Zantac (Ranitidine) Cancer Lawsuits

Has Zantac Been Recalled?

Zantac hasn't technically been recalled, but it's no longer available after the U.S. Food and Drug Administration requested complete market removal of the once-popular heartburn medication, and drugmakers complied by pulling Zantac (and its generic counterpart ranitidine) from shelves nationwide.

For decades, Zantac and ranitidine were available over the counter and via prescription to treat heartburn, ulcers, acid reflux, and similar conditions. Ranitidine products have been linked to a number of well-understood and mostly mild side effects over the years, but the recent discovery of a carcinogenic contaminant in ranitidine—and evidence that health risks can increase with time and temperature depending on how the products are stored—brought increased scrutiny, along with hundreds of product liability lawsuits linking Zantac/ranitidine to cancer.

Can Zantac Ever Legally Come Back on the Market?

As of late 2021, ranitidine products have not come back on the market. The FDA has said:

If a company can show, through scientific data, that their ranitidine product is stable and the NDMA levels do not increase over time to unsafe levels, FDA may consider allowing that ranitidine product back on the U.S. market.

For now, a number of safer options continue to be available to consumers. According to the FDA, the agency's own testing has shown no NDMA in a number of medications that can treat the same (or similar) health conditions as those targeted by ranitidine, including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).

Somewhat surprisingly, given the potential for negative consumer associations between the brand name and a seemingly unsafe product, Sanofi (the manufacturer of Zantac) launched Zantac 360, formulated with famotidine, in early 2021.

Are Generic and Liquid Ranitidine Also Recalled?

All ranitidine medications, in all forms, were subject to the FDA's April 2020 request for market removal, and all manufacturers of ranitidine products complied with the agency's recommendation. So that means it's not just brand name Zantac that can no longer be purchased over the counter or via prescription, but all forms of ranitidine (tablet, capsule, liquid, and injectable medication) are unavailable as well.

What Is the Link Between Zantac and Cancer?

As mentioned above, the link between Zantac/ranitidine and cancer is based on the discovery of a cancer-causing contaminant in the medication. Specifically, in the summer of 2019, the FDA learned that samples of ranitidine revealed the presence of N-nitrosodimethylamine (NDMA), a known carcinogen. The agency's initial response was measured, since low levels of NDMA are often ingested as part of a normal diet, and trace amounts are even found in water. But the agency was concerned enough to issue a warning to consumers in September 2019, stating that while NDMA levels detected in samples of ranitidine were "similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats," consumers should talk to their doctors about non-ranitidine treatment options. Drug manufacturers were instructed to monitor their products and issue recalls if NDMA levels were found to be above acceptable limits.

Things escalated significantly six months later, when the FDA requested the market withdrawal of all ranitidine products. The agency's heightened concern came after lab tests revealed that NDMA levels can increase in ranitidine products while the medicine is stored over time, especially at higher-than-normal room temperatures. So the longer Zantac sits on store shelves or in medicine cabinets, the more dangerous it becomes.

Who Can File a Zantac Lawsuit?

The potential link between ranitidine products and cancer has led to the filing of hundreds of lawsuits against Sanofi (Zantac's manufacturer) and other companies in recent years. NDMA isn't linked to a specific type of cancer, and with the science related to NDMA in ranitidine being relatively new, many of these lawsuits are proceeding on the logic that:

• the plaintiff used Zantac or another ranitidine product, often for years
• the plaintiff has no particular predisposition to cancer (based on family history or environmental factors)
• dangerous levels of NDMA, a known carcinogen, can be found in ranitidine products, and
• the plaintiff has been diagnosed with a form of cancer.

That last component is the key to filing a lawsuit alleging harm caused by Zantac or another ranitidine product. Even if you've used Zantac for years, and are concerned that you might get sick, that's not enough of a basis to file a viable injury lawsuit. Cases like these require measurable harm, and that usually means diagnosis of cancer or some other illness that can be traced back to use of Zantac or another ranitidine product. That's the first step in establishing the nature and extent of your losses ("damages" in legalese), including the cost of necessary medical treatment, and other, more subjective effects like "pain and suffering."

A lawsuit seeking to tie cancer or some other illness to a ranitidine product will likely be based on a legal fault theory known as "product liability," through which manufacturers and others in a product supply chain can be held responsible for injuries and illnesses caused by that product. Product liability can also hold manufacturers responsible when their failure to warn consumers of risks associated with the product's use leads to illness or injury. (Learn more about proving a product liability case.)

What If I Got Sick Years After I Last Used Zantac?

If you're thinking about filing a lawsuit over an illness that could be linked to Zantac, a big preliminary issue is the lawsuit-filing deadline, which is set by a law called a statute of limitations. But when you're claiming illness tied to long-term use of a product, it's rarely possible to figure out exactly when that use actually triggered health problems. That's why the statute of limitations "clock" might not necessarily start running on the date of your last use of a ranitidine product. Learn more about how the statute of limitations works in product liability cases. And, regardless of how long it's been since you last used Zantac or another ranitidine product, talk to an injury attorney for details on how the lawsuit-filing deadline might apply to your potential case.

How Much Is a Zantac Case Worth?

Putting a dollar value on any injury case is difficult. A particular Zantac/ranitidine plaintiff's damages—and therefore the amount of compensation they're likely to receive—depends on their very specific circumstances, including:

• the details of the plaintiff's ranitidine-related health problems, including the nature and extent of the illness, prognosis for a full recovery, and necessary future care
• effects on the plaintiff's ability to earn a living, now and in the future
• impact on the plaintiff's life, including ability to perform household chores, care for loved ones, enjoy hobbies, etc.
• the extent of the plaintiff's pain and discomfort, and
• any other negative effects of the illness and medical treatment.

(Get more tips on damages in a product liability case.)

You might be wondering how much compensation other Zantac plaintiffs have received. But a comparison of case outcomes isn't usually a useful exercise in product liability cases, and that's especially true when it comes to Zantac/ranitidine lawsuits. For one thing, by their very terms, settlement agreements are almost always confidential. And even when a Zantac/ranitidine case does go to trial, a jury verdict in the plaintiff's favor probably isn't the best predictor of the potential value of a different talc-cancer lawsuit. That's because when a plaintiff wins a product liability trial, they often win big. But perhaps most significantly, while hundreds of lawsuits have been filed alleging a link between Zantac/ranitidine and a number of forms of cancer, much of this litigation is in the early stages.

Does a Recall Affect the Way a Lawsuit Works?

The market withdrawal of Zantac isn't going to be the final evidentiary word in a lawsuit in which the plaintiff tries to link the medication to a diagnosis of cancer or any other illness. The plaintiff still needs to prove his or her particular case against Sanofi or any other defendant, and if the lawsuit goes to trial, the jury is largely free to give whatever weight it deems appropriate to the FDA's recommendation. In short, this kind of action, even on the heels of a top health agency's prompting, isn't always the "smoking gun" it appears to be.

On one hand, the FDA's recommendation and the subsequent market withdrawal of Zantac might indicate that the medication was unreasonably dangerous, and that Sanofi and others should have done more to warn consumers (as is done with side effects associated with taking any medication), or to make the product safer. But on the other hand, Sanofi and other defendants facing a lawsuit over illness linked to ranitidine could turn this argument around and claim that for decades there was no reasonable basis to suspect a link between Zantac and cancer, and once a potential connection was found, appropriate remedial action (total market removal) was taken.

Is There a Class Action Lawsuit for Zantac?

There is no class action seeking compensation for illness or injury caused by use of Zantac or other ranitidine product, mostly because there's too much disparity among individual cases (in terms of variables like severity of the plaintiff's ranitidine-related illness and the subjective impact on the plaintiff) to make an injury-related class action appropriate. (Note that there are several consumer protection-focused class action lawsuits against Sanofi and other companies, but those proceedings don't seek a remedy for illness or injury.)

The largest single consolidation of Zantac/ranitidine claims is a federal "multidistrict litigation" (MDL) action, which includes hundreds of lawsuits. The MDL, called In Re: Zantac (Ranitidine) Products Liability Litigation, is being handled by Judge Robin L. Rosenberg in the U.S. District Court for the Southern District of Florida, and is in its very early stages. Keep in mind that the MDL is a consolidated group of individual cases in which the plaintiffs still largely control their own legal destinies. Your attorney will determine the best course of action for your case. Learn more about how multidistrict litigation works in product liability cases.

How Do I Find a Lawyer for My Zantac/Ranitidine Case?

If you've been diagnosed with cancer or another health problem that you think might be linked to your use of Zantac or another ranitidine medication, making sure you have the right lawyer on your side can make all the difference toward a positive outcome for your case. But it's not always easy to figure out how to choose an injury lawyer who is right for you.

You can always start with a state bar association website, which should allow you to research lawyers in your area, find out what kinds of cases they might specialize in, and learn whether they've been suspended or otherwise subjected to any discipline. And of course, websites like Nolo can connect you with a Zantac/ranitidine lawsuit attorney via our chat and information submission features.

Another great way to find an attorney for your Zantac case might be to ask around in your network of friends and family, and see if anyone you trust has had a positive experience with a lawyer. Even if that lawyer doesn't typically handle injury cases against big drug companies like Sanofi, they may be able to refer you to a qualified lawyer in their network.

What Should I Ask a Potential Zantac Cancer Attorney?

However you connect with a potential Zantac/ranitidine attorney, it's important to be prepared for your first meeting (even if it's virtual). Here are some topics to touch on.

• How many years has the lawyer been in practice? The answer here shouldn't necessarily be make-or-break. An experienced lawyer offers obvious benefits, but a younger (possibly "hungrier") lawyer can also be a plus.
• What percentage of the attorney's time is spent litigating personal injury cases? Does that include product liability cases in general, or claims for illness linked to medication like Zantac in particular? Experience in product liability cases often means a certain level of comfort in going up against large corporations like Sanofi (and their rosters of lawyers).
• Would the lawyer handle your case personally? It's normal for other members of a firm to work on a client's case, but it helps to know whom you'll be dealing with directly. (Learn about working with a lawyer on an injury-related case.)
• Will the lawyer work under a contingency fee agreement? (That means if your case settles, or a trial ends in a verdict in your favor, the lawyer receives an agreed-upon share of your compensation). What's the lawyer's share? Does the share increase as the case progresses (this is known as a "sliding scale")? Who is on the hook for case expenses or "costs", and will any deduction of costs come before or after the attorney takes his or her share of your compensation? Learn more about how injury lawyers get paid.

See more questions to ask a potential personal injury attorney and tips on getting help from an injury lawyer.