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The Zantac Lawsuits

If you have found your way here, you have likely been searching the question “Can I sue Zantac?” When we take any medication, we have faith that it will cure and/or eliminate unpleasant or dangerous diseases and symptoms. But unfortunately, that is not always the case. On April 1, 2020, the FDA mandated that all manufacturers remove all “prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.” This includes Zantac which is manufactured by Sanofi and all generic versions containing N-Nitrosodimethylamine. After an extensive investigation, the agency determined that when stored at higher than room temperatures, the presence of the carcinogen N-Nitrosodimethylamine (NDMA) was found to be higher than normal in products containing ranitidine, the active ingredient. It is this increase in NDMA that has now been linked to cancer.

Zantac and Cancer FAQs

In June 2019, Valisure, an online pharmacy that routinely tests the medications that it offers, found carcinogenic levels of NDMA in Zantac and generic equivalents. Valisure found unstable ranitidine molecules in medicines containing the drug. The Connecticut-based online pharmacy informed the FDA of its findings.

In the summer of 2019, the FDA announced independent laboratory testing found NDMA in ranitidine. 

On September 13, 2019, the FDA announced that preliminary tests found low levels of NDMA in ranitidine. During the same week, drug companies Novartis (through its generic division, Sandoz) and Apotex announced that they recalled all of their generic ranitidine products sold in the US.

In October 2019, major U.S. pharmacies, including CVS and Walgreens,  pulled Zantac and its generic equivalent from their shelves due to concerns with their carcigonic levels of NDMA. Memorial Sloan Kettering Cancer Center, a leading cancer center in the United States also stopped offering Zantac as a list of medications offered to patients while the Food and Drug Administration performed an investigation. Also in early October, the UK recalled four prescription Zantac medications. 

On April 1, 2020, the FDA requested manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market. The decision was based on an ongoing investigation of N-Nitrosodimethylamine (NDMA) in ranitidine medications. The FDA determined that heat increases NDMA levels in ranitidine products to carcinogenic levels

What is Zantac?

Zantac, generic Ranitidine Hcl, is a medication that belongs to a class of drugs called Histamine-2 or H2 blockers. Ranitidine is available by prescription and over-the-counter, and works by reducing the amount of acid the stomach produces.

Raninidine is used to treat stomach problems, such as GERD, and associated heartburn symptoms caused by acid indigestion.

WebMD lists the following common and more serious side effects:

  • nausea,
  • vomiting,
  • stomach pain;
  • diarrhea,
  • constipation,

Less common and more serious side effects include:

  • stomach pain, loss of appetite;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • fever, chills, cough with mucus, chest pain, feeling short of breath;
  • fast or slow heart rate;
  • easy bruising or bleeding; or
  • problems with your skin or hair.

What is NDMA, the impurity found in Zantac products?

NDMA, N-nitrosodimethylamine, is a semivolatile chemical that forms in both industrial and natural processes. In the United States, NDMA is not currently produced for commercial purposes. NDMA may be present in food sources, such as smoked meats, contaminated drinking water, cosmetic products, or at places such as tanneries, pesticide manufacturing plans, and tire and rubber plants. The primary pathway for human exposure is the oral consumption of NDMA.

A number of findings had repeatedly found NDMA to have a strong correlation to gastrointestinal cancers. In 2017, the Environmental Protection Agency (EPA) reported that NDMA may cause liver damage in humans. The symptoms of overexposure to NDMA includes gastrointestinal symptoms such as: enlarged liver, abdominal cramps, vomiting, nausea, reduced function of the kidney, liver, and lungs, to other symptoms such as headache, fever, jaundice, and dizziness.

In 2017, the EPA listed NDMA as a probable human caricinogen based on various mammals exposed to the chemical. The Department of Health and Human Services (HHS) also stated that NDMA was a probable human carcinogen after reporting that the chemical caused tumors in various animals.

During the summer of 2019, the amount of NDMA found in ranitidine products was nearly thirty-times the daily intake limit.

Studies linking NDMA and Gastric Cancer

Gastric cancer is the third leading cause of cancer deaths in the world, according to the WHO. Prior to 2020, a number of studies have called for more investigation into the association between acid-suppressive drugs such as ranitidine and gastric cancer. A number of these studies found a correlation between ranitidine and cancer.

A follow-up study in 1999 looked at data to determine whether the intake of nitrate, nitrite, and NDMA through food consumption was correlated to an increased risk of gastro-intestinal tract cancers in a cohort of nearly 10,000 adults. The authors found a significant positive association between the intake of NDMA and the subsequent diagnosis of colorectal cancers.

In 2010, researchers examined the extent to which acid-suppressive drugs, namely containing ranitidine, were tested for carcinogenic properties. The researches called for more testing of the drugs to determine the extent to which the drugs were linked to human cancers.

In 2013, a gastroenterology journal released the results of a study of cancer patients that indicated acid suppressive drugs were associated with an increase in gastric cancer.

A study published in 2014 suggested that there had been a correlation between NDMA and cancers in animals. The data on humans at the time also pointed to the carcinogenic effects of NDMA in humans and researchers called for additional information to further understand the association.

By 2016, several studies suggested that under certain environmental conditions, ranitidine could develop NDMA, a known human carcinogen at the time. Even within the human body, the ranitidine sustained carcinogenic properties. For example, research showed that NDMA was secreted in urine following the consumption of ranitidine. The authors concluded that the widespread use of ranitidine called for further analysis to find out how much the drug increased the risk of human cancer.

In 2017, another study determined that the chronic use of acid-suppressive drugs was associated with a 2.4 fold increase in the risk for gastric cancer.

By 2018, further studies from around the world showed an association between acid-suppressive drugs containing NDMA and cancer. Many of these studies found a link between these drugs and carcinomas in animals and the researchers often emphasized the need for more studies to determine the risk of the drugs to humans. One study in 2018, for example, found a link between intake of ranitidine and liver cancer, and the researchers called for more analysis to determine whether the drugs caused cancer or not.

Qualifying for a Zantac Legal claim

There are three major conditions that must be met before suing the makers of Zantac.

  1. You have had to be taking Zantac regularly prior to your cancer diagnosis.
  2. You must have a qualifying cancer.
  3. Your cancer diagnosis must have come after 2000.

Can I sue because I took Zantac?

In order to successfully sue Sanofi or other manufacturers of ranitidine, you must show a link to causing you harm, typically specific cancers. We can help you prove that the exposure to NDMA caused your illness including cancer of the small intestines, kidney, bladder, esophagus, stomach, liver, and colon/rectum. Additionally, we can work with the research that shows a direct link between NDMA and ovarian cancer, pancreatic cancer, prostate cancer, thyroid cancer, uterine cancer, breast cancer, and brain cancer.

What type of compensation can you expect if you sue Zantac?

  • Medical bills (past and future).
  • Pain and suffering for you including physical, emotional, and mental. This includes your cancer diagnosis, discomfort, and pain due to illness and treatment.
  • Loss of wages both now and in the future including diminished earning capacity.
  • Punitive damages.

The MDL in Florida for Zantac

In February of 2020, Multidistrict Litigation (MDL) was created in Florida due to the large number of cases (approximately 140) filed. MDL will allow victims like you to retain your own counsel, but casework will be consolidated since they would all follow a similar procedure. The judge will have significant flexibility in how to handle these suits as a unit but also separately.

Zantac in the news:

NPR featured a story during the fall of 2019 about a number of pharmacies taking ranitidine off their shelves.

Bloomberg reported that medical establishments stopped offering ranitidine to their patients.

Harvard Health addressed the removal of the popular acid-suppressive drug from pharmacies and health care centers.

Why choose Clayton Lawyers for your Zantac Lawsuit?

These lawsuits are new, with the first one filed in 2019. Determining liability and proving a direct link to your case will require a skilled litigation team. We know that the drug makers Sanofi and Boehringer Ingelheim knew about or should have been aware of the risks in taking their product. Yet, they continued to market and sell it to customers just like you.

William Clayton has been successfully handling cases just like this since 1994 and is recognized at the state and national level as an elite trial attorney. Contact us to learn more today!