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Zantac and other forms of ranitidine with probable human carcinogens already has begun producing lawsuits. Patients who have taken Zantac for years and subsequently developed cancer have started to sue Sanofi and makers of generic ranitidine, alleging that their illness was caused by the presence of NDMA in their medications.
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Sanofi, the current maker of over-the-counter Zantac, followed this revelation with an announcement on October 18 that it was recalling all over-the-counter Zantac in the United States.
“As a precautionary measure, Sanofi on Friday, October 18, initiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States,” the company announcement reads. “This includes Zantac 150, Zantac 150 Cool Mint, and Zantac 75. Zantac tablets are an oral, over-the-counter product to prevent and relieve heartburn associated with acid indigestion and sour stomach.”
Sanofi added that it also had initiated a voluntary recall of Zantac products in Canada. The company seemed to blame the contamination on overseas suppliers.
“Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers,” the October 18 company announcement says, also highlighting the difficulty inherent in tracing the contamination back through the complex pharmaceutical supply train to its source.
Zantac (Ranitidine) Carcinogen Contamination Leads To Recalls, Lawsuits
Dating back to July 2018, the United States Food and Drug Administration (FDA) has been providing public warnings about contamination in generic blood-pressure medications known as angiotensin II receptor blockers (ARBs). These medications include drugs by the names of valsartan, irbesartan, and losartan, some lots of which were found to be contaminated with substances known as nitrosamines, which have been identified as probable human carcinogens. Certain of these drugs have been subject to ongoing voluntary recalls, leading to shortages and price spikes.
FDA Announces Zantac Contamination
While the FDA continued to grapple with the scope and causes of the ARB contamination, in September 2019, the agency dropped another bombshell, announcing that NDMA, the first nitrosamine to have been detected in generic valsartan, had also been found in the popular heartburn medication Zantac as well as generic forms of the drug, known as ranitidine.
“FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” the FDA’s September 13 statement warned. “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results from laboratory tests.”
The Questions Raised
While the ongoing valsartan contamination fiasco already had led many to question the ability of the US Food and Drug Administration (FDA) to adequately oversee an increasingly global pharmaceutical supply chain, the revelations that similar contaminants have been detected in the popular over-the-counter heartburn medication Zantac has only amplified those concerns.
With regards to the contamination of valsartan and other ARBs with nitrosamines, the FDA appears to have traced the source back to a change in manufacturing practices specifically related to the use of solvents. In response, the FDA has sent multiple warning letters to several parties who play a role in the drug manufacturing process, identifying various violations and giving the companies a limited amount of time to correct their problematic practices.
Most recently, the FDA sent on November 13, 2019 a warning letter to Mylan Pharmaceuticals, Inc., an Indian-based manufacturer of active pharmaceutical ingredients (APIs) used in valsartan.
“The warning letter outlines several current good manufacturing practice (CGMP) deviations at this Mylan facility, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils,” the FDA announced at the time. “Failure to correct these deviations may result in further action by the agency.”
The November warning letter to Mylan Pharmaceuticals followed a similar letter sent to Torrent Pharmaceuticals Limited roughly a month prior, outlining similar concerns with the facility in question’s adherence to industry best practices.
Under United States law, the fact that a drug was manufactured in a facility that does not meet current best practices means that drug is automatically considered “adulterated.”
“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act,” the FDA’s warning letter states.
Despite these actions, many observers, including the FDA’s overseers in congress, have said that the still-unresolved drug contamination crisis raises huge questions about the FDA’s ability to ensure the safety of medications entering the United States’ pharmaceutical supply stream.
The Zantac (ranitidine) Lawsuits
As one might expect, the contamination of Zantac and other forms of ranitidine with probable human carcinogens already has begun producing lawsuits, as patients who have taken Zantac for years and subsequently developed cancer have started to sue Sanofi and makers of generic ranitidine, alleging that their illness was caused by the presence of NDMA in their medications.
Anatomy of a Zantac (ranitidine) Lawsuit: Nine Plaintiffs Sue In The District Of New Jersey
In one of the first legal actions to be filed in response to the announced Zantac (ranitidine) contamination and subsequent Sanofi recall, a group of nine plaintiffs on October 25, 2019 sued all makers of Zantac and generic ranitidine in the District of New Jersey.
The 67-page lawsuit alleges that, unlike the nitrosamine contamination detected in valsartan and other ARBs, the nitrosamine present in Zantac (ranitidine) is not a byproduct of faulty manufacturing processes but rather is, and has been for decades, an inextricable feature of the drug.
“Recently, the public has been deluged by reports of serious impurities in pharmaceutical drugs,” the lawsuit explains. “In 2019 alone, there have been dozens of recalls of blood pressure medications such as valsartan (and other angiotensin receptor blockers or “ARB”) that contained dangerous levels of a potent carcinogen called N-Nitrosodimethylamine or NDMA. In the case of valsartan, the NDMA impurities resulted from shoddy manufacturing practices. This case also involves NDMA associated with a common drug. But unlike the NDMA present in valsartan, the NDMA associated with this common drug is not an impurity caused by faulty manufacturing processes. Rather, the NDMA is inherent in the drug itself.”
The lawsuit further accuses the makers of Zantac (ranitidine) of having been aware of this problem for decades, yet continually concealing this fact from patients, doctors, and regulators in “perhaps one of the most sinister and gravest public-health frauds in modern times.”
“Since its launch in 1983, every manufacturer of prescription and over-the-counter Zantac has aggressively pushed a poisonous pill into the stream of commerce, while knowing that, when ingested, every single tablet [emphasis in original] (or every single dose) of Zantac produces levels of NDMA in amounts that exceed the U.S. Food and Drug Administration’s permissible daily limits for the carcinogen by thousands of times,” the lawsuit alleges.
How NDMA Harms The Human Body
The New Jersey Zantac (ranitidine) lawsuit goes into some detail about how NDMA causes serious damage to the very building blocks of the human body. According to plaintiffs, not only is NDMA itself a probable carcinogen, but it develops into additional carcinogenic materials once it has entered the human body.
“As if the formation of NDMA in the body from Zantac use isn’t bad enough, once it is present in the body, NDMA further metabolizes into other known carcinogens such as formaldehyde,” the lawsuit says. “In short, Zantac is nothing more than a cancerous poison that at all times was sold by Defendants with the actual or constructive knowledge that it was a poison. As a proximate result of Defendants’ callous conduct, Plaintiffs have cancer or are at serious risk of developing cancer.”
The lawsuit then explains how NDMA inflicts its damage on humans by targeting our very DNA.
“NDMA and its metabolites damage DNA through a variety of mechanisms,” the complaint describes. “NDMA or its metabolites can induce alkylating damage. NDMA can literally break the phosphodiester backbone of the double helix (i.e. a ‘strand break’), directly induce mutations in the DNA sequence, it can chemically modify the DNA molecule, forming ‘DNA adducts,’ and split chromosomes.”
The History of Zantac
Originally developed by GlaxoSmithKline for release in 1983, Zantac (ranitidine) achieved what was at the time unparalleled financial success for a pharmaceutical product. Within three years of its release, Zantac had become “the first drug to total $1 billion in sales,” according to the New Jersey lawsuit.
This remarkable success would more or less sustain itself for the next two-and-a-half decades.
“As recently as 2018, Zantac was widely used and remained one of the most popular tablet brands of antacid in the United States,” the complaint says.
With such record-breaking sales, Glaxo and subsequent makers of Zantac (ranitidine) were highly incentivized to conceal information pertaining to NDMA from the public, doctors, and regulators.
“But Zantac’s unprecedented sales were possible only because of the deception perpetrated by all Zantac manufacturers since the drug hit the U.S. market in 1983,” the lawsuit alleges.
“Each Defendant knew, or should have known, at all times that it sold Zantac, that the drug has a critical and deleterious defect: When ingested, Zantac produces in the human body high quantities of NDMA, a chemical that the World Health Organization has described as ‘clearly carcinogenic,” the plaintiffs argue. “The dangers of NDMA have been publicly known for over 40 years, well before Zantac hit the market.”
Since 1983, defendant GlaxoSmithKline has held the rights to sell prescription Zantac (ranitidine) in the United States. Since January 2017, Sanofi has owned the right to produce and sell over-the-counter (OTC) versions of Zantac (ranitidine). Prior to that, the OTC rights were held by the defendant Boehringer, which produced and distributed OTC Zantac from on or around October 2006 until Sanofi assumed those rights in January 2017. Before Boehringer, pharmaceutical giant Pfizer had owned the rights to OTC Zantac (ranitidine), which it held from 1996 until about 2005.
All of these pharmaceutical makers are named defendants in the New Jersey federal lawsuit.
The plaintiffs suing the various makers of Zantac (ranitidine) are individuals who have taken Zantac (ranitidine) in different forms over the course of multiple decades. They herald from a range of states, suffer from different forms of cancer, and include one individual suing on behalf of an estate and another who has not yet been diagnosed with cancer.
For example, “Plaintiff George Cravens is a resident of Cushing, Oklahoma,” the lawsuit says. “Plaintiff Cravens began purchasing and ingesting Zantac in or round 1988. From then on, Plaintiff Cravens ingested at least Zantac 150 or Zantac 300 on average twice a day, seven days per week. As a direct and proximate result of ingesting Zantac, Plaintiff contracted colorectal cancer in or around 2017.”
Had Craven been adequately warned of the risks associated with Zantac (ranitidine), he would never have put the substance in his body, the lawsuit argues.
“Had Plaintiff been informed that taking Zantac would expose him to unsafe quantities of NDMA such that it could and did cause him to contract colorectal cancer, he never would have purchased and ingested Zantac,” the complaint contends.
Similarly, “Plaintiff Kileen D. Gromelski is a resident of Manchester, Connecticut. Plaintiff Gromelski began purchasing and ingesting Zantac in or around 1989. From then on, Plaintiff Gromelski ingested at least Zantac 300 on average twice per week. As a direct and proximate result of ingesting Zantac, Plaintiff contracted kidney cancer in or around 2012.”
In the instance of plaintiff Venus Sykes, she has sued the makers of Zantac (ranitidine) as an individual and on behalf of the estate of her deceased husband, who died in April 2019 after a years-long battle with stomach cancer.
“Chris Sykes began purchasing and ingesting Zantac in or around 1990,” the lawsuit says. “From then on, Chris Sykes ingested Zantac 150 on average three times per day. As a direct and proximate result of ingesting Zantac, Chris Sykes contracted stomach cancer in or around 2016.”
Other plaintiffs herald from places such as Milwaukee, Wisconsin; Millington, Maryland; Austin, Texas; Punta Gorda, Florida; Egg Harbor Township, New Jersey; and Sicklerville, New Jersey, demonstrating the negative health impacts of NDMA’s relation to Zantac (ranitidine) know no geographic bounds.
The nine original named plaintiffs suffer from ailments including esophageal cancer, colorectal cancer, bladder cancer, and stomach cancer. They also include one individual, plaintiff Paul Burpulis, who has been taking Zantac (ranitidine) since 1998. Although plaintiff Burpulis has not yet been diagnosed with cancer, the lawsuit alleges that, “[a]s a direct and proximate result of ingesting Zantac,” he is “at an increased risk of developing cancer.”
The New Jersey lawsuit contains numerous counts, some of which are brought under the laws of the states where the various plaintiffs reside.
For instance, the first count—for strict products liability (design defect)—“is asserted by the following Plaintiffs as follows: Plaintiff George Cravens brings this claims against the Sanofi defendants under Oklahoma law; Plaintiff Venus Sykes brings this claim against the Sanofi Defendants under Illinois law; Plaintiff Jarquisha Harris brings this claim against the Sanofi Defendants under Wisconsin law,” and so on.
In all, the complaint contains a total of nine counts:
1. Strict products liability – design defect
2. Strict products liability – failure to warn
3. Connecticut Products Liability Act (Plaintiff Gromelski only)
4. New Jersey Products Liability Act (Plaintiffs Burpulis and DeLuccia only)
5. Negligence and gross negligence
7. Fraud by omission
8. Breach of implied warranty of merchantability
9. Medical monitoring
Based on the defendants’ alleged violations, plaintiffs request that the court award both compensatory and punitive damages, as well as “[c]osts, including reasonable attorneys’ fees, court costs and other litigation expenses” and “[s]uch other and further relief as the Court deems proper.”
Whereas, true to their name, compensatory damages are intended to “make plaintiffs whole” for the financial costs and other losses they have incurred as a result of the defendants’ alleged wrongdoing, punitive damages are intended to punish perpetrators for their bad acts and to disincentive their reoccurrence. Consequently, plaintiffs request “punitive damages sufficient to punish and deter the Defendants and others from future wrongful practices.”
The nine plaintiffs named in the New Jersey Zantac (ranitidine) lawsuit are hardly the only individuals to sue the makers of the drug over the presence of NDMA, and observers expect that, given the popularity of the drugs and the length of time they have been on the market, the number of individual plaintiffs may ultimately grow into the thousands, perhaps necessitating the creation of multidistrict litigation (MDL) to centralize pretrial proceedings.
For example, on November 19, 2019, a female resident of North Carolina sued the makers of Zantac (ranitidine) alleging that, after taking the drug regularly since 1992, she was diagnosed with stomach cancer in 2012. Unaware at the time of any potential connection between Zantac (ranitidine) and her cancer diagnoses, the plaintiff continued taking the medication for several more years until the FDA’s September 2019 announcement [https://www.fda.gov/safety/medical-product-safety-information/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines] regarding the relationship between Zantac (ranitidine) and NDMA.
“The plaintiff blames the manufacturers for failing to warn about this potential danger, and for failing to make sure their products were safe for the public,” the Legal Examiner reported January 2.
Plaintiffs And Defendants Request Creation Of Zantac (ranitidine) MDL
On November 4, 2019, just weeks after Sanofi announced its recall of all over-the-counter Zantac products in the United States and Canada, plaintiffs in six different federal lawsuits filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) requesting that their cases be centralized as multidistrict litigation (MDL) in the District of New Jersey, Lexis Legal News reported at the time.
The defendant pharmaceutical companies—Boehringer, GlaxoSmithKline, Pfizer, and Sanofi—filed their response November 27, agreeing with plaintiffs’ request.
“Defendants agree that the Panel should centralize this litigation in the District of New Jersey, and suggest that the MDL be assigned to the Honorable Freda L. Wolfson, an experienced MDL judge currently overseeing all of the Zantac actions already pending in that jurisdiction,” the defendant drugmakers wrote to the JPML, adding later, “All indications are that the Zantac litigation will be complex and hard-fought litigation.”
“All indications are that the Zantac litigation will be complex and hard-fought litigation.”
-Defendant Drugmakers To JPML
On December 19, 2019, the JPML filed a Notice of Hearing Session announcing that a hearing on the request to create a Zantac (ranitidine) MDL would be held January 30, 2020 in Tampa, Florida. According to the Notice of Hearing, by the time of its filing, the potential MDL had grown to include 15 cases from nine districts.
Where Things Go From Here
With only a matter of months having passed since the FDA announcement and subsequent Sanofi recall, legal actions against the makers of Zantac (ranitidine) are still in their relative infancy. However, these early cases are likely to set the stage for the numerous lawsuits expected to follow.
For example, in the instance of the New Jersey federal lawsuit discussed above, the plaintiffs clearly are seeking to test the bounds of Zantac (ranitidine) litigation, purposefully including plaintiffs from a variety of geographic regions and even one plaintiff who had not yet been diagnosed with cancer. The inclusion of this plaintiff was clearly an effort to test the limits of courts’ and juries’ willingness to ascribe harm to defendants in the ongoing fallout from the NDMA crisis, as was the inclusion of plaintiffs having taken various doses of the drug and for different periods of time.
More broadly, the Zantac (ranitidine) recalls represent yet another doubt undermining the public’s confidence in the ability of regulators like those at FDA to properly ensure the safety of the nation’s drug supply. If the makers of the first $1 billion drug have been able to conceal the relationship between Zantac (ranitidine) and NDMA for nearly four decades, what other hidden dangers lurk in our supposedly safe pharmaceutical supplies?
Zantac cancer: how we got here - Timeline
The FDA, and scientists around the world, discovered a cancer causing
compound (NDMA) in Zantac and other brands of generic ranitidine
(one of the most commercially successful heartburn drugs in history).
Zantac, and its generic equivalents, have been pulled from store shelves.
This is the timeline on the Zantac recall:
Glaxo receives FDA approval for Zantac as a short-term treatment of a common form of ulcers and was approved in dozens of countries around the world. (More recently it has become scientifically accepted that most ulcers actually come from the H.Pylori bacteria and not from stomach acid).
Zantac quickly becomes one of best-selling drugs in the world with over a billion dollars annual revenues.
Glaxo’s U.S. patent for ranitidine expires and competitors launch generic alternatives to the drug. Generic manufacturers and Glaxo continue to make Zantac (ranitidine).
Pfizer starts making non-prescription Zantac in the U.S. The over-the- counter (non-prescription) brand of Zantac was bought and sold and is eventually acquired by Sanofi SA (generally considered the third largest pharmaceutical company in the world.
FDA recalls blood pressure drug valsartan made in China after finding the cancer causing impurity N-nitrosodimethylamine (NDMA). This causes increased scrutiny of drugs that may contain the NDMA toxin.
Sept. 18, 2019
Due to the presence of the NDMA toxin in ranitidine (the chemical in Zantac) Novartis says it is halting the distribution of its generic versions of Zantac all over the world. Canada stops distribution of Zantac/ranitadine.
Sept. 28, 2019
CVS, Walmart, Walgreens and RiteAid pharmacies stop selling Zantac and their own generic ranitidine products.
Oct 2, 2019
FDA confirms it has found “unacceptable levels” of N- nitrosodimethylamine (NDMA) in samples of drugs containing ranitidine/Zantac in its testing.
Oct 8, 2019
Glaxo, the original maker Zantac, recalls prescription Zantac around the world.
Oct 18, 2019
Sanofi, the maker of the “over-the-counter” non-prescription Zantac, recalls Zantac in the United States and Canada.
PRESENT: The dangerous concentrations of NDMA in Zantac are believed to cause regular users of Zantac the following cancers of the digestive system and related major organs: Esophageal cancer
Stomach cancer, Bladder cancer, Kidney cancer, Pancreatic cancer, Colon cancer, Liver cancer and Prostate cancer (if under 65 years old at time of diagnosis). The attorneys at TheLawFirm.com have spent over 20 years helping victims of greedy pharmaceutical companies. Call TheLawFirm.com now, if you or a loved one has been diagnosed with one of the above cancers after at least one year of regular use of Zantac.
United States Food and Drug Administration (FDA). (13 September 2019). Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines. Medical Product Safety Information
Sanofi. (22 October 2019). Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. Company Announcement. Recalls, Market Withdrawals, & Safety Alerts. United States Food and Drug Administration (FDA)
United States Food and Drug Administration (FDA). (13 November 2019). FDA Warns Mylan for CGMP deviations. FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). Drug Safety and Availability
United States Food and Drug Administration (FDA). (8 October 2019). Warning Letter 320-20-03. From US FDA Center for Drug Evaluation and Research (CDER). To Mr. Samir Mehta, CEO, Torrent Pharmaceuticals Limited. Warning Letters
United States District Court for the District of New Jersey. (Filed 25 October 2019). Complaint / Jury Trial Demanded. George Cravens, et al., plaintiffs, v. Boehringer Ingelheim Pharmaceuticals, Inc., et al., defendants. Case 3:19-cv-19368
Luhana, R. (2 January 2020). North Carolina Woman Blames Zantac for Stomach Cancer. The Legal Examiner
Lexis Legal News. (8 November 2019). Zantac MDL Creation Sought By Plaintiffs Seeking Refunds, Cancer Compensation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 January 2020). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Judicial Panel on Multidistrict Litigation. (Filed 27 November 2019). Defendants Boehringer Ingelheim, GSK, Pfizer, and Sanofi’s Response to Motion for Transfer and Consolidation Under 28 USC 1407. In Re: Zantac/Ranitidine NDMA Litigation. MDL 2924
United States Judicial Panel on Multidistrict Litigation (JPML). (19 December 2019). Notice of Hearing Session
Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.