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.
If you have taken Zantac or a related ranitidine medication, you may have heard that these products could contain unsafe levels of N-nitrosodimethylamine (NDMA), a known carcinogen.
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. The FDA tested multiple products containing ranitidine, including Sanofi’s 150-mg and 75-mg OTC tablets and 150-mg prescription tablets, Cardinal Health’s 150-mg tablets, Novitium’s 300-mg capsules, Dr. Reddy’s 300-mg tablets, Sandoz’s 300-mg product, Aurobindo’s 300-mg tablets, Silarx Pharma’s 150-mg syrup, and Amneal Pharmaceuticals’ 300-mg syrup. All of these products contained levels of NDMA that exceeded the 96 ng limit.
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 carcinogenic 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.
Ranitidine 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:
- stomach pain;
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 plants, and tire and rubber plants. The primary pathway for human exposure is the oral consumption of NDMA.
During the summer of 2019, the amount of NDMA found in ranitidine products was 30,000 times the daily intake limit. In fact, during routine lab testing that year, it was estimated that the levels of NDMA in Zantac was up to 3,267,968 nanograms. The FDA has stated that daily intake of NDMA should not exceed 96 nanograms. Further, FDA testing has found that NDMA may rise to such unacceptable levels after the medication is exposed to higher than normal temperatures and when it is stored in normal conditions. Also, the length of time the Zantac has been on the shelf may also yield unsafe amounts of NDMA. Thus far, it has been observed that different batches of Zantac may also contain varying levels of NDMA.
A number of findings have 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 include 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 carcinogen based on studies that included various mammals that were exposed to the chemical. Similar to the EPA, the Department of Health and Human Services (HHS) has also stated that NDMA was a probable human carcinogen after reporting that the chemical caused tumors in animals. The Agency for Toxic Substances and Disease Registry (ATSDR), based in Atlanta, Georgia, is a federal public health agency of the U.S. Department of Health and Human Services and has reported that indigestion of NDMA is associated with decreased survival rates for animals, including its gastrointestinal, hepatic, and carcinogenic effects. For example, the ATSDR has noted that hepatotoxicity is a prominent and characteristic systemic effect of NDMA. Liver cancer has also been reported after intermediate use in some animals.
Zantac lawsuits are based on the premise that the high levels of NDMA that were in Zantac products would produce similar toxicity and carcinogenic effects that were found in animals.
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 gastrointestinal 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 researchers 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
While the investigation into the potential harm ranitidine products may cause will continue, cancer is now cited as one of the most devastating effects of the drug. That being the case, plaintiffs and potential claimants often cite a cancer diagnosis after using Zantac over a period of time. Typically, plaintiffs and potential claimants must meet three major conditions before suing the makers of Zantac.
- Providing proof of Zantac use
- Cancer diagnosis following Zantac use
- Proving the link between Zantac use and cancer diagnosis
Zantac Use – An individual who has had a prescription for Zantac may provide proof that they used Zantac through their prescription medical records. An individual who has bought over-the-counter Zantac must provide receipts that they purchased Zantac or have a note from a doctor that states they were taking the drug. If an individual does not have proof of Zantac use through medical records, including those from a pharmacy or a doctor’s note or receipts to show the purchase of ranitidine products, then a statement describing Zantac use may also be used for evidence.
Cancer Diagnosis – The primary personal injury involved in Zantac lawsuits is a cancer that is linked to NDMA. Lawyers are including gastrointestinal and digestive cancers such as colon cancer, kidney cancer, liver cancer, and stomach cancer, to other cancers that include esophageal cancer, along with cancers of the bladder, prostate, breast, ovaries, and melanoma.
We may ask you the following questions about your cancer to help gather evidence for your case. When were you diagnosed with cancer? Do you or your family have a family history of cancer? How are you receiving cancer treatment?
Other medical issues associated with Zantac may include:
Outside of cancer, there are other potential side effects to Zantac use that may have altered your daily living, including neurological effects, liver issues, from damage to failure, other gastrointestinal issues, primary pulmonary hypertension, and Crohn’s disease, among others. We will want to know about other medical issues you have faced since starting Zantac.
Link between Zantac use and Cancer diagnosis – If someone has taken their medication regularly for up to one year prior to their cancer diagnosis, a link between Zantac use and cancer may be established. The length of time someone has been taking Zantac is important, and with longer use of the drug, there is a more substantive link between Zantac use and the cancer someone has developed. We can help you establish a timeline from when you started Zantac to the time of your cancer diagnosis.
Can I sue because I took Zantac?
Zantac and its generic equivalents have been popular medications for millions of individuals since it was first introduced in 1983, and thousands of individuals diagnosed with cancer may have previously taken ranitidine products to help relieve their symptoms of heartburn and indigestion. Since there is a possible link between the use of ranitidine medications and cancer, hundreds of personal injury lawsuits have been filed since the FDA recalled Zantac in April 2020. While these lawsuits will primarily involve the link between Zantac and cancer, you or a loved one do not necessarily need to develop cancer in order to file a lawsuit. You can file a lawsuit if you took Zantac for an extensive amount of time and weren’t diagnosed with cancer, and attempt to recover compensation for the amounts spent on the drug.
If you or a loved one wants to sue Sanofi or other manufacturers of ranitidine for a personal injury, you must show a link that the product caused you harm. 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.
Furthermore, in order to successfully sue a Zantac manufacturer under negligence, which is the backbone of personal injury law, you will have to prove the following elements:
- The manufacturer or distributor undertook a duty of care to the general public.
- The manufacturer or distributor violated that duty of care.
- Zantac has caused you or a loved one to develop cancer or suffer from another serious condition.
- Cancer or the other serious condition caused by Zantac has impacted your quality of life and has caused expenses.
In the case of the harmful effects of Zantac, negligent parties are those who failed to warn their patient or consumer about Zantac’s possible cancer-causing risks and, as a result, risked that person’s safety. These parties can be drug manufacturers, distributors, pharmacies, physicians, and any other parties who marketed, sold, or distributed Zantac to individuals and who were aware of its harmful, cancer-causing risks.
The Status of Zantac Lawsuits
While the link between Zantac and cancer is subject to ongoing research and investigation, legal claims have been filed and these Zantac lawsuits have begun their initial stages.
The MDL in Florida for Zantac
Hundreds of Zantac legal claims are now centralized as multidistrict litigation. Multidistrict litigation involves cases that are consolidated to a single federal court after multiple lawsuits with similar complaints are filed across various districts. The Zantac MDL has been transferred to the Southern District of Florida (In Re: Zantac (Ranitidine) Products Liability Litigation, but potential claimants may be from anywhere in the United States. The main defendants in Zantac MDL are some of the biggest pharmaceutical powerhouses, such as Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi.
As of May 2021, the Zantac MDL is still in pre-trial and discovery has yet to be concluded. The plaintiffs argue that defendants should have known the risks ranitidine products pose to patients while the defendants claim that they were not aware of the possible contamination of NDMA in their products. This page will continually be updated to reflect status changes to the litigation.
The difference between MDLs and Class Action Lawsuits
Multidistrict Litigation (MDL) lawsuits are similar to class action lawsuits in many ways. However, MDLs are composed of many individuals filing singular lawsuits against a party or parties.
The main difference between a class action and an MDL lawsuit is that a class action becomes a single lawsuit in which one person or a few select people act as the lead plaintiff. Settlement amounts are divided among all plaintiffs, with settlement amounts determined on several individual factors. Conversely, MDL lawsuits remain individual.
In February of 2020, Zantac MDL was created in Florida due to the large number of cases (approximately 140) filed. Zantac MDL will allow victims like you to retain their 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.
Are there any Zantac Lawsuit Settlements?
These lawsuits are in the initial stages and there are not any settlements yet. Since legal claims involving ranitidine products have been transitioned to the Zantac MDL, the litigation is ongoing. The potential amount of compensation will depend on a number of factors, and critically, whether plaintiffs can prove that defendants knew that their products contained high levels of NDMA, a known carcinogen. Generally, the ability for plaintiffs to show evidence of Zantac use, a cancer diagnosis after Zantac use, and linking the use of Zantac to cancer will be necessary for victims to be awarded compensation for damages that they incurred.
Statutes of Limitations and Zantac Lawsuits
The statutes of limitations apply to personal injury lawsuits, including those involving Zantac. These statutes vary from state to state and the amount of time that can pass from when your personal injury occurs to when you may file a lawsuit. Therefore, it is critical to contact an attorney if you have received a cancer diagnosis and have taken Zantac products to ensure that you do not lose your right to sue by missing the deadline set by the time limits.
Zantac lawsuits may include a number of legal concepts, including product liability and failure to warn. In cases relying on product liability, the manufacturer may be held liable for damages caused by defective products, such as Zantac products containing ranitidine. Additionally, it is also possible that distributors and retailers may also be held liable for the injuries sustained after long-term Zantac use. Legal claims may also allege that the makers of Zantac showed a failure to warn consumers about the potential contamination of NDMA in its ranitidine products.
Personal injury cases that involve suing a Zantac manufacturer and pursuing damages would normally fall under the premise of product liability. In Florida, the statute of limitations for product liability gives you four years to file a suit. However, this time may vary depending on the details of your case.
Zantac in the news:
In May 2021, Bloomberg reported that Sanofi (French drugmaker of Zantac) allegedly destroyed emails that were involved in the 2019 recall of its products containing ranitidine.
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!