Zantac Ranitidine Lawsuit - Legal Claims for Cancer Caused by NDMA


A Zantac lawsuit is a claim for financial compensation by people who got cancer after taking the heartburn medication. Plaintiffs allege that drug manufacturers failed to warn them that Zantac (ranitidine) contains the carcinogen NDMA. This is the same carcinogen that is believed to have caused cancer in consumers of the blood pressure medications Valsartan and Losartan.

In 2019, the Food and Drug Administration (FDA) announced it found "unacceptable amounts" of NDMA in ranitidine. Since then more than a dozen pharmaceutical companies have recalled the drug. And many pharmacies have stopped selling it as a prescription or over the counter (OTC).

Shouse Law Group is helping Zantac victims throughout the United States sue the drug manufacturers. We are fighting to collect money damages to cover their doctor's bills, lost earnings, and pain and suffering.

Our ranitidine lawsuits are not part of a class action. Instead, they are individual lawsuits of the victim against the manufacturer. The claims will be consolidated into multidistrict litigation (MDL). This will expedite the settlement process.

We are accepting clients who developed any of the following diseases after taking Zantac or its generic ranitidine:

  • Bladder cancer
  • Liver cancer,
  • Stomach cancer,
  • Intestinal cancer (including colon or rectal cancer),
  • Esophageal cancer,
  • Pancreatic cancer,
  • Leukemia,
  • Prostate cancer (for patients diagnosed at age 65 or younger),
  • Non-Hodgkins lymphoma, or
  • Multiple myeloma

There is a short window to file suit. So be sure to consult with an attorney soon.

In this article, our Zantac lawyers discuss:

Zantac box
Zantac users who developed cancer may have legal grounds to sue.

1. What are the grounds for a Zantac lawsuit?

Two claims victims can sue drug manufacturers for are:

  1. The drug had a defective design, and
  2. The drug's labeling failed to warn about its risks

1.1 Defective design

Courts hold ranitidine manufacturers to a strict liability standard. Therefore, drug makers are responsible if:

  1. The drug's defective design posed a foreseeable risk, and
  2. The drug was manufactured and used as it was supposed to be1

According to online pharmacy Valisure, ranitidine molecules are inherently unstable. When a person ingests a normal dosage, it converts into the carcinogen NDMA (N-nitrosodimethylamine). In short, NDMA is a natural by-product of ranitidine's ingredients.2

Therefore, it does not matter which pharmaceutical company manufactured the drug. By design, Zantac reacts with the body's chemistry to create NDMA. Therefore, all lots of Zantac are potentially cancer-causing.

Common evidence of design defects includes the original Zantac formula. Plaintiffs' attorneys will also rely on expert witnesses to testify about the design problems.

1.2 Improper labeling/ failure to warn

Like all medications, Zantac has a warning label. But its label omits any mention of its carcinogenic risks.

Had physicians been informed of the risks, they may not have recommended or prescribed Zantac. And had patients known of the risks, they may have elected against taking it.

The best evidence of failure to warn is the Zantac packaging itself. Its omission of NDMA-related information suggests consumers were not fully informed of the dangers.

(In some states, brand name drug manufacturers have a legal duty to warn users of generic versions they do not make. In other states, these manufacturers do not have a duty to warn. So which state the victim sues in will dictate how to craft the lawsuit.)3

2. What is the evidence that Zantac causes cancer?

According to online pharmacy Valisure, ranitidine's inherent instability causes a chemical reaction that produces high levels of NDMA in the digestive track. This is particularly true when nitrates are present.

The FDA disagrees. It claims that typical stomach conditions should not cause ranitidine to metabolize into NDMA. Instead, the FDA maintains that NDMA is an impurity found in the drug itself. But it also admits more research is needed.4

Either way, the US Environmental Protection Agency (EPA) classifies NDMA as a “probable human carcinogen." In other words, it probably causes cancer in people. Currently, research scientists use NDMA to cause cancer in lab rats.5

NDMA is safe in humans if limited to 96 nanograms per day.6 But one Zantac tablet contains about 2.5 to 3 million nanograms. That is 26,000 to 31,000 times the recommended daily maximum.7 And studies show that people who take Zantac have a 400-fold increase of NDMA in their urine.8

Plaintiffs in a Zantac lawsuit need proof they took the drug. Frequent usage over a sustained period of time strengthens their case. Helpful evidence includes:

  • Pharmacy records (if the Zantac was prescribed),
  • Receipts,
  • Pill bottles/ packaging, and
  • Medical records that show the plaintiff developed cancer after taking Zantac

It may be challenging for OTC users to show proof of Zantac usage. Most people do not keep their receipts or pill bottles. But the following records could help:

  • Rx prescription drug cards,
  • Health flexible spending accounts (FSA),
  • Health saving accounts (HSA),
  • Health reimbursement accounts (HRA), and/or
  • Affidavits or declarations by the victim that he/she took OTC Zantac

3. Is this a class action or individual lawsuits?

Individual lawsuits. But every Zantac lawsuit will eventually be joined into an MDL -- short for "multi-district litigation." Currently, there is an MDL out of the Southern District of Florida (West Palm Beach). The MDL number is 2924. The judge is US District Judge Robin L. Rosenberg.

MDLs are a way for courts to streamline pretrial proceedings. Eventually, the MDL judge will permit a handful of cases to proceed to trial. The results of these bellwether trials set the tone for future negotiations.

MDLs are fundamentally different from class actions. In MDLs, every case remains separate. In class actions, they are all combined.

There currently are some pending class actions against ranitidine manufacturers. But they are geared for people who bought ranitidine but have not gotten sick. These plaintiffs simply want their money back. They would not have bought the ranitidine had they known of the risks.9

4. Has Zantac been recalled?

The FDA issued a warning on September 13, 2019. Since then, more than a dozen manufacturers have voluntarily recalled their ranitidine products. And the FDA is evaluating whether ranitidine should be officially recalled.

In addition, the following are some of the retailers that stopped selling ranitidine:

5. Have there been any settlements yet?

No. Settlement talks typically do not begin until some cases go to trial. How these bellwether trials turn out helps gauge what money victims can demand.

Predictably, plaintiffs attorneys are aiming very high. No amount of money can make up for getting cancer.

6. Who makes Zantac?

More than 10 manufacturers make prescription Zantac. And more than 20 make OTC Zantac. Manufacturers that have recalled its ranitidine products include:

GSK originally developed prescription ranitidine in 1977. It was FDA-approved in 1983 and went generic the following year. It helps prevent and treat:

  • Heartburn,
  • GERD (gastroesophageal reflux disease),
  • Ulcers,
  • Acid reflux, and
  • Sour stomach

Pfizer developed OTC ranitidine in 2004. Boehringer Ingelheim purchased it in 2006. Then Sanofi purchased it in 2017.

Ranitidine is available in various forms, including capsules, tablets, and syrup. Common dosages include 75 mg, 150 mg, and 300 mg.

Ranitidine was one of the first drugs to bring in a billion dollars in sales.10

Receptionists waiting for your call.
Call our Zantac attorneys today. 877-504-7750. We offer FREE consultations.

Are you a Zantac victim? Contact us for help...

Diagnosed with cancer after taking Zantac? We are so sorry. Please let us help you.

Contact our Zantac lawsuit attorneys at (877) 504-7750. Or fill out the form on this page. We offer free consultations 24/7.

We are resolved to fighting for the biggest settlement available in your case. And we take no payment unless we win.

Legal References

  1. See, e.g., In re Testosterone Replacement Therapy Prods. Liab. Litig., 136 F. Supp. 3d 968 (N.D. Ill. 2015).

  2. Valisure, Citizen Petition on Ranitidine (September 9, 2019).
  3. See, e.g., Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 481-483 (2013); see, e.g., TH Novartis Pharm Corp., 4 Cal 5th 145, 407 P.3d 18 (Cal. 2017); Katie Thomas, "In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs", New York Times (June 24, 2013). 
  4. 12/4/2019: UPDATE – FDA requires additional testing of ranitidine and nizatidine as part of agency's ongoing effort to help ensure product safety for patients and consumers, FDA Updates and Press Announcements on NDMA in Zantac (ranitidine).
  5. Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA (January 2014).
  6. See note 4.
  7. See note 2.
  8. Teng Zeng, William A. Mitch, Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine, Carcinogenesis, Volume 37, Issue 6, June 2016, Pages 625–634.
  9. Garza et al v. Sanofi-Aventis U.S. LLC et al, 19-cv-05772, U.S. District Court for the Northern District of California (filed September 13, 2019); MDL transfer order
  10. TIMELINE-Popular heartburn medicine Zantac pulled off store shelves, (October 2, 2019).        

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