Zantac

It is important that any person who has suffered severe harm such as a cancer diagnosis as a result of taking a dangerous drug such as Zantac obtains legal representation with extensive experience in litigation against pharmaceutical manufacturers. Taking legal action against rich and powerful drug corporations to hold them accountable for their gross negligence may sound intimidating. Still, it can be extremely financially rewarding if you hire the right legal representative.

In this article:

• Zantac Was Recalled in April 2020
• Zantac Lawsuits
• What Criteria Must I Meet In Order to Bring a Zantac Claim?
• Questions Regarding a Zantac Lawsuit
• Monetary Damages Available in a Zantac Lawsuit
• Wrongful Death Claims related to Zantac
• Zantac Class Action Lawsuits
• What Was Zantac Used For?
• How Did Zantac Work?
• What is NDMA?
• Human Exposure to NDMA Causes Disease
• Zantac’s Link to Cancer
• Feds Take Action Due to Zantac Danger
• Scope of Impact
• What To Do If You Were a Zantac User
• Which Cancers Are Linked to Zantac?
• The Makers of Zantac Failed to Protect Consumers
• When to Seek Medical & Legal Help
• Negligent Drug Manufacturers
• Did Drug Manufactures Know that Zantac Could Cause Cancer?

On April 1, 2020, the U.S. Food and Drug Administration (FDA) issued for immediate release its request that all manufacturers withdraw all over-the-counter (OTC) and prescription ranitidine (Zantac)  medications. This means that Zantac will no longer be available for sale or use within the United States. The request represented the latest development in a continuous investigation of the contaminant NDMA, a known cancer-causing agent, found in Zantac. The FDA found that the levels of NDMA within some Zantac formulations increase over time and/or when stored at higher temperatures.  The levels of impurity could result in consumers being exposed to unacceptably high levels of NDMA and pose unacceptable health risks. Therefore the decision was made to pull the products from store shelves.

The testing results and FDA statements are understandably very concerning to individuals who have used Zantac, or who love someone who has taken the medication.  If this applies to you, read on to learn some key points about recalls and lawsuits related to Zantac.

If you or a loved one has sustained injuries (cancer or another disease) resulting from the use of the carcinogenic Zantac medication, you may have questions about taking legal action against powerful drug manufacturers.  

What are the Benefits of filing a personal injury claim for injuries or disease caused by Zantac?

• Compensation for direct harm caused to you or a loved one by the use of Zantac - monetary damages paid for the physical injury or disease that the use of Zantac caused.
• Monetary compensation for indirect harm resulting from  Zantac usage - this relates to the pain and suffering associated with your physical injury or disease and the effects it has had on your relationships, for example.
• It is important for society to hold dangerous drug manufacturers, marketers, and distributors accountable for the actions that cause harm to consumers.
• Filing a lawsuit against a danger drug manufacturer can spark policy changes, which in turn will help to ensure that the drugs marketed to consumers are safe.  This can save future lives.
• On a larger scale, some legal cases against drug manufacturers have resulted in laws being repealed or rewritten.  This societal change can happen when enough people are injured by a product and take legal action against the wrongdoers.

The term “damages” in a personal injury lawsuit refers to monetary compensation paid for losses caused to a plaintiff (the injured party) by the negligence of a defendant (the party who caused the injury).   Damages in a Zantac personal injury suit will depend on a variety of factors, such as the severity of the injuries caused by the medication.

Factors that may determine how much money is awarded in a personal injury lawsuit include:

• The plaintiff’s immediate and long-term health condition(s) caused by the medication usage
• The effects of cancer or another disease on the plaintiff’s quality of life
• The effects of the injury or disease on those that are close to the plaintiff, such as a spouse
• The effects of the injury or disease on the plaintiff’s financial situation and ability to earn money - both short term and long term

A wrongful death lawsuit falls under the umbrella of personal injury but is filed on behalf of someone who died as a result of the injury or disease process.  The lawsuit is initiated by the deceased person’s heirs (usually a spouse and/or children). A Zantac wrongful death lawsuit may help family members who have suffered the loss of a loved one due to the cancer-causing effects of Zantac.

There is a recently filed case against a manufacturer of Zantac involving the death of the plaintiff’s husband from esophageal cancer.  The husband had been taking Zantac regularly in the 15 years leading up to his death.

A class-action suit has already been filed against the manufacturers of Zantac for a failure to disclose the risks of the drug.  

If you have not been diagnosed with cancer or another disease related to the use of Zantac but were prescribed the medication for a long period of time, you may be eligible to participate in a class-action lawsuit against Zantac to recover the money you spent on the medicine.  If you only want to recover the money that you have spent on Zantac medication throughout your life, joining a class action suit may fulfill your needs.  

However, if you have been diagnosed with cancer, liver or kidney disease, or other significant health issues related to the use of Zantac, filing an individual personal injury lawsuit is the better choice in order to seek damages sufficient to compensate for your more extensive losses.

Ranitidine was a medication sold under the brand name Zantac and was a very popular medication used to treat excess acid production in the stomach. It was in a category of drugs called histamine-2 (H2) blockers.  The medication was distributed in OTC and prescription formulations. Over the years, the medication became one of the leading products used to treat heartburn and similar conditions. The reduction of stomach acid production gave relief to individuals who suffered from symptoms of acid reflux. The medication was used either alone or in combination with other medications to help people suffering from excessive acid production.

In addition to its top role as an acid reflux treatment, Zantac was also used to treat a number of other serious conditions. These include peptic ulcer disease and the rare condition, Zollinger-Ellison syndrome, which can lead to significant gastrointestinal complications. Both of these conditions cause excessive acid production, which Zantac was used to alleviate.

Outside of its role as an acid suppressant, Zantac could be used to treat individuals suffering from certain allergic reactions, since allergic reactions and acid production have similar mechanisms, Zantac played a role in the treatment of both.

As stated above, Zantac worked by reducing the production of acid in the stomach. In the stomach, the cells responsible for producing acid are called the parietal cells. These cells have a set of receptors (H2 receptors) that sit on the surface of these cells. A molecule called histamine binds to these receptors, causing the cells to release more acid during the digestive process. Unfortunately, this acid can cause uncomfortable symptoms.

Zantac worked by blocking the ability of histamine to bind to these receptors. The medication has a molecular structure that is similar to histamine. The drug binds to these receptors without triggering them, simultaneously blocking histamine from reaching the target site. As a result, the receptors aren’t triggered, and the parietal cells do not release acid. Without the release of acid, symptoms start to fade.

The Agency for Toxic Substances and Disease Registry (ATSDR) has an information sheet on its website that explains the chemical in question.  

N-Nitrosodimethylamine (commonly known as NDMA) is a yellow liquid without a distinct odor. It was produced in the United States only for use as a research chemical to make rocket fuel.  The use was discontinued after unusually high levels of the chemical were found in water, air, and soil samples, which were collected near a plant that was manufacturing rocket fuel. 

NDMA is also formed unintentionally in the course of other manufacturing processes at numerous industrial sites.  It is also found in water, air, and soil due to reactions involving other man-made and natural chemicals known as alkylamines. Alkylamines are widely found throughout the environment. 

NDMA breaks down in sunlight in a matter of minutes. It is theorized that it breaks down within a few months when it makes its way into the deep soil. When released in water, NDMA may break down by natural biological processes or by exposure to sunlight. 

Human exposure to NDMA happens through the following primary sources: 

• Food Items such as cured meats, fish, cheese, beer, and other consumables
• Tobacco smoke
• Chewing tobacco
• Toiletry and cosmetic products (for example, cleansers and shampoos)
• Various other household goods, such as detergents and pesticides
• Interior air of motor vehicles

NDMA is hepatotoxic, which means it is very harmful to the liver of humans and animals. There have been instances of humans being intentionally poisoned with NDMA (levels unknown) within their food or beverage.  The poisoning resulted in death due to severe liver damage and internal bleeding. Animal testing with water, food, or high levels of NDMA in the air resulted in severe non-cancer liver disease over days or weeks.  

The ATSDR document also states that it is reasonable to expect that exposure to NDMA by breathing, drinking, or eating could cause cancer in humans. 

Zantac’s potential link to cancer has been theorized for years.  Recent studies have established a link that can no longer be ignored and led to the FDA recall. 

In June 2019, a research facility based out of Connecticut, Valisure, discovered a link between Zantac and multiple types of cancer.  On the basis of that study, in September 2019, Valisure filed a citizen’s petition, which is a process through which individuals and organizations can make requests to the FDA for health policy changes.  Valisure’s petition stated that the Zantac study had found NDMA levels higher than 3 million nanograms per tablet, amounts 3,000 to 31,000 times greater than the FDA’s permissible daily allowance of 96 nanograms. In short, the Valisure studies revealed toxic levels of NDMA, an environmental contaminant, and known carcinogen, in specific products sold under the brand Zantac.  

NDMA is a chemical commonly found in meats, dairy, vegetables, and even water.  However, NDMA is classified as a carcinogen, and consumption of excessive amounts (higher than the daily 96 milligram FDA limit) of the chemical is linked to multiple types of cancer.  Studies establishing a link between NDMA and cancer go back to the 1980s. Excessive consumption of NDMA can also lead to liver damage.

Based on the independent Valisure study, the FDA conducted its own lab tests.  In September 2019, the FDA issued an official release that alerted healthcare providers and patients that Zantac could pose significant health threats.  Certain manufacturers, but not all, chose to pull their products after the September 2019 FDA release.  

FDA testing continued, and third party laboratories provided information that confirmed NDMA levels in Zantac increased under normal storage conditions and increased significantly when samples were stored at higher temperatures.  Furthermore, the tests showed that the older the Zantac product, the higher the levels of NDMA. It was determined that the conditions of the age of product and storage temperature could increase the NDMA level in Zantac products beyond the acceptable daily limit.  

In the following video, CBS This Morning reports on the findings of a cancer-causing chemical in Zantac.

The immediate market withdrawal request issued by the FDA on April 1, 2020, means that Zantac is no longer available over the counter or for new or existing prescriptions within the United States.  This statement from the FDA differs from its past releases because it is the first time the FDA is requesting the market withdrawal of all products containing ranitidine.  

According to the April 2020 FDA release, the agency did not observe unacceptable levels of NDMA in every sample.  In fact, numerous tested samples did not reveal unacceptable levels of NDMA. However, because the FDA did not know how long the products may have been stored, the agency made the decision to pull all Zantac products unless or until the quality can be assured.   The FDA does not expect the drug to return to the market unless a company can submit scientific data that the medication is stable and that the NDMA levels within the product do not increase to unsafe levels over time.

How many people will be potentially affected by the Zantac recall is not currently clear.  Over 15 million prescriptions for Zantac drugs were issued in the United States in 2016.  According to one Zantac manufacturer, Sanofi, 2018, global sales of OTC Zantac were approximately $142 million, which represented a nearly 14% increase from the prior year.  

Pursuant to the April 1, 2020 statement from the FDA, it is advised that you dispose safely of any Zantac medication still in your possession by following disposal instructions within the packet insert or medication guide.  According to the FDA website, Zantac is not on the list of medications that are safe to flush, so the site provides the following disposal instructions:

1. Mix liquid or pills with dirt, used coffee grounds, catbox litter, or other unappealing substance.  Do not crush the capsules, tablets, or pills.
2. Put the unappealing mixture in a sealed plastic bag or storage container.
3. Throw away the filled, sealed plastic bag or container in your home trash receptacle.
4. Remove/obscure all personal information written on the prescription label, then throw away or recycle the empty bottle.

If you were taking OTC Zantac, it is suggested that you try another type of similar medication for symptom relief.  According to the FDA, alternative medications that have not been determined to contain NDMA include: 

• Pepcid (famotidine)
• Tagamet (cimetidine)
• Nexium (esomeprazole)
• Prevacid (lansoprazole)
• Prilosec (omeprazole)

Another safe medication to try in the interim is calcium carbonate.  Calcium carbonate neutralizes stomach acid. These medications, such as the popular brand Tums, rather than blocking acid production, target acid after it is produced and can provide relief from acid reflux symptoms.

If you are taking Zantac in a prescription form, you are advised to contact your prescribing health care provider immediately in order to discuss treatment alternatives.

The chemical NDMA is recognized as a carcinogen and has been found in recent tests to be present in Zantac drugs to the degree that resulted in immediate action by the FDA.  The types of cancer that have been linked to NDMA, and therefore to Zantac include but may not be limited to:

• Bladder cancer
• Stomach cancer
• Liver cancer
• Esophageal cancer
• Kidney Cancer
• Lung cancer
• Angiosarcoma (a blood cancer)

Health problems that could be linked to Zantac usage are not limited to cancers.  NDMA is also linked to fibrosis (scarring) of the liver, and reduced function of the lungs, liver, or kidneys.

Recent lawsuits have been filed against several Zantac product drug manufacturers on the grounds that they failed to protect consumers from the risk of increased levels of NDMA.  Some of the pharmaceutical corporations who have been making money hand-over-fist on the carcinogenic Zantac products include:

• Pfizer
• Sanofi
• Boehringer Ingelheim

The plaintiffs involved in the suits against Zantac manufacturers claim they were marketed and sold medicines that were contaminated with NDMA in toxic amounts, and that the drug manufacturers failed to disclose the health risks associated with the unacceptable amounts of NDMA.

It is important for everyone who has experienced dangerous and adverse effects from Zantac to seek medical care right away. After talking with your doctor, it is also prudent to speak with an experienced drug product liability attorney. There might be channels through which individuals and families can recover damages.

Some of the plaintiffs that have filed suit against Zantac and its manufacturers have initiated the lawsuit because they developed cancer after using the medicine  People who have sustained direct harm (such as cancer or scarring of the liver) related to Zantac use have suffered a type of personal injury, - if you took Zantac and developed one of the other health conditions linked to the medicine, you may be a candidate for filing a personal injury claim.  There are several elements involved in a personal injury claim against the manufacturers of Zantac:

A personal injury plaintiff must establish negligence against the defendant, in this case, the manufacturer(s) of Zantac.  The negligence of the drug manufacturer stems from its failure to warn consumers and patients of the known possible cancer risks associated with the use of the medication.  Drug manufacturers have a reasonable duty to protect those that use their products. If that duty is breached and harm is caused to a user of a medication, negligence can be established.  While the FDA states that it does not have scientific evidence to determine how long NDMA has been present in Zantac products, there appears to be plenty of evidence-based on well-known prior studies that the cancer-causing risks were known.

Not unlike what happened with litigation against cigarette corporations in the past, drug manufacturers will undoubtedly argue that they were not aware of the potential harm caused by Zantac.  It is crucial to your claim to hire an experienced, hard-working lawyer to work on your personal injury case against the drug manufacturers of Zantac to present evidence related to a defendant’s awareness of the drug’s effects.

According to several peer-reviewed studies, it is likely that the drug manufacturers knew of the risk for increased levels of NDMA and did not disclose the risk.  One such study, published in 2016 in the medical journal Carcinogenesis found that healthy patients who had taken Zantac medications were 400x more likely to have increased levels of NDMA within their urine than those who did not take it.  That 2016 study was conducted at Stanford University, and it involved 10 healthy volunteers who were given 150 milligrams of Zantac. Afterward, NDMA levels within the volunteers’ urine exceeded 47,000 nanograms - and this was after the metabolization of most of the NDMA before the remainder was excreted in the urine, so the actual amount within the body was likely much higher.  

Another study conducted in 2004 found that people with peptic ulcers who took either Zantac or another popular anti-acid drug had an increased risk of bladder cancer.  

There are many layers involved in proving negligence and prior knowledge against a dangerous drug manufacturer.  The drug makers have deep pockets to fight lawsuits.  If you or someone you love has received a serious health diagnosis such as cancer due to taking Zantac is crucial that you obtain an attorney who has extensive experience in litigation against pharmaceutical manufacturers.

If you or a loved one has been diagnosed with severe disease or condition such as cancer after taking Zantac, please reach out to our law office for free, friendly advice at (916) 921-6400 or (800) 404-5400. An online contact option is available for your convenience.

We are honored to be a member of the Million Dollar Advocates Forum as well as the National Association of Distinguished Counsel.

Our client reviews can be viewed on Google, Yelp, and Avvo. Please also see our successful verdicts and settlements.

DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer/Services Agreement. No attorney-client relationship will exist between you and our firm unless and until we enter into a signed Retainer/Services Agreement. The information you obtain at this site is not, nor is it intended to be medical or legal advice. Do not stop taking any medication without consulting your physician.

^{Editor’s Note: updated for accuracy and relevancy [cha 7.7.23] Photo by Michal Jarmoluk via StockSnap MM [cs 3264] bw}