Can I Sue If Zantac Gave Me Cancer?

by Jeffrey Nadrich Managing Partner, Nadrich & Cohen, LLP

Yes, you can file a lawsuit if Zantac (ranitidine) gave you cancer. A multidistrict litigation (MDL) was formed in February consolidating 15 Zantac lawsuits and over 125 “tag-along” actions. Experts expect the MDL to cover over 100,000 claimants before it ends and expect the MDL to end in a settlement instead of a trial. Defendants in the MDL include Pfizer Inc., Sanofi US Services Inc., GlaxoSmithKline and Boehringer Ingelheim Pharmaceuticals Inc. Defendants in the MDL are accused of hiding the presence of N-nitrosodimethylamine (NDMA), a probable carcinogen, in their drugs, false advertising, failure to warn and more. The MDL’s plaintiffs have been diagnosed with colon cancer, esophagus cancer, breast cancer, bladder cancer and other types of cancer. The MDL’s focus is on NDMA’s presence in medications containing ranitidine and corporations’ duty of care to test their drugs for the presence of NDMA.

Zantac cancer claims fall under the area of law known as product liability. There are three general types of product liability claims:

• Design defect: Products with a design defect are made correctly according to manufacturing specifications. However, the design makes the product unreasonably dangerous or the product doesn’t perform as it is expected to when used correctly.

• Manufacturing defect: Products with manufacturing defects are designed safely but something goes wrong in the manufacturing process causing the product to become unsafe.

• Failure to warn: Products in these claims are designed and manufactured properly, but the product’s packaging fails to warn about potential dangers or fails to provide adequate instructions. The failure to warn or provide adequate instructions makes the product dangerous.

All three of these areas of law may eventually come into play in the Zantac MDL.

Valsartan is another drug which has been found to be tainted by NDMA. It is believed that the cause of valsartan contamination was changes in how the drug was manufactured in overseas manufacturing plants in China and India. If this suspicion is true, it would mean that contaminated valsartan would be an example of a medication with a manufacturing defect. It is possible that Zantac NDMA contamination was also the result of changes in manufacturing methods.

Testing laboratory Emery Pharma found that NDMA is gradually formed over time in ranitidine samples which are exposed to heat. Emery exposed a ranitidine sample to 158 degrees Fahrenheit and the sample exceeded the FDA daily NDMA intake limit of 96 nanograms after five days of being exposed to the heat. The sample contained 142 nanograms of NDMA after 12 days at the same temperature. A sample Emery exposed to 77 degrees Fahrenheit contained 25 nanograms of NDMA after 12 days. If this phenomenon of NDMA forming in the drug when the drug is exposed to heat was caused by changes in manufacturing methods, then there would be legitimate grounds for a manufacturing defect claim. If this phenomenon of NDMA forming in the drug occurs even when the drug is manufactured correctly, then there would be legitimate grounds for a design defect claim.

Zantac’s labeling did not warn of the presence of NDMA and did not warn of any cancer risk attached to the drug. Physicians may not have recommended or prescribed Zantac if they had been informed of these risks by Zantac’s label. Patients may have decided not to take the drug if they had been informed of these risks by the label. Thus, there may be legitimate grounds for a failure to warn claim in the Zantac MDL.

The United States Food and Drug Administration (FDA) requested that all ranitidine products be removed from the United States market in April. The agency determined that the amount of NDMA in some ranitidine products increases over time and when exposed to heat and this might expose consumers to unacceptable NDMA levels.

NDMA is classified as a probable carcinogen by the U.S. Environmental Protection Agency. Rats are sometimes given NDMA because the NDMA gives the rats cancer which scientists can then study. NDMA has been in the news regarding its use in cases of intentional poisoning.

Exposure to NDMA can lead to nausea, vomiting, headaches and fever. It can also affect liver, kidney and lung function.

Ranitidine is a histamine-2 blocker. It decreases the amount of acid which the stomach produces. It was approved for over-the-counter relief and prevention of acid indigestion and heartburn associated with sour stomach. It was approved for many prescription uses, including treatment and prevention of ulcers of the stomach and intestines as well as treatment of gastroesophageal reflux disease.

About the author

Jeffrey Nadrich is the managing partner of Nadrich & Cohen, LLP, a California personal injury law firm with offices in Los Angeles, San Francisco, Fresno, Modesto, Tracy and Palm Desert. He founded Nadrich & Cohen, LLP in 1990 and the firm has recovered over $350,000,000 on behalf of clients in the time since. For more information on Zantac lawsuits, visit https://www.personalinjurylawcal.com/zantac-attorneys/