LITIGATION UPDATE: On December 6, 2022, Judge Robin L. Rosenberg of the Southern District of Florida dismissed all the Zantac MDL lawsuits. She claimed insufficient evidence tied ranitidine to cancer. We are appealing to the Eleventh Circuit and are hopeful for a positive outcome. In the meantime, we are not taking any new Zantac clients.
Zantac manufacturers are being sued by customers who developed cancer after taking the heartburn drug (also called ranitidine). The main manufacturers include Sanofi, Boehringer Ingelheim, and GSK. The drugmakers allegedly 1) sold a “defectively designed” medication and 2) “failed to warn” physicians and consumers about the cancer risks.
In this article, our Zantac lawyers discuss:
- 1. Who are Zantac’s manufacturers?
- 2. Are they being sued?
- 3. What are the drug makers being sued for?
- 4. Is there a class action against the Zantac manufacturers?
- 5. Have there been settlements so far?
1. Who are Zantac’s manufacturers?
Prescription Zantac was initially created by GSK in 1977. The FDA approved it in 1983. Then it went generic in 1984. More than 10 manufacturers make ranitidine RX.
Pfizer then created OTC ranitidine in 2004. Boehringer Ingelheim bought it in 2006. Then Sanofi bought it in 2017. More than 20 manufacturers make OTC ranitidine.
The companies that have recalled their ranitidine products are (in alphabetical order):
- American Health Packaging
- Amneal Pharmaceuticals, LLC
- Apotex Corp.
- Appco Pharma LLC
- Aurobindo Pharma USA
- Denton Pharma, Inc. dba Northwind Pharmaceuticals
- Dr. Reddy’s Laboratories Ltd.
- Glenmark Pharmaceutical Inc.
- GSMS, Inc.
- Lannett Company, Inc.
- Mylan
- Novitium Pharma
- Perrigo Company plc
- Precision Dose Inc.
- Sandoz Inc.
- Sanofi
There are several forms of ranitidine, such as tablets, capsules, and syrup. Typical dosages are 75 mg, 150 mg, and 300 mg. People usually take it to relieve heartburn.
2. Are they being sued?
Yes. People who developed cancer after taking RX or OTC ranitidine are suing the manufacturers. Currently, there is an MDL (multi-district litigation) out of the Southern District of Florida (West Palm Beach). The judge is U.S. District Judge Robin L. Rosenberg. And the MDL ID number is 2924.
Even though the MDL is out of Florida, Zantac victims from anywhere may be eligible to join. But there is a statute of limitations for victims to file suit. Depending on the state, this time limit to sue can be as soon or one or two years after the diagnosis.
3. What are the drug makers being sued for?
Zantac lawsuits are still in their early stages. But there are two main claims plaintiffs are accusing the manufacturers of:
- Defective design; and
- Failure to warn
3.1. Defective design
A drug suffers from a defective design if both:
- The defect posed a foreseeable risk; and
- The drug was made and used the way it was supposed to be
Defectively designed drugs are inherently unsafe. This means the original chemical formulation is problematic.
This is different from a manufacturer’s defect. A manufacturer’s defect is when a drug is inherently safe — but it becomes contaminated during the manufacturing process.
The FDA claims that ranitidine has NDMA (N-nitrosodimethylamine). This is a carcinogen. Scientists actually use NDMA on research rats to give them cancer.
There is some question about whether the Zantac pills have NDMA in them. Or whether the ingredient ranitidine causes NDMA to develop in the person’s body. Either way, this arguably qualifies as a design defect.
3.2. Failure to warn
Drug companies are obligated to warn physicians and consumers about their drugs’ non-obvious dangers and side effects. This way, people can make informed decisions about whether the drug is right for them.
Zantac’s labeling did not mention NDMA or its carcinogenic risks. So arguably, the drug companies are liable for “failure to warn.”
(States differ on “failure to warn” lawsuits. In some states, brand drug makers have a duty to warn generic drug users. In other states, brand drug makers do not have this duty.)
4. Is there a class action against the Zantac manufacturers?
Zantac lawsuits by cancer patients are being joined into an MDL (multi-district litigation), as discussed above in section 2. MDLs are legal mechanisms for combining similar cases in order to expedite litigation.
MDLs are not class actions. When a class action reaches a settlement, it is divided equally among all the members in the class. When an MDL reaches a settlement, each plaintiff gets a different amount based on his/her unique injuries.
This way, each MDL plaintiff’s case remains separate. And each attorney advocates for his/her particular client separately. By being part of the MDL, plaintiffs get the benefit of “safety in numbers.” And it helps streamline the pretrial stage and settlement process.
5. Have there been any settlements so far?
No. Zantac litigation started at the end of 2019. So litigation is in early stages.
There probably will not be any settlements until the MDL judge lets a few of the cases go to trial. How these bellwether trials turn out will steer negotiations.