Zantac Lawsuits

Zantac lawsuits claim high levels of the cancer-causing chemical N-Nitrosodimethylamine, or NDMA, in the medication can increase the risk of bladder, stomach and other cancers. According to the U.S. Food and Drug Administration, the acceptable daily level of NDMA is 96 nanograms, but tests found that the amount in a single pill far exceeds that limit.

Zantac
Zantac Lawsuit Facts
  1. Injuries in Lawsuits Bladder cancer, stomach cancer and other cancers
  2. Defendants Sanofi-Aventis U.S. LLC, Sanofi US Services Inc., Chattem, Inc., Boehringer Ingelheim, Pfizer and GlaxoSmithKline
  3. Litigation status Initial stages, no trials scheduled

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.

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. So far, 14 generic manufacturers and Zantac’s brand-name manufacturer Sanofi have recalled the medication in the United States.

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.

According to the latest Zantac lawsuit update 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.” So far, 140 cases are pending in the newly formed MDL No. 2924.

The valsartan lawsuits were consolidated into MDL No. 2875 in February 2019. There are currently 219 cases pending in that litigation.

Were you diagnosed with stomach cancer or bladder cancer after taking Zantac? Get Your Free Case Review

Pharmacy Detected “Extremely High Levels” of NDMA

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.

Fact
The FDA has determined people should consume no more than 96 nanograms of NDMA a day. Valisure’s lab testing found some Zantac formulas contain more than 3,000,000 ng per tablet.

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 contaminant after “early, limited testing” of the samples using a low-heat method.

Dangers of NDMA

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.

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 of the lawsuit claims.

Lawsuits argue ranitidine is unstable. It can form NDMA when exposed to stomach conditions or a substance called nitrite found in some foods like grilled meat or preserved foods including bacon or hot dogs.

Ranitidine Linked to NDMA Formation

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.

Joseph L. Galimidi Sued Sanofi for Breast Cancer

Florida resident Joseph L. Galimidi was one of the first to file an 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.”

Galimidi v. Sanofi et al.

“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.

Zantac lawsuits concern NDMA

How Do I Qualify for a Zantac Lawsuit?

According to lawyers accepting Zantac claims, 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.

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. 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.

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

21 Cited Research Articles

  1. Agency for Toxic Substances and Disease Registry. (n.d.). Public Health Statement. Retrieved from https://www.atsdr.cdc.gov/toxprofiles/tp141-c1.pdf
  2. Combs v. Boehringer Ingelheim et al. (2019, November 14). United States District Court District Of New Jersey Trenton Division, Complaint Jury Trial Demanded. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-11-14-zantac-combs-complaint.pdf
  3. Curley, M. (2019, October 22). Pfizer, Sanofi Sued Over Possible Zantac-Cancer Link. Retrieved from https://www.law360.com/articles/1212031/pfizer-sanofi-sued-over-possible-zantac-cancer-link
  4. Curley, M. (2019, September 16). Sanofi Faces 1st US Suit Over Likely Carcinogen in Zantac. Retrieved from https://www.law360.com/articles/1199481/sanofi-faces-1st-us-suit-over-likely-carcinogen-in-zantac
  5. DeLauro, R.L. (2019, December 18) Letter to FDA. Retrieved from https://delauro.house.gov/sites/delauro.house.gov/files/DeLauro_Letter_FDA_HHS_Ranitidine.pdf
  6. Galimidi v. Sanofi US Services Inc. et al. Complaint and Demand for Jury Trial. Retrieved from https://www.law360.com/articles/1199481/sanofi-faces-1st-us-suit-over-likely-carcinogen-in-zantac
  7. Garcia, S.E. (2019, September 30). Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears. Retrieved from https://www.nytimes.com/2019/09/30/health/zantac-recall-cancer.html
  8. Shen, R. & Andrews, S.A. (2011). Demonstration of 20 pharmaceuticals and personal care products (PPCPs) as nitrosamine precursors during chloramine disinfection. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/20950838
  9. Toxicology Data Network. (n.d.). N-NITROSODIMETHYLAMINE. Retrieved from https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+1667
  10. U.S. Food and Drug Administration. (2019, October 11). FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  11. U.S. Food and Drug Administration. (2019, October 11). Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac#targetText=To%20date%2C%20two%20manufacturers%20have,take%20are%20safe%20and%20effective.
  12. United States District Court for the District of Connecticut. (2019, September 26). Class Action Complaint, Jury Trial demanded. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-09-26-Complaint.pdf
  13. United States District Court for the Northern District of California. (2019, September 13). Class action Complaint, Jury Trial Demanded. Retrieved from https://www.classaction.org/media/garza-et-al-v-sanofi-aventis-us-llc-et-al.pdf
  14. United States District Court of New Jersey. (2019, September 20). Complaint and Demand for Jury Trial. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-9-20-zantac-class-action.pdf
  15. United States Environmental Protection Agency. (2014). Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA). Retrieved from https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf
  16. United States Judicial Panel on Multidistrict Litigation. (2019, February 25). In Re: Valsartan Products Liability Litigation, Conditional Transfer Order. Retrieved from https://www.njd.uscourts.gov/sites/njd/files/2875cto1.pdf
  17. United States Judicial Panel on Multidistrict Litigation. (2020, February 19). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-Febraury-19-2020.pdf
  18. United States Judicial Panel on Multidistrict Litigation. (2020, February 6). In Re: Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924. Transfer Order. Retrieved From https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2924-Transfer%20Order-1-20.pdf
  19. Valisure. (2019, September 9). Valisure Citizen Petition on Ranitidine. Retrieved from https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf
  20. World Health Organization. (2002). Concise International Chemical Assessment Document 38: N-Nitrosodimethylamine. Retrieved from https://www.who.int/ipcs/publications/cicad/en/cicad38.pdf
  21. Zeng, T. & Mitch, W.A. (2016). Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Retrieved from https://academic.oup.com/carcin/article/37/6/625/1744630
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