Zantac Lawsuit

The U.S. Food and Drug Administration (FDA) recently announced that it is investigating Zantac cancer risks after testing of Zantac 150 tablets found the commonly-used heartburn medication contains a carcinogenic chemical up to 3,000 times greater than the FDA’s daily intake limit. The carcinogenic chemical present in Zantac is known as N-nitrosodimethylamine (“NDMA”).

The law firm of Baum, Hedlund, Aristei & Goldman is representing people from across the country in personal injury and wrongful death Zantac lawsuits. We intend to hold the drug makers accountable for allegedly concealing the Zantac cancer link and putting profit before people.

Since the 1980s, numerous studies have demonstrated a link between the NDMA in Zantac and cancer. Mounting evidence also allegedly shows that Sanofi and Boehringer Ingelheim, the big pharma companies that make Zantac (ranitidine hydrochloride), concealed the Zantac cancer link from millions of people who took the drug for heartburn, gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), sour stomach, Barrett’s esophagus, acid reflux and other issues. This deception came as the companies made unprecedented profits from Zantac, the first drug to generate $1 billion in sales.

With countless people now stricken with cancer after taking Zantac, many are turning to the courts and filing a Zantac lawsuit to hold Sanofi and Boehringer Ingelheim accountable for their reckless disregard for human health and willingness to put profit over people.

Zantac Cancer Lawyer

If you took Zantac and developed cancer, it is in your best interest to speak with an experienced personal injury attorney about filing a Zantac lawsuit. Attorneys from the law firm of Baum, Hedlund, Aristei & Goldman have vast experience holding big corporations accountable for concealing the true dangers of consumer products. Across all areas of practice, the firm has obtained more than $4 billion in verdicts and settlements on behalf of clients.

In 2018 and 2019, Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner served as co-lead trial counsel in two of the first three Roundup cancer cases against Monsanto Company (now Bayer).

During the trials, Brent and his colleagues showed the juries mountains of scientific evidence demonstrating that Monsanto went to great lengths to conceal the risk of cancer to consumers who used Roundup.

zantac cancer wisner quote

One of these cases, Johnson v. Monsanto Co., resulted in a $289.2 million verdict on behalf of our client, the second largest jury verdict in the state of California for 2018. The other case, Pilliod v. Monsanto Co., resulted in a $2.055 billion verdict for our clients. The Pilliod verdict is the second-largest personal injury verdict in the nation so far this year, and the ninth-largest personal injury verdict in American history.

“Having represented people whose lives were turned upside down by the deception of a corporate giant like Monsanto, I can say with 100% certainty that if these cancer-stricken people were told, if they were given the choice to avoid a product that could cause them to develop cancer, they would never have taken Zantac,” — R. Brent Wisner, award-winning trial attorney

Baum, Hedlund, Aristei & Goldman was also actively involved in the Actos litigation. Our firm successfully represented numerous clients from across the country who had developed bladder cancer following the use of the diabetes drug Actos.

Baum, Hedlund, Aristei & Goldman knows how to win big cases against big companies. Our track record of success—which goes back over 40 years—speaks for itself. If you developed cancer after taking Zantac, call us today for a free Zantac lawsuit evaluation.

Zantac lawsuit cancer attorney

What is Zantac?

Chemically known as ranitidine hydrochloride, Zantac is a very popular antacid medication that has been on the market since the early 1980s. Zantac is available over the counter (Zantac OTC) and by prescription. People commonly use Zantac for acid reflux, heartburn, and a host of other stomach, throat, and gastrointestinal issues. Others use Zantac for allergies to supplement their treatment regimen.

Zantac dosage varies between 75 and 150 mg tablets, though some patients take a once daily Zantac 300 mg dosage.

Attorneys R. Brent Wisner, Michael L. Baum, Bijan Esfandiari, Nicole K.H. Maldonado, Adam M. Foster, and Pedram Esfandiary filed the Zantac lawsuits on behalf of two plaintiffs:

Earlier this year, Wisner and his colleagues obtained a historic $2.055 billion jury verdict on behalf of clients who alleged their cancer was caused by Monsanto’s Roundup weed killer. The verdict was the ninth-largest personal injury verdict in U.S. history. According to Mr. Wisner, “based on preliminary scientific findings, these lawsuits involving Zantac will dwarf what we are seeing for Roundup.”

The complaints, filed in federal court in Sacramento and Philadelphia, seek punitive damages against the defendants:

  • Boehringer Ingelheim Pharmaceuticals, Inc., a subsidiary of Boehringer Ingelheim Corporation of Germany
  • Sanofi US Services Inc., a Delaware corporation with its principal place of business located in Bridgewater, New Jersey, a wholly owned subsidiary of Sanofi S.A.
  • Chattem Inc., a Tennessee-basedwhollyowned subsidiary of Sanofi S.A.
  • Pfizer Inc., a Delaware corporation based in New York, NY
  • GlaxoSmithKline LLC, a Delaware corporation (named in complaint wherein plaintiff(s) took any brand-name prescription Zantac prior to 2009), based in Philadelphia, PA

GlaxoSmithKline (GSK) was the original creator of Zantac and controlled the New Drug Application (NDA) for prescription Zantac between 1983 and 2009. GSK, along with Warner Lambert (acquired by Pfizer in 2000), launched over-the-counter (OTC) Zantac in 1995, and after a few years, Warner Lambert (now Pfizer) took control over the OTC brand until 2006.  After that, Boehringer Ingelheim acquired the OTC rights to Zantac from October 2006 to January 2017. Sanofi and its subsidiaries have controlled OTC Zantac since January 2017 with Chattem as its U.S. distributor.

The allegations against the defendants include:

Count I: Strict Liability – Design Defect

Count II: Strict Liability – Failure to Warn

Count III: Negligence

Count IV: Breach of Express Warranties

Count V: Breach of Implied Warranties

“In my experience representing cancer victims against a corporate giant like Monsanto, I can say with 100% certainty that if these drug companies had warned my clients, if they were given the choice to avoid a dangerous product that could cause them to develop cancer,they never would never have taken Zantac,” says R. Brent Wisner, attorney and vice president of Baum, Hedlund, Aristei & Goldman.

“Based on recent scientific findings, the levels of NDMA in Zantac are staggering. Considering how many people took Zantac in the U.S. since 1983, we are staring into the face of a public health crisis, and these defendants—in particular GSK and Pfizer—are to blame.”

NDMA in Zantac

Zantac (ranitidine) is used to treat various gastrointestinal conditions, including acid reflux, heartburn, and sour stomach. The drug was brought to market in the United States in 1983. Three years later, Zantac became the first drug to reach $1 billion in sales.

According to the allegations, however, Zantac’s groundbreaking sales figures were only possible because of a deception perpetrated by the drug’s manufacturers, most recently Sanofi and Boehringer.

The complaints allege that the makers of Zantac products never disclosed to consumers that Zantac has a critical defect: when ingested, Zantac produces high quantities of N-Nitrosodimethylamine (“NDMA”), a potent carcinogen.

NDMA was initially discovered in the process of manufacturing rocket fuel. For more than 40 years, studies have shown that NDMA is dangerous. Today, the chemical only has one purpose—to induce cancer in laboratory experiments.

The FDA, the U.S. Environmental Protection Agency (EPA) and the World Health Organization (WHO) all classify NDMA as a cancer-causing chemical. NDMA belongs to “a family of potent carcinogens,” according to the EPA. The WHO maintains that “NDMA is clearly carcinogenic. There is overwhelming evidence that NDMA is mutagenic and clastogenic.”

Animal Studies Overwhelmingly Link NDMA to Cancer

According to the complaints, various animal studies on NDMA have found the following:

  • In mouse studies examining the carcinogenicity of NDMA through oral administration, animals exposed to NDMA developed cancer in the kidney, bladder, liver, and lung.
  • In comparable rat studies, similar cancers were observed in the liver, kidney, pancreas, and lung.
  • In comparable hamster studies, similar cancers were observed in the liver, pancreas, and stomach.
  • In comparable Guinea-pig studies, similar cancers were observed in the liver and lung.
  • In comparable rabbit studies, similar cancers were observed in the liver and lung.
  • In other long-term animal studies in mice and rats utilizing different routes of exposures—inhalation, subcutaneous injection, and intraperitoneal (abdomen injection)—cancer was observed in the lung, liver, kidney, nasal cavity, and stomach.

Human Epidemiological Studies on NDMA and Cancer

In addition to the overwhelming animal data linking NDMA to cancer, the complaints note that there are numerous human epidemiological studies exploring the effects of dietary exposure to various cancers:

  • In a 1995 epidemiological case-control study looking at NDMA dietary exposure with 220 cases, researchers observed a statistically significant 700% increased risk of gastric cancer in persons exposed to more than 0.51 ng/day.
  • In another 1995 epidemiological case-control study looking at NDMA dietary exposure with 746 cases, researchers observed statistically significant elevated rates of gastric cancer in persons exposed to more than 0.191 ng/day.
  • In yet another 1995 epidemiological case-control study looking at, in part, the effects of dietary consumption on cancer, researchers observed a statistically significant elevated risk of developing aerodigestive cancer after being exposed to NDMA at .179 ng/day.
  • In a 1999epidemiological cohort study looking at NDMA dietary exposure with 189cases and a follow up of 24 years, researchers noted that “N-nitroso compounds are potent carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing colorectal cancer.
  • In a 2000 epidemiological cohort study looking at occupational exposure of workers in the rubber industry, researchers observed significant increased risks for NDMA exposure for esophagus, oral cavity, pharynx, prostate and brain cancer.
  • In a 2011 epidemiological cohort study looking at NDMA dietary exposure with 3,268 cases and a follow up of 11.4 years, researchers concluded that “[d]ietary NDMA intake was significantly associated withincreased cancer risk in men and women” for all cancers, and that “NDMA was associated with increased riskof gastrointestinal cancers”including rectal cancers.
  • In a 2014 epidemiological case-control study looking at NDMA dietary exposure with 2,481 cases, researchers found a statistically significant elevated association between NDMA exposure and colorectal cancer.

Lawsuit Alleges Zantac Drug Makers Knew About NDMA Defect but Failed to Warn or Test

This summer, an online pharmacy company conducting FDA-approved testing of Zantac found more than 3,000,000 ng (nanograms) of NDMA in a Zantac 150mg tablet, a dosage that many people take every day. The FDA’s daily allowable limit for NDMA is 96 ng, though according to the U.S. Agency for Toxic Substances and Disease Registry (ATSDR), this limit may be too high.

Valisure, the pharmacy company responsible for the testing, submitted a Citizen’s Petition to the FDA on Sept. 13, 2019, noting that it found “extremely high levels of NDMA in all lots [of ranitidine] tested, across multiple manufacturers of ranitidine products.” The petition also included a request to recall and suspend the sale of Zantac.

According to the complaints, a person who takes a daily maintenance Zantac dosage of 150 mg is exposed to 889,000,000 ng (0.889 grams) of NDMA over the course of a year. FDA’s permissible intake limit of NDMA translates to just 0.000034 grams per year.

The drug is not solely indicated for adult use—teenagers, children, and pregnant mothers are also prescribed Zantac to treat a variety of gastrointestinal issues.

The lawsuit maintains that the makers of Zantac (ranitidine), knew or had reason to know that Zantac exposes consumers to unsafe levels of the cancer-causing chemical NDMA:

“Under biologically relevant conditions, when nitrites are present, staggeringly high levels of NDMA are found in one dose of 150 Zantac, ranging between 245 and 3,100 times above the FDA-allowable limit. In terms of smoking, one would need to smoke over 500 cigarettes to achieve the same levels of NDMA found in one dose of 150 mg Zantac at the 25 nM level (over 7,000 for the 50 nMlevel)…During the time that Defendants manufactured and sold Zantac in the United States, the weight of scientific evidence showed that Zantac exposed users to unsafe levels of NDMA. Defendants failed to disclose this risk to consumers on the drug’s label—or through any other means—nor did Defendants report these risks to the FDA.”

According to the complaints, the makers of Zantac deliberately refused to test Zantac products because they knew that the chemical posed serious health risks to humans.Nothing prevented the drug makers from being honest in their promotional activities for Zantac and, according to the lawsuits, had a duty to disclose the truth about the risks associated with Zantac in their promotional efforts, outside of the context of labeling.

The complaints further allege that if the drug makers had disclosed and disseminated the risks associated with their Zantac products, the plaintiffs could have avoided the risk of developing injuries and could have obtained or used alternative medication.

Background on the Plaintiffs

Shawn L. Francis

Shawn Francis, 46, took Zantac at least four times a week for more than a decade. In 2015, an MRI revealed that he had kidney cancer. Following his diagnosis, Mr. Francis was forced to undergo surgery to remove 55% of his kidney.

Walter H. Hansen

Walter Hansen, 49, took Zantac 150 mg daily as an antacid over the span of about nine years. In January of 2017, he was diagnosed with colorectal cancer, which soon spread to other parts of his body. He is currently undergoing weekly chemotherapy treatments.

About Baum, Hedlund, Aristei & Goldman

The law firm of Baum, Hedlund, Aristei & Goldman is representing individuals across the nation who have developed cancer after taking Zantac. The firm’s award-winning personal injury attorneys have extensive experience holding big corporations accountable for concealing the dangers of consumer products.

For two years in a row, The National Law Journal and ALM Media awarded the firm as first place winners for 2018 and 2019 Elite Trial Lawyers for a groundbreaking pharmaceutical drug verdict and a landmark Roundup cancer verdict. The National Trial Lawyers Top 100 also awarded Baum, Hedlund, Aristei & Goldman’s Roundup cancer trial team and co-counsel with “2019 Trial Team of the Year.” In addition, The National Law Journal and Trial Lawyer Magazine named Baum Hedlund trial attorney R. Brent Wisner one of “America’s Most Influential Trial Lawyers,” and Law360 named him a “Titan of the Plaintiffs Bar.

Since 1973, Baum, Hedlund, Aristei & Goldman has obtained more than $4 billion in verdicts and settlements on behalf of clients across all areas of practice. This year, the firm co-tried a cancer case against Monsanto on behalf of a California couple who alleged exposure to Roundup weed killer caused them to develop non-Hodgkin lymphoma. The jury trial culminated in a $2.055 billion verdict for our clients, the ninth-largest personal injury jury verdict in U.S. history.

Does Zantac Cause Cancer?

Zantac and its generic active ingredient, ranitidine hcl, metabolizes into N-nitrosodimethylamine (NDMA) a chemical that the FDA, the U.S. Environmental Protection Agency (EPA) and the World Health Organization (WHO) all classify as a (cancer-causing) carcinogen.

Over the last 40 years, several studies have made the case that Zantac causes cancer. According to the World Health Organization (WHO), “NDMA is clearly carcinogenic. There is overwhelming evidence that NDMA is mutagenic and clastogenic.”

NDMA is a semi volatile organic chemical that belongs to a family of chemicals known as N-nitrosamines. According to the EPA, N-nitrosamines are “a family of potent carcinogens.”

The FDA established a 96 ng (nanograms) per day intake limit of NDMA (though even this intake limit may be too high). However, recent testing of Zantac using FDA-approved methods found more than 2,500,000 ng of NDMA in a Zantac 150 mg tablet, the dosage countless people take every day.

Online pharmacy company Valisure tests batches of drugs before they sell them to consumers. During its testing, Valisure found unprecedented levels of NDMA in Zantac and other ranitidine tablets.

“Every manufacturer and every type of Zantac or ranitidine that we’ve analyzed seems to have the same problem of the drug itself being very unstable and degrading, or even potentially reacting to, the condition in the human stomach to create NDMA.” – David Light, Valisure CEO

Valisure alerted the FDA to the issue, and the FDA issued a statement saying the agency is investigating the Zantac NDMA link to cancer. While an investigation into this serious public health issue is a necessary step, our firm believes the FDA is downplaying the true danger of this cancer-causing chemical in Zantac by claiming the amount of NDMA found during testing is low.

Our Firm Believes FDA is Failing to Protect the Public from Dangerous Zantac Side Effects

In its statement, FDA noted that it “has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.”

The Zantac attorneys at the law firm of Baum, Hedlund, Aristei & Goldman believe the FDA’s statement falls well short of addressing a serious threat to public health. Further, we believe the FDA is confusing consumers by saying the presence of NDMA in Zantac is an “impurity.” This cancer-causing chemical is not an impurity, but a design defect that the makers of Zantac knew or should have known about before, during, and after the drug came to market.

Numerous regulators outside the U.S. have cautioned patients against taking Zantac, noting the availability of safer alternatives. The FDA, on the other hand, continues to confuse the American public by telling consumers that they do not need to stop taking Zantac or Zantac OTC generics.

Zantac Recall

In response to the September 2019 FDA announcement, retailers like CVS and Walgreens pulled Zantac and Zantac over-the-counter generics from their shelves, citing the link between Zantac NDMA and cancer. In statements, both pharmacy companies noted that consumers who purchased the drugs could get Zantac refunds. Generic drug makers like GlaxoSmithKline (GSK), Sandoz and Apotex have also recalled its ranitidine hydrochloride products.

In October 2019, Sanofi announced a Zantac recall of its own in the United States and Canada, and the U.K. unit of Teva Pharmaceuticals, the largest generic drug maker in the world, recalled batches of ranitidine.

At least 22 countries have either banned, halted shipping of, or recalled ranitidine hcl. Four other countries have issued warnings and/or launched their own investigations, according to the news media.

In 2018, several companies issued recalls for blood pressure medications that contained levels of NDMA that exceeded FDA limits. However, the levels of NDMA found in these products paled in comparison to that of Zantac.

Australia Finds High Levels of NDMA in 75% of Zantac Tested

Australia, one of the many countries to issue a ranitidine recall, conducted testing on Zantac tablets weeks after Valisure submitted its Citizen’s Petition to the FDA. According to Australia’s Therapeutic Goods Administration (the country’s drug regulatory agency), 75% of the Zantac tested were found to have high levels of NDMA.

The country decided to take a “precautionary approach” and issue a Zantac recall.

Zantac Side Effects

The link between Zantac and cancer goes back decades. Below are some of the cancers associated with Zantac:

  • Bladder cancer
  • Colon and rectal cancer
  • Esophageal cancer
  • Intestinal cancer
  • Kidney cancer
  • Liver cancer
  • Lung cancer (non-smokers)
  • Ovarian cancer
  • Pancreatic cancer
  • Prostate cancer
  • Stomach cancer
  • Testicular cancer
  • Thyroid cancer
  • Uterine cancer

Other ranitidine Zantac side effects include headaches, abdominal discomfort, nausea and vomiting.

Common Zantac Brands | Products That Contain Ranitidine

Below are some of the most common Zantac brands and generic ranitidine brand names:

  • Zantac 150 Tablets
  • Zantac 150 Maximum Strength
  • Zantac 150 Maximum Strength Cool Mint
  • Zantac 75 Tablets
  • Wal-Zan 150
  • Wal-Zan 75
  • Heartburn Relief (ranitidine)
  • Acid Reducer (ranitidine)
  • Acid Control (ranitidine)

What is NDMA?

NDMA is a molecule that was discovered long ago in the process of developing rocket fuel. It is a chemical that is a combination of DMA and Nitrogen (N). Together, N + DMA forms NDMA, a highly carcinogenic compound. NDMA has not been studied in humans because it is an extremely potent carcinogen. However, in every animal study looking at this issue, animals exposed to NDMA developed cancer.

Zantac NDMA Cancer Risk

The interesting thing about NDMA and Zantac is that, contrary to the FDA’s assertion that NDMA is an impurity, NDMA is not added to Zantac; it is a byproduct of the chemical processes that happen when a person ingests Zantac.

When Zantac interacts with stomach acid and heat in that environment, the molecule transforms into NDMA. That is why people who take Zantac are shown to have more than 400 times the legal allowable limit of NDMA in the urine. Put simply, NDMA is created during the process of digesting Zantac, which is why the Zantac cancer risk had not been discovered until recently.

“We have an epidemic of cancer in our society. For years we have been trying to figure out what’s behind it. Our firm has done a lot of work exposing the causes of non-Hodgkin lymphoma in our Monsanto Roundup litigation. Now we have another source of cancer – it appears that for decades, Zantac has been causing cancer, and we’re only now just seeing it. People from all across the country have cancer today because they took Zantac. That is a wrong that we will fight to make right.” – R. Brent Wisner

Zantac Class Action Lawsuit

  • People who purchased Zantac who do not have a cancer claim may be eligible to join a class action lawsuit to hold Sanofi and Boehringer Ingelheim accountable for making allegedly false and/or misleading statements about Zantac.
  • The makers of Zantac (ranitidine hydrochloride) marketed their antacid medication as being safe for use to treat acid reflux, heart burn, and various other gastrointestinal issues.

Zantac has been found to have a carcinogenic chemical called N-nitrosodimethylamine (NDMA) at levels up to 3,000 times the US Food and Drug Administration’s (FDA) daily intake limit.

  • In a letter to the FDA, Valisure—an online pharmacy company that tests drugs in its accredited laboratory before selling them—notes that Zantac is heavily prescribed to adults and infants “due to a very high perception of safety.”
  • The FDA is now investigating a possible link between ranitidine and cancer, following Valisure’s letter.

What is the Difference Between a Zantac Class Action Lawsuit and a Zantac Cancer Lawsuit?

A Zantac class action lawsuit allows consumers who bought Zantac (ranitidine hcl) to recover the money they spent making that purchase, based on allegations that the manufacturer failed to warn about the risk of NDMA cancer. The makers of Zantac made money by concealing the risks of dangerous Zantac side effects and should be held accountable for misleading consumers about the risk of such side effects.

These class action lawsuits can be filed on behalf of anyone who purchased Zantac and has not developed cancer, but wants to hold the makers accountable for profiting from misleading information.

Zantac personal injury or Zantac wrongful death lawsuits are filed by individuals (or their family members) who developed cancer after taking Zantac. Filing an individual personal injury lawsuit allows people who developed cancer to obtain the maximum possible compensation for their injuries. The law on damages varies from state to state, but there are different kinds of damages that the law allows you to receive, such as those for medical bills, lost wages, pain and suffering, loss of past and future earnings, temporary or permanent disability, and any other compensable damages.

Who Can Join the Zantac Class Action Lawsuit?

Anyone who purchased Zantac and can prove they did so may be eligible to participate in a Zantac class action claim. Unlike individual lawsuits against Zantac’s makers, in a class action lawsuit, plaintiffs do not have to prove that they were harmed, only that that they purchased the drug and were not warned about the Zantac cancer risk.

Such plaintiffs argue that they suffered economic losses because they purchased the drug believing it was safe and would not have made that purchase had they known about the risk of life-threatening Zantac adverse effects.

You Need a Zantac Attorney with a Proven Track Record of Success

Determining liability and proving your case in court can be difficult. To give you and your family the best chance for success, you need a law firm with a winning tradition against major corporations to handle your Zantac lawsuit.

Our trial lawyers know how to win big cases against big companies. If you developed cancer after taking Zantac, call 800-827-0087 today for a free, no-obligation Zantac lawsuit evaluation.

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