Zantac Maker Facing Lawsuits Over Carcinogen
Last Updated on May 10, 2024
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Case Update
- May 10, 2024 – Sanofi Agrees to Settle 4,000 Zantac Cancer Lawsuits
- On April 3, 2024, Sanofi announced that it had agreed to settle 4,000 personal injury claims filed by individuals who alleged the pharmaceutical company failed to warn them that the heartburn medication Zantac (ranitidine) can cause cancer.
Bloomberg reports that Sanofi, as part of the settlement, will pay $100 million to resolve thousands of lawsuits lodged against it in various state courts, except those filed in Delaware. The deal provides former Zantac users with an average of more than $25,000 per claim, Bloomberg reported.
Sanofi is one of several Zantac sellers—including GSK, Pfizer and Boehringer Ingelheim—who still face about 75,000 claims filed in Delaware state court over the heartburn drug.
Details of the Zantac settlement remain confidential, a Sanofi spokesperson told FiercePharma.com.
At A Glance
- This Alert Affects:
- Anyone who took Zantac (ranitidine) and was diagnosed with cancer.
- What’s Going On?
- Allegations have surfaced that Zantac’s manufacturer knew that the drug could cause cancer but failed to warn doctors and patients about the risk.
- How Could a Lawsuit Help?
- A lawsuit could help recover money for medical bills, physical pain and other damages.
- How Much Does an Attorney Cost?
- Most attorneys handling these cases will only get paid if they win your case. Further, it costs nothing to speak with an attorney about your rights.
Lawsuits have been filed alleging that Sanofi-Aventis, maker of Zantac, failed to warn users that the medicine could produce unsafe levels of a probable carcinogen after being ingested.
The lawsuits, if successful, could help pay for medical expenses and other damages associated with taking Zantac.
Why Were Lawsuits Filed?
The first lawsuits were filed after online pharmacy Valisure notified the FDA that it had detected “extremely high levels” of a probable carcinogen known as n-nitrosodimethylamine (NDMA) in “every lot tested, across multiple manufacturers” of ranitidine products, including Zantac.
According to Valisure, an “inherent instability” in ranitidine can cause it to react with itself to produce NDMA. Testing performed by the pharmacy detected more than 3 million nanograms of NDMA per tablet, which amounts to more than 31,000 times the FDA’s maximum daily intake limit.
After receiving Valisure’s petition to recall ranitidine products, the FDA announced that its own testing revealed “unacceptable levels” of NDMA in samples of ranitidine.
The lawsuits are arguing that Zantac’s manufacturer, Sanofi, knew Zantac could convert to NDMA in the body, yet failed to warn users about the serious health risks—including cancer—that came with taking the medicine.
Did Zantac Get Recalled?
Yes. On April 1, 2020, the FDA requested that manufacturers immediately recall all prescription and over-the-counter (OTC) ranitidine medications.
According to the FDA, testing has revealed that NDMA levels in ranitidine drugs increase over time “even under normal storage conditions” and especially in warmer temperatures. The testing also showed that the older the product is, the greater the level of NDMA it contained, the agency said.
The FDA recommends that consumers stop taking OTC ranitidine products and dispose of the drugs. The agency also stated that those taking prescription products should speak to their healthcare providers before stopping the medicine.
According to the FDA, ranitidine medication, including Zantac, “should not be available to consumers and patients unless its quality can be assured.”
Are These Class Action Lawsuits?
Although class action lawsuits have been filed over Sanofi’s alleged misrepresentations of Zantac as “safe and effective,” those lawsuits are typically seeking to repay users for the money they spent on the medicine itself—and not any damages associated with developing cancer.
What Can I Get From a Lawsuit?
Zantac users may be able to recover money for the following in a successful case:
- Medical bills
- Lost wages
- Mental anguish
- Physical pain
In the case of death, family members may also be able to collect money for funeral expenses, loss of expected earnings, and loss of companionship.
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