A Zantac lawsuit is a mass tort claim against pharmaceutical companies that make the heartburn pill Zantac and its generic versions. The U.S. Food and Drug Administration (FDA) recently found that drugs containing ranitidine, like Zantac, had been compromised with an impurity that is known to cause cancer. Some of the generic versions have been recalled, and some drug stores have already pulled Zantac off their shelves.
These lawsuits claim that Zantac was defectively designed and defectively manufactured. They also claim that the companies making Zantac failed to warn patients of the risks of taking the drug. The lawsuits demand compensation for people who took Zantac without knowing the risks.
In this article, our California personal injury lawyers go over:
- 1. What is Zantac?
- 2. What are Zantac's side effects?
- 3. What carcinogenic chemical was found in generic versions of Zantac?
- 4. Have there been any recalls of Zantac?
- 5. Have lawsuits already been filed over the cancerous side effects of Zantac?
- 5.1 How could Zantac have been defectively designed?
- 5.2 How could drug companies have failed to warn people of the risks of Zantac?
- 6. What compensation is available in a Zantac lawsuit?
- 7. What should I do if I take Zantac?
1. What is Zantac?
Zantac is a heartburn medication based on the drug ranitidine. It can be sold over the counter, and as a prescription. It is manufactured by Sanofi.
Ranitidine is a histamine-2 antagonist that works by slowing down the production of histamine in the stomach. This reduces the amount of stomach acid that gets produced. The chemical mechanism used by histamine-2 antagonists like ranitidine and Zantac to reduce stomach acid has fallen out of favor, though. Proton pump inhibitors, or PPIs, have taken over as the stomach acid medication of choice. Nevertheless, Zantac continues to be used to treat intestinal conditions like:
- Upper gastrointestinal bleeding,
- Peptic ulcers and stress ulcers,
- Gastroesophageal reflux disease,
- Zollinger-Ellison syndrome,
- Stomach damage from non-steroidal anti-inflammatory drugs (NSAIDs),
- Heartburn relief, and
- Erosive esophagitis.
Ranitidine has been in use in the U.S. since the 1984. Generic versions of Zantac began to hit the market in 2005. These generic versions of Zantac are made by different pharmaceutical companies, including:
- West-ward Pharmaceutical,
- Zydus Pharmaceutical,
- Mylan Labs,
- Sanis Health Inc.,
- Sivem Pharmaceuticals,
- Sandoz Inc., the generic-producing arm of Novartis, and
- Apotex Corp.
These generic versions of Zantac try to copy the chemical composition of the original brand name drug. In most cases, generic versions are identical to the original drug. However, pharmaceutical companies that make generic versions of a drug have to sell them for less because of the stiff competition from other drug companies. This can lead to cost-cutting techniques at the manufacturing level.
2. What are Zantac's side effects?
Zantac and its generic versions have been linked to numerous side effects in the past.
Some of the most common, but least severe side effects have included:
- Loss of appetite,
- Constipation, and
- Stomach pain.
Ranitidine, in both generic form and brand name form, has also been linked to more severe side effects, including:
- Liver damage and failure,
- Kidney and renal failure,
- An increased risk of developing a stomach infection, and
- Reduced heart rate.
However, contaminated ranitidine drugs could also cause cancer.
3. What carcinogenic chemical was found in generic versions of Zantac?
Recently, the FDA found that some batches of Zantac had been contaminated with a carcinogenic substance called N-nitrosodimethylamine, or NDMA.1
NDMA has been labeled as a probable human carcinogen. This means that the substance is believed to cause cancer in human beings. It is known to cause cancer in animals. Medical researchers suspect that NDMA is especially likely to cause the following types of cancer:
- Colorectal cancer,
- Kidney cancer,
- Liver cancer,
- Pancreatic cancer, and
- Stomach cancer.
An independent laboratory tested Zantac and its generic equivalents. The results of those tests found that stomach acids could break the ranitidine down and unleash the NDMA that was already in the drug.2 That NDMA was over the FDA's recommended daily limits.
The findings prompted the FDA to conduct its own tests. While the FDA's results were not as strong as the independent lab's, the NDMA readings were high enough to release a statement in September, 2019.
3.1 Has NDMA contamination been found in any other drugs?
NDMA contamination has also been behind the recent recalls of blood pressure drugs containing Valsartan and Losartan.3
The NDMA contamination of Losartan, though, seems to involve poor manufacturing by generic drug makers. The lab test results seem to indicate that the NDMA contamination of Zantac could be a result of the drug's design, not a manufacturing oversight.
4. Have there been any recalls of Zantac?
Since the FDA notified the public of NDMA contamination in Zantac and its generics, several drug companies that make generic versions of the pill have voluntarily recalled them. Additionally, some major pharmacies have pulled the drugs from their shelves.
Some generic drug companies that make Zantac equivalents have pulled their drugs out of the market, including:
- Sandoz, and
- GlaxoSmithKline, though they only sold Zantac generics overseas.5
Retailers have taken matters into their own hands. In the wake of the FDA's announcement, Walgreens, Rite Aid, and CVS all took Zantac and its generic equivalents off their shelves.6 WalMart followed suit shortly afterwards.7 Some of these stores are offering refunds to anyone who bought the drugs in their store.
However, the FDA has not issued a mandatory recall, yet.
5. Have lawsuits already been filed over the cancerous side effects of Zantac?
Lawsuits against drug companies for the cancerous side effects of Zantac are already being formulated. These lawsuits will likely be products liability claims that allege 2 separate things:
- The drug companies behind Zantac and its generics defectively designed the drug, and
- The drug companies negligently marketed the drug by failing to warn people of the risks of taking it.
The lawsuits would demand that the drug companies compensate the victims who suffered from their negligence.
5.1 How could Zantac have been defectively designed?
Zantac and drugs based on ranitidine can be defectively designed if they either:
- Needlessly put people at risk, or
- Do not work as well as one could reasonably expect.
If either of these is the case, then the drug makers could be held strictly liable for the faulty design. This means victims do not have to show that there was negligence on the part of the pharmaceutical companies.
5.2 How could drug companies have failed to warn people of the risks of Zantac?
Zantac and its generics can also be defectively marketed if the warnings labels do not inform doctors and patients of the risks of taking the drug.
Doctors rely on a drug's warning labels when they prescribe medication for a patient. Patients also rely on those warning labels when they weigh the pros and cons of using the drug to treat a medical condition. When drug companies leave risks of developing cancer off the warning label, it keeps doctors and patients in the dark. Doctors prescribe the drug and patients take it without the possibility of knowing it could do more harm than good.
6. What compensation is available in a Zantac lawsuit?
Zantac lawsuits demand compensatory damages. These are meant to make victims whole, once again, by covering the costs of their:
- Medical bills,
- Wages lost,
- Lost earning capacity,
- Pain and suffering, and
- Loss of consortium for their family.
As evidence accumulates, Zantac lawsuits might also start to demand punitive damages be assessed against the pharmaceutical companies behind the drug. These damages would aim to punish the drug makers for especially disturbing conduct that put people at risk.
7. What should I do if I take Zantac?
The FDA has not advised people who are currently taking Zantac or a Zantac generic to stop taking the drug. Instead, the FDA has suggested that people taking a ranitidine drug over the counter should consider looking for an alternative. For people who were prescribed Zantac or a Zantac generic by their doctor, the FDA recommends talking to the doctor about other treatment options, first.8
Call us for help…
If you have taken Zantac or a generic version of the drug and think you have suffered from the drug's side effects, you may be entitled to compensation. Our California personal injury and defective drug lawyers can help. Contact us today to get started on your case.
FDA Press Release, “Statement alerting patients and health care professionals of NDMA found in samples of ranitidine,” (September 13, 2019).
See Ken Alltucker, “Cancer worries prompt generic Zantac recalls at Walgreens, Walmart and Rite Aid: What you need to know,” USA Today (September 26, 2019).
U.S. Food and Drug Administration, “FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan).”
FDA Company Announcement, “Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) Impurity in the product,” (September 25, 2019).
See note 2.
Sandra E. Garcia, “Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears,” The New York Times (September 30, 2019).
Doug Criss, “Walmart, CVS, Walgreens pull Zantac and similar heartburn drugs because of cancer worries,” CNN (October 2, 2019).
See note 1.