LLC) due to the potential presence of NDMA above the FDA’s accepted threshold.
- November 19, 2019 – Precision Dose Inc. recalled several lots of ranitidine because of the possible presence of NDMA at levels higher than the FDA’s standards.
On the same day, the FDA made its first public statement concerning Zantac, the first class action lawsuit was filed against multiple Zantac drug manufacturers. Several other individual and class action lawsuits against ranitidine manufacturers have been filed so far.
Early Ranitidine Class Action Lawsuits
The first Zantac class action lawsuit was filed in the Northern District of California. Four plaintiffs filed a legal complaint against Sanofi, the current manufacturer, and Boehringer Ingelheim, the previous manufacturer. The plaintiffs claimed the two manufacturers failed to warn consumers of the established scientific link between ranitidine and NDMA on the drug’s labeling, thereby misleading and endangering patients.
The second class action lawsuit against ranitidine was filed on September 20, 2019, in the District of New Jersey. It lists similar allegations to the first complaint. Additional Zantac class action lawsuits have since been filed in New York and Connecticut.
A class action lawsuit groups together similar cases under one plaintiff or lead representative. This results in one legal proceeding for the group of lawsuits rather than one individual lawsuit per plaintiff.
Zantac Lawsuit FAQs
Who Is Eligible to File a Zantac Cancer Lawsuit?
If you or a loved one developed cancer while taking the heartburn drug Zantac or another drug containing ranitidine, you may be eligible to file a lawsuit against Zantac manufacturers. You may have a viable case if you have been diagnosed with any of the following cancers:
- Stomach Cancer
- Bladder Cancer
- Small Intestine Cancer
- Colorectal Cancer
- Esophageal Cancer
- Kidney Cancer
- Liver Cancer
- Prostate Cancer
- Pancreatic Cancer
- Non-Hodgkin’s Lymphoma
- Multiple Myeloma
Learn more about your legal options today by submitting a free case review.
What Compensation Is Available for a Zantac Lawsuit?
No ranitidine lawsuits have been settled or gone to trial yet, so the range of compensation has yet to be determined for these specific cases. However, in similar litigation, plaintiffs tend to claim common legal damages:
- Legal damages may include the cost of additional medical treatments related to a cancer diagnosis.
- Legal damages may include loss of income due to the cancer diagnosis and treatments.
- Legal damages may include physical and emotional pain from cancer.
- Some ranitidine lawsuits may seek punitive damages to punish the manufacturer for negligence and wrongdoing.
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