Zantac, a common heartburn medication, has been at the epicenter of significant litigation in recent years. This over-the-counter and prescription drug, known generically as ranitidine, has long been trusted by millions of individuals seeking relief from heartburn and acid reflux. However, the discovery of a carcinogenic substance called NDMA (N-nitrosodimethylamine) in Zantac has led to a cascade of lawsuits across the United States. Plaintiffs allege that the manufacturers failed to warn the public about the increased risk of cancer while taking the medication.
About Zantac Lawsuits
Heartburn is a prevalent gastrointestinal condition, with more than 60 million Americans experiencing it at least once a month. For individuals experiencing persistent or severe heartburn, there are several treatment options to alleviate the symptoms, including lifestyle modifications such as dietary changes, weight management, and elevating the head during sleep.
Additionally, over-the-counter and prescription antacids are popular remedies for heartburn. In this context, Zantac (ranitidine) gained prominence for relieving heartburn symptoms by decreasing stomach acid production. Zantac belongs to a class of drugs called histamine-2 blockers. The FDA approved Zantac in 1983, and in just a few short years, Zantac skyrocketed to become the world’s best-selling drug by 1987.
Zantac lawsuits began to emerge as early as 2019 when testing became public and revealed NDMA, a known carcinogen, in the medication. Injuries alleged in these lawsuits include various types of cancer, like bladder, liver, pancreatic, stomach, and esophageal.
Companies Involved in Zantac Lawsuits
Glaxo Holdings Ltd., a pharmaceutical company based in the United Kingdom, first developed Zantac. Glaxo Holdings Ltd. later merged with SmithKline Beckman Corporation in 1989 to form GlaxoSmithKline (GSK), which continued to manufacture and distribute Zantac. GSK became one of the major pharmaceutical companies involved in the production and marketing of Zantac globally.
While GlaxoSmithKline (GSK) is one of the primary companies associated with the Zantac lawsuits, there are several other manufacturers, distributors, and retailers that have been named as defendants in the litigation. Some of the notable companies involved in Zantac lawsuits include:
- Sanofi
- Boehringer Ingelheim Pharmaceuticals
- Pfizer
Testing Uncovers Carcinogens in Zantac
In September 2019, an independent laboratory, Valisure, tested various ranitidine products, including Zantac, and detected concerning levels of NDMA. This discovery raised red flags as NDMA is considered a probable human carcinogen based on animal studies, and prolonged exposure to high levels of NDMA may increase the risk of cancer in humans.
Initially reluctant to order a recall of ranitidine products following the 2019 Valisure testing, the FDA subsequently initiated its own investigations and confirmed the presence of NDMA in Zantac and other ranitidine medications. In April 2020, the FDA requested the immediate withdrawal of all prescription and over-the-counter ranitidine products, including Zantac, from the market. The agency cited that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures, possibly resulting in consumer exposure to unacceptable levels of NDMA.
The concern lies in the fact that NDMA is not an intentional ingredient but rather a byproduct formed during the drug’s storage or breakdown in the body. The presence of NDMA in Zantac posed concerns about the potential long-term health effects for individuals who have been using the medication, particularly if they have been exposed to elevated levels of NDMA over an extended period. These concerns have fueled the litigation surrounding Zantac, as plaintiffs allege that the manufacturers failed to adequately warn consumers about the potential risks associated with NDMA exposure and its link to certain cancers and other health conditions.
Injuries in Zantac Lawsuits
Plaintiffs argue that taking contaminated Zantac caused individuals to develop several forms of cancer, including:
- Breast cancer
- Stomach cancer
- Bladder cancer
- Intestinal cancer
- Colorectal cancer
- Prostate cancer
- Pancreatic cancer
- Kidney cancer
- Lung cancer
In January 2022, the plaintiff attorneys in the Zantac federal multidistrict litigation notified the court that they would only move forward with five types of cancer: bladder cancer, esophageal cancer, gastric cancer, liver cancer, and pancreatic cancer. Originally, attorneys appointed to plaintiff leadership expressed the party would move forward with ten types of cancer linked to Zantac, but ultimately, they filed a final disclosure stating they would serve export reports on five types of cancer.
Although the MDL does not support claims that Zantac causes breast, kidney, colorectal, prostate, and lung cancer, individuals are pursuing lawsuits in state courts for these injuries.
Zantac Multidistrict Litigation
In February 2020, the Judicial Panel on Multidistrict Litigation consolidated Zantac cancer lawsuits into MDL No. 2924 IN RE: ZANTAC (RANITIDINE) PRODUCTS LIABILITY LITIGATION. Plaintiffs claim that the heartburn medication Zantac—and specifically the ranitidine molecule, its active ingredient—breaks down during storage or in the body to form an alleged carcinogen known as N-Nitrosodimethylamine (NDMA). Lawsuits argue that the manufacturers, sellers, and distributors of Zantac and other ranitidine medications knew or should have known that these medications exposed consumers to NDMA. The panel transferred the cases to the Southern District of Florida and appointed the Honorable Robin L. Rosenberg to oversee the MDL.
Federal Zantac lawsuits reached over 2,000 by November 2022, with tens of thousands of Zantac lawsuits in state courts.
Judge Disbands Zantac MDL
On December 6, 2022, Judge Rosenberg ruled in favor of the drug makers by granting their motion to exclude the plaintiffs’ expert testimony. The court expressed concerns regarding the testing procedures conducted by Valisure, a private company that discovered elevated levels of NDMA in ranitidine. Judge Rosenberg’s order highlighted Valisure’s practice of subjecting ranitidine to temperatures as high as 266 degrees, resulting in NDMA levels that far exceeded the 98 degrees Fahrenheit typically found in the human body. The court also noted that Valisure’s mixing of potentially hazardous salt concentrations with ranitidine led to the creation of unsafe levels of NDMA.
Despite the plaintiffs not utilizing Valisure’s testing as evidence, Judge Rosenberg observed that the plaintiffs’ experts and chemists relied on similar testing methodologies. Without expert testimony, plaintiffs had no evidence to support their claims that Zantac was responsible for their cancer, effectively dismissing the MDL. However, this order did not apply to state Zantac lawsuits.
Status of Zantac Claims
In March 2023, California Superior Court Judge Evelio ruled that plaintiffs’ expert testimony is admissible, rejecting GSK’s request to exclude expert testimony in an upcoming trial. Judge Evelio ruled opposite Judge Rosenberg, concluding that expert witnesses supporting claims that Zantac can increase the risk of cancer should be allowed to testify.
While plaintiffs have submitted an appeal to overturn Judge Rosenberg’s decision to exclude expert testimony to the 11th Circuit Court of Appeal, this will take some time. In the meantime, given Judge Evelio’s approval of expert testimony, the next California Zantac trial is scheduled for July 24, 2023.
Zantac Settlements and Verdicts
There is no global Zantac settlement at this time.
In August 2022, the first Zantac case scheduled for court reached a $500,000 Zantac settlement shortly before trial. Plaintiff Joseph Bayer, who blamed Zantac for his bladder cancer, voluntarily dismissed his case due to a Zantac settlement he reached with generic drugmakers. Plaintiffs and attorneys eagerly await the upcoming California Zantac trial set for July 2023, which could turn the tide in Zantac litigation.