Which Cancers is NDMA Associated With?

There are numerous causes for cancer ranging from infectious agents; to genetic predisposition; to environmental factors and behaviors such as smoking, alcohol use, diet, obesity, and exposure to pollution. Furthermore, studies and research have yet to draw a conclusive link between NDMA in Zantac and cancer. Accordingly, at this time, it is difficult to calculate the specific cancer risk from NDMA contamination.

With that in mind, researchers have theorized that long-term exposure to NDMA contamination in Zantac could be linked with the following cancers:

• Stomach
• Bladder
• Colorectal
• Liver
• Esophageal
• Small Intestinal

Although less prevalent in research, NDMA has also been linked to these types of cancers:

• Prostate
• Ovarian
• Pancreatic
• Lung
• Uterine
• Brain
• Breast
• Thyroid
• Testicular
• Leukemia
• Non-Hodgkin’s Lymphoma
• Multiple Myeloma

FDA Recall

NDMA contamination in Zantac first came to light following the work of a small laboratory in Connecticut known as Valisure. This laboratory was created after one of its founders suffered from a contaminated batch of medication. Valisure began testing Zantac in March 2019 on the founder’s whim after it was prescribed for his infant daughter to combat acid reflux.  The testing immediately revealed abnormal levels of NDMA contamination.

After more testing, Valisure notified the FDA and European drug regulators who each immediately began their own investigations. In October 2019, the FDA ordered all manufacturers of ranitidine products to test for NDMA. That order was followed-up with a broad recall order from the FDA in April 2020, clearing all ranitidine products off the shelves throughout the United States.

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Alleged Breathing Issues Tied to Vaping

E-Cigarette manufacturers have long pushed the notion that their products are either safe or safer than cigarettes. However, users of e-cigarettes and their families have come forward in recent years telling of horrible suffering that they believe is directly attributable to vaping. 

• In September 2019, 18-year old Adam Hergenreder was hospitalized and on respiratory support after two years of steady vaping. Mint and mango were his favorite flavors. Doctors have told Adam that his chest X-rays reveal the lungs of a 70-year old man and that they may never truly heal or be the same again.
• The American Thoracic Society (ATS) published an article on the prevalence of Bronchiolitis Obliterans Organizing Pneumonia (BOOP) in patients claiming they use e-cigarettes. BOOP is a rare inflammatory lung disorder involving flu-like symptoms and coughing that make breathing very difficult in sufferers.
• The December 2019 Mayo Clinic Proceedings examined the potential for breathing issues and vaping in its article: “Vaping-related Acute Lung Injury: A New Killer Around the Block.” Among the article’s highlights was the conclusion that the incidence of vaping-related acute lung injury is increasing and that electronic cigarette compounds present the potential for a range of detrimental effects on the human respiratory system.
• The Journal of the Missouri State Medical Association’s November 2019 edition gave an extensive look into the increasingly bleak outlook for Vaping Associated Lung Injury (EVALI) in the United States. The articles noted that as of its publication, there were 2,051 cases of e-cigarette or vaping lung product uses associated with lung injury (with 39 reported deaths) in the U.S. Overwhelmingly, EVALI patients complain of symptoms like cough, chest pain, and shortness of breath. Of the documented cases expressing EVALI, 86% of the patients reported using THC-containing products. In February 2019, the New England Journal of Medicine and the Centers for Disease Control (CDC) had both established research pieces linking Vitamin E Acetate, a thickening fluid used predominantly in THC vaping products with EVALI.

Legal Exposure for Juul and Other E-Cigarette Manufacturers

State Lawsuits Over Targeting of Children

The New York State Attorney General, Letitia James, announced in November 2019 that her office would lead a lawsuit against Juul Labs for “deceptive and misleading” marketing aimed at children. In her announcement, James referenced Juul “launch parties” which involved direct outreach to high schoolers by Juul reps who repeatedly assured students that Juul was safer than cigarettes. The New York lawsuit mirrored similar lawsuits filed earlier in 2019 by California Attorney General Xavier Becerra and Los Angeles District Attorney Jackie Lacey.

Alleged Hemorrhagic Stroke

Maxwell Berger is a 22-year old Syracuse University student that began using Juul in 2015 and quickly developed a two-pod-per-day habit.  In 2017, Maxwell suffered a severe hemorrhagic stroke that paralyzed the left side of his body and caused him to lose half of his vision in both eyes. He has suffered from cognitive impairment and brain damage as well.  In 2019, Maxwell sued Juul in New York alleging that his use of Juul caused his stroke and injuries.

Contaminated Juul Pods

In October 2019, a former Juul Labs executive, Siddarth Breja, filed a lawsuit in federal court in California that at least one million contaminated Juul pods were let onto the market by the company despite his warnings to the company’s leadership. Among the claims made by Breja in the case was Juul’s CEO Kevin Burns said: “Half our customers are drunk and vaping like mo-fos, who the f**k is going to notice the quality of our pods.”

Breja’s lawsuit did not specify what type of contamination was alleged to manifest in the pods. Furthermore, Juul’s CEO has publicly denied the allegations and claimed that Juul products are tested for toxicity.

Multidistrict Litigation in California

In 2018, two lawsuits were filed in California alleging that Juul was inappropriately marketed as safe even though it contains more nicotine than a traditional cigarette. Thus began a wave of civil lawsuits naming Juul which have now been consolidated into Multi-District Litigation (MDL) before the federal court in the Northern District of California. As of this moment, MDL-2913 has approximately 651 cases pending and is growing.

FDA Investigation Over Possible Juul LInk to Seizures

Bloomberg News obtained communications and memoranda between FDA officials in October 2018 detailing three cases of seizures alongside significant Juul use. While the FDA documentation did not detail any causality between Juul and the seizures, they believe that at a minimum there was an “association” with Juul. Over the next few months, the FDA uncovered an additional 32 reports of e-cigarette use that were believed to be linked to seizures. The FDA announced an investigation into the link between seizures and vaping in April 2019.

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Flexible Physiomesh Complications

The market for synthetic mesh products is both profitable and competitive.  Additionally, synthetic mesh devices, like Physiomesh, are almost always routed through the FDA”s fast-track 510(k) clearance process which does not require manufacturers to support marketing applications with large amounts of safety and efficacy data. Consequently, these products make it onto the market and into our bodies without much scrutiny and potential complications are sometimes overlooked.

Post-market surveillance of flexible (laparoscopic) Physiomesh indicated defects causing premature disintegration, tissue adhesion, contraction, and organ perforation. Due to the number of post-market “adverse event” reports coming back to Ethicon and the FDA, Ethicon voluntarily withdrew the flexible version of its Physiomesh line from the market in 2016. The “open” version is still available on the market for ventral hernia repair.

Physiomesh Lawsuits

Starting in 2017, patients claiming they were injured and suffering from implantation with flexible Physiomesh filed the first initial lawsuits naming Ethicon and J&J. As these lawsuits began to accumulate and grow in number, they were consolidated into multidistrict litigation in federal court in Georgia (MDL-2782). Today there are thousands of claimants integrated into the MDL and the first “bellwether” cases are expected to commence in late 2020. In addition to the MDL, several state cases are proceeding on another track in New Jersey.

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Issues and Complications from Polypropylene

Polypropylene mesh is commonly associated with chronic postoperative pain. It is believed that the mesh sometimes stiffens dramatically once it is implanted due to oxidative stress. Other issues and complications may include bleeding and infection, tissue adhesion, migration, bowel obstruction, and in some cases, erectile dysfunction.

Problems associated with the use of polypropylene in synthetic mesh devices are not new, either to the patients suffering from them or to manufacturers. According to evidence obtained during court proceedings in the United States, it emerged that Davol/C.R. Bard was told by the manufacturer of the resin they used that it was inappropriate for implantation in the human body.  

Notably, on the Materials Safety Data Sheet (MSDS) for Marlex polypropylene published by the resin manufacturer Chevron Phillips Chemical Company, it states clearly: “Do not use this [manufacturer’s] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”  Beyond this admonition, a Vice President at C.R. Bard admitted in court that he received a call in 1997 from an executive at Chevron Phillips that, “…they (Chevron) were concerned about litigation and the association with the Marlex name with a permanent medical implant.”  

Finally, in 2004, Chevron Phillips formally warned Davol/C.R. Bard and others that Marlex was “not for human implantation” and told Davol/C.R. Bard that they did not want to sell them Marlex at any price. Despite these warnings from Marlex’ own manufacturer, Davol/C.R. Bard continued using polypropylene in mesh devices for years afterward, allegedly going to great lengths to secure the resin while concealing its end purpose from suppliers.

Composix Kugel Patch Recall and Lawsuits

The Composix Kugel Patch was a mesh device marketed widely and aggressively by Davol/C.R. Bard in the 1990s through the mid-2000s. It was distinguished by a “memory recoil ring” that allowed the mesh to be inserted into the body through a small incision then unfold and lay flat.  Unfortunately, the Kugel’s signature feature also demonstrated a propensity for breaking in the abdomen, causing bowel perforations and chronic intestinal fistulas. Between 2005 and 2007, the Kugel Patch was subject to a number of recalls, culminating with a Class I recall – the most serious type of recall mandated by the U.S. Food and Drug Administration (FDA). In the end, Davol/C.R. Bard had recalled nearly 140,000 units and paid $184 million to settle 2,600 lawsuits in 2017.

Current Davol/C.R. Bard Mesh Lawsuits

Davol/C.R. Bard are currently defendants in large multidistrict litigation (MDL) spanning a range of polypropylene devices in federal court in Ohio (MDL-2846).  The first bellwether cases in this MDL are expected to open for trial late in 2020.

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FDA Recalls and Administrative Action on IVC Filters

To date, the FDA has yet to issue any formal recalls for an IVC filter device.  Nonetheless, between 2005 and 2019, at least eight types of IVF filters have been voluntarily withdrawn from the market by their manufacturers.  In its first warning letter concerning IVC filters in 2010, the FDA detailed over 921 injuries from IVC filters spanning: migration through the body; migration into the heart and lungs (embolization); perforation of the vena cava; and filter fracturing.  Since 2014, filter manufacturers have been given the option of either participating in the FDA’s 522 Postmarket Surveillance Studies program or an independent clinical study known as “Predicting the Safety and Effectiveness of Inferior Vena Cava Filters” (PRESERVE).

IVC Filter Lawsuits

In re: Bard IVC Filters (MDL-2641)

Lawsuits involving C.R. Bard’s Recovery and G2 IVC filter lines began emerging in late 2013 and early 2014.  Due to the number and similarity of the allegations leveled in the complaints, they were consolidated into multidistrict litigation in Arizona.  In their complaints, the implantees alleged that manufacturing and design defects in the Recovery and G2 lines, which they claimed C.R. Bard knew all along, were causing them to experience significant rates of fracture and migration.  Some studies cited in the complaints stated that the Recovery line suffered from a 21% to 31.7% rate of fracture.  Beyond the manufacturing and design defect claims, implantees also alleged that C.R. Bard actively denied and concealed knowledge of the dangers posed by the Recovery and G2 IVC filters and withheld such evidence in an attempt to delay court filings.

In March 2018, at the conclusion of the first bellwether trial for this MDL, a jury awarded plaintiff, Sherr-Una Booker $3.6 million in compensatory and punitive damages.  Thereafter, C.R. Bard prevailed in two bellwether trials in June 2018 and October 2018.  In May 2019, the judge presiding over this MDL announced a limited settlement for thousands of cases with the rest sent back to continue proceedings in state courts across the country.  The MDL itself is now closed out, however, cases may still be brought in state court.

In re: Cook Medical, Inc. IVC Filters (MDL-2570)

Similar to the MDL involving C.R. Bard, cases revolving around the Gunther Tulip and Celect lines of IVC filters manufactured by Cook Medical, Inc., began to make their way into courtrooms around the country in 2013 and 2014.  These cases were then consolidated into multidistrict litigation in Indiana.  Like the plaintiffs in the C.R. Bard cases, the implantees in this MDL complained of alleged design and manufacturing defects such as tilt, migration, and fracturing.  Specifically, some claimants referenced a study published in Cardiovascular Interventional Radiology in 2012 which assessed that the Gunther Tulip and Celect lines failed at a rate of 100% up to 71 days following implant and caused some degree of perforation of the wall of the vena cava.  The same study reported that tilt was witnessed in 40% of the Gunther Tulip and Celect filter lines.

The outcomes of the various bellwether trials in this MDL have been a mixed-bag:

• In November 2017, a jury sided with Cook Medical and failed to find the company liable.
• A second bellwether case was dismissed in April 2018 due to the statute of limitation issues.
• A Houston firefighter was awarded $1.2 million by a Texas jury in May 2018 (not actually a bellwether case and not part of the MDL).
• In December 2018, the presiding judge in the MDL granted summary judgment to Cook Medical in a Georgia case brought by Tonya Brand.
• Most recently, in February 2019, an Indiana jury awarded $3 million to a woman who suffered a range of injuries from one of its IVC filter lines.

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Acquisition by the Getinge Group

By 2011, Atrium had swollen to become a company with revenues in excess of $200 million annually, more than 700 employees, a sales force throughout North America, Europe, Asia, and Australia/New Zealand, and 106 distributors across 102 countries. In that moment, Getinge Group, a multi-billion dollar Swedish device manufacturer moved-in and orchestrated the acquisition of Atrium for $680 million through a German subsidiary, Maquet.

Advertised Uses for C-Qur Mesh

Initially, C-Qur was intended as a mesh for surgical use with ventral and inguinal hernia conditions.  C-Qur was advertised as a novel approach to implantation and a way to ameliorate past issues with polypropylene mesh organ adhesion by virtue of its coating with O3FA, a pharmaceutical-grade fatty-fish acid coating.

Issues and Complications Associated with C-Qur Mesh

It is well-established that certain proteins in oily bio-product derived from fish are bound to cause allergic reactions. Common human responses to fish proteins such as those contained in fatty fish oil can range from increased sensitivity and rashes – all the way up to death. Concerns about the possibility of allergenic contamination were allayed by assurances that the O3FA coating utilized by Atrium would be screened, tested, and inspected to ensure that no non-soluble proteins would be present in the coating.

Almost immediately following the introduction of the C-Qur line and for years following afterward, physicians and surgeons reported disturbing levels of infection and other conditions following implantation with the C-Qur line. One “adverse event” report to the FDA involved a woman implanted with C-Qur mesh who began suffering intense pain and a “constant burning sensation” within 6 hours following her hernia repair procedure. She was immediately taken back for a second operation wherein the surgeon noted that the woman’s abdomen and the pelvic area looked like “a bomb went off” and “like a third-degree burn” due to the intense infection and inflammation.

Other similar adverse event reports have C-Qur mesh implantees complaining of “purulent discharge” and swelling from abdomen wounds.  A patient in 2012 required mesh removal, drainage of his abdomen, treatment with intravenous antibiotics, surgery for obstruction, and five days in the hospital less than a week after a hernia procedure involving C-Qur mesh.  

FDA Warning Letter and Class II Recall of C-Qur

The FDA expressed serious concerns to Atrium in a letter dated October 11, 2012, wherein the agency believed that Atrium was not adequately addressing the issues corresponding to numerous adverse events involving C-Qur mesh. Most of these complaints involved infections and other reactions to the C-Qur mesh that pointed directly at either insufficient or deficient sterility and sanitary procedures at the point of manufacture.

In August 2013, the FDA announced a Class II recall of the C-Qur Edge Mesh due to manufacturing and sterilization issues that caused the device to adhere to its packaging after exposure to conditions of high humidity.  Although the recall impacted over 1,500 meshes, Atrium did not pull any products from shelves and merely warned physicians to inspect meshes prior to implantation.

FDA Lawsuit and Consent Decree of Permanent Injunction

The issues with Atrium and C-Qur became so pronounced that the U.S. Department of Justice, on behalf of the FDA, filed a lawsuit in federal court in February 2015, to stop Atrium from the production of meshes at its production line in Hudson, New Hampshire. The lawsuit was followed by a permanent injunction and “consent decree” which accused Atrium of violating the Federal Food, Drug and Cosmetic Act (FFDCA) by putting mesh devices on the market which were illegally “adulterated” and mis-branded; and which were not manufactured utilizing “current good manufacturing processes”.  

C-Qur Mesh Lawsuits

There, at present, over 2,200 lawsuits naming Atrium and its C-Qur mesh line seeking damages for injuries, suffering, and medical expenses.  Lawsuits involving C-Qur mesh accumulated to the point that in 2016, they were consolidated into a single multidistrict litigation taking place in federal court in New Hampshire.  The first “bellwether” trial in this MDL (MDL-2753) is expected in late 2020.

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Design Defect

However, as injured soldiers claim in multiple lawsuits, the earplugs did not perform as advertised.  They believe that the combat earplugs’ instruction manual, in combination with an inherent design defect, involving the third-flange of the non-inserted end, prevented the plugs from fitting snugly in the ear canal.  When the flange of the non-inserted end pressed against the ear, it folded and loosened the seal.  Troops who believed their ears were being adequately shielded from battlefield noise were allegedly exposed to much higher-than-safe levels of decibels.  It is believed that, at a minimum, thousands if not millions of soldiers have suffered significant hearing loss as a consequence.

3M and Aearo Knowledge of the Defect

At the dawn of the program in January 2000, testing of the combat arms earplugs began at Aearo’s own laboratories, rather than at an outside and independent laboratory.  Aearo employees closely monitored the results of testing, which suggested that the noise reduction factor offered by the devices was far below what was considered adequate. Aearo determined that the positioning and fitting of the flanges in the design were the cause of the deficiency in the earplugs’ performance.

Aearo employees and engineers concluded that a snug fit on the “closed” end of the earplugs required the user the fold back the flanges on the “open” end in what was termed as a “modified” fitting procedure.  Testing resumed in February 2000 using the modified fitting technique and the results of these tests were the basis for Aearo’s and eventually 3M’s claims about the noise reduction ratings for the combat arms earplugs.

Instructions for Proper Use

Despite allegedly knowing that their product contained a serious design defect that could render its claims of noise protection virtually meaningless, Aearo and 3M went ahead and sold the dual-ended combat arms earplugs to the U.S. military for several years. And potentially more damning, given what they knew about the defect and their own testing, they failed to include the “modified” fitting procedure in the standard “instructions for proper use” issued with the device.

Whistleblower Settlement

In 2016, a competing firm of Aearo/3M filed a federal whistleblower complaint claiming that 3M violated the False Claims Act concerning statements and representations it made to the U.S. Government concerning the safety record of the dual-ended combat arms earplugs. Specifically, Moldex’ claimed that 3M employees were well-aware that the earplugs did not perform as claimed to go all the way back to 2000.  In July 2018, 3M agreed to settle the claims in the whistleblower complaint for $9.1 million without a direct admission as to any liability on the part of 3M.

Tinnitus and Hearing Loss

Tinnitus is described as a general ringing in the ears.  According to the U.S. Department of Veterans Affairs, tinnitus is one of the most commonly reported disabilities among servicemen and women. It is widely understood that our nation’s fighting men and women are especially vulnerable to tinnitus and hearing loss due to excessive noise exposure from gunfire, explosions, and helicopter rotors.  

These loud noises can permanently damage the cells within the inner ear causing much discomfort and loss of enjoyment of life.  Veterans with tinnitus can hear a ringing, hissing, or buzzing that prevents concentration or sleep.  On the other hand, hearing loss can make it difficult for someone to maintain relationships with loved ones and friends leading to depression or even cognitive decline.

Is there a Dual-End 3M Combat Arms Earplugs Lawsuit?

In 2019, veterans from across the United States began filing lawsuits naming 3M which claim that the company sold defective earplugs and then intentionally made false representations to the U.S. Government concerning the safety and effectiveness of the combat arms earplugs.  These lawsuits have now been aggregated into a multidistrict litigation taking place in a federal court in Florida (MDL-2885).  The first bellwether trials in the MDL began in April 2021. Some of the lead plaintiffs include:

Andrew Bridges

Bridges is a veteran of the United States Marine Corps who joined in 2006 at the age of 18 and was deployed to Iraq in 2009.  He was supplied with dual-end 3M Combat Arms earplugs during his service and wore them during tank firing, training exercises, live-fire training, vehicle maintenance, and combat exercises.  According to his complaint, Bridges was never instructed to fold back the flanges on the earplugs and in 2010 was first diagnosed with hearing issues, including sensorineural hearing loss and tinnitus.

John Ciaccio

Also a veteran of the United States Marine Corps, Ciaccio joined the Marines in 1991 and served until 2017, during which he was deployed to Iraq (twice) and Afghanistan. He worked extensively in maintenance, demolition, and as a convoy team member. Like Bridges, he was supplied dual-end 3M Combat Arms earplugs and wore them throughout the remainder of his service. Like Bridges, Ciaccio was never instructed on how to bend back the third flange on the opposite side of the earplug.  In 2009, he was diagnosed with tinnitus and hearing loss which requires him to wear hearing aids.

Trial Progress Update

The first three trials involving 3M’s Combat Arms earplugs under the consolidated multidistrict litigation taking place in Pensacola resulted in at least two jury verdicts in favor of injured veterans with damages totaling $8.8 million.  One of the three resulted in a jury verdict in favor of 3M.

Fourth Trial – Brandon Adkins

On October 1, 2021, a jury in a Pensacola federal court found 3M liable for hearing damages suffered by U.S. Army veteran Brandon Adkins.  Adkins served in the Army from 2004 to 2009 and did two tours in Afghanistan.  The jury ruled that a design defect in the 3M Combat Arms Earplugs caused Adkins’ to suffer tinnitus and permanent hearing loss and that the company failed to warn of the defect.  It then awarded Adkins $8.2 million in damages.

Additional Bellwether Trials Authorized

On October 8, 2021, the federal judge overseeing all of the consolidated lawsuits involving 3M Combat Arms Earplugs authorized an additional four “bellwether trials” used by the parties to gauge the range of damages and define settlement options.

What Do I Need to File a Dual-End 3M Combat Arms Earplug Lawsuit?

Veterans who served in the U.S. military between 2003 and 2015 may consider filing a lawsuit to recover compensation for injuries and loss of quality of life. The first step is to contact an experienced 3M Combat Arms earplugs case attorney for an initial consultation. These visits are an excellent opportunity to learn more about the ongoing litigation and what it means for you. Furthermore, they are always free-of-charge to you.

Some things to have organized for your initial consult with an attorney include:

• Service records detailing your time in the military, deployments, and work fields/occupations while in service.

• Any paperwork, records, or notes you have recalling when you were issued the 3M Combat Arms earplugs and when you wore them.

• Reports and records from the Veterans Administration detailing hearing tests and results (these can also be supplied by the V.A. upon request).

Disability Benefits and Filing a Lawsuit

Veterans who receive disability benefits should not be concerned that any award resulting from filing a lawsuit for their injuries will adversely impact those benefits. According to attorneys familiar with this process, disability benefits are given on the basis of injury and are not based upon income or financial need. Bearing this in mind, any benefits received which are needs-based or income-based could be affected. It is important to consult with an attorney knowledgeable about these matters when starting the claims process.

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What is NDMA?

Also known as “N-Nitrosodimethylamine”, NDMA is an organic chemical that is part of a family of compounds known as N-Nitrosamines.  This group has been recognized as potent carcinogens with substantial dangers to human health and life.  The United States Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) both classify NDMA as a probable human carcinogen.  The World Health Organization’s (WHO) own testing indicates that NDMA exposure is associated with gastric and/or colorectal cancer.  NDMA is generally never intentionally produced in the United States unless it is going to be used to induce tumor growth in lab experiments.

How Did NDMA Get in Zantac?

The presence of NDMA in Zantac is not generally believed to be caused by a defect in the manufacturing process itself.  Rather, it is alleged that NDMA is inherently a structure present in the molecular structure of ranitidine.  Specifically, claims allege that when anyone takes ranitidine, the active ingredient in the medication produces NDMA, exposing every user to the carcinogen.

Is There a Zantac Lawsuit?

Beginning in 2019, cancer sufferers, believing that they developed their illnesses after taking Zantac, began filing lawsuits against the manufacturers of ranitidine in several courts across the United States.  The manufacturers named in many of these lawsuits are:

• Boehringer Ingelheim Pharmaceuticals, Inc.

• Sanofi Aventis, S.A./Sanofi-U.S. Services, Inc.

• Chattem, Inc.

• Pfizer, Inc.

• GlaxoSmithKline, Inc.

Specific Cases:

Joseph John Balisteri

Mr. Balisteri began using OTC Zantac in 2000 and continued using the 150mg variety 2-3 times a week until 2019.  In November 2018, he was diagnosed with bladder cancer, a condition associated with NDMA contamination.  After learning about the recall and his cancer diagnosis, he filed suit in California in November 2019.

Walter H. Hansen

Walter Hansen, a resident of Solano County, California, began taking OTC Zantac in 2010 and used the 150mg dosage at least once a day through 2019.  In 2017, he was diagnosed with colorectal cancer, which later spread into his liver and lungs.  These are all cancer vectors associated with NDMA contamination.  He filed suit in California in October 2019.

Cases similar to those filed by Mr. Hansen and Mr. Balisteri have now been filed all over the United States and in 2020 were consolidated into a single multidistrict litigation (MDL) taking place in federal court in Florida (MDL-2924).  Judge Robin L. Rosenberg of the Southern District of Florida (West Palm Beach) is presiding over the MDL and new cases are being added at this time.

Joining a Zantac Lawsuit

If you believe that your cancer diagnosis – in particular: liver, bladder, stomach, intestinal, colorectal or esophageal; was the result of taking Zantac or generic ranitidine, and are interested in participating in a lawsuit seeking damages, you and your lawyer will need to establish a few preliminary facts as part of a claim. Specifically:

• That You Took Zantac or Generic Ranitidine.

While this may not sound difficult, in reality, it can be an issue depending upon which type of Zantac you ingested. If you took a prescription Zantac, then those records may be simple to obtain. However, if you took OTC Zantac or ranitidine, you may have to produce receipts and doctor’s notes or similar evidence to establish your identity as a consumer.

• You Have a Cancer Diagnosis.

Although Zantac consumers may suffer from any of a wide variety of cancers, a certain few are generally associated with NDMA contamination, such as liver, bladder, stomach, intestinal, colorectal, or esophageal cancers.

• A Linkage Between Cancer Diagnosis and Use of Zantac or Generic Ranitidine.

If you took Zantac daily for 20 years, it may be easier to establish a linkage between your cancer diagnosis and the medication, than if you only took Zantac periodically for a very short period of time (less than a year).

Regardless of whether you feel you have answers to all of these threshold questions, if you feel you have been harmed then you should take the opportunity to consult with an attorney to learn more about your rights and possible entitlement to compensation for injuries.  Consultations with law offices in these types of matters are free-of-charge and do not oblige you to any further action unless you wish to proceed.

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Sources Cited (22):

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2) “A tiny pharmacy is identifying big problems with common drugs, including Zantac” https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html

3) “FDA Requests Removal of All Ranitidine Products (Zantac) from the Market” https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

4) “Three Plaintiffs File New Zantac Cancer Lawsuits” https://newyork.legalexaminer.com/legal/three-plaintiffs-file-new-zantac-cancer-lawsuits/

5) “Statement alerting patients and health care professionals of NDMA found in samples of ranitidine” https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine#:~:text=NDMA%20is%20classified%20as%20a,%2C%20dairy%20products%2C%20and%20vegetables.

6) “WHAT IS N-NITROSODIMETHYLAMINE?” https://www.atsdr.cdc.gov/toxprofiles/tp141-c1.pdf

7) “Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA)” https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf

8) “N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review” https://superfund.berkeley.edu/pdf/231.pdf

9) “Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)” https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac#:~:text=FDA%20has%20found%20N%2Dnitrosodimethylamine,ranitidine%20they%20may%20currently%20have.

10) “Hansen v. Boehringer Ingelheim Pharmaceuticals, Inc., et al” https://ecf.caed.uscourts.gov/doc1/033111300340

11) “Balisteri v. Boehringer Ingelheim Pharmaceuticals, Inc., et al” https://ecf.cand.uscourts.gov/doc1/035118602775

12) “Our Mission” https://www.valisure.com/about-us/

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14) “The Finding of N‐Nitrosodimethylamine in Common Medicines” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/

15) “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” https://pubmed.ncbi.nlm.nih.gov/26992900/

16) “Zantac, Ranitidine Pulled From Market, Here Are FDA’s Latest Cancer Concerns” https://www.forbes.com/sites/brucelee/2020/04/02/zantac-ranitidine-pulled-from-market-here-are-fdas-latest-cancer-concerns/#e60d6fb2b8c5

17) “Zantac is prescribed 15 million times a year. So how did it become a potential cancer risk?” https://www.usatoday.com/story/news/health/2019/11/07/how-did-zantac-become-potential-cancer-risk-fda-wants-find-out/2509043001/

18) “Popular heartburn drug ranitidine recalled: What you need to know and do” https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911

19) “Ranitidine (Zantac) recall expanded, many questions remain” https://www.health.harvard.edu/blog/ranitidine-zantac-recall-expanded-many-questions-remain-2020040218044

20) “Lab finds NDMA in Zantac can develop during storage” https://www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg

21) “FDA Recalls All Ranitidine (Zantac) Products, Citing Increased Risk of Cancer” https://www.ajmc.com/view/fda-recalls-all-ranitidine-products-zantac-citing-increased-risk-of-cancer

22) “Valisure Detects NDMA in Ranitidine” https://www.valisure.com/blog/valisure-news/detection-of-ndma-in-raniditine/