Since the 1980s, millions of people have used Zantac, or its generic form ranitidine, to treat various gastrointestinal issues like heartburn and indigestion. At the height of its popularity, Zantac became one of the world’s first ever drugs to top $1 billion in annual sales. But in 2019, the U.S. Food and Drug Administration (FDA) issued a recall request because a dangerous carcinogen was detected in ranitidine products. Now, scores of people diagnosed with cancer after using ranitidine products have come forward with lawsuits. If you’ve ever taken Zantac or a similar drug containing ranitidine and been diagnosed, here’s what you need to know about filing a lawsuit.
Ranitidine was discovered in the late 1970s and came into commercial use in 1981 to help prevent or relieve heartburn, acid reflux, ulcers, and other gastrointestinal issues. It was sold under many brand names, the most popular of which was Zantac. Ranitidine went on to become one of the most commonly prescribed medications in the United States, with over 15 million prescriptions written each year. Some preparations were also available as an over the counter (OTC) drug.
Hundreds of millions of prescriptions later, scientists discovered something worrisome: A substance known as NDMA was detected in ranitidine products, including Zantac. NDMA has been classified as a probable human carcinogen (a substance likely to cause cancer). The FDA moved swiftly to recall the drug, requesting a full market withdrawal in 2020.
Understandably, many consumers are alarmed. They are left wondering if their cancer diagnosis, or the diagnosis of a loved one, could be linked to a drug prescribed to them by a trusted doctor.
Given the unique details surrounding ranitidine, including the FDA’s withdrawal order, those who decided to file a lawsuit against drug makers are in a strong position to win their cases. Let’s dig deeper to learn why.
What Started Zantac Lawsuits?
Multiple third-party studies led to the eventual FDA investigation that would result in ranitidine’s removal from the market and a flood of legal action. As far as corporate malfeasance cases go, these are especially unique given the sheer amount of evidence supporting plaintiffs’ claims.
The First Red Flag
In 2018, European and American regulators issued a recall on a blood pressure drug made by a Chinese pharmaceutical company. Researchers found a cancer-causing impurity, N-nitrosodimethylamine (NDMA), in samples of drugs containing ranitidine. By 2019, multiple drug makers announced they would halt the distribution of ranitidine products while additional studies could be done.
You may be surprised to hear that NDMA is actually very commonly ingested through food and water–but in levels so low, it poses no known health risk. However, as the FDA looked closer into Zantac and other ranitidine drugs, they were concerned about the dangers of sustained, higher levels of exposure to NDMA. After all, millions of Americans had been using this drug, some for years at a time.
The FDA Takes Fast Action on Ranitidine
Researchers’ fears were confirmed shortly thereafter. Studies showed that NDMA levels in ranitidine products like Zantac can actually rise over time, even under normal storage conditions. Most concerningly, NDMA levels rise significantly when stored at higher temperatures for longer periods of time. These are the exact conditions virtually every bottle of Zantac was exposed to, from distribution all the way to consumer handling.
Ultimately, the FDA concluded that NDMA levels in ranitidine drugs exceeded acceptable levels and requested a full market withdrawal in the United States.
Zantac Plaintiffs Have an Advantage
The FDA’s report and subsequent withdrawal request mean that Zantac lawsuit plaintiffs have a strong advantage right out of the gate. Victims are not claiming that ranitidine, as an ingredient, causes cancer. Instead, they argue, the issue is that ranitidine can create dangerous levels of NDMA, which is itself a known carcinogen.
With this approach, which is backed by the FDA, defendants have little room to argue. We can consider ranitidine as prima facie–meaning, evidence is so overwhelming it can prove the case–defective because it poses a risk beyond those reasonably expected by the consumer.
In terms of product liability law, plaintiffs have another strong advantage. In general, the law requires that the product be defective “at the time it left the manufacturer’s hands.” At a molecular level, ranitidine is capable of conversion to NDMA, even at room temperature, according to the FDA. That means every single pill produced has the potential to contain NDMA, thus posing a cancer risk to anyone who uses it.
Which Illnesses Are Linked to Zantac Use?
Most commonly, Zantac/ranitidine use is linked to various types of cancer: gastro/stomach, esophageal, liver, bladder, and rectal. Bladder cancer seems to be most strongly linked to Zantac use. As always, consult a doctor if you are experiencing symptoms.
According to the Mayo Clinic, bladder cancer is a common type of cancer that begins in the cells of the bladder. It can be diagnosed at an early stage when the disease is highly treatable, but even then cancer can return after successful treatment. Symptoms include:
- Blood in urine, which may cause urine to appear bright red or cola colored, though sometimes the urine appears normal and blood is detected on a lab test
- Frequent urination
- Painful urination
- Back pain
Also known as gastric cancer, stomach cancer is an abnormal growth of cells that begins in the stomach. It can affect any part of the stomach, but in the United States, it is most likely to affect the area where your esophagus meets your stomach. Symptoms include:
- Difficulty swallowing
- Feeling bloated after eating
- Feeling full after eating small amounts of food
- Stomach pain
- Unintentional weight loss
Usually, esophageal cancer begins in the cells lining the esophagus, the long tube that connects your throat to your stomach. It’s the sixth most common cause of cancer deaths worldwide, affecting men more commonly than women. Symptoms include:
- Difficulty swallowing
- Unintentional weight loss
- Chest pain, pressure, or burning
- Worsening indigestion or heartburn
- Coughing or hoarseness
There are a few types of cancer that can form in the liver. The most common is hepatocellular carcinoma. However, it is more common for cancer to spread from another part of the body to the liver. In this case, it’s called metastatic cancer rather than liver cancer. Symptoms in the early stages of primary liver cancer (that is, it began there rather than spreading from another body part) are rare. When they do occur, they can include:
- Unintentional weight loss
- Loss of appetite
- Upper abdominal pain
- Nausea and vomiting
- General weakness and fatigue
- Abdominal swelling
- Yellow discoloration of skin and whites of the eyes
- White, chalky stools
Rectal cancer begins in the rectum, comprised of the last several inches of the large intestine. Because the rectum is situated in a very small space close to other organs, surgery for removal can be extremely difficult. Long-term survival for rectal cancer patients used to be uncommon, but advances in treatment options have improved survival rates. Symptoms can include:
- Unexplained weight loss
- A change in bowel habits, such as diarrhea, constipation, or more frequent bowel movements
- Dark maroon or bright red blood in stool
- Narrow stool
- A feeling that your bowel doesn’t empty completely
- Abdominal pain
- Unexplained weight loss
- Weakness or fatigue
Who Can File a Zantac Lawsuit?
It’s important to note that generic ranitidine is no longer included in lawsuits. So, only plaintiffs who took brand name Zantac should file claims.
- Anyone who used Zantac for at least a year before being diagnosed with cancer.
- Anyone who is officially diagnosed with cancer due to known and confirmed Zantac use and currently undergoing treatment/medication
- Anyone who is officially diagnosed with cancer due to known and confirmed Zantac use but has not been required to undergo treatment/medication
- Anyone who lost a loved one to cancer due to known and confirmed Zantac use
Drug Makers Named in Zantac Lawsuits
As noted earlier, lawyers are only accepting claims from people who took brand name Zantac at this time. Generic ranitidine defendants have been dismissed, although that order is pending appeal. As of February 2022, these manufacturers are involved in the federal multidistrict litigation (MDL) in the Southern District of Florida before Judge Robin L. Rosenberg:
GlaxoSmithKline (GSK): The UK-based company that first introduced ranitidine to the market as Zantac in 1981.
Pfizer: A U.S.-based company that made Zantac OTC from 2000-2006 after gaining approval from the FDA.
Boehringer Ingelheim (BI): A private German company that bought the rights to Zantac OTC from Pfizer in 2006.
Sanofi: The French-based company that owned the rights to Zantac at the time of the FDA recall.
Sanofi Accused of Destroying Evidence
Ahead of upcoming trials, one manufacturer, Sanofi, has been accused of destroying evidence that may impact over 70,000 former patients.
A court filing in May 2021 details how deleted emails, including those of Michael Baily, the head of regulatory affairs, will likely make it harder for consumers to show how Sanofi and other manufacturers allowed NDMA to contaminate ranitidine products.
A spokeswoman for Sanofi said in a statement that the company voluntarily revealed that some documents were not preserved as intended:
“There was no intentional destruction of data,” she said. “Sanofi is working to obtain as much of the data as possible from alternative sources.”
Generic Ranitidine Makers Go Low
Following the ruling that dismissed generic ranitidine drug makers from litigation, some of these companies decided to attempt to recoup their legal fees.
Around 1,000 plaintiffs who had their cases dismissed may now be on the hook to pay some defense costs for companies like Apotex, Sandoz, and Teva. These companies are asking plaintiffs to cover things like e-discovery fees and fees associated with the court-appointed special master of the MDL. However, the companies are refusing to unseal invoices that would give plaintiffs an idea of how much they could potentially owe, citing privacy concerns.
Lawyers for the plaintiffs in question have expressed dismay at the defendant’s actions and urged the judge to not allow them to file. The move would not only place financial hardship on plaintiffs, but it could also deter others from participating in the judicial process in the future.
The Zantac Verdicts So Far
There have been no Zantac verdicts–yet. Litigation is moving forward, with cases consolidated into an MDL in the Southern District of Florida.
Zantac Lawsuit Settlement Amounts
As with all cases of this nature, settlements will not be handed down in fixed amounts. Decisions will depend on a number of factors, including age and health of the plaintiff. We will have a better understanding of how these cases can play out once trials begin.
Factors That Affect the Zantac Lawsuit Settlement Amounts
While each Zantac case is very different from the next, there are some common factors we can point to that help us better understand potential settlement amounts.
- Previous, ongoing, and future medical costs
Plaintiffs who used Zantac may be eligible to recover the costs of past, present, and even expected future medical bills related to their cancer diagnosis. It’s also reasonable to expect the long-term physical and emotional suffering that happens as a result could lead to higher-than-usual medical bills. All this factors into a settlement decision.
- Lost income
Suffering from cancer after using Zantac can cause victims to be unable to work and provide for their families as their disease progresses. Although some plaintiffs can receive treatment for and recover from their cancer, it’s possible they aren’t able to work in the same capacity as before. In some cases, victims are left completely disabled. Settlements may account for this.
- Pain and suffering damages
Prolonged illness and, of course, the death of a loved one can cause severe emotional and mental distress. This is more difficult to quantify in court, as there often are no bills or receipts to look to. But these factors are no less important and worthy of restitution.
- Loss of joy of living
If a cancer diagnosis renders a victim unable to enjoy life like they once did, perhaps because they are now permanently disabled as a result, they can pursue damages to compensate for the ways the disease has affected their life.
Why Would You Choose a Zantac Settlement vs. Trial?
Pursuing a Zantac settlement versus taking the manufacturer to trial may not be the best decision for everyone. But in some cases, this course of action can be more beneficial than a long, drawn-out litigation.
- Guaranteed payout
In a Zantac lawsuit settlement, the compensation is guaranteed once both the plaintiffs and the defendant agree on the terms. Taking on a multi-billion dollar company is time-consuming and costly, so a settlement can be a favorable option.
- Avoiding the additional financial burden
Not everyone who brings forward a Zantac lawsuit can afford to pursue a verdict in court. Even defendants aren’t willing to spend more than they need to in legal costs.
- Saves time
The legal system can sometimes move at a glacial pace. Unfortunately, many Zantac plaintiffs do not have time on their side. It could be months or years before a trial verdict is reached. A settlement is often quicker.
Another advantage of a Zantac settlement is the opportunity for the plaintiffs and defendant to structure the settlement in a way that works for both of them. This may involve the defendant agreeing to pay a settlement in installments, rather than in a lump sum.
- Preventing a negative verdict
There are two types of valuation used to determine the settlement amount in Zantac cases: trial value and settlement value. The trial value is the amount you expect the court to award, while the settlement value is the amount the plaintiffs hope to settle their Zantac cases for.
These values are rarely equal to each other. Because victims are settling a Zantac case to avoid the risk of losing at trial, the settlement value will always be much lower than the trial value. But even though the settlement value is less than the trial value, at least the compensation is guaranteed.
Latest Updates on Zantac Lawsuits
As of February 2022, there were just over 2,000 cases filed in the MDL in the Southern District of Florida, but a registry that holds cases that are “quasi-filed” includes about 30,000 cases. The first Zantac class action lawsuit is set for trial in October 2022.
Key Takeaways for a Potential Zantac Lawsuit
The legal battle against Zantac/ranitidine drug makers is still only beginning. If you believe your cancer diagnosis is linked to Zantac, you should not wait to file your claim. Even though the evidence against the defendants is staggering, a qualified, compassionate legal team is your best weapon in this fight.