Popular Heartburn Medication May Contain Carcinogens, Says FDA

The Food and Drug Administration recently announced an immediate recall of all over-the-counter heartburn drugs containing the active ingredient ranitidine. Popularly sold under the brand name Zantac, these medications are designed to treat chronic acid reflux and stomach ulcers.

In 2019, the FDA scrutinized Zantac and related pharmaceuticals for containing trace amounts of probable cancer-causing contaminants. However, at that time the FDA did not issue a recall and also did not recommend to the public that they should stop taking the medication despite a voluntary recall of ranitidine by some manufacturers.

The administration has seemingly reversed course—now recommending that consumers immediately stop taking Zantac and discard any remaining supply.

Zantac Recalled for Possible Cancer Link

The Food and Drug Administration (FDA) recently announced an immediate recall of all over-the-counter heartburn drugs containing the active ingredient ranitidine. Popularly sold under the brand name Zantac, these medications treated chronic acid reflux and stomach ulcers.

In 2019, the FDA scrutinized Zantac and related pharmaceuticals for containing trace amounts of probable cancer-causing contaminants. However, at that time, the FDA did not issue a recall. Nor did it recommend to the public that they stop taking the medication despite a voluntary recall of ranitidine by some manufacturers.

The administration has seemingly reversed course—now recommending that consumers immediately stop taking Zantac and discard any remaining supply.

Why Did the FDA Recall Zantac?

An agency spokesperson admitted that levels of a carcinogen known colloquially as NDMA could increase in the drug after its manufacture, depending on how it was stored or transported. High storage temperatures could naturally increase levels of the cancer-causing agent. Over time, prolonged use of drugs containing the contaminate may cause cancer in humans.

“Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients,” explains FDA Division Director Dr. Janet Woodcock.

Woodcock also notes that alternatives to Zantac remain on the market today, including brand-name products like Nexium, Prilosec, and Tagamet. These drugs are not known to contain the same cancer-causing chemical (NDMA) as Zantac.

While dozens of companies issued voluntary recalls of Zantac within the last year, this mandated removal of the product from store shelves is sure to raise questions about culpability on the part of the company and the FDA. Making matters worse is the indefinite suspension of all foreign and domestic FDA inspections due to travel restrictions put in place following the novel coronavirus outbreak.

It remains unclear when the agency may complete an investigation into the contamination of the popular heartburn medication Zantac. At this time, however, at least one manufacturing plant in India has been sanctioned.

After more study, it became apparent that the level of contamination in Zantac is far worse than the FDA initially let on in 2019 when it first warned about the possible danger. At the time, the FDA went out of its way to stress the low levels of NDMA in the drug. The FDA did not even urge an immediate recall. This soon was overcome by events, namely the private testing undertaken by the online pharmacy Valisure. This company’s research showed that the levels of NDMA could be far beyond the dangerous levels.

Since NDMA occurs naturally in ranitidine based on storage temperature, there is no way of knowing exactly how much exposure they had. Some lots may be untainted, while others could contain highly dangerous levels of NDMA.

Should Consumers Dispose of Existing Zantac Tablets?

The FDA advises consumers to stop taking Zantac immediately and throw any remaining liquids or tablets in the trash. As mentioned above, many name-brand heartburn medications and generic antacids are still available for purchase. Lifestyle and dietary changes are also recommended for people experiencing chronic acid reflux and stomach ulcers.

Ranitidine was already beginning to lose ground competitively to other types of heartburn medication. Your doctor may switch you to a proton pump inhibitor to treat your heartburn.

Consumers who have used Zantac to treat heartburn and have received a subsequent cancer diagnosis may consider safely storing any remaining supply in its original packaging and sealing it in a plastic bag. An attorney may wish to retain opened Zantac containers for use as evidence if the consumer seeks legal representation.

What Should Consumers Do Now?

Thousands of people may have developed cancer from regularly using Zantac and its generic versions. Many may have died from their illness.

If you or a loved one were a regular Zantac user and were diagnosed with these cancers, you may have grounds for a lawsuit:

• Prostate
•  Pancreatic
• Esophageal
• Stomach/gastric
• Breast 
• Liver
• Bladder
• Colorectal/intestine
• Kidney
• Lung

When you are injured by a product that you bought, you could make both the company that made it and the one that sold it to you pay for your injuries. You do not need to prove who was actually responsible. That is for the court to worry about. All you need to prove is that the product was defective, and that you suffered injuries from it. Alternatively, you could show that a company negligently designed or sold the product.

Grounds for Your Zantac Lawsuit

In the Zantac case, here are some allegations that you could raise in your lawsuit:

• The manufacturer knew or should have known that the active ingredient could cause cancer, and they failed to warn the public about it or pull the product from the market.
• The manufacturer was negligent by not realizing that they were selling a product that was a carcinogen.
• The sellers breached express and implied warranties to design and sell a safe product.

It was never a secret that the active ingredient in Zantac could become tainted with NDMA. There have been numerous research studies dating back decades that have shown the possibility that ranitidine could contain NDMA. These were out well before the news came out, and drugstores acted to pull Zantac from store shelves. However, the product still rolled out of the factory and onto store shelves. Given the popularity of Zantac, there was too much money to be made.

Defendants in the Zantac Cases

Now, the plaintiffs can make the companies that made and sold Zantac answer for their actions in a growing number of product liability lawsuits. Plaintiffs filed the first cases not long after the news broke that Zantac was tainted with NDMA.

Plaintiffs have filed lawsuits against:

• Sanofi US Services Inc.
• Chattem, Inc.,
• Boehringer Ingelheim,
• Pfizer
• GlaxoSmithKline
• Walgreens
• CVS
• Rite Aid
• Kroger
• Amazon

The number of lawsuits has now reached close to 600, and we expect it to grow further. Tens of millions of people took Zantac in the nearly 40 years that it was on the market. Therefore, this could become one of the largest mass tort cases of all time, even if the drug only injured a small number of the people who took it. When such a widely-used product turns out to be defective, the implications can be far-reaching, and the lawsuit fallout could take years to navigate.

For now, the lawsuit process is still in the early phases. Mass tort cases take some time to work through the legal system. The cases reached a milestone in the process when they were consolidated into multidistrict litigation. This does not guarantee that the plaintiffs will win. The federal court system does this for efficiency reasons when it expects large numbers of similar cases to be filed.

Right now, the cases are all in the Southern District of Florida. This does not mean that you physically need to go to Florida to file your case. Your attorney would make sure that the court gets the necessary paperwork to begin your case.

Damages in a Zantac Case

If your case is successful, you may receive:

• Lost wages for the time that you missed from work due to your illness
• Pain and suffering for what you have been through in the past and may experience in the future
• Your medical bills
• Wrongful death damages if your loved one passed away from a Zantac-related illness
• Punitive damages if the jury thinks that the company’s conduct merits this punishment

While punitive damages are rare, the plaintiffs are requesting them in this case. As your lawyer, we would argue that you deserve them because the defendants allegedly kept selling a product that they should have known was harmful. Punitive damages are what increases jury awards.

In the meantime, these lawsuits are a good candidate for a settlement, given the possible liability that the defendants face. If there is a global settlement, we believe that the possible settlement could be between $200,000 and $500,000 per plaintiff. It would all depend on your circumstances. Some of the mass tort product liability cases that relate to cancer have had settlements in this range.

For now, the best thing that you can do for your case is to get legal help immediately. You have a limited amount of time to file your lawsuit before you lose the right to sue. Based on when you received your diagnosis, the statute of limitations in your case may be running. Contact a Zantac lawyer for assistance today.