The Zantac lawsuits claim that Zantac can be contaminated with the cancer-causing substance N-nitrosodimethylamine (NDMA).
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What Do We Know About the Zantac Lawsuits?
On September 13, 2019, the U.S. Food and Drug Administration (FDA) reported the discovery of the carcinogenic contaminant N-nitrosodimethylamine (NDMA) in Zantac (ranitidine), a common heartburn medication available in both prescription and over-the-counter versions.
In April of 2020, the FDA announced that all Zantac brand heartburn drugs, prescription and over-the-counter, should be immediately pulled from the market because of potential NDMA contamination, a chemical linked to cancer.
The first Zantac lawsuit was filed in California in 2019. In that lawsuit, the plaintiffs accuse drugmakers Sanofi and Boerhringer Ingelheim of manufacturing, marketing, and selling a product they knew or should have known had been contaminated with an industrial chemical known to cause cancer.
The exact cause of the NDMA contamination is still under investigation. However, during the period in which Boerhringer Ingelheim and Sanofi manufactured and marketed Zantac, scientific research demonstrated a clear link between ranitidine, the active ingredient in Zantac, and NDMA. Specifically, when ranitidine comes in contact with water, it creates a chemical reaction that causes the formation of NDMA.
Despite the availability of this information, the drugmakers chose not to disclose this risk to the government or to consumers.
Zantac Injuries & Side Effects
In addition to causing cancer, NDMA is a potent hepatotoxin. Short-term exposure to NDMA can cause liver damage (such as liver fibrosis and scarring). Long-term exposure can increase the risk of liver, kidney, and lung tumors.
Symptoms of NDMA overexposure include headaches; fever; nausea; jaundice; vomiting; abdominal cramps; enlarged liver; reduced function of the liver, kidneys and lungs; and dizziness.
Other adverse effects that have been associated with Zantac include:
- nervous system disorders
- arrhythmia or tachycardia (irregular or rapid heartbeat)
- vitamin B-12 deficiency
- hepatitis, liver failure, and jaundice
- increased risk of pneumonia
- low platelet levels in the blood
- skin rashes and hair loss
What Do We Know About NDMA?
NDMA is used in aviation and rocket fuel and industrial lubricants. It is also a by-product of several industrial processes, including gasoline refining and the treatment of wastewater containing nitrogen.
Other applications for NDMA include inducing carcinogenesis in laboratory rats for cancer research. NDMA may also be found in a number of food products, such as cured meats, and is an ingredient in tobacco fumes. Fortunately, NDMA does not appear to accumulate in tissues.
Under the federal Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), NDMA is classified as “extremely hazardous.” Because of this, there are stringent reporting requirements for companies and individuals who produce, store, or use the substance in large amounts.
FDA Studies and Recalls Regarding Zantac
On April 1, 2020, The U.S. Food and Drug Administration (FDA) announced its request that all Zantac brand heartburn drugs, prescription and over-the-counter, be immediately pulled from the market.
This action came after the FDA’s ongoing investigation, which concluded that storing this drug at “higher-than-normal temperatures” elevates levels of a probable human carcinogen within the drugs. The federal agency determined that, because there is no way to know how the drugs currently in the market are being stored, their presence and use poses a “risk to public health.”
In January of 2021, JAMA Network Open and MedRxiv published findings about Zantac’s ability to produce NDMA. The data came from research conducted by online pharmacy Valisure. According to the report, the findings from a 2019 Valisure study, which initially detected NDMA in both general ranitidine and Zantac, were no accident. Rather, the new research showed that, under certain conditions, these drugs can and do produce NDMA inside the human body.
How Liability Law Applies to the Zantac Cases
Under most state laws, a patient injured through the use of a defective drug can bring a lawsuit based on the following legal theories:
- Design Defect: When a drug is manufactured per design specifications, but the design itself renders the drug ineffective or unsafe;
- Manufacturing Defect: When a drug is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
- Failure to Warn: When the drug manufacturer fails to warn the public of the risks or to provide adequate instructions about the use of the drug, thereby rendering it unsafe or dangerous.
All states enforce a statute of limitations that limits the amount of time you have to file a lawsuit against a drug manufacturer. A member of our legal team can inform you of your state’s laws.
Zantac Lawsuit News
Florida Judge Rules for Generic, Over-the-Counter Manufacturers of Zantac Knockoffs, Backing Preemption Claim
U.S. District Court Judge Robin Rosenberg dismissed claims against makers of over-the-counter and generic versions of Zantac. In July 2021, the judge weighed whether FDA labeling decisions should protect drug manufacturers from claims made in state court. Rosenberg affirmed this position. The decision will affect nearly 1,500 claims that sued the makers for failure to warn and for negligence. Tens of thousands of claims have been filed in the MDL. To read more, click on FiercePharma.
Zanofi Claws Back Some Zantac Emails as Privileged
In early July 2021, a magistrate judge ruled that plaintiffs in the Zantac MDL must return or destroy internal Sanofi emails. The company says the emails were privileged and that they had mistakenly provided them in discovery. However, the judge denied the drug maker’s claims over certain emails, including those that discussed a meeting between non-lawyers (hence, not protected by attorney-client privilege) on possible litigation over Zantac. To read more, click on Reuters.
Zantac Maker Allegedly Destroyed Recall-Related Emails
In May of 2021, lawyers for the plaintiffs in more than 70,000 claims against Zantac makers alleged that the drug makers destroyed emails linked to the 2019 recall of the drug. The destroyed emails include some from the head of regulatory affairs for Zantac’s U.S. Consumer Health Division, Michael Bailey. Sanofi spokespeople responded with assertions that the destruction of the emails was unintentional and that the company was applying efforts to recover the missing data from “alternative sources.” To read more, click on Bloomberg.
GlaxoSmithKline Sells off $155M Zantac Plant in India to Hetero Labs for a Fraction of its Cost
In March of 2021, the GlaxoSmithKline (GSK) board of directors approved the sale of its manufacturing facility in India for $25 million. The selling price reflects a fraction of the plant’s original cost. The facility was opened in 2018 with the capacity to produce 8 billion tablets and 1 billion capsules annually. In 2019, Zantac became the center of global attention from its link to cancer, resulting in GSK’s pulling the branded version of the drug, which was sold outside the U.S. This greatly impacted the need for the India plant. Read more at Fierce Pharma.
Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
The FDA has learned that some ranitidine medicines, including Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. To read more, click FDA Communication
Company Halts Ranitidine Production Over NDMA Contamination Concerns
Novartis's Sandoz unit has announced that they are halting distribution of generic ranitidine (Zantac), after some lots of ranitidine were found to contain small amounts of N-nitrosodimethylamine (NDMA). To read more, click Pharmacy Times
Heartburn Drug Found to Contain Traces of Cancer-Causing Chemical
U.S. health officials have found low levels of a potentially cancer-causing chemical in a popular heartburn drug. To read more, click Live Science