Zantac is a common heartburn drug available over-the-counter and by prescription to treat a variety of acid reflux-related issues and ulcers. It is commonly used as a long-term treatment for gastroesophageal reflux disease, or GERD.
Brand-name Zantac and its generic equivalent, ranitidine, have recently been recalled by over a dozen drug manufacturers after the U.S. Food and Drug Administration (FDA) confirmed the presence of the chemical, NDMA, in certain Zantac products. This chemical has been linked to a variety of health issues, including several types of cancer.
As of March 2020, thousands of individuals across the United States have begun filing lawsuits against the primary manufacturers of Zantac on the grounds of product liability, personal injury, and wrongful death.
Zantac lawsuits in the state of Florida have seen a recent development, with 140 of these lawsuits now being grouped into multidistrict litigation in the Southern District of Florida. This consolidates federally filed lawsuits against Zantac drugmakers to a single court for litigation.
Zantac Recalls: What To Know
The recent wave of Zantac (ranitidine) recalls have become a global issue, impacting pharmaceutical markets across the world.
In the United States alone, an estimated 15 million prescriptions are written for Zantac each year, not including the many people who have used over-the-counter (OTC) Zantac previously available at stores like CVS and Walgreens.
Many people are concerned about whether they’re at risk for serious health issues such as cancer after taking Zantac. If you or a loved one has taken Zantac for acid reflux or another health condition, here is what you should know about the latest Zantac recalls and lawsuits.
Why Zantac Was Recalled
Over-the-counter and prescription Zantac products have recently been recalled due to a discovered link between regular use of these drugs and cancer.
These drugs were discovered to contain a chemical known as NDMA, which is classified by the Centers for Disease Control (CDC) as a probable carcinogen that, in excessive amounts, can cause cancer.
Types of cancer linked to the NDMA in Zantac include:
- liver cancer
- bladder cancer
- lung cancer
- breast cancer
- kidney cancer
- esophageal cancer
- stomach cancer
- testicular cancer
- ovarian cancer
- pancreatic cancer
- angiosarcoma (cancer of the blood)
Although the U.S. Food and Drug Administration has not issued a mandatory recall for Zantac, many manufacturers of Zantac drugs have voluntarily recalled their products to further investigate their safety.
When Was NDMA Found In Zantac?
NDMA was first detected in Zantac in June 2019 by the online pharmaceutical research company, Valisure. Through routine testing of their ranitidine products, the company’s laboratory discovered unsafe amounts of the cancerous chemical, NDMA.
Following this discovery, the company then notified the U.S. Food and Drug Administration (FDA), the federal agency responsible for drug safety evaluation, of this public health concern.
On September 9, 2019, Valisure filed a FDA Citizen Petition, requesting that the federal agency:
- issue a recall for all Zantac in the United States
- inform the public of the NDMA found in Zantac
- suspend all Zantac and ranitidine drug sales pending further investigation into their safety
Days later, the FDA released an initial statement informing healthcare providers and the broader public about the discovery of a cancerous chemical in Zantac and ranitidine drugs. While the FDA is continuing to investigate the potential dangers of the NDMA in Zantac, the agency has not required these drugs be taken off the market.
The FDA has also not recommended that people who are taking Zantac for a health condition stop taking the drug, suggesting that people who are concerned about their risk for cancer discuss alternative treatment options with their doctor.
When Was Zantac Recalled?
The first voluntary recall for Zantac products came from the drug manufacturer, Sandoz, on September 23, 2019—10 days after the FDA’s initial statement on the NDMA in Zantac.
General timeline for Zantac recall information:
- September 9, 2019 — Online pharmaceutical research company, Valisure, files a Citizen Petition to the FDA, requesting they issue a recall of all ranitidine-containing drugs.
- September 13, 2019 — The U.S. FDA releases a statement alerting doctors and the public of a discovered NDMA impurity in certain Zantac (ranitidine) products.
- September 23, 2019 — Sandoz Inc., a pharmaceutical company that manufactures ranitidine hydrochloride capsules, becomes the first drugmaker to voluntarily recall their ranitidine products.
- October 2, 2019 — The FDA reports that their own testing of ranitidine products confirms “unacceptable” amounts of NDMA found in ranitidine, although they discovered amounts that were less than those found in Valisure laboratories.
- October 23, 2019 — The primary manufacturer of Zantac OTC products, Sanofi, recalls all of their Zantac OTC products. At this point, five drugmakers total (including Sanofi and Sandoz Inc.) have issued voluntary recalls.
As of March 2, 2020, 15 manufacturers of Zantac and ranitidine have voluntarily recalled their ranitidine-containing products due to NDMA concerns.
Is All Zantac Unsafe?
The answer to this is unclear.
Various Zantac and ranitidine products have been found to contain NDMA and have been recalled for safety concerns, including:
- Zantac 150
- Zantac 150 Cool Mint
- Zantac 75
- prescription ranitidine tablets, capsules, and oral syrups
- generic OTC ranitidine products
- other brand-name ranitidine products (e.g. Wal-Zan 150, Wal-Zan 75, Heartburn Relief)
The FDA does not believe all Zantac (ranitidine) products are unsafe for use at this time, as only certain lots of Zantac drugs have been found to contain unsafe amounts of NDMA.
However, according to multiple researchers who have studied the chemical makeup of Zantac, the excessive NDMA in Zantac may not be a contamination of NDMA as much as a result of how Zantac works in the body. There is evidence to support the assertion that taking Zantac can cause the body to produce dangerously high amounts of NDMA due to an “instability” of the ranitidine molecule.
According to Valisure, the company that first detected NDMA in Zantac:
“all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body…There’s no acceptable cancer risk for a drug like this.”
The safety of Zantac and ranitidine products is still under investigation. The FDA has not issued a mandatory recall of all Zantac products, although over a dozen manufacturers have voluntarily recalled their ranitidine products as of February 2020.
The latest ranitidine recall comes from the pharma manufacturer, Amneal Pharmaceuticals LLC, which issued a recall for their production of ranitidine tablets on February 27, 2020.
NDMA In Zantac: What Is It?
N-nitroso-dimethylamine (NDMA) is a chemical that is formed through both natural and industrial processes, according to the U.S. Environmental Protection Agency.
The primary ways people tend to be exposed to NDMA is through the consumption of certain foods (e.g. smoked or cured meats) and contaminated water. NDMA has been classified as a probable human carcinogen, meaning it can be cancerous in high doses. It can also cause issues such as liver disease, kidney damage, vomiting, and stomach pain.
Some cleaning and household products, as well as certain cosmetic products, may also contain NDMA. Being exposed to trace amounts of NDMA is unlikely to significantly increase a person’s risk for developing cancer.
How Much NDMA Is In Zantac?
Different laboratories have found varying amounts of NDMA in Zantac. Valisure, the company that first detected the NDMA in Zantac, found over 3,000,000 nanograms (ng) of NDMA in each drug tablet, far exceeding the FDA-recommended daily limit of 96 ng.
The FDA conducted testing of Zantac products and found amounts of NDMA that were less than those reported by Valisure, yet have nonetheless been determined “unacceptable” for consumer use.
Defendants In Zantac Lawsuits
Multiple manufacturers of brand-name Zantac and ranitidine products have been named as defendants in the recent wave of Zantac lawsuits.
Top manufacturers named in Zantac lawsuits include:
- Sanofi (manufacturer of Zantac OTC products)
- Chattem, Inc.
- Boehringer Ingelheim
- GlaxoSmithKline (original branded maker of Zantac)
Zantac Lawsuits: Types Of Lawsuits Against Zantac Drugmakers
Lawsuits against Zantac drugmakers have been filed across the country, with several coming out of the state of Florida.
Jill Goldstein from Palm Beach, for instance, filed a lawsuit against several Zantac manufacturers in late 2019, alleging that her long-term use of Zantac directly led to her breast cancer diagnosis in August 2019.
The types of lawsuits being filed against Zantac drugmakers include:
- personal injury lawsuits
- wrongful death lawsuits
- product liability (defective drug) lawsuits
Many of these lawsuits, including that of Jill Goldstein, have been filed individually and have since been grouped into multidistrict litigation (MDL). Class action lawsuits against Zantac drugmakers have also been filed to represent groups of individuals alleging similar harm caused by their use of Zantac products.
Understanding The Differences: Zantac Florida Multidistrict Lawsuits Vs. Class Action Lawsuits
While a Florida attorney can provide a comprehensive explanation of the differences between multidistrict and class action lawsuits to you during an initial consultation, it can be helpful to understand some basic differences and key terms.
Multidistrict Litigation (MDL)
Multidistrict litigation (MDL) is a procedure in which a number of individual lawsuits against the same defendants are grouped together to be presented to a single court.
For large-scale product liability and personal injury cases such as this, centralizing the many Zantac lawsuits into multidistrict litigation can make these cases more manageable for a court.
Individual lawsuits that are grouped into multidistrict litigation lawsuits, however, maintain their singular nature. This means that each individual plaintiff, and their lawyer, retain the ability to negotiate their own settlement and receive the entirety of their awarded compensation in a favorable outcome.
Class Action Lawsuits
Class action lawsuits are lawsuits that involve at least 20 plaintiffs who join together to form a group, or “class,” of individuals who have been similarly harmed by a person, product, or service.
In every class action, there is one named plaintiff who becomes the primary person responsible for plaintiff representation, communicating with the case lawyer, and negotiating a settlement amount on behalf of the class.
One key difference between multidistrict and class action lawsuits is how settlement amounts (compensation) are awarded. In a class action suit, the awarded compensation is divided equally among all plaintiffs, operating on the assumption that all plaintiffs have suffered identical losses.
The types of damages that may be awarded in class action suits may also vary, depending on the details of the case.
Types Of Damages Awarded In Zantac Lawsuits
Damages is a legal term that refers to the amount of compensation a plaintiff can be awarded in a lawsuit. There are several types of damages that can be awarded in a lawsuit, based on the nature of a case and the extent of the person’s losses.
Damages are typically awarded in the form of monetary compensation. This can include special damages (injury-related costs) and general damages (non-economic losses).
For instance, if you are suing on behalf of a loved one for wrongful death, or on the grounds of a defective product, the types of damages you can receive may differ from someone who is suing for personal injury.
Based on the details of your case, the types of damages awarded in Zantac lawsuits may include:
- current and future medical expenses
- cancer treatment costs
- lost wages
- loss of earning capacity
- loss of companionship
- physical and mental anguish
- pain and suffering costs
- money spent on Zantac
- funeral and burial costs
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What To Do If You’ve Taken Zantac
If you’ve taken Zantac for a health condition, don’t panic. Follow these steps to determine your risk for cancer after taking Zantac, and whether you qualify to take legal action against Zantac manufacturers:
Contact Your Doctor
Your doctor is the best person to determine what, if any, health issues you may be at risk for after using Zantac. In general, people who have taken Zantac only once or a few times are unlikely to be at risk for serious NDMA-related health issues.
The primary population believed to be at potential risk for cancer after taking Zantac are those who have been taking Zantac on a regular basis (twice or more a week) for years as a long-term treatment for a health condition.
If you’ve been diagnosed with cancer after taking Zantac, your doctor may be able to determine whether your use of Zantac led to your cancer diagnosis based on how long you took the drug and other factors related to your personal and medical history.
Seek Legal Guidance
If you’ve taken Zantac regularly for an extended amount of time and believe it may have caused you or a loved one to develop cancer, you may be eligible to sue Zantac manufacturers. A lawyer who has been following Zantac recalls and the latest lawsuits can determine if your case qualifies for legal action.
Based on the details of your case, a lawyer can offer a recommendation for your best course of legal action, whether that is filing an individual lawsuit against Zantac manufacturers or joining a class action.
The benefits of filing a Zantac lawsuit include:
- holding drug manufacturers accountable for producing, marketing, and profiting from consumer use of potentially cancerous products
- seeking compensation for losses associated with your Zantac use, including medical treatment expenses, pain and suffering, and lost wages
- placing further pressure on Zantac manufacturers to recognize their role in putting consumers at risk for cancer
- encouraging more rigorous research into the potential side effects and dangers of new drugs entering the U.S. pharmaceutical market
- dissuading other drugmakers from putting consumers at risk by trying to market and sell potentially dangerous products
- ensuring the safety of others by pressuring Zantac drugmakers to review the safety of their products’ chemical makeup
- encouraging others who have also been harmed by Zantac to feel more confident in joining those who are taking legal action
Many law offices, including the Florida offices of Florin|Roebig, can offer you a free case evaluation to discuss the details of your case and determine your eligibility to file a lawsuit, free of charge.
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Florida Zantac Lawyers
At Florin|Roebig, our Florida lawyers have experience handling large-scale cases with powerful defendants—including pharmaceutical giants—and the vast legal defense resources they often employ to avoid compensating individuals seeking justice.
Since 1985, our law firm has secured over $1 billion in results for clients who have been unlawfully harmed.
Our team of award-winning Florida lawyers includes:
- Wil H. Florin, B.C.S.
- Tommy D. Roebig, B.C.S.
- Chase P. Florin, B.C.S.
- Shaun M. Cummings
- Luca G. Esposito
- Chad K. Florin, M.B.A., LL.M.
- Nicholas S. Costantino
- Michael A. Ossi, O.C.
- Lawrence J. Najem, O.C.
- Andrew M. Leone, O.C.
- Nollys R. Solarte, O.C.
- Brian R. Dettman, O.C.
Find Help Filing A Zantac Cancer Lawsuit
If you’re a Florida resident who has developed cancer or lost a loved one to cancer after taking Zantac, our lawyers can help you determine your legal options.
Contact us today to schedule a free case evaluation with one of our top-rated Florida Zantac attorneys to see if you qualify to join others in suing Zantac manufacturers.