A Zantac lawsuit is a legal claim for financial compensation by plaintiffs who took the heartburn medication and were later diagnosed with cancer. Zantac (and the generic version ranitidine) have been found to contain the carcinogen NDMA. Studies have linked this hepatotoxin to cancer in both animals and humans.
On April 1, 2020, the U.S. Food and Drug Administration (FDA) requested that all companies withdraw their ranitidine products. The FDA had found “unacceptable amounts” of NDMA in the ingredient ranitidine. Since then, more than a dozen pharmaceutical companies have recalled the drug.
Shouse Law Group is a mass tort law firm that represents Zantac victims throughout the United States. We represent victims who took the prescription, over-the-counter, and/or generic ranitidine versions. Our Zantac lawyers are seeking to collect money damages to cover
- medical bills,
- lost earnings,
- pain and suffering,
- loss of enjoyment, as well as
- punitive damages.
The ranitidine lawsuits are not part of a class action. Instead, these are individual lawsuits of the victim against the drugmaker. Many of the claims will join into a multidistrict litigation (MDL). This will expedite the litigation and settlement process.
In terms of case criteria, our firm is accepting cases where the person took Zantac or ranitidine and afterward was diagnosed with any of the following types of cancer:
There is a short statute of limitations or time limit in which to bring a claim following the cancer diagnosis. So be sure to consult with an attorney quickly.
In this article, our personal injury lawyers will answer the following 8 key questions:
What are the grounds for a Zantac lawsuit?
Two claims victims can sue drug manufacturers for are that:
- The drug had a defective design, and
- The drug’s labeling failed to warn about its risks
Courts hold ranitidine manufacturers to a strict liability standard. Therefore, drug makers are responsible if:
- The drug’s defective design posed a foreseeable risk, and
- 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 of Zantac products, the active ingredient ranitidine hydrochloride converts into the carcinogen NDMA (N-nitrosodimethylamine). In short, the presence of NDMA contaminants 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 contamination. Therefore, all batches of Zantac are potentially carcinogenic.
Common evidence of design defects includes the original Zantac formula. The plaintiffs’ attorneys will also rely on expert witnesses to testify about the design defects.
Improper labeling and 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 likely would not have recommended or prescribed Zantac. And had patients known of the risks, they likely would have elected against taking it. After all, there are plenty of alternative heartburn and acid reflux medications that don’t carry these risks.
The best evidence of failure to warn is the Zantac packaging itself. The disclaimer’s 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
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 tract. This is particularly true when nitrates are present. (Nitrates are found in foods such as bacon, hot dogs, or grilled meats.)
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 on April 1, 2020, it also admitted that storing ranitidine at higher than room temperature “may result in consumer exposure to unacceptable levels of this impurity.” Since then, the FDA discovered that NDMA may form by storing ranitidine even at room temperature, and that more NDMA forms the longer the ranitidine is stored before consumption.4
Either way, the World Health Organization and the US Environmental Protection Agency (EPA) classify NDMA as a “probable human carcinogen.” In other words, it probably causes cancer in people. Currently, research scientists use NDMA to induce cancer in lab rats for research purposes.5 NDMA has actually been used to make rocket fuel. It has also been found in the blood pressure medicines Valsartan and Losartan. These drugs are also the subject of a large set of lawsuits by cancer victims.
NDMA exposure is safe in humans if limited to 96 nanograms per day. 6 But one tablet of the heartburn drug Zantac 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 levels in their urine. 8 It will be difficult for drug companies to deny the increased cancer risk that this level of exposure causes.
Plaintiffs in a Zantac lawsuit need to prove that they took the drug. Frequent usage over a sustained period of time strengthens their case. Helpful evidence includes:
It may be challenging for OTC (over the counter) users to show proof of Zantac usage. Most people do not keep their receipts or pill bottles for over the counter Zantac. But the following records could help:
Is this a class action or individual lawsuits?
Individual claims rather than class-action lawsuits. But every Zantac lawsuit is being joined into an MDL – short for “multi-district litigation.” 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.
Has all Zantac been recalled?
On April 1, 2020, the FDA issued in effect a Zantac recall requesting that all name-brand and ranitidine manufacturers withdraw the drug. This follows a warning the FDA issued on September 13, 2019. In the interim, more than a dozen manufacturers have made a voluntary recall of their ranitidine medications:
|Recall Date||Brand Name||Recalled Product||Company|
|02/27/2020||American Health Packaging||Ranitidine Tablets, USP 150mg||American Health Packaging|
|01/08/2020||Mylan Pharmaceuticals Inc.||Nizatidine Capsules 150mg and 300mg (similar to Ranitidine)||Mylan N.V.|
|01/08/2020||Northwind||Ranitidine Tablets 150mg and 300mg||Denton Pharma, Inc. dba Northwind Pharmaceuticals|
|01/07/2020||ani||Ranitidine Tablets 150mg and 300mg||Appco Pharma LLC|
|12/17/2019||Glenmark||Ranitidine Tablets 150mg and 300mg||Glenmark Pharmaceuticals, Inc.|
|11/22/2019||Amneal||Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL||Amneal Pharmaceuticals, LLC|
|11/19/2019||PrecisionDose||Ranitidine Oral Solution, USP 150 mg/10 mL||Precision Dose Inc.|
|11/15/2019||GSMS Incorporated||Ranitidine HCl 150mg and 300mg Capsules||GSMS, Inc.|
|11/08/2019||AHP||Ranitidine Liquid Unit Dose Cups||American Health Packaging|
|11/06/2019||Aurobindo & DG Health||Ranitidine||Aurobindo Pharma USA, Inc.|
|10/25/2019||Novitium Pharma||Ranitidine Hydrochloride Capsules 150 mg and 300 mg||Novitium Pharma|
|10/25/2019||Lannett Company, Inc.||Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL||Lannett Company, Inc.|
|10/23/2019||Dr. Reddy’s, Kroger, Walgreens, and others||Ranitidine Tablets & Capsules||Dr. Reddy’s Laboratories Ltd.|
|10/23/2019||Sanofi||Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products)||Sanofi|
|10/23/2019||Perrigo Company plc||Ranitidine (all pack sizes)||Perrigo Company plc|
|09/25/2019||Apotex Corp.||Ranitidine Tablets 75mg and 150mg||Apotex Corp.|
|09/23/2019||Sandoz Inc.||Ranitidine Hydrochloride Capsules||Sandoz Inc.|
The FDA also asked manufacturers to do their own laboratory tests on all their ranitidine products and to mail the FDA samples. The FDA further instructed manufacturers not to sell any lots that show more than the daily NDMA limit of 96 nanograms. And manufacturers must notify the FDA if any lots do exceed the NDMA limit.
The following are some of the retailers that stopped selling ranitidine:
Some of the common ranitidine brands include:
Alternatives to generic Zantac that do not contain NDMA include:
Have any settlements been reached 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.
Although the Zantac litigation has incurred some delays because of the COVID 19, it is still proceeding according to schedule. The biggest obstacle at the moment is the difficulty in (safely) impaneling juries for the bellwether trials.
MDL settlements typically resolve through either:
- Global (or matrix) settlements: Defendants pay out a sum that covers all claims. And plaintiffs’ attorneys use a matrix of criteria to determine how much each plaintiff receives; or
- Inventory settlements: Each plaintiff agrees to an acceptable minimum amount. And if their attorneys win a larger amount, each client will receive a percentage of the bonus funds.
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. As a histamine-2 / H2 blocker antacid, ranitidine drugs help to neutralize stomach acid and prevent and treat:
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
What are Zantac’s long-term effects?
Cancer is not the only potential consequence of taking Zantac. There are at least twenty other medical conditions linked to the use of ranitidine:
- Liver failure or reduced liver function
- Reduced kidney function
- Reduced lung function
- Enlarged liver
- Skin rash
- Hair loss
- Vitamin B-12 deficiency
- Reduced platelet levels
- Cardiac arrhythmia (irregular heartbeat) and/or tachycardia (rapid heartbeat)
- Nervous system problems
- Elevated pneumonia risks
- Nausea and vomiting
- Stomach cramps, constipation and/or diarrhea
- Dizziness, drowsiness, and/or sleep problems
- Tender breasts (in males)
- Decreased sex drive
Some short-term effects of Zantac include scarring and fibrosis of the liver.
In addition, many people diagnosed with cancer after taking Zantac are also being diagnosed with:
- Crohn’s Disease – an inflammatory bowel and digestive track disease, causing diarrhea, pain, losing weight, and cramping; and/or
- PPH (Primary Pulmonary Hypertension) – when the lungs’ blood vessels narrow, causing high blood pressure in the pulmonary artery
What is happening with recent Zantac cases?
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. The defendants include:
This MDL is for people who developed cancer after taking ranitidine. All similar lawsuits will be consolidated into this MDL. And they are seeking substantial damages to cover all of their expenses. As of February 17, 2021, there are 562 plaintiffs; thousands more are expected. Discovery is expected to be done by the end of 2021.
There currently are some pending Zantac class actions against ranitidine manufacturers. But they are geared for people who bought ranitidine but have not gotten sick:
The first class action was filed on Sept. 13, 2019, in the Northern District of California federal court. The plaintiffs claim Sanofi and Boehringer Ingelheim knowingly made and sold OTC Zantac with a carcinogen. These plaintiffs want their money back. They would not have bought the ranitidine had they known of the risks.
Another class action with 13 plaintiffs was filed in the Southern District of Ohio federal court on January 22, 2020. Plaintiffs are seeking equitable remedies. This includes medical monitoring.11
If you, a loved one, or a family member were diagnosed with cancer after taking Zantac, call our attorneys for a free case evaluation. Or fill out the form on this page. Our legal team is available to assist you 24/7.
- Valisure, Citizen Petition on Ranitidine (September 9, 2019). In its study, Valisure employed gas chromatography testing and a HS-C-MS methodology. Ranitidine’s Nitroso (O=N) combines with its own DMA (H3C-N-CH3) to form NDMA. Valisure also says that the enzyme dimethylarginine dimethylaminohydrolase (DDAH) interacts with ranitidine to free DMA from ranitidine, which in turn allows it to combine with available nitrites, which in turn could increase the amount of NDMA in the body. During tests, Valisure found 2,511,469 ng of NDMA in Zantac OTC and 3,267,968 ng of NDMA in Zantac Cool Mint. Brendan Pierson, Judge finds economic injury, design defect claims preempted in Zantac MDL, Reuters (January 8, 2021). See also Andrea D. Steffen, Some Drugs Transform Into A Cancer-Causing Chemical In The Stomach, Intelligent Living (Marc 28, 2021).
- 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).
- 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); 4/1/20: FDA Requests Removal of All Ranitidine Products (Zantac) from the Market.
- Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA (January 2014), NDMA is a B2 carcinogen; note that EPCRA (the Emergency Planning and Community Right-to-Know Act of 1986) classified NDMA as “extremely hazardous.”; the International Agency for Cancer Research (IARC) of the World Health Organization categorized the genotoxin NDMA as Group 2A (probably carcinogenic to people) – rats developed tumors whether they were exposed orally, through inhalation, subcutaneous (under the skin), or through an injection.
- See note 4. NDMA can also be found in some cured meats and in the fumes from tobacco.
- See note 2.
- 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 (aka “The Mitch Study” or “The Stanford Study”).
- N-nitrosodimethylamine (NDMA) in Ranitidine: Emery Pharma’s Perspective, the road to filing the company’s first Citizen Petition, CBS News coverage, and the FDA’s response (April 6, 2020)(even normal transport and storage conditions cause NDMA to accumulate).
- TIMELINE-Popular heartburn medicine Zantac pulled off store shelves, CNBC.com (October 2, 2019); currently, more than 41 counties have acted – South Korea, Egypt, Canada, and Bangladesh have banned ranitidine, and it was recalled from shelves and distribution by Denmark, Pakistan, and Germany.
- MDL transfer order; 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); Dodson et. al. v. Sanofi et. al, Case No. 20-356, U.S. District Court for the Southern District of Ohio (filed January 22, 2020). See also Kevin Dunleavy, Manufacturing GlaxoSmithKline sells off $155M Zantac plant in India to Hetero Labs for a fraction of its cost, FiercePharma (March 31, 2021).