People who suffered bladder cancer, stomach cancer or other cancers after taking contaminated Zantac are filing lawsuits against drug manufacturers. After lab tests found high levels of the cancer-causing chemical N-nitrosodimethylamine (NDMA) in some batches of Zantac, retailers stopped selling it, and some manufacturers recalled the drug. Defendants face individual and class action lawsuits.
In September 2019, Valisure, an online pharmacy based in Connecticut, informed the U.S. Food and Drug Administration that it had found the cancer-causing chemical N-nitrosodimethylamine (NDMA) in some batches of Zantac (ranitidine).
Shortly after the FDA announcement, retailers including Walmart, Walgreens, CVS and Rite Aid pulled prescription and over-the-counter formulas of Zantac from their shelves.
Drug makers Sanofi, Sandoz and Apotex issued recalls for some lots of the drug.
Zantac lawsuits claim Sanofi and other defendants knew about the dangers of NDMA in Zantac but failed to properly warn the public. People who developed cancer — especially bladder and stomach cancer — may be entitled to compensation.
This isn’t the first time manufacturers found NDMA contamination in drugs. In 2018, contamination led to valsartan recalls and lawsuits.
Pharmacy Detected “Extremely High Levels” of NDMA
Online pharmacy Valisure found the NDMA contamination in ranitidine during “routine analysis of drug products in its pharmacy,” according to the company’s Sept. 9, 2019, citizen petition to the FDA.
Based on its findings, Valisure asked the FDA to “recall and suspend sale of all lots of all products containing ranitidine.”
To date, the FDA has not told consumers to stop taking the drug.
The FDA has determined that daily intake of NDMA should not exceed 96 nanograms — one billionth of a gram — according to Valisure’s petition.
When Valisure tested individual tablets, it found 2,511,469 ng of NDMA in Zantac OTC and 3,267,968 ng of NDMA in Zantac Cool Mint from CVS.
The FDA has said that Valisure’s method of high-temperature testing may have increased the levels of NDMA in samples, but still reported unacceptable levels of the contaminate after “early, limited testing” of the samples using a low-heat method.
Plaintiffs Claim Defendants Failed to Warn About Cancer Risk
The main claim in individual Zantac lawsuits is that defendants failed to properly warn the public of the dangers of NDMA and cancer. While Zantac’s active ingredient may cause other side effects, these are not a part lawsuit claims.
Joseph L. Galimidi Sued Sanofi for Breast Cancer
Florida resident Joseph L. Galimidi filed the first individual Zantac lawsuit in the United States against Sanofi on Sept. 13, 2019. Galimidi had been taking Zantac since 2009 and developed breast cancer, which is rare in men, in 2013.
He demands compensation for his injuries, pain and suffering.
“Despite their knowledge of the risks of cancer associated with Ranitidine and Zantac … Defendants continued to represent that Ranitidine products, including Zantac, did not pose any risks of cancer or other serious health conditions.”
“While his heartburn was healed, Zantac — laden with N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen — wreaked havoc in his body and led to his breast cancer,” Galimidi’s complaint said.
During the time Zantac and other ranitidine products have been sold in the United States, there have been reports of cancers linked to Zantac. Galimidi argues Sanofi had plenty of time to study the link and warn the public, but it did not.
Mark Allan Blake Said Zantac Caused Bladder Cancer
Colorado resident Mark Allan Blake filed his Zantac lawsuit against Sanofi US Services Inc., Chattem, Inc., Boehringer Ingelheim, Pfizer and GlaxoSmithKline on Oct. 21, 2019.
Blake started taking prescription Zantac in 1996. He then switched to Zantac OTC which he took four times a week. Doctors diagnosed him with bladder cancer in 2018, and he believes the drug caused it.
According to Blake’s complaint, research has shown that Zantac can produce high levels of NDMA since at least 1981. Manufacturers should have known this and warned the public, but they did not.
“This was not done by accident or through some justifiable negligence. Rather, Defendants knew that it could turn a profit by convincing consumers that Zantac was harmless to humans, and that full disclosure of the true risks of Zantac would limit the amount of money Defendants would make selling Zantac,” Blake’s complaint said.
Is There a Zantac Class Action?
There are several proposed Zantac class actions filed by attorneys on behalf of people in New Jersey, California, Florida, Connecticut and Massachusetts.
Rather than claiming Zantac physically injured plaintiffs, these class actions say the drug is defective and that people who bought it are entitled to refunds.
“Neither Sanofi nor Boehringer ever disclosed to consumers that the drug has a critical defect: When ingested, Zantac produces in the human body high quantities of N-Nitrosodimethylamine (NDMA), a chemical that the World Health Organization has described as ‘clearly carcinogenic,’” according to the plaintiffs’ complaint and demand for a jury trial.
When Valisure tested Zantac “in conditions simulating the human stomach,” the quantity of NDMA detected was 3,171 times more than the FDA’s recommended daily limit, the complaint said. If plaintiffs had known the drug was defective, they would not have purchased it.
Ranitidine Manufacturers and Recalls
Drug retailers Walmart, Walgreens, CVS and Rite Aid have pulled Zantac from their shelves. In addition, manufacturers Sandoz and Apotex have recalled certain lots of the drug.
At first, Sanofi — the manufacturer of brand-name Zantac — did not issue a recall even when other companies did. The company told the New York Times that preliminary NDMA levels in the medicine “barely exceed amounts found in common foods.”
Then on Oct. 18, 2019, Sanofi said it was issuing a voluntary recall of brand-name Zantac OTC, the over-the-counter formula of the drug, in the United States and Canada.
The company said evaluations were ongoing. Sanofi told people to talk to their health care providers and pharmacists if they had additional questions.
The Sandoz recall issued on Sept. 23, 2019 affects 150 mg and 300 mg doses of ranitidine in 20, 60 and 500 count bottles. Consumers can ask their local pharmacists for help identifying recalled lot numbers.
Apotex supplies generic ranitidine to Walgreens, Walmart and Rite Aid. The company issued a precautionary recall on Sept. 25, 2019. Its recall affects store brands of ranitidine 75 mg and 150 mg tablets.
- Ranitidine tablets, USP 150 mg - acid reducer (Rite Aid, Walmart)
- Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer (Walgreens)
- Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer (Walgreens)
- Cool mint ranitidine tablets, USP 150 mg - acid reducer (Rite Aid)
Dr. Reddy’s Recalls
On Oct. 1, 2019, Dr. Reddy’s Laboratories issued a recall for its ranitidine products, available from several retailers. It affects ranitidine tablets in 75 mg, 150 mg and 300 mg strengths packaged in counts from 24 to 500.
For information on specific NDC numbers, check Dr. Reddy’s recall announcement on the FDA’s website.
- Sam’s Club
- Thirty Madison
- Chain Drug Marketing Association (CDMA)
- HCA Pharmacy
How Dangerous Is NDMA?
So far, the FDA doesn’t have enough information to know when the NDMA contamination of Zantac began or whether people should continue taking ranitidine. It is still conducting tests and will provide more information as it becomes available.
Food and water have some levels of NDMA, but typically the levels are not enough to cause harm. However, according to Valisure’s data, a single tablet of Zantac may contain amounts of NDMA several thousand times more than is safe.
According to the Environmental Protection Agency, animals exposed to the chemical have developed tumors in the liver, blood vessels, kidneys and respiratory tract.
NDMA is a “probable human carcinogen.” This means it is a potent carcinogen in animals, but there aren’t enough studies to verify its carcinogen effects on humans.
In humans, the most common signs of acute NDMA poisoning are stomach cramps, nausea and vomiting that can occur within hours, according to studies from the U.S. National Library of Medicine’s Toxicology Data Network. Headaches, fever and weakness may occur, followed by jaundice and enlargement of the liver.
Please seek the advice of a medical professional before making health care decisions.