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It’s a chemical researchers have used to give laboratory animals cancer – something you’d keep your distance from.
Yet, for decades, patients throughout the United States and across the world may have been unknowingly ingesting it in massive and dangerous quantities when they took the popular heartburn medication Zantac.
Every dose of Zantac prescribed to treat your stomach ulcers – every tablet of over-the-counter Zantac you casually popped to treat occasional acid reflux – has potentially exposed you to NDMA, a powerful carcinogen linked to more than a dozen types of cancer. The danger is so great that, in April 2020, the FDA announced the removal of all brand-name and generic Zantac medications from the market.
You never would have taken Zantac if you’d known the risks. But a growing body of scientific research suggests that someone did know the risk.
In fact, thousands of lawsuits have already been filed across the U.S. on the basis that the makers of Zantac knew or should have known of this danger. If that’s true, failing to warn the public, the government, and the medical community of the serious risks is a particularly heinous act of negligence.
Is Zantac Safe?
Research suggests that a chemical reaction in the body produces the carcinogen NDMA when you take Zantac. Scientists believe the risk is part of the drug’s formulation, so all medications made with the active ingredient in Zantac could be dangerous. Learn more about NDMA in Zantac.
Can I Sue the Makers of Zantac for Contributing to My Cancer?
The makers of Zantac and other ranitidine products are facing thousands of lawsuits over the link between the popular heartburn medication and cancer. Find out how you can sue the makers of Zantac.
Why Did It Take So Long to Find Out About the Cancer Risk?
Zantac has been on the market for decades – and so has evidence of a link between Zantac’s active ingredient and cancer-causing NDMA. Yet the drug’s manufacturers never came forward. Find out who finally got Zantac off the market.
The link between the active ingredient in Zantac and many types of cancer is undeniably strong.
Anyone who developed cancer following regular use of any ranitidine heartburn medicine should speak to a Zantac lawsuit attorney right away.
The consultation is free and risk-free, so don’t wait. Contact us to get help.
For decades, Zantac has been a go-to medicine that was considered safe for treating conditions like heartburn, acid reflux, gastroesophageal reflux disease (GERD), and more.
As concerns surfaced in recent years about the dangers of the proton-pump inhibitor (PPI) class of heartburn drugs, Zantac seemed like a safer option.
Now, though, research suggests otherwise.
Laboratory tests and studies have found NDMA, a known animal carcinogen and probable human carcinogen, in all heartburn medications made with the active ingredient in Zantac. A single dose of Zantac can expose you to NDMA levels tens of thousands of times the maximum level that the FDA considers safe.
At this time, many consumers are rightfully concerned about the safety of the heartburn medication they have taken for years. Don’t assume that the drug is safe. Follow the FDA’s recommendation to stop taking over-the-counter ranitidine or to speak to your physician about switching to an alternative type of prescription heartburn medication.
The danger cited in the thousands of Zantac lawsuits filed since September 2019 revolves around this alleged contamination with NDMA.
Often, cases of drug contamination involve a mistake made somewhere in the process of manufacturing, processing, or packaging the drug or its ingredients. In other instances of NDMA drug contamination in recent years, the contamination can be traced back to a company or facility. Usually, only certain batches of the medication are contaminated.
That isn’t the case with Zantac. Instead, it appears that, under certain conditions – unfortunately, the ones usually found in the human body or those the drug is exposed to during distribution – the active ingredient in Zantac, ranitidine, may create NDMA as a byproduct of chemical reactions that occur as the medication breaks down.
If that’s true, the problem would be far larger than a few, or even a few million, lots of Zantac. The danger would exist across all lots of heartburn medications using the active ingredient ranitidine, from all manufacturers, in all forms and dosages, produced in all areas and, quite possibly, over the entire time – a span of decades – that the drug has been on the market.
As any cancer patient knows, cancer isn’t one single disease. Instead, there are numerous types of cancer.
The evidence from research studies that links NDMA to cancer is certainly stronger for different kinds of cancer. However, the findings of a 2016 study into oral intake of ranitidine and urinary NDMA excretion, conducted out of Stanford University, noted the worrying possibility of
“broader implications for systemic cancer risk.”
That means possible increases in cancer risk related to NDMA aren’t only limited to those few cancers whose relationship with NDMA have been most thoroughly studied.
The types of cancer that have been linked to NDMA, through research studies in animals and humans or through ongoing Zantac lawsuit claims, include:
A Personal Message From Founder and Managing Attorney Richard P. Console, Jr.
If you are fighting a cancer battle right now or have lost a loved one to this brutal type of disease, my heart goes out to you. Please give me the opportunity to support you during this terrible time by reviewing your situation absolutely free and offering you the same caliber of guidance I would give to my own family.
I know that a lawsuit won’t give you back all you have lost. Nothing can. But I also know what an impact it can have on your wellbeing to have an advocate, to get justice, and to get compensation that minimizes the crushing financial impact of a cancer battle.
Here to help,
Richard P. Console, Jr.
NDMA has been used – effectively – as a poison in intentional murders of human victims. A dose of just 2 grams of the chemical can cause a human to die in a matter of days.
NDMA is short for N-nitrosodimethylamine, a mouthful of a chemical name for a substance that has a dangerous reputation. Although NDMA is an “organic” compound, the National Center for Biotechnology Information reported, it’s far from safe.
Even though the United States Environmental Protection Agency (EPA) reports that NDMA forms in natural as well as industrial processes, the chemical is classed as a pollutant and environmental contaminant. NDMA was once used to make rocket fuel, although the EPA stated that it is now used “only for research purposes.” However, the chemical is a byproduct that results from industrial purposes such as gasoline refining, pesticide manufacturing, and wastewater treatment and chlorination.
Based on studies of laboratory animals, NDMA is considered to be both hepatotoxic – hazardous to the liver – and genotoxic, or capable of damaging the genetic information contained in a cell.
The lawsuits currently being filed against the makers of Zantac and other ranitidine medications have evolved from a specific danger associated with NDMA: its ability to increase the risk of cancer.
Is NDMA a carcinogen?
NDMA is so dangerous that research pertaining to human subjects has generally taken the form of epidemiological case control studies – retrospective, observational studies that look for patterns to identify correlations and causal relationships – rather than active experimentation.
Among human deaths attributed directly to NDMA, conditions such as liver failure, cerebral hemorrhage, enlarged livers and spleens, distended abdomens, and other serious conditions were identified, the World Health Organization (WHO) reported.
Case control studies in humans have linked NDMA to certain kinds of cancer, including cancers of the upper digestive tract, stomach or gastric cancer, and lung cancer. What’s even more concerning is that, the WHO reported, the amount of NDMA in these cases came not from contaminated drugs with massive amounts of NDMA, but instead from the cancer patient’s “typical diet.”
This detail could suggest that even the amount of NDMA consumed as part of an individual’s normal diet may be enough to increase cancer risk. The high levels of NDMA that some researchers have reported finding in ranitidine medications far exceeds that amount. In fact, to reach the same level of NDMA exposure that some researchers reported finding from a single ranitidine pill – 17 micrograms – you would need to eat 48 pounds of bacon, Bloomberg Businessweek reported.
Researchers have also noted an increase in the relative risk of developing colorectal cancer for individuals who were exposed to more NDMA compared to those exposed to lower levels of the chemical, the (WHO) reported.
“In almost all studies” that looked at the three factors of NDMA, nitrite and nitrate on cancer risk, researchers found consistent results pointing to “there being an association with cancer most commonly with NDMA.”
Besides what’s known primarily from these case control observational studies in humans, a lot of the data concerning the risks of NDMA was gleaned through animal studies. Fortunately, these animal studies are able to shed a lot of light on how NDMA acts on the human body.
“There appears to be no qualitative difference between rodents and humans in the formation of DNA adducts” – changes to an individual’s DNA caused by exposure to cancer-causing chemicals – “following exposure to NDMA,” the WHO reported. It would be wise, then, to pay close attention to the insights discovered through these animal studies.
Research has shown that “NDMA is clearly carcinogenic” in all species studied, the WHO reported. These species include cats, dogs, and monkeys, as well as rodents.
Is there really such a thing as a “safe” level of a known animal carcinogen and probable human carcinogen?
Ideally, you wouldn’t ingest any of a chemical linked with cancer, but NDMA is a contaminant in so many different items that it is difficult to avoid. You’ll find it not only in cured meats but also in cheese, fish, beer, tobacco, detergent and shampoo, according to Everyday Health.
The limit set by the FDA as “safe” is 96 nanograms (ng) per day, according to The Washington Post. That’s a pretty small amount, equivalent to one billionth of a gram – the weight, on average, of a single cell in the human body.
The problem with the NDMA levels found in ranitidine is that – under certain testing conditions designed to simulate the way the medication breaks down inside the human body – they were as many as 31,000 times that maximum level considered safe, according to researchers.
In their laboratory tests, “ranitidine formed millions of nanograms of NDMA,” said online pharmacy Valisure. If NDMA in excess of 96 nanograms is hazardous, exposure to amounts of NDMA upwards of 3,000,000 ng – as found in Valisure’s study – is certainly cause for concern.
The FDA’s subsequent findings using different testing measures haven’t reflected nearly as alarming levels of NDMA as Valisure’s did. But the agency did acknowledge the presence of “unacceptable levels” of NDMA, according to Reuters. The 300 mg doze of generic ranitidine made by Novartis, for example, would expose consumers to nearly 9 times the acceptable NDMA level under the FDA’s findings.
The data suggests that NDMA exposure from ranitidine is nothing new. Evidence of a link between Zantac’s active ingredient and cancer-causing NDMA has also been around for decades, nearly as long as the drug has been on the market. Yet the tale of how it finally came to light that Zantac and other ranitidine products can expose consumers to NDMA is quite a story.
It starts not with the Food and Drug Administration, the federal agency charged with protecting patients and consumers across the United States. Instead, a Connecticut-based online pharmacy, Valisure, was the first one to sound the alarm.
How did a small startup company that, at the time, consisted of just 14 employees take on pharmaceutical giants like GlaxoSmithKline and Pfizer?
What sets Valisure apart is the company’s identity as an analytical pharmacy. Valisure “validates” the pharmaceutical products its customers receive by testing each batch of medication by means of chemical analysis. In its research laboratory that is registered with both the FDA and the Drug Enforcement Administration (DEA), Valisure tested both brand-name Zantac and generic formulations of ranitidine.
Valisure wanted to understand the safety of the drug as it acted upon the human body. So the company tested the drug in conditions intended to mimic what goes on during digestion – including exposure to “simulated gastric fluid” and to nitrites commonly found in processed meats and other foods.
Through these tests, Valisure “detected extremely high levels” of NDMA “in every lot tested, across multiple manufacturers and dosage forms.”
To Valisure personnel, these results suggested more than a bad batch of medicine that should be sent back to the manufacturer. They spoke to what the company feared could be a much bigger problem. And, given the massive popularity of Zantac and its generic formulations, that could mean that millions of consumers across the globe may be at risk.
“There’s no acceptable cancer risk for a drug like this,” said Valisure CEO David Light.
On September 9, 2019, Valisure wrote to the FDA in the form of what’s called a “citizen petition” – a method private citizens and companies can use to inform the FDA of concerns and ask the agency to take action.
Shortly after the FDA received the petition, the agency responded by issuing an advisory to healthcare professionals and patients, in which it spoke to launching its own investigation. In the months that followed, there were numerous recalls from several different drug manufacturers, as well as FDA communications regarding the testing measures the agency expected drugmakers and distributors to follow. What happened next?
When the FDA first published its laboratory findings in November 2019, it confirmed that several of the ranitidine batches it tested contained “unacceptable levels” of NDMA.
However, at that time, the FDA took issue with Valisure’s high-heat testing method, calling that method “not suitable” for the situation. As a result, the NDMA levels found through the FDA’s investigations were much lower than those uncovered by Valisure – though still in excess of the amount permitted.
When the FDA received a second citizen petition regarding ranitidine in January 2020, though, Emery Pharma raised further concerns about what happens to Zantac under high temperatures. The research laboratory’s testing included a preliminary stability study that reflected doubts about the stability of ranitidine molecules when exposed to heat.
“Even limited exposure of Ranitidine to high heat, such as in a hot car or a delivery truck, could cause problems,” said Dr. Ron Najafi, CEO of Emery Pharma.
Because Zantac isn’t delivered in temperature-controlled conditions, this could mean that batches of ranitidine that were within acceptable levels of NDMA at the time they left the manufacturing plant may not be by the time they get to consumers. These drugs may be exposed to environmental factors over a prolonged period of time during transportation, CBS reported.
What does this mean for consumers affected by ranitidine? Although the FDA wasn’t completely sold on Valisure’s high-heat testing methods, this research data still holds value as a form of evidence to support claims like yours. A Zantac lawsuit attorney uses all of the available research data, including the highly-publicized results of Valisure and Emery Pharma’s findings, to build a comprehensive body of evidence that bolsters your claim for compensation.
Additionally, on April 1, 2020, the FDA announced the removal of all ranitidine products from the market. The agency’s investigations showed that the NDMA impurity can increase over time, and that the more time has passed since the manufacture of a batch of ranitidine medication, the higher the level of NDMA became apparent through testing, according to Reuters.
How does a drug like Zantac get contaminated by NDMA in the first place? Often, NDMA contaminates an ingredient or a manufacturing site used to produce the contaminated pharmaceutical.
However, in this instance, the NDMA “impurity” is less a result of external contamination and, more than likely, a result of what happens when the active ingredient begins to break down under conditions of high heat or contact with the chemicals found in the digestive system.
In its citizen petition to the FDA, Valisure explained that the “instability of the ranitidine molecule in human conditions” is the likely cause of the development of NDMA. That’s because, as Valisure noted, a molecule of ranitidine is made up of a nitrite and a dimethylamine, or DMA. Nitrates and DMA are known to form NDMA when they combine and react.
As a result, “ranitidine can react with itself,” Valisure said – and its laboratory test results support this conclusion. When the drug reacts to environmental factors like high heat, to the gastric juices, nitrites, and other contents of the human stomach, or even to water, there may be the potential for NDMA to develop. Ranitidine users could be exposed to NDMA levels much higher than trace amounts.
The FDA in November 2019 said that, based on its investigation, the agency believes that, “within the human digestive system, the Zantac medication does not form” NDMA, CNN reported.
However, Emery Pharma launched an independent investigation that shed brand new light on the relationship between Zantac and NDMA. After developing and validating a new LC-MS/MS method, which it used to initiate the stability study, the research laboratory showed for the first time “that ranitidine is a classical time- and temperature-sensitive pharmaceutical product that generates NDMA as a breakdown product when exposed to heat,” Neeki Mahdavian, Business Development Manager for Emery Pharma, told our attorneys by email.
If there’s a possibility that NDMA exposure results from some inherent instability of ranitidine, then all ranitidine medications – name-brand Zantac and generic formulations, prescription-strength and over-the-counter – could potentially be affected.
In fact, the FDA later announced – on April 1, 2020 – that it was requesting the immediate removal of all prescription and generic Zantac products and advising users to stop taking any of the medication they had remaining. The agency reported that this request was in response investigations that showed “that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”
Cancer patients and their families should speak to a Zantac cancer lawyer right away if they:
If you took Zantac and developed cancer, you may have the right to pursue a claim for compensation for damages that include the medical expenses you have incurred and the pain and suffering you have been through. Find out more about filing a cancer lawsuit.
Researchers have found a strong link between the impurity that has been found in ranitidine, NDMA, and numerous types of cancer. In light of the compelling links between ranitidine and NDMA exposure and between NDMA exposure and many types of cancer, there have also been Zantac lawsuits filed in cases of other types of cancer. Although these cancers may not often be associated with NDMA, their development was somewhat rare and determined by medical experts to be likely related to Zantac use.
Bladder cancer is perhaps the type of cancer most closely associated with ranitidine. Not only has bladder cancer been a common consequence of NDMA exposure in research studies conducted on mice and other animals, but it has been linked to bladder cancer in case studies involving human exposure, such as through drinking water.
Researchers have also learned that, after taking ranitidine, the levels of NDMA excreted through urine increased 400 times. In fact, the NDMA levels found in the urine of Zantac users rise to levels that met or exceeded that of patients with schistosomiasis, a parasitic infection common in some parts of the world in which is associated with bladder cancer. In this disease, N-nitrosamines like NDMA are believed to be the “etiological agents” – or cause – of bladder cancer. The researchers behind this study went so far as to note that their results “suggest a need to evaluate the risks attributable to NDMA associated with chronic consumption of ranitidine, and to identify alternative treatments that minimize exposure to N-nitrosamines.”
Bladder cancer is also one of the most common cancers, period, according to the Mayo Clinic. Although bladder cancer is highly treatable when diagnosed at an early stage – and most are detected early – even early-stage cancer can recur in the bladder years after completing treatment.
Treatment for bladder cancer may include radiation, chemotherapy, immunotherapy, and surgical removal of tumors. In some cases, you may need to have your bladder removed entirely in a procedure called a radical cystectomy. Although some patients are able to have a neobladder reconstruction that allows you to urinate normally, others need different means of urinary diversion and reconstruction, which may include draining it into a pouch or urostomy bag outside your body or a reservoir inside your body that you must drain with the help of a catheter multiple times a day.
The overall 5-year survival rate for patients with bladder cancer is 77 percent, but some instances of the disease are far more serious than others. For patients with bladder cancer tumors that are in situ, or in the surface layer of the bladder only, the survival rate is an encouraging 96 percent. If the cancer has spread to distant sites like the liver or lungs, or to the bones, the survival rate drops to just 5 percent.
Colorectal cancer, the umbrella which includes both colon cancer and rectal cancer, is one of the leading causes of cancer death in the United States, according to the American Cancer Society. It has also been strongly linked to NDMA exposure, with researchers discovering back in 1999 that diets that contain high levels of NDMA can double your risk of developing colorectal cancer.
When detected early, this type of cancer can be treated or even prevented entirely. Through the screening process, doctors can remove the polyps, or growths, that can turn into cancer over time – as long as 10 to 15 years.
The ability to remove these growths before they turn cancerous has helped reduce the death rate due to colon cancer, but too many Americans still aren’t undergoing the potentially life-saving screenings that are recommended for them. As a result, just 40 percent of colorectal cancers are discovered during the early stage when survival rates are very high. For too many patients, the cancer isn’t discovered until after it has spread.
The overall survival rate for colorectal cancer is 63 percent, but as with other forms of cancer, your prognosis depends highly on the stage of your cancer. When the cancer is still localized, the five-year survival rate is as high as 90 percent, but once it has spread to distant organs, lymph nodes, or parts of the abdominal cavity lining, that survival rate plummets to 14 percent.
In the best case, you may need only a polypectomy, or surgical removal of precancerous polyps performed during a colonoscopy, to treat your cancer. In more advanced cases, you may need as much as a total colectomy, or complete surgical removal of the colon. You may also undergo chemotherapy, radiation, or other forms of treatment.
In some cases, your doctor may need to create a whole in your abdomen through which you then have to pass stool into an external bag. Called either a colostomy or an ileostomy, depending on how it is accomplished, this diversion is usually temporary, and able to be rerouted once the patient is strong enough to undergo a reversal surgery. In some cases, however, it is permanent.
Since ranitidine must act on the stomach to ease heartburn symptoms, it makes sense that stomach or gastric cancer is another of the types of cancer most closely associated with the medicine. Numerous studies dating back to at least 1995 have shown that there is a statistically significant increase – by some accounts, of up to 700 percent – in gastric cancer incidence among humans exposed to NDMA through their diets.
Although stomach cancer was once the leading cause of cancer death in the United States, that hasn’t been the case since the 1930s, according to the American Cancer Society. Today, stomach cancer is far less common in the U.S. than in many other nations, and its prevalence has continued to drop each year.
However, when stomach cancer does strike, it can be very serious. While early-stage, localized stomach cancer has a 69 percent five-year survival rate, that survival rate is just 5 percent in cases where the cancer has spread to distant regions. The overall survival rate for all stages of stomach cancer is only 32 percent.
Some gastric cancers are treated by surgically removing all or part of the stomach. If this occurs, you will need to eat smaller amounts of food at a time, eat more frequently, and change your diet considerably. You may need to get nutrition from a feeding tube, temporarily or permanently, if you struggle to get enough nutrients through eating alone – especially if your treatment plan also involves chemotherapy or radiation.
Besides the stomach and the colon, cancer can also develop in the small or large intestine. Intestinal cancer is considered rare, with only around 10,590 new cases – accounting for just 0.6 percent of new cancer cases – each year in America, according to the National Cancer Institute.
Survival rates for patients with intestinal cancer range from 85 percent in localized cancer cases to 41 percent when the cancer has spread to distant regions. Across all stages, the overall survival rate is 68 percent.
Intestinal cancer is most commonly treated through surgery, which may include the resection of the intestines or the bypass of the tumor.
The esophagus, or the tube that connects your throat and stomach, is closely related to the problem of heartburn to begin with.
Reflux occurs when stomach acid flows back up the esophagus. When heartburn is persistent and severe enough to develop into gastroesophageal reflux disease (GERD), the stomach acid and resulting inflammation can alter the cells that line the esophagus, in a precancerous condition called Barrett’s esophagus.
Developing Barrett’s esophagus raises your risk of developing esophageal cancer, although progression to cancer is rare, occurring in just one percent of patients, according to the University of Chicago Medical Center. However, the number of cases of adenocarcinoma esophageal cancer in America is on the rise, according to the Dana-Farber Cancer Institute. A medication used to manage heartburn absolutely should not increase your risk of this serious cancer even more.
The overall 5-year survival rate for patients with esophageal cancer at all stages is 20 percent, according to the American Cancer Society. Patients with localized esophageal cancer have a 47 percent survival rate, while the rate for patients whose cancer has spread to distant parts of the body is 5 percent. Some of your treatment options for esophagus cancer include chemotherapy, radiation and surgery, including esophagectomy, the surgical removal of part or all of the esophagus.
Among the lawsuits filed against Zantac in New Jersey in January 2020 was a wrongful death claim on behalf of a widow who blames her husband’s 2018 death from esophageal cancer on Zantac, which he used for 15 years.
Cancer of the nasal cavity, or the passageway within the body that your nose leads into, is rare, according to the American Cancer Society. Only around 2,000 cases of nasal cavity cancer and paranasal sinus cancers are diagnosed each year in the United States.
When you develop a cancer that is rare or for which you don’t have risk factors, this fact can further support your claim that ranitidine use is the likely cause of your cancer. Further, in long-term use studies, nasal cancer was one of the types of cancer laboratory animals developed.
Although the overall 5-year survival rate for patients with nasal cancer is 58 percent, those with only localized nasal cancer have a greater survival rate of 84 percent. Sufferers of nasal cancer may need to undergo radiation, chemotherapy, immunotherapy and surgery.
As a highly hepatotoxic substance, NDMA is known to cause serious damage to the liver, including hemorrhage, necrosis (death of cells and tissues), damage to the DNA of liver cells, and the development of liver tumors, the WHO reported.
Liver cancer often presents few signs and symptoms in its early stages, according to the Mayo Clinic. This factor, combined with the reality that the cause of liver cancer is often undetermined, can make early detection of this type of cancer difficult, the American Cancer Society reported.
For that reason, the overall five-year survival rate for patients with liver cancer is lower, at 18 percent. Patients with localized liver cancer have the highest survival rate, 33 percent, while those whose cancer has spread to distant organs have a survival rate of just 2 percent. Treatments for liver cancer can range from chemotherapy and radiation to, in certain situations, surgical transplant of the liver.
Researchers have learned that NDMA exposure can lead to genetic effects, including DNA damage, to the kidneys and other organs in laboratory animals. Animal research has produced documentation of an association between NDMA exposure and kidney cancer, according to the U.S. Agency for Toxic Substances and Disease Registry.
Kidney cancer is another form of cancer for which the cause often isn’t known, the Mayo Clinic reported. Most kidney cancers developed by adults are a type of cancer called renal cell carcinoma.
The good news is that kidney cancers have a somewhat higher survival rate than many other types of cancer. For all stages combined, the five-year survival rate is 75 percent, according to the American Cancer Society. Patients with localized kidney cancer have the best prognosis, with a 93 percent survival rate, but even once the cancer spreads regionally, the survival rate is still 70 percent. That rate decreases to 12 percent once the cancer has spread to distant areas of the body.
Treating kidney cancer can include several different options. Because you have two kidneys, it is even possible to have the kidney with the tumor completely removed without significantly impacting your body functions, as long as your remaining kidney is healthy. Kidney tumors tend to grow so slowly that, in some cases, your treatment plan may be “active surveillance,” or regular imaging tests to observe any growth or changes in the tumor, as well as to better determine whether the tumor is cancerous or benign.
Studies on multiple types of laboratory animals have historically linked NDMA exposure to pancreatic cancer. More recent research into dietary consumption of NDMA and other N-nitroso compounds has led researchers to label NDMA one of “the most potent dietary and pancreatic carcinogens” and to suggest that “biologically plausible findings for pancreatic carcinogens” that include NDMA are important enough to “warrant further prospective investigation.”
There is no routine screening test for pancreatic cancer, according to the American Cancer Society. That’s less because pancreatic cancer is relatively rare, accounting for just 3 percent of all cancer diagnoses in America, and more because no test has yet been developed that has proven to be effective at reducing deaths due to pancreatic cancer.
The 5-year survival rate for pancreatic cancer ranges from 37 percent for localized cases to 3 percent for cases that have spread distantly, according to the American Cancer Society. Overall, the survival rate for this kind of cancer is 9 percent. Your treatment may include chemotherapy, radiation, immunotherapy, and special targeted drugs, the American Cancer Society reported.
In epidemiological case control studies of cancer in humans, “there were clear exposure–response relationships for NDMA and lung cancer,” the WHO reported. Years of NDMA exposure through Zantac could be the cause of your lung cancer – especially if you’re a non-smoker.
This type of cancer causes more deaths among both men and women in the United States than any other kind of cancer, according to the Mayo Clinic. In fact, the death toll from lung cancer is higher than the combined total of deaths due to prostate cancer, ovarian cancer, breast cancer and colon cancer.
Most instances of lung cancer are non-small cell lung cancer, for which the prognosis is somewhat better than for small cell lung cancer. The overall 5-year survival rate for patients with non-small cell lung cancer is 24 percent, with a 61 percent survival rate when the disease is detected at the localized stage, the American Cancer Society reported. For rarer small cell lung cancers, the overall survival rate is 6 percent, with localized cases having a 27 percent survival rate. The treatments used to address these different kinds of lung cancers are different, with chemotherapy being the most common form of treatment for small cell lung cancer and surgery being more common in patients with non-small cell lung cancer.
Your likelihood of developing brain or spinal cord cancer at any point during your lifetime is less than 1 percent, according to the American Cancer Society. Given that NDMA has been linked to brain cancer in case studies pertaining to human occupational exposure as well as in animal studies, it’s very possible that NDMA could be the culprit.
For all of the most common types of brain cancer, the younger you are, the higher your survival rate, according to the American Cancer Society. Although this is a condition that you shouldn’t even have to worry about in your young adult or middle-aged years, your odds of getting through it are better now than they would be later in life.
Although different kinds of brain and spinal cord cancers are treated through different means, surgery is the first line of treatment for many of these cancers. You might also undergo chemotherapy, radiation, targeted drug therapies, and a special kind of treatment called alternating electric field therapy.
NDMA exposure may disrupt the function of the thyroid, and given the substance’s genotoxic characteristics, it’s not surprising that the development of thyroid cancer is believed to be attributable to NDMA exposure in some instances.
Thyroid cancer is cancer that begins in the butterfly-shaped gland in the neck that is responsible for producing hormones needed to keep your body operating normally. Thyroid cancer cases have been on the rise, at one point considered “the most rapidly increasing cancer in the US,” according to the American Cancer Society, but that increase is believed to be due primarily to better methods of early detection and has leveled off since 2017.
Although there are different types of thyroid cancer, many of these types are highly treatable. The overall 5-year survival rate for this type of cancer is near 100 percent for patients with papillary thyroid cancer, 98 percent for patients with follicular thyroid cancer, and 90 percent for patients with medullary thyroid cancer, according to the American Cancer Society. Even for the most advanced cases, in which the cancer has spread to distant sites such as the liver, lung, or bones, the survival rate is as high as 78 percent for patients with papillary thyroid cancer and 63 percent for patients with follicular thyroid cancer. The prognosis for patients with anaplastic thyroid cancer is less encouraging.
Most thyroid cancers can be successfully cured, according to the American Cancer Society. Often, treatment includes the partial or complete removal of the thyroid gland. If you must have your thyroid removed completely, then you may need to be a hormone replacement medication after surgery to do the work that your missing thyroid used to do, according to the Mayo Clinic.
Long-term studies of rubber industry workers who were exposed to NDMA and other N-nitrosamines have linked occupational exposure to this class of chemicals to the development of leukemia, or cancer of the blood-forming cells and tissues.
There are many different types of leukemia, and treatment of these different types of leukemia can include radiation, chemotherapy, targeted therapies, and bone marrow transplants, according to the Mayo Clinic. Leukemia can often be successfully treated or even cured, and the 5-year survival rate for all kinds of leukemia is 68 percent, although the prognosis is better for patients with some kinds of leukemia than others.
Multiple myeloma, cancer of the plasma cells, is another of the types of cancer that has been associated with N-nitrosamines exposure through long-term follow-up studies of occupational exposure related to the rubber industry. Treating this uncommon form of cancer may require local interventions, such as surgery or radiation therapy, or systemic treatments like stem cell transplants. The development of more effective treatments for multiple myeloma in recent years has helped increase the survival rates for patients with this type of cancer, the American Cancer Society reported.
In rubber industry workers, as well as in laboratory animals, researchers have found a link between exposure to N-nitrosamines like NDMA and non-Hodgkin lymphoma. Although this is one of the most common cancers diagnosed in America, the overall 5-year survival rate reported for all kinds and stages of non-Hodgkin lymphoma is 72 percent, according to the American Cancer Society.
The prognosis is somewhat better for patients with follicular lymphoma – with survival rates ranging from 85 percent in cases that involve distant spread to 96 percent in localized cases, with an 88 percent overall survival rate – than for those with diffuse large B-cell lymphoma, whose survival rates range from 55 percent to 73 percent and have an overall survival rate of 63 percent.
Angiosarcoma, a rare cancer that forms in the lining of the blood vessels in any part of the body, grows so rapidly that it must be treated aggressively through surgery, radiation, and chemotherapy, according to the National Cancer Institute.
Exposure to carcinogenic chemicals is one of the known risk factors for developing angiosarcoma. Animal studies have linked NDMA to angiosarcoma development particularly in the liver.
Prostate cancer is the second most common cancer in men in the United States, but most cases are diagnosed after age 65, according to the American Cancer Society. When prostate cancer is caused by NDMA exposure – which research shows can happen – it is more likely to have an early onset, before age 65. Some of the early Zantac cancer lawsuits were filed by plaintiffs who blame ranitidine for causing them to develop prostate cancer at an unusually young age.
Thanks to screening tests that allow for early detection, the slow rate of growth of most prostate cancers, and numerous treatment options, the overall 5-year survival rate for men with prostate cancer is 98 percent, the American Cancer Society reported. Almost 100 percent of patients with localized prostate cancer and those whose cancer has only spread regionally will survive at least 5 years.
Despite these encouraging survival rates, prostate cancer is still the second leading cause of death from cancer for American men, and the 5-year survival rate drops to 31 percent if the cancer is not found until it has spread to distant sites. Additionally, the interventions used to treat prostate cancer, even when successful, can cause significant changes to your quality of life.
Although many cancers are more common among older patients, testicular cancer isn’t among them. Young and middle-aged men are the ones who most often develop this condition, with the average patient diagnosed around age 33.
For men with testicular cancer, the prognosis is usually good. This type of cancer is uncommon, affecting only one in 250 men over their lifetime, and only one in 5,000 men will die from testicular cancer, according to the American Cancer Society. The overall 5-year survival rate for all types and stages of testicular cancer is 95 percent, and even in the most severe cases, where the cancer has spread to distant areas of the body, treatments are effective enough to achieve a 73 percent survival rate.
However, most testicular cancers require surgical removal of the testicle that contains the tumor, which can compromise fertility to some degree and cause changes in physical appearance. Testicular cancer survivors sometimes choose to have a prosthesis implanted for a more natural appearance.
Multiple Zanatac lawsuits have been filed on behalf of patients who developed breast cancer that is thought to be caused by NDMA exposure from ranitidine use, according to NBC. On September 13, 2019, the same day the FDA issued its initial advisory and just a few days after Valisure’s citizen petition went public, Florida rabbi Joseph Galimidi became one of the very first to file a Zantac cancer lawsuit.
Although breast cancer is one of the most common cancers among women in America, it is rare among men, with male instances of breast cancer – such as the one that prompted Galimidi’s lawsuit – accounting for less than one percent of breast cancer diagnoses globally, the Journal of Breast Health reported. However, women, too, have been able to file ranitidine lawsuits pertaining to breast cancer diagnoses, when the facts support the argument that Zantac NDMA exposure caused the cancer.
For both men and women, breast cancer can often be treated effectively, especially when found early. The overall 5-year survival rate for all types and stages of breast cancer is 90 percent for women and 84 percent for men, the American Cancer Society reported. When the cancer is treated while still localized, the survival rate is 99 percent for women and 96 percent for men. However, breast cancer remains the second leading cause of cancer death in women.
In primate studies dating back to 1996, researchers found that the ovaries, uterus, and other urogenital organs, along with gastrointestinal organs, are “sensitive targets for DNA adduct damage due to NDMA.”
There are numerous kinds of ovarian and uterine cancers. Among cancers of the ovaries, the overall 5-year survival rate for all stages ranges from just 47 percent, among patients with invasive epithelial ovarian cancer, to 93 percent, among patients with germ cell tumors of the ovary, the American Cancer Society reported. For all types of ovarian cancer, early detection is a significant factor, and treating the disease while it is still localized can, in some instances, double your survival rate compared to not treating it until after it has spread to distant sites.
Uterine cancer is most commonly a type of curable cancer called endometrial cancer, according to the National Cancer Institute. A rarer form of uterine cancer, called uterine sarcoma, is usually more difficult to treat effectively because it is more aggressive. The overall 5-year survival rate for endometrial cancer is 81 percent, according to the American Cancer Society.
Treatment of both ovarian and endometrial cancers often begins with surgery to remove the uterus and cervix. Patients with ovarian cancer and some patients with endometrial cancer might undergo a total hysterectomy bilateral salpingo-oophorectomy, which includes the removal of the uterus, ovaries and fallopian tubes. Other treatments, like chemotherapy, radiation, targeted therapies, and hormone therapies may also be used to treat ovarian and endometrial cancers.
There’s no guarantee that any individual user of Zantac or a generic ranitidine medication will develop cancer. There is, however, compelling evidence that the unacceptably high levels of NDMA that can occur when ranitidine molecules break down, either in the body or in the packaging as a result of exposure to heat and other elements, can increase the risk of developing cancer.
The potential harm caused by NDMA exposure is cumulative, according to Valisure CEO, WebMD reported. As a result, patients and consumers who took Zantac regularly for an extended period of time, whether over-the-counter or prescribed, are at a greater risk of developing cancer than occasional users. Many of the lawsuits currently pending against the manufacturers of Zantac and generic ranitidine involve patients and consumers who have been using the heartburn drug for years or even decades.
If you have been diagnosed with cancer and suspect that Zantac use played a part in causing your illness, your next step should be to reach out to a ranitidine lawsuit attorney – while you continue to move forward with your medical treatment, of course. Zantac users who have not been diagnosed with cancer but are worried about their cancer risk should discuss their concerns with their medical providers, who can help them determine what, if any, screening tests are appropriate.
As of April 1, 2020, the FDA has announced the removal of all Zantac and generic ranitidine products from the market due to the issue of cancer-causing NDMA impurities, according to Reuters. The nature of the problem is such that any ranitidine product – whether sold under the brand name or a generic formulation, whether consumed as a tablet, caplet, or syrup – could include the unacceptably high levels of the probable human carcinogen NDMA.
Prior to April 2020, only certain manufacturers, lots, and batches of ranitidine medication had been voluntarily recalled, and only certain retailers had pulled the over-the-counter version of the heartburn drug from their shelves. As a result, many consumers were confused about which ranitidine products were dangerous and which ones were safe. On April 1, 2020, though, the FDA officially requested all ranitidine manufacturers to immediately remove the products from the market and advised consumers to throw away remaining over-the-counter Zantac tablets and patients taking the prescription drug to discuss alternative options with their doctors. At this time, no ranitidine medication is considered safe to take or permitted to be sold on the U.S. market.
Like many other carcinogens, the NDMA impurity that is the reason behind the recent Zantac recalls and lawsuits isn’t linked to just one kind of cancer. The known animal carcinogen and probable human carcinogen has been linked to 20+ different types of cancer. Even that list may not be exhaustive, as researchers who looked at “all cancers” reported findings that NDMA was, generally, “significantly associated with increased cancer risk.”
That potential to cause numerous kinds of cancer is likely due, in part, to the ability of NDMA to damage the genetic information contained in cells. However, among the cancers most commonly linked to NDMA exposure are bladder cancer, colorectal cancer, and stomach cancer.
Yes, breast cancer is one of the types of cancer that has been linked to NDMA exposure, and in turn to ranitidine use, through research studies. In fact, one of the very first Zantac cancer lawsuits filed in the United States arose from a diagnosis of male breast cancer, and subsequent claims have been filed over breast cancer diagnoses in women. Read more about Zantac and breast cancer.
Yes, there is evidence that exposure to NDMA, the same impurity that caused ranitidine to be pulled from the shelves, could be linked to the development of prostate cancer. Find out more about ranitidine and prostate cancer.
Yes, thyroid cancer is another of the cancers that has been linked to NDMA exposure. Learn more about ranitidine and thyroid cancer.
Yes, colorectal cancers are among the types of cancer most strongly linked to NDMA exposure, and patients who have been diagnosed with colon cancer – and their families – have already filed numerous lawsuits against the manufacturers of Zantac and generic ranitidine. Read more about Zantac and colon cancer.
Yes, kidney cancer is one of the many kinds of cancer that researchers have linked to NDMA exposure, which, recent findings suggest, can occur at unsafe levels when taking prescription or over-the-counter ranitidine. Find out more about ranitidine and kidney cancer.
Bladder cancer isn’t just one of the kinds of cancer linked to the NDMA that has been found in Zantac – it’s the type of cancer that has been most heavily publicized in the coverage of ranitidine lawsuits.
There’s a wealth of evidence from both animal research studies and human case studies that links NDMA to bladder cancer as well as research that more directly links ranitidine to an increase in NDMA levels found in the urine of users.
If you are or were a regular Zantac user and developed bladder cancer, it is definitely worth your while to speak with an attorney about your right to pursue a ranitidine cancer lawsuit. Learn more about Zantac and bladder cancer.
Historically, Zantac has been considered safe to use during pregnancy, but these new developments since 2019 may suggest otherwise.
The drug has long been classified as a Category B drug for pregnant women. This means that, although there have not been any adequate, well-controlled studies of the medication in pregnant women, no risk to the fetus has been observed in animal reproduction studies, the U.S. Department of Health and Human Services reported. As a result, Category B medications are generally assumed to be safe for use during human pregnancy, even though they have not been proven safe.
However, the recently unearthed link between ranitidine and cancer-causing NDMA is a cause for concern not only about pregnant mothers-to-be, but also about their developing babies. Because research suggests that any NDMA contained in or produced by ranitidine can potentially cross the placental barrier, there’s a chance exposure to Zantac in the womb could be less than safe.
Additionally, in animal reproduction research studies that focused directly on the effects of NDMA, rather than ranitidine specifically, the babies of pregnant mice were often stillborn or died following birth, WebMD reported.
Even months after Valisure shared its concerns with the FDA, not all lots of all ranitidine medications had been fully recalled in the United States, so you might be tempted to think that only some Zantac and generic ranitidine products are a cause for concern. However, the evidence suggesting that elevated NDMA levels aren’t merely a case of contamination – that they instead develop as the drug breaks down either during transportation or in the body – makes this potential danger more widespread.
Until there are more definitive answers available regarding how and when NDMA becomes present in ranitidine, particularly at these unacceptable levels, it would be wise for pregnant women, and all consumers, to be wary of potential NDMA contamination in all ranitidine formulations. In fact, as of April 1, 2020, the FDA has asked all ranitidine manufacturers to completely remove the product from the market and advised all patients, pregnant and otherwise, to stop taking the medication.
Given the high stakes – an increased risk of many different kinds of potentially deadly cancers – it’s no surprise that millions of consumers are now wondering whether they should stop taking Zantac.
As of April 1, 2020, the FDA’s answer is (finally) yes.
Even six months after Valisure’s laboratory findings and citizen petition brought to light unacceptable levels of cancer-causing NDMA in ranitidine, the FDA had not directed Americans to stop taking Zantac. But for good reason, many former users of Zantac no longer wanted to take this heartburn drug. With the number of recalls by individual manufacturers and distributors, and of retailers choosing to voluntarily pull ranitidine medications from their shelves, even finding ranitidine became a challenge for many consumers.
The latest guidance from the FDA not only urges consumers to “stop taking any tablets or liquid they currently have” but also to “dispose of them properly and not buy more.”
However, you weren’t taking Zantac for no reason. To address the heartburn and other digestive and gastrointestinal problems for which you previously took Zantac, the FDA recommends the following:
Some of the alternatives to Zantac may include another type of H2 blocker, Pepcid (famotidine); Zantac’s original competitor, Tagamet (cimetidine), although that drug was previously linked to bladder cancer along with ranitidine in research by the National Cancer Institute; and the class of drugs known as proton-pump inhibitors (PPIs), which includes Prilosec (omeprazole), Nexium (esomeprazole), and Prevacid (lansoprazole).
Additionally, lifestyle changes can often help reduce heartburn symptoms so that you no longer need to rely on medication. Those changes may include altering your diet to avoid foods that trigger heartburn, such as fatty or spicy foods, according to Harvard Medical School.
Prior to the recalls, there was no shortage of Zantac medication options.
Among name-brand, over-the-counter formulations alone, consumers could choose from 3 different products: Zantac 75 Regular Strength, Zantac 150 Maximum Strength, and Zantac 150 Cool Mint Maximum Strength.
At the prescription-strength level, users of name-brand Zantac might take capsules containing ranitidine in the amount of 150 mg or 300 mg; tablets in 75 mg, 150 mg and 300 mg dosages; or tablets that contain 150 mg of ranitidine hydrochloride. Prescription Zantac was also available in a 15 mg/mL oral solution or syrup and in an injection formulation that is usually used in hospitals and administered through an IV line or injected into a muscle.
As evidenced by the numerous recalls, generic ranitidine is also manufactured, packaged, and distributed by many different companies. Generic ranitidine can also come in different dosages and formulations.
Any formulation and dosage level of ranitidine medication, produced by any manufacturer, could potentially pose a risk of cancer-causing NDMA exposure and form the basis for a Zantac cancer lawsuit.
The people potentially harmed by NDMA exposure from taking ranitidine include the young, the elderly, the middle-aged – and even babies. In fact, the reason Valisure decided to test ranitidine in the first place is because the drug had been prescribed to the infant daughter of one of the pharmacy’s founders, Adam Clark-Joseph, The Washington Post reported.
The extreme popularity and prevalence of Zantac use might surprise you. However, the full extent of what Zantac is used for is broader than even many patients may believe.
Consumers used over-the-counter Zantac to treat conditions such as:
At its prescription-strength level, Zantac and its generic formulations have the following uses:
Who takes Zantac? The popular medication’s worldwide consumer base defies categorization. Zantac users include people who experience occasional, irritating heartburn and those suffering from chronic, intense stomach ulcers.
Zantac and generic ranitidine products belong to a class of drugs called histamine-2 blockers, also known as H2 blockers or H2 antagonists.
H2 blockers work by decreasing the amount of gastric acid the stomach produces. This acid is necessary for digestion, but too much of it contributes to stomach issues like acid reflux, ulcers and GERD.
Ranitidine is just one type of H2 blocker. Generally, H2 blockers with a different active ingredient – like famotidine (Pepcid) and cimetidine (Tagamet) – haven’t been found to be contaminated with NDMA.
However, as of November 1, 2019, the FDA had announced that its testing had identified NDMA in H2 blockers containing nizatidine as the active ingredient, as well as in ranitidine-based H2 blockers. Nizatidine, the FDA said, is “chemically similar” to the ranitidine found in Zantac and its generic formulations. On January 8, 2020, pharmaceutical manufacturer Mylan voluntarily recalled prescription nizatidine over concerns that the drug “may may contain unacceptable levels” of NDMA, the FDA reported.
The ranitidine molecule that is the active ingredient in this H2 blocker consists of a nitrite and a dimethylamine (DMA). Nitrates and DMA “are well known to combine to form NDMA,” resulting in an “inherent instability” in the structure of the ranitidine molecule, according to Valisure, the company that first alerted the FDA to the potential danger in September 2019.
When exposed to what Valisure categorized as “standard analysis conditions” – including high-heat conditions that, the company said, were “representative of those in the human body” – the pharmacy’s laboratory tests found that “ranitidine can react with itself… at high efficiency to produce NDMA at levels well in excess of the permissible daily intake limit for this probable carcinogen.”
Further, Valisure drew on findings from other researchers, as well as its own, to compile evidence that, the company asserted, “shows this instability and the resulting NDMA occurs in the conditions and builds a compelling case for ranitidine being a likely human carcinogen.” Later, research laboratory Emery Pharma would present its own evidence on ranitidine’s instability and its potential to begin forming NDMA even before ingestion when exposed to heat – even to the temperatures commonly reached while transporting the medication in non-climate-controlled processes.
What this means for you is that simply taking Zantac as prescribed by a doctor or according to the manufacturer’s directions for over-the-counter use may have been all that was needed to expose you to cancer-causing NDMA. Even in absence of mixing with other medications or taking more than directed, the ranitidine molecule has the potential to form high levels of NDMA.
The findings from Valisure, and the past findings made by other researchers that the company presented in its petition to the FDA, were serious enough to launch further investigation into NDMA impurities in Zantac and generic ranitidine products. Ultimately, the evidence that Zantac could potentially increase users’ cancer risk was compelling enough to lead not only to voluntary recalls of specific lots of medication by individual manufacturers but also to the FDA’s decision to remove all ranitidine products from the American market in 2020.
Laboratory findings suggest that name-brand and generic ranitidine can contain an “impurity” known as NDMA, which can develop either in the packaging as the product is exposed to high temperatures as it moves through the supply chain or once the medication is ingested and begins breaking down within the body.
NDMA is considered a known animal carcinogen and probable human carcinogen based on decades of laboratory animal research and case studies on human exposure.
Prescription forms of Zantac were the first of the brand-name ranitidine medications to be recalled. GlaxoSmithKline, the manufacturer of prescription (but not over-the-counter) Zantac, announced a full “precautionary” recall of the drug across all global pharmaceutical markets on October 8, 2019, according to U.S. News & World Report. The recall at that time included prescription Zantac syrup, 150 mg and 300 mg tablets, and injections.
On October 18, 2019, Sanofi, the drugmaker behind over-the-counter Zantac, announced a “precautionary” recall of all 3 of its OTC products available in the United States.
As of April 1, 2020, the FDA has announced that all name-brand and generic ranitidine products would be removed from the U.S. market immediately. By this time, many other nations had already seen widespread recalls or complete removals of ranitidine medications from the market.
Many of the manufacturers, packagers, distributors, and other parties involved in the production of generic ranitidine products issued voluntary recalls of some or all of these medications or otherwise halted distribution and sales of the prescription and over-the-counter drugs. These companies that have announced recalls include:
Additionally, Mylan Pharmaceuticals recalled H2 blockers with nizatidine as the active ingredient, after investigations suggested that this medication could contain a similar NDMA impurity.
The FDA’s April 2020 request that manufacturers immediately remove all ranitidine products from the U.S. market extends to all manufacturers of generic Zantac and to all lots, batches, dosage amounts and formulations. At this time, all generic forms of Zantac have effectively been removed from the market due to FDA’s findings regarding the investigation of NDMA impurities.
The full history of ranitidine is full of record-breaking sales milestones and of concerning research findings – and, in the past year, of recalls, petitions, and lawsuits.
There’s a lot of information to wade through regarding the link between Zantac and cancer – the decades of research results, the more than 20 types of cancer associated with NDMA, the numerous recalls announced in the months following the initial alert.
But all you really need to know right now is that individuals who used Zantac and developed cancer, and their families, have the legal right to pursue a lawsuit.
Any regular user of Zantac or generic ranitidine may be entitled to compensation through different types of ongoing litigation.
You may have the right to take part in a class action lawsuit. A class action lawsuit means that you are part of a single claim on behalf of an entire “class” of plaintiffs – which could be as large as hundreds of thousands of people, or even millions of people.
Class action lawsuits against ranitidine manufacturers are generally based on the premise that you would not have purchased the medication if you were aware of the NDMA impurity and the potential for the heartburn medication to increase your cancer risk. What you are able to recover in a Zantac class action lawsuit is the amount of money you spent on the drug.
You may have the right to pursue a class action lawsuit if you used either prescription or over-the-counter Zantac and to seek compensation for what you spent on this medication potentially over many years. However, you must be able to prove how much you are owed through receipts or other documentation of your spending on Zantac.
Cancer patients and their families deserve far more from drugmakers than reimbursement for the money they spent on Zantac. Instead of a class action claim, you would pursue a type of personal injury lawsuit called a pharmaceutical injury lawsuit or “bad drug lawsuit.”
A personal injury lawsuit against one or more ranitidine manufacturers would present evidence of the harm you suffered due to the negligence of the drugmaker. This claim would be specific to you, focusing on the pain, suffering, and losses you have endured, and your attorney would seek a settlement or jury award that fully covers these damages.
There’s a lot more to prove in a personal injury claim than in a class action case against a drugmaker, so it is particularly important that you choose a knowledgeable and experienced attorney – one who will give your case the individual attention it deserves – to represent you in this matter.
As you’re exploring your options regarding a Zantac lawsuit claim, you may encounter the legal term “multidistrict litigation,” sometimes abbreviated as MDL. In multidistrict litigation, separate personal injury lawsuits against the same or similar defendants – in this case, manufacturers of ranitidine – that involve similar fact patterns are consolidated to streamline the process of resolving these claims. In multidistrict litigation, all of the legal proceedings needed for each of these separate individual personal injury cases are heard by the same judge.
There are a few conditions that must be met before you can move forward with a Zantac personal injury claim.
If you were prescribed Zantac, this documentation will be a lot easier to compile. Your medical records should include information about how long you took the prescription-strength drug, how often you were supposed to take it, and what dosage you took. You might also be able to get records of prescriptions filled from your health insurance company or from the pharmacy that filled the prescriptions.
Users of OTC Zantac products may have a harder time documenting their ranitidine use. You may not have kept every receipt for every purchase of over-the-counter ranitidine you have made. However, even in these cases, your medical records may help document your Zantac usage.
If you discussed your heartburn symptoms with your doctor and decided to use over-the-counter Zantac, the details of your usage may be included in your doctor’s notes. Even if you never discussed heartburn with your doctor, you may have provided information about over-the-counter medications you take regularly when any doctor – not necessarily one you would consult about heartburn – asked about the medications you are taking. If so, this crucial information could be documented as part of your medical records.
Generally, the more frequently or the longer you took Zantac, the more of a basis you have to pursue a claim. Most cases are brought by cancer patients who took Zantac regularly for at least 60 days.
If you have reason to suspect that you may have cancer, you’re welcome to reach out to us to learn more about the claims process. However, you will need an official diagnosis before you can pursue a claim. Both for the purposes of moving forward with your potential case and because early detection and treatment are crucial to having the best possible prognosis, you should work with your medical providers to complete any further testing that is required to rule out or diagnose cancer and determine the next steps in your treatment plan.
Until you speak to an attorney about your situation, you may not know whether there’s a connection between ranitidine and your cancer. That’s okay. We don’t expect you to have all of the answers, and if it turns out that you don’t have a claim, you’ve lost nothing by discussing your legal rights with us (because the consultation is always free).
Generally, a Zantac cancer lawsuit argues that the company that made the drug was negligent in producing a dangerous product and failing to warn consumers of the risks. The defendant, or the party you would be suing in your Zantac cancer lawsuit, would be the manufacturer of the medication you took.
If you took prescription Zantac, the manufacturer would be GlaxoSmithKline. Consumers who took OTC Zantac may sue Sanofi, Boehringer Ingelheim, Pfizer, or some combination of these manufacturers, depending on when they took the medication – since the rights to make over-the-counter name-brand Zantac have been transferred between these companies since the drug came onto the U.S. market.
Patients and consumers who took generic Zantac would need to pursue a claim against the company that manufactured the generic product they took. If you used more than one generic ranitidine formulation over the years or switched from name-brand Zantac to a generic version, you may have claims against multiple manufacturers.
You may also be entitled to pursue claims against other parties involved in the production of ranitidine, including distributors, marketers, and sellers of the medication. Determining who to sue in a pharmaceutical injury case requires extensive knowledge and meticulous investigation, not guesswork. Our Zantac lawsuit attorneys will thoroughly review the unique circumstances of your claim and make sure that any party who is potentially at fault for causing your cancer is named as a defendant in your claim.
At the crux of Zantac lawsuits are the questions of how much drugmakers knew about the potential for ranitidine to produce unacceptable levels of NDMA and when they became aware of these possibilities.
Among plaintiffs’ attorneys – lawyers like us, who represent the party suing for an injury, rather than the company being sued – the prevailing opinion is that the evidence suggesting that manufacturers knew or should have known of the drug’s potential to increase cancer risk is compelling enough to pursue claims on this basis.
The numerous studies conducted over the decades since Zantac first came onto the market don’t just address the links between NDMA and cancer. Some of them also investigated researchers’ suspicions, dating back to at least 1987, that ranitidine use could increase the levels of nitrosamines, including NDMA, in the stomach contents.
Why, then, did it take so long to find out about the cancer risk related to Zantac? The 1987 study conducted by the makers of Zantac seemed to disprove these concerns that ranitidine might produce NDMA in the stomach.
However, Valisure’s scientists later disputed the findings of this study and the methods used to attain them, noting what the pharmacy characterized as “important weaknesses.” Thanks to the impressions given from these past studies, Valisure asserted, it’s possible that “evidence of the potentially carcinogenic nature of ranitidine could have gone largely unreported to the FDA for 38 years.”
Since Zantac cancer lawsuits are ongoing, it remains to be seen how juries and judges will respond to the evidence in support of the argument that drugmakers knew or should have known of the risk. Ultimately, unearthing and presenting that evidence is the job of your attorney – not a matter you personally need to worry about, especially when you need all of your energy for the cancer battle you’re fighting.
When you pursue a personal injury lawsuit against the makers of Zantac, you are entitled to compensation for all of the harms you have suffered as a result of developing cancer. In the legal industry, we call these harms or losses “damages.”
Your damages may be economic, which means they have a clear dollar amount associated with them. They can also be non-economic, which means that you may not have a precise monetary figure that accompanies them.
For example, the medical bills you have already incurred, the income you have lost due to time missed from work, and expected costs of future medical care are all economic losses. An attorney can calculate actual financial losses and projected future costs for these harms you have suffered.
Non-economic damages may include things like the pain and suffering you went through as a result of the cancer itself and the treatments you endured. You may have seen a short-term or long-term loss in your quality of life. Perhaps you can no longer do certain activities you once enjoyed or have lost some normal bodily functions, which can compromise your independence and your enjoyment of life. All of these losses are a result of the cancer that you believe was caused by ranitidine use, so they are all part of your claim for compensation.
Some Zantac lawsuits are filed by family members of patients who have passed away as a result of the cancer they developed. This kind of lawsuit is known as a wrongful death claim. In a wrongful death claim, your attorney will seek to get you compensation for the many kinds of losses that your family has sustained as a result of your loved one’s death as well as damages your loved one suffered prior to passing away. These losses may include financial losses due to medical expenses and lost income, emotional losses, and the loss of services provided to the family.
Realistically, you can’t go up against pharmaceutical giants in high-profile cases involving best-selling drugs like Zantac on your own.
These companies have plenty of resources, influential legal teams, and a great deal of motivation to fight you every step of the way. After all, in just one fiscal quarter, the voluntary global recall cost Sanofi, the maker of brand-name over-the-counter Zantac $186 million in sales. The last thing Sanofi and other ranitidine manufacturers want is to pay out what could potentially be large claims to an untold number of people whose lives have been turned upside-down by a cancer diagnosis.
To win a complex claim like this, you need the capable legal representation of a professional, one who understands all of the intricacies of the relationship between Zantac and cancer and the legal requirements to prove this connection.
Our attorneys take our responsibilities to clients very seriously. Just a sampling of those responsibilities include:
Your attorney’s job is to represent and advocate for you. At times, this can mean being your educator on the legal system and processes and supporting you through the worries that are almost inevitable when you’re going through a cancer battle. Whatever you need, we are here for you.
Too often, patients in serious medical situations forgo the legal help they need. With all of the stress and expense of cancer treatment, you may think that you can’t afford a lawyer.
But the financial, physical and emotional toll of cancer is exactly the reason you need an attorney. Only pursuing a legal claim can help you afford the very best cancer treatments and insulate your family from the financial impact of being out of work. To make legal help accessible and affordable for every person affected by a pharmaceutical injury, we offer no-win, no-fee legal help.
When you pay attorneys’ fees on a contingency basis, you pay only a percentage of what your lawyer gets for you. That means you’re never stuck paying for a case you didn’t win, and you can’t possibly end up with a settlement that doesn’t even cover your attorneys’ fees.
In a no-win, no-fee arrangement, you don’t have to take on any of the risks of pursuing a legal claim. Your attorney advances all legal costs and gets paid nothing unless and until they successfully get you compensation.
Most personal injury attorneys handle claims on a contingency basis. Some law firms, like ours, take this commitment further by outlining for our prospective clients a full list of what our policies pertaining to fees and billing are. We call this commitment our No Fee Promise.
If you have even the slightest suspicion that your situation may be the grounds for a Zantac cancer lawsuit, then speaking to one of our attorneys is the next step you should take.
The consultation is free and risk-free, so you have nothing to lose by talking to an experienced lawyer. If it sounds like you may have a case, we can get your claim started right away – and if not, at least you won’t have to keep wondering whether things might be different if you had an attorney fighting this battle alongside you.
The consultation is confidential, free, and comes with no obligation or pressure to move forward with a claim if you don’t want to. Give us a call today and get your questions answered.