Why Was Zantac Taken Off the Market?

Zantac was taken off the market in 2020 because of a possible link to several types of cancer. In addition, the U.S. Food and Drug Administration (FDA) issued a recall that affected Zantac’s parent company and all other ranitidine products. 

You could have legal rights if you used Zantac or a generic product and later received a cancer diagnosis. There is multidistrict litigation already underway in these cases. You may qualify to join and seek damages for your medical bills, lost income, and other damages. Connect with a law firm today to learn more about your legal options. 

Here’s What You Should Know About the Zantac Recall

Studies found that ranitidine—the active ingredient in this heartburn and GERD medication—can be contaminated with unacceptable levels of N-Nitrosodimethylamine (NDMA), a compound known to cause cancerous tumors in lab animals.

Once the FDA realized there was a significant risk that those who used this medication regularly could be exposed to this known carcinogen, the agency pulled its approval. 

More than 2,000 people who took the medication and later received a cancer diagnosis filed suit as of June 2022. The United States Judicial Panel on Multidistrict Litigation (JPML) consolidated these cases into MDL 2924: RE: Zantac (Ranitidine) Products Liability Litigation. The Honorable Robin L. Rosenberg will oversee the process in the Southern District of Florida. According to the JPML, there are currently 2,106 active lawsuits in the MDL as of June 15, 2022.

How Many Years Was Zantac on the Market?

Zantac received FDA approval in 1983 and spent more than 35 years on the market. During this time, it was a very commonly-prescribed medication and also available in over-the-counter versions and generic formulations. Millions of people likely used this product regularly to address: 

  • Heartburn
  • Stomach ulcers
  • Gastroesophageal reflux disease (GERD)

This means the number of those affected by the increased cancer risk could rise considerably. 

While ranitidine-based Zantac products are no longer available, consumers can still use other Zantac products. This includes Zantac 360, which is formulated with famotidine. 

Why Did the FDA Recall Zantac and Other Ranitidine Products?

Ranitidine medication manufacturers began voluntarily pulling their products from the market in late 2019, including Zantac’s French drugmaker, Sanofi. The FDA followed this by requesting a recall of all prescription and over-the-counter ranitidine formulations on April 1, 2020. 

The FDA’s press release announcing the recall noted the concern over NDMA levels. This environmental contaminant is something that everyone receives some exposure to in their daily life. However, more extensive exposures may be carcinogenic. This could occur when someone takes a small dose of the medication every day for years, for example. 

According to the FDA, the tested samples did not show extreme levels of NDMA. Still, the impurity levels can increase over time and when stored at high temperatures, and there is evidence that the body metabolizing the drug could raise levels even higher. 

The FDA Requests Zantac Recall and Manufacturers Pull it From the Market

As of April 1, 2020, the FDA requested that drug manufacturers pull any remaining ranitidine products off the market. They effectively pulled the agency’s approval for this medication. 

What Is in Zantac That Causes Cancer?

The FDA and other agencies set acceptable levels of some environmental contaminants. This includes NDMA, which has a daily threshold level of 96 nanograms set by the FDA. In November 2019, The Washington Post reported that an independent laboratory found extremely high levels of NDMA in Zantac and other ranitidine products. 

This chemical compound is known to cause cancerous tumor growth in laboratory animals and is known to be a probable human carcinogen.

What Types of Cancer Does Zantac Cause?

According to MDL 2924, numerous studies link NDMA exposure to cancer development in several body systems. The lawsuits refer directly to seven types of cancer: 

  • Stomach cancer
  • Intestinal cancer
  • Liver cancer
  • Pancreatic cancer
  • Esophageal cancer
  • Kidney cancer
  • Bladder cancer

During the initial bellwether trials in the MDL, experts will use all available evidence in the case to show a strong link between NDMA and cancer. The evidence for the plaintiffs’ case draws on hundreds of scientific articles, animal studies, occupational exposure tracking, and human dietary studies.

A lawyer can help you build a case to link your cancer or a loved one’s cancer to Zantac use. To do so, they may use your medical records, expert testimony, doctors’ statements, and other evidence. 

The FDA Did Not Recall All Zantac or Heartburn Treatment Products 

This recall does not affect all histamine H2-receptor antagonists, or H2 blockers, used for heartburn, ulcers, and GERD. Many have similar-sounding names. However, the recall and resulting lawsuits only include ranitidine. Other H2 blockers remain widely available.  

The Zantac brand also still has products on the market. Most notably, this includes Zantac 360. This formulation relies on famotidine as its active ingredient.

It is important to understand, though, that the recall affects any Zantac product containing ranitidine. If you use these products or have them in your home, you need to act now. Dispose of any you have in your cabinet and talk to your doctor about alternatives.

Potential Changes to Drug Approval for Ranitidine

Zantac and ranitidine do not currently have approval for prescription or over-the-counter sales in the United States. However, this could change. According to the FDA, they will consider approval of this drug if the company can provide data that shows: 

  • Ranitidine is stable
  • The NDMA levels do not increase over time

However, this is unlikely given the evidence presented in the filings for MDL 2924. It seems the issue with the drug stems from ranitidine directly. 

Consumers have several other options, including many other H2 blockers that work similarly. Discuss your options with your prescribing doctor or pharmacist. The FDA checked for NDMA in the following medications and did not find any disturbing impurities: 

  • Famotidine (Pepcid)
  • Cimetidine (Tagamet)
  • Esomeprazole (Nexium)
  • Lansoprazole (Prevacid)
  • Omeprazole (Prilosec)

What to Do If You’ve Been Diagnosed With Cancer

Contact a law firm reviewing these cases if you took a ranitidine product and later received a cancer diagnosis. You may only have a limited time to file an individual civil action or join the MDL already in progress. State statutes of limitations may apply. 

A Zantac lawsuit attorney can handle your case for you and offer advice about joining the MDL or taking other legal action. You may be eligible to recover damages for:

  • Cancer treatment and related medical care
  • Lost income and benefits (short and long term)
  • Miscellaneous out-of-pocket expenses
  • Pain and suffering
  • Mental anguish

Punitive damages may be available in these lawsuits. Punitive damages penalize the drug manufacturer or another liable party for their intentional or especially negligent actions. In many defective medication mass torts, punitive damages are substantial. We are too early in the process to know if these damages are available in the Zantac lawsuits.

During this time, it is essential that you also continue your treatment and follow the doctor’s orders. You do not want to miss out on a payout because the jury did not believe you took the necessary steps to get well. 

If your loved one passed away from cancer before they had a chance to join the MDL or file a lawsuit, a wrongful death claim may be possible. Others have already filed lawsuits based on their loved one’s Zantac cancer death. You may be able to file suit if you can show your loved one took ranitidine and passed away from a related cancer.

How Does Multidistrict Litigation Work And When Do Plaintiffs See Results?

Understanding how multidistrict litigation works is key to knowing how long it could take to receive justice. The goal of multidistrict litigation is to combine the cases for pretrial motions, discovery, and the initial trials, known as bellwether trials. This keeps thousands of individual cases with the same allegations from backing up smaller courts across the country. 

In MDL 2924, the allegations include that ranitidine products cause cancer and that the manufacturers knew about the possibility of NDMA exposure. Judge Rosenberg of the U.S. District Court in the Southern District of Florida will oversee evidence gathering and other early steps in these cases. This makes it much easier and more affordable for plaintiffs to prove a case against major drug manufacturers.

Then, bellwether trials will begin. This process includes:

  • Choosing several cases to serve as tests to see how juries react
  • Moving forward with jury trials in these cases

Several things can happen after bellwether trials. The outcome of these cases often influences all the other lawsuits. This could happen when:

  • The defendant offers a tiered or global settlement.
  • The plaintiffs understand they do not have a strong enough case.

Any cases that have not settled or dropped when the bellwethers are over return to their original jurisdiction to go to trial. Local courts will hear and decide these cases.

This is much different from a class action lawsuit. In class action cases, the plaintiffs all suffered similar injuries, and the outcome of the trial applies to all members of the class. They generally receive a payout from a single settlement or award split between the class members.

What Next in the Zantac Lawsuits?

According to the U.S. District Court in the Southern District of Florida, MDL 2924 is still in its initial stages. Both sides are carrying out discovery and pretrial motions as of June 2022. They are considering which plaintiffs will serve as bellwether cases and moving toward the first trial later in 2022. 

The court set a target of October 2022 for the first bellwether trials to begin, but it is not unusual for delays and rescheduling in these cases. This may be especially true in this case because it will likely rely on several expert witnesses, scientific studies, and considerable data analysis.

The multidistrict litigation process could take another year or more, depending on the number of bellwether cases chosen, the strength of the evidence available, and other factors. In many successful mass torts, settlement negotiations occur either before or after the bellwether trials wrap up. This could occur in the Zantac multidistrict litigation. 

Is it Safe to Take Zantac Now?

Any Zantac purchased new today or provided by your doctor or pharmacist should be safe to take. Only approved formulations are on the shelves. These drugs do not contain ranitidine. 

You should not take any ranitidine medications you currently have. You should throw these away. This is especially important since they have not been on the market for more than two years now, and the NDMA levels could increase with time and hot storage conditions. Encourage your friends and family to dispose of any affected products, as well.

When Will Zantac Be Back on the Market?

Due to the potential risk of developing several types of cancer, the FDA recalled all forms of ranitidine in 2020. This included all prescription, over-the-counter, and generic formulas containing this active ingredient. You cannot purchase ranitidine products in the United States in June 2022. 

While Zantac’s parent company has new products on the market using the brand’s name, these are not the traditional ranitidine medications they sold for almost 40 years. They are new formulations that rely on a similar—but safe—H2 blocker.

Get Legal Help With a Zantac Case Today

You can use our contact form to be connected with a personal injury lawyer in our network. Get a free consultation to learn more about your legal options. 

A mass torts attorney can handle your case for you. Your lawyer will navigate the legal system for you and pursue the compensation you deserve based on the facts of your case and the outcome of MDL 2924 if you join. You will not need to pay anything upfront for legal representation. Act now to get started.