Zantac (Ranitidine) Lawsuit Information
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, or NDMA, in some batches of Zantac and its generic, ranitidine.
Retailers including Walmart, Walgreens, CVS and Rite Aid pulled prescription and over-the-counter formulas of Zantac from their shelves. And 14 generic manufacturers and Zantac’s brand-name manufacturer Sanofi recalled the medication in the United States.
On April 1, 2020, the FDA announced it was requesting manufacturers of all ranitidine products remove prescription and over-the-counter ranitidine drugs from the market. The agency said new FDA tests show a risk to public health.
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. But unlike valsartan, which was contaminated with NDMA during manufacturing, Zantac lawsuits claim ranitidine actually forms NDMA in the body.
In February 2020, the United States Judicial Panel on Multidistrict Litigation consolidated the lawsuits in the Southern District of Florida under U.S. District Judge Robin Rosenberg. In its transfer order, the panel said the anti-acid drug cases “could be a large litigation.”
According to the panel’s Aug. 17, 2020, statistics report, 299 cases were pending in the newly formed MDL No. 2924.
The valsartan lawsuits were consolidated into MDL No. 2875 in February 2019. There are currently 575 cases pending in that litigation.
Valisure alerted the U.S. Food and Drug Administration that it “detected extremely high levels of N-Nitrososdimethylamine (‘NDMA’), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine,” according to its citizen petition.
The FDA has determined that daily intake of NDMA should not exceed 96 nanograms — one billionth of a gram. 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.
While the Agency for Toxic Substances and Disease Registry doesn’t have adequate studies to show how exposure to NDMA in food or drink may affect humans long term, evidence shows NDMA can cause cancer and death in animals. It is also very toxic to the liver in animals and humans.
In a public health statement, the agency said, “Although there are no reports of NDMA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.” Exposure to NDMA doesn’t necessarily lead to health problems.
Organs potentially affected by NDMA include the bladder, brain, liver, kidneys, lungs and stomach, according to a report by the World Health Organization.
In December 2019, Congresswoman Rosa L. DeLauro urged the FDA to remove ranitidine from shelves and ban all sales in the United States because of the cancer risk.
“Valisure’s data, in combination with four decades of scientific research, strongly suggests that ranitidine is a fundamentally unstable molecule and all products containing this drug have a risk of cancer,” DeLauro said in her letter to the FDA.
Lawsuits argue that as far back as 1981, drugmakers were aware of several studies pointing to the dangers of NDMA formation with Zantac. The studies found that the potential of forming NDMA increases when ranitidine makes contact with nitrite in the body, according to a lawsuit filed by Michael and Deborah Combs.
The Combs’ complaint lists other more recent studies that connect ranitidine to NDMA formation. One 2011 study by Ruqiao Shen and Susan A. Andrews observed that ranitidine could form NDMA when exposed to drinking water disinfected with chlorine.
Another cited study from 2016 by Teng Zeng and William A. Mitch found evidence suggesting ranitidine could form NDMA when combined with nitrite in “stomach relevant pH conditions.” They also found NDMA excreted in the urine over a 24-hour period after taking ranitidine “increased 400-folds from 110 to 47 600ng, while total N-nitrosamines increased 5-folds.”
Despite this information, lawsuits say drugmakers failed to warn the public.
How Do I Qualify for a Zantac Lawsuit?
According to Zantac lawyers, people must satisfy three conditions to potentially qualify for a lawsuit — proven Zantac use, a cancer diagnosis and a connection between the diagnosis and Zantac.
Only a lawyer can properly evaluate a claim, and they can help gather medical records and evidence to build a case.
Zantac Use
Potential claimants have to prove they took Zantac or other ranitidine product. People who have a prescription can provide proof of prescription through medical records. But those who took over-the-counter Zantac must have a receipt and other evidence that shows they took the drug, such as a statement or doctor’s note.
Cancer Diagnosis
The main injury claimed in Zantac and ranitidine lawsuits is cancer. Potential claimants have to have a diagnosis of a type of cancer linked to NDMA. Lawyers list stomach, intestine, colorectal, bladder, esophageal and liver cancer as the main cancers associated with NDMA in claims.
Connection Between Cancer Diagnosis and Zantac
Generally, taking higher medication doses consistently can help prove the connection. The length of time someone has used the drug also affects the case. For example, some lawyers say claimants should have taken the drug for at least a year before receiving a cancer diagnosis.
There are several proposed Zantac class actions filed by attorneys on behalf of people in New Jersey, California, Florida, Connecticut and Massachusetts. Anyone who bought Zantac or generic ranitidine can join the class action. They don’t have to have a cancer diagnosis. They only have to prove they bought the drug and did not receive a warning about the cancer risk.
Rather than claim individual injuries, 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.
I will keep all members of this support group up to date as more information regarding the lawsuits regarding Zantac become available.
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