Zantac Recall Lawsuit

Zantac, the most popular brand of ranitidine, is used to help reduce stomach acid. The medication is commonly prescribed to treat ulcers, gastroesophageal reflux disease (GERD), chronic indigestion, and Zollinger-Ellison syndrome. It comes in both over-the-counter and prescription strengths that may be taken by mouth or administered via injection into a muscle or vein.

Ranitidine belongs to a class of drugs known as H2 blockers that work by reducing the amount of acid the stomach produces. H2 receptors are present on the cells in the stomach lining. A histamine chemical normally stimulates these receptors to produce acid to the body help digest food. Ranitidine blocks these receptors, and prevents histamine from producing its normal effect, which causes the stomach to produce less acid.

N-nitrosodimethylamine (NDMA) is a probable carcinogen. It is an industrial waste product, yellowish in appearance with a faint, distinctive odor. Found in cured meats and tobacco smoke, it is a common environmental contaminant. This substance has also been used as a stabilizer in industrial lubricants as well as an ingredient in rocket and jet fuel.

NDMA may also be formed as a by-product of other manufacturing processes.  According to the Centers for Disease Control and Prevention (CDC), humans can be exposed to NDMA through a wide variety of sources, including:

• The environment—the air, rivers and lakes, and soil
• Tobacco smoke, chewing tobacco
• Food—cured meat, beer, fish, cheese, and other items
• Toiletry and cosmetic products
• Interior air of cars
• Household items like detergents and pesticides

NDMA can even form in the stomach during digestion of alkylamine-containing foods and has been detected in small amounts in breast milk.  In addition to WHO and IARC, NDMA has been classified by the Environmental Protection Agency (EPA) as probably carcinogenic to humans, because it can modify DNA.  Studies have shown the chemical to increase cancer risk in animal experiments.

According to a toxicology review from the World Health Organization, NDMA induces cancer through a process known as biotransformation, interacting with a certain enzyme in the liver. This causes DNA mutation, which is known to be a precursor to the formation of malignant tumors.

As of October 2019, neither the FDA or drug manufacturers had received any adverse event reports associated with NDMA in ranitidine. A class action lawsuit filed in San Francisco in September claims that defendants Sanofi and Boehringer Ingelheim were aware of the danger and failed to warn patients. More recently, a Zantac lawsuit was filed in Florida by a plaintiff who claims his prostate cancer was the result of taking Zantac over a seven-year period.

Types of injuries associated with Zantac and generic forms of ranitidine may include:

• Bladder cancer
• Breast cancer
• Colon and rectal cancer
• Kidney cancer
• Liver cancer
• Ovarian cancer
• Pancreatic cancer
• Prostate cancer
• Stomach cancer
• Testicular cancer

Some plaintiffs have already filed lawsuits against the makers of Zantac and of generic ranitidine, and more are expected to be filed in the future.  In September 2019, for example, five plaintiffs joined together to file a class-action lawsuit against Zantac manufacturer Sanoti-Aventis LLC and former owner of the rights to Zantac, Boehringer Ingelheim, which manufactured and distributed the drug between October 2006 and January 2017.

The plaintiffs claimed that the defendants failed to warn healthcare providers and the public about the dangers of taking Zantac, and did not reveal that Zantac could produce NDMA in the human body.

If you or one of your loved ones have received a cancer diagnosis in connection with your use of Zantac, you could qualify to file a Zantac cancer lawsuit against the manufacturer of the drug.

In April 2020, the Food and Drug Administration (FDA) ordered all wholesalers and retailers to stop selling the heartburn medication, Zantac. It also urged consumers to cease using any Zantac they may already have in their homes and throw it away immediately. The announcement came after the FDA announced its findings in September 2019 that the medication contains a carcinogen called N-nitrosodimethylamine, or NDMA – or, at least, has a tendency to form NDMA as a result of the chemical breakdown of the product during long periods of storage.

NDMA has the ability to alter the structure of human DNA. If it is consumed at levels beyond the recommended daily intake of .096 micrograms per day, this contaminant has been shown to put consumers at considerable risk of contracting cancer. After testing ranitidine, the active ingredient in Zantac, the FDA published results indicating that the medication contains NDMA levels ranging from .01 to.36, placing the users of the product at very high risk of developing cancer.

It is uncertain at this stage whether the formulation of Zantac is faulty or if NDMA seeps into the drug during the manufacturing process. Zantac is one of several commonly used, over-the-counter medications found to have unacceptably high quantities of the chemical. It has been suggested, in an article published in Scientific American, that such contamination may result from side reactions during the synthesis of certain drugs, the manner in which unstable drug compounds break down, and contamination from recycled manufacturing solvents.

There are large-scale research efforts currently underway to determine exactly how NDMA has been allowed to reach such unacceptable levels in these common medications.

Studies of NDMA have revealed a variety of adverse effects, both acute and chronic, on both animals and humans. It has been found to be acutely toxic to rats and mice when administered orally or inhaled. It has been found to be extremely damaging to the liver and also linked to the development of lung cancer in both humans and laboratory animals.

Short- and medium-term exposures ranging from five days to 12 weeks are associated with liver damage in several different species. In other animal studies, the drug has been linked to gastrointestinal hemorrhage and harmful effects in the kidneys, lungs, spleen, and myocardium following several weeks of administration. Rodent studies also demonstrate a consistent carcinogenic effect of NDMA. The effects of lifetime exposure to NDMA in rats’ drinking water were described in a dose-response study, in which the incidence of liver tumors was increased and survival rates decreased, in a dose-dependent manner. In humans, overexposure to NDMA has been linked to a variety of symptoms, including nausea, vomiting, abdominal cramps and diarrhea, headache, fever, enlarged liver, and jaundice. Sustained exposure to levels higher than the .096 recommendation has been linked to severe liver damage. Other potential symptoms of overexposure include headache, fever, nausea, vomiting, abdominal cramps, enlarged liver, dizziness, and reduced function of the liver, kidneys and lungs.

After the FDA published its initial findings about the NDMA content of Zantac, it stated that there would be no need for consumers to stop taking the medication immediately, as the amount of the chemical found in the drug was not conclusively found to be linked to any overall risk of cancer. However, it did find significant links to specific types of cancer, including those of the lungs and liver – a discovery that merited further study. Finally, in April 2020, the FDA announced that the links between NDMA and cancer were significant enough to order the withdrawal of the drug from pharmacy and supermarket shelves, as well as advising consumers to stop using it immediately.

Due to the fact that Zantac has been found to contain unacceptable quantities of NDMA, thousands of people across the country have joined class-action lawsuits against the drug’s manufacturer, Sanofi. The complaint against the drug company states that it knowingly deceived millions of consumers into “purchasing and ingesting a defective, misbranded, adulterated, and harmful drug,” without any warnings about the presence of NDMA and its possible harmful effects.

Plaintiffs who made use of the drug between its introduction to the market in 1983 and its withdrawal in April 2020 are now at increased risk of developing various kinds of cancer – if they have not already done so. These plaintiffs have said that, had they known of Zantac’s NDMA content, they would never have taken the medication. They state that the manufacturer knew of the presence of NDMA in their product – or the possibility for it to be formed over time – and that it continued to produce and supply the medication without making any effort to inform and protect consumers.

Plaintiffs cited a study that claims that a 150-milligram pill of Zantac contains over 2.5 million nanograms of NDMA – exponentially higher than the recommended daily dosage of about 100 nanograms. Over-the-counter Zantac is typically sold in 150-milligram tablets; the recommended dosage to treat peptic ulcer disease for adults is 300 milligrams a night for four to eight weeks. What this indicates is that users of the drug are routinely consuming NDMA in amounts well above the threshold, exposing themselves to severe risk of cancer.

The plaintiffs who have so far filed complaints over Zantac have a variety of cancers, including the following:

• Bladder Cancer
• Brain Cancer
• Breast Cancer
• Esophageal/Nasal/Throat Cancer
• Intestinal Cancer
• Kidney Cancer
• Liver Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Stomach Cancer
• Testicular Cancer
• Thyroid Cancer
• Uterine Cancer

Although NDMA is known for its hepatotoxic characteristics, and therefore, its links to liver cancer and other hepatic disorders, its connections with other forms of cancer are less specific. NDMA is classified as ‘a probable carcinogen’ as a result of its ability to alter DNA. While there is no necessary and direct correlation between NDMA and cancer in all cases in which the two coincide, there is still sufficient cause to consider the chemical as a severe health risk – one that should, at the very least, be brought to consumers’ attention in drug packaging and labels, which Sanofi has failed to do even though they knew of the potential for NDMA to be formed in their medications, and of the dangers that this entailed.

If you have suffered from any form of cancer after extended use of Zantac, you can join the ongoing mass tort actions being taken against Sanofi. You would be one of the thousands of people who have laid Zantac-related complaints, claiming that Sanofi has exposed them to the risk of developing cancer, without including any warning in this regard on their package inserts.

Before you file, familiarize yourself with the civil litigation process so that you understand how mass torts progress. A mass tort is not the same as a class action (which are already in progress against Sanofi). Whereas a class action consists of several plaintiffs filing their suits collectively, moving towards a collective compensation package which is then divided among the plaintiffs, a mass tort case involves a number of individual claims, each claiming its own distinct set of damages.

You should also take all necessary steps to mitigate your injuries, including seeking the proper medical care and immediately discontinuing your use of Zantac, while doing everything in your power to reduce your costs and losses.

Your next step is to contact a Zantac recall lawyer and discuss your case with them to determine whether you are eligible to be included in the mass tort action. You can also pursue a lawsuit if you are representing a loved one who has passed away as a result of cancer developed after the use of Zantac. The lawyer will then build a case to prove that your illness – or that of your loved one – is a result of long-term exposure to Zantac. After assessing all your damages, your attorney will then file a complaint demanding both compensatory and punitive damages.