Zantac: Critical Info for the Public

What is Zantac?

Zantac, a Ranitidine product, belongs to a class of drugs called histamine H2-receptor antagonists (also referred to as H2 blockers). H2 blockers decrease the amount of stomach acid produced. Zantac was the first drug to generate $1 billion in sales.  It commonly used to treat the following symptoms:

• Heartburn
• Stomach Ulcers
• GERD (Gastroesophageal reflux disease)
• Gastric and Duodenal Ulcers
• Sour Stomach,
• Barrett’s Esophagus
• Acid reflux

Zantac/ranitidine has been around since 1976 or 45 years and was a widely prescribed drug.  Over the last few decades, Zantac became a very popular antacid medication to treat such stomach symptoms. About 15,000,000 Zantac/Ranitidine prescriptions were written a year.  Users could either purchase the drug over-the-counter or receive a prescription from their physician.

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Why is Zantac dangerous?

Zantac’s active ingredient, ranitidine HCl, metabolizes into NDMA or N- Nitrosodimethylamine. Since the 1970s, NDMA is a chemical that the FDA and WHO have classified as a (cancer-causing) carcinogen. NDMA acts as a carcinogen by modifying DNA and causing inflammation, resulting in tumor growth and promotion.  NDMA is a bi-product of manufactured rocket fuel.  NDMA is only used to induce tumors in animals as part of laboratory experiments.

For example, in long-term animal studies in mice and rats utilizing different routes of exposure– inhalation, subcutaneous injection, and abdomen injection, cancer was observed in the lung, liver, kidney, nasal cavity, and stomach.

There have been other drugs that NDMA contaminated, but the NDMA in Ranitidine is not caused by any direct contamination like other contaminated drugs.  The ranitidine molecule contains the requisite molecules to form NDMA.  The O=N (Nitroso) on one side of the ranitidine molecule can combine with the H3 C-N-CH3 (DMA) on the other side to form NDMA.

Despite NDMA being labeled as a carcinogen, Zantac remained available for consumer use. The FDA established a 96 ng per day intake limit of NDMA.   NDMA can potentially be discovered in processed foods and beverages such as water, vegetables, whiskey, beer, cured meats, bacon, and cheeses.  However, recent testing of Zantac, using FDA-approved methods, found more than 250 to 3,100 ng of NDMA in a Zantac 150 mg tablet, the dosage countless people take every day. A person would have to smoke over 500 cigarettes to achieve the same levels of NDMA found in one dose of 150 mg Zantac at the 25 nanogram level (over 7,000 cigarettes for the 50 nanogram level.)

Under higher temperatures, Zantac has been able to produce 3,000,000 ng of NDMA per tablet.

After years of being available for public consumption, on April 1, 2020, the FDA ordered manufacturers to remove all Zantac and generic Zantac OTC ranitidine drugs from the market immediately. The FDA determined Zantac’s withdrawal from the market was the most appropriate and necessary action after the FDA discovered through testing that NDMA levels increase in Ranitidine while in regular storage and significantly increase under high temperatures. After it was found that the older the drug, the FDA also decided the higher the level of NDMA.

What is the NDMA Risk?

NDMA is all around us. We’re exposed to it in several ways, but the primary sources of NDMA tend to come from shampoo and cleansers, detergents and pesticides, tobacco, cured meats such as bacon, and fermented foods such as beer and cheese. For example, in bacon, NDMA formation occurs when nitrite preservatives react with amines and amino acids in the meat. This happens when the bacon is cooked. NDMA is classified as a group 2A carcinogen, or “probably carcinogenic to humans,” according to the International Agency for Research on Cancer. This means that there isn’t any direct evidence that the compound causes cancer in humans, but it’s likely that it does because it has caused cancer in animals.

In 2016, researchers at Stanford University experimented on healthy volunteers. First, they measured the NDMA in the urine of healthy individuals over the course of 24 hours. After administering one dose of Ranitidine, they measured the NDMA in the urine of the same individuals for another 24 hours. On average, the level of NDMA increased 400 times, to approximately 47,000 nonograms. The only change during those 24 hours was the consumption of Ranitidine. Researchers directly demonstrated that unsafe levels of NDMA are formed in the human body as a result of ranitidine ingestion. Researchers further explained that humans do not typically excrete NDMA in their urine, so that the observed 47,000 nanograms likely only captured 1/100 of the actual NDMA levels in the human body.

NDMA is itself a tiny molecule. Because it is so little, it freely passes through all areas of the body, including the blood-brain and placental barrier. This is dangerous as Ranitidine has been marketed for pregnant women and young children for years. Before the FDA’s ban on Ranitidine-Containing Drugs, the FDA considered the drug a category for congenital disabilities. This means Ranitidine drugs are considered safe to take during pregnancy. However, in animal experiments, for those animals exposed to NDMA during pregnancy, the offspring tended to develop elevated rates of cancer in the liver and kidneys.

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Zantac Recall

 What are FDA Citizen Petitions?

The FDA is the Food and Drug Administration. It is responsible for protecting public health by enacting measures that ensure the efficacy, safety, security of human, veterinary drugs and biological products, and medical devices. The FDA also ensures the safety of our nation’s food supply, cosmetics, and products that emit radiation.

An FDA citizen petition is a process provided by the FDA for individuals and community organizations to make written requests to the FDA to change its stance on health policy.  Most petitions arise when concerns surround the safety evaluation of substances or good manufacturing practices, new or revised nutrition facts or warning label requirements, or product recalls.

Before the official recall of Zantac and the publicizing of the ill effects of Zantac and its generic counterfeits, several pharmaceutical research laboratories filed a citizen petition with the FDA.

Valisure Pharmacy Lab Findings

Valisure is an online pharmacy that provides consumers with increased safety, quality, and transparency in the medication that it delivers. Valisure created its laboratory to independently check the chemical composition of drugs before they reach consumers. It was working with stakeholders throughout the healthcare and the pharma supply chain.  Valisure became recognized for finding and identifying several medications manufactured in China and India that were contaminated.

In June of  2019, after significant testing on Zantac and other Ranitidine products, Valisure’s lab testing found some Zantac formulas contain more than 3,000,000 ng per tablet of NDMA. Valisure discovered these levels of NDMA after exposing the samples to high-temperatures.

In response, the FDA said that Valisure’s method of high-temperature testing might have increased the levels of NDMA in samples and requested that Valisure do a second test under average temperatures.

Despite the change in temperature when testing, unacceptable levels of the NDMA after “early, limited testing” of the samples using a low-heat method were still found.

On September 13, 2019, Valisure filed a Citizen Petition. They requested a recall of all ranitidine-containing products because of recent developments that such products contained exceedingly high levels of (NDMA). Valisure’s research and that of Stanford University discovered that NDMA resulted from “inherent instability” of the ranitidine molecule. The CEO of Valisure, David Light, stated: “There’s no acceptable cancer risk for a drug like this.”

This meant that all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected. The drugs all have the potential to create very high levels of NDMA in the human body.

As mentioned above, recent testing of Zantac, using FDA-approved methods, found more than 250 to 3,100 ng of NDMA in a Zantac 150 mg tablet, the dosage countless people take every day. A person would have to smoke over 500 cigarettes to achieve the same levels of NDMA found in one dose of 150 mg Zantac at the 25 nanogram level (over 7,000 cigarettes for the 50 nanogram level.) Below were Valisures results:

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Emery Pharma Findings

Emery Pharma is a full-service contract research laboratory organization (CRO) for microbiology, cell biology, analytical chemistry, and medicinal chemistry.

Before the USDA recall, on January 2, 2020, after extensive research and findings, Emery Pharma’s Citizens Position to FDA found that Ranitidine is a time-and temperature-sensitive pharmaceutical product that develops NDMA when exposed to heat, a common occurrence during shipping, handling, and storage.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in Ranitidine even under normal storage conditions. NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

April 2020 Recall

On April 1, 2020, the U.S. Food and Drug Administration (from now on referred to as “USDA”) announced that it ordered manufacturers to withdraw all Zantac and generic Zantac OTC ranitidine drugs from the market effective immediately. The FDA determined that N-Nitrosodimethylamine (NDMA) in some ranitidine medications “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…”

As mentioned earlier, the FDA, the Environmental Protection Agency (EPA), and the World Health Organization (WHO) all classify NDMA as a cancer-causing substance.

What does this recall mean?

• All Zantac and ranitidine products are recalled and removed from the U.S. market.
• Products recalled present severe and deadly health risks.
• There has been significant testing to show that in some ranitidine stored at room temperature, NDMA levels can increase to unacceptable levels.

• Over 41 countries have recalled Zantac.

To read more about the April 2020 recall, visit the link below at FDA.gov

https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

Should You Keep Taking Zantac?

The FDA was not recommending people stop taking all ranitidine medications. Instead, according to the agency, people taking over-the-counter Ranitidine could consider using other OTC medicines approved for their condition.  Patients taking prescription Ranitidine should speak with their health care professional about other treatment options before stopping the medication. Multiple drugs are approved for the same or similar uses as Ranitidine without carrying the same risks from NDMA.

December 2020 Study by Organic Process Research & Development

In December 2020, a study was published that gave consumers a clearer picture of what happened with Zantac and NDMA.  The study linked increasing NDMA levels to the degradation of hydrochloride molecules in Zantac.  It provided credibility to the theory that heat that is created when ingesting the drug might contribute to the process that increases the NDMA levels.

Are all heartburn medications cancer-causing?

The FDA reports that early tests of alternatives to Zantac such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec have not been found to contain NDMA.

Why Are These Studies Important?

Bigger picture, the study demonstrates that the medical litigation on the association between Ranitidine and Zantac continues to support plaintiffs’ lawyers’ theories of liability in the Zantac litigation.

Furthermore, millions of Americans use Zantac and ranitidine drugs for both short-term and long-term heartburn issues, and it’s estimated that doctors write over 15 million prescriptions for Zantac each year. As the lawsuits and recalls for Zantac continue to grow, injury victims must hold pharmaceutical companies accountable for failing to identify and prevent dangerous drug defects.

Who Manufactured Zantac and Ranitidine Drugs?

 The following manufacturers manufactured Zantac and other active ranitidine drugs:

• GlaxoSmithKline
• Pfizer
• Boehringer Ingelheim
• Sanofi
• Sandoz Inc.
• American Health Packaging
• Mylan N.V.
• Denton Pharma, Inc.
• Appco Pharma LLC
• Glenmark Pharmaceuticals, Inc.
• Precision Dose, Inc.
• Apotex Corp.
• GSMS, Inc.
• Aurobindo Pharma USA, Inc.

Furthermore, the following have also been sued in lawsuits on this drug:

• Generic Manufacturers
• Wholesalers/Distributors
• Pharmacies/Retailers (CVS, Walmart)

Common Zantac Brands

Below are some of the most common Zantac brands and generic ranitidine brand names:

• Zantac 150 Tablets
• Zantac 150 Maximum Strength
• Zantac 150 Maximum Strength Cool Mint
• Zantac 75 Tablets
• Wal-Zan 150
• Wal-Zan 75
• Heartburn Relief (Ranitidine)
• Acid Reducer (Ranitidine)
• Acid Control (ranitidine)

Zantac’s Connection with Cancer

Unfortunately, Zantac and other ranitidine drugs have been linked to cancer. Cancer is the primary injury resulting from the use of Zantac and other ranitidine drugs. Those seeking to pursue a legal claim against Zantac have to diagnose a type of cancer linked to NDMA. The following are the list of cancers related to NDMA in claims:

• Bladder cancer
• Breast cancer (No familial history or BRCA gene)
• Colon, rectal cancer, or colorectal cancer
• Esophageal cancer (Not throat cancer) (No Achalasia as pre-existing)
• Intestinal cancer
• Gastric cancer (No H. Pylori as pre-existing)
• Kidney cancer (No Hep B or C as pre-existing)
• Liver cancer (No Hep B or C as pre-existing)
• Lung cancer (If primary cancer, must not have a history of smoking for at least 20 years before the lung cancer diagnosis)
• Pancreatic cancer
• Prostate cancer (Under age 69 at time of diagnosis)
• Stomach cancer (No H. Pylori as a pre-existing condition)

* Please see the chart of symptoms and related cancers on the following pages.

Furthermore, generally, taking higher medication doses play a large part in connecting the cancer diagnosis with the medication. The length of time someone has used the drug also impacts a client’s case. Many have suggested that the person has taken the drug for at least a year before receiving a cancer diagnosis.

Additionally, those diagnosed with cancer after taking Zantac were frequently diagnosed with primary pulmonary hypertension (PPH) and Crohn’s disease.

 

What are the Symptoms Associated with These Cancers?

CANCER	SYMPTOMS
Liver Cancer	●      Liver failure or reduced liver function ●      Enlarged liver ●      Impaired liver function ●      Jaundice	●      No appetite ●      Fever ●      Fatigue
Bladder/Gallbladder Cancer	●      Jaundice ●      No appetite	●      Fever
Kidney Cancer	●      Impaired kidney function ●      Interstitial nephritis (Kidney Inflammation) ●      No appetite	●      Fatigue ●      Anemia ●      Angioedema (swelling)
Gastric Cancer	●      Jaundice ●      Nausea and vomiting	●      Stomach cramps ●      No appetite
Esophageal Cancer	●      Difficulty and pain with swallowing ●      Pressure or burning in the chest ●      Indigestion or heartburn ●      Vomiting	●      Frequent choking on food ●      Unexplained weight loss ●      Coughing or hoarseness ●      Pain in the breastbone or the throat
Stomach Cancer	●      Nausea and vomiting ●      No appetite ●      Constipation ●      Diarrhea	●      Weakness ●      Fatigue ●      Stomach cramps
Colon Cancer	●      Weakness ●      Fatigue ●      No appetite	●      Stomach cramps
Colorectal Cancer	●      Clay-colored stools ●      Weakness ●      Fatigue	●      Stomach cramps ●      No appetite
Intestinal Cancer	●      Clay-colored stools ●      Weakness ●      Fatigue	●      Stomach cramps ●      No appetite
Anal Cancer	●      Bleeding from the anus or rectum ●      Pain in the area of the anus	●      Anal itching ●      A mass or growth in the anal canal
Testicular Cancer	●      A painless lump or swelling on either testicle. ●      Pain, discomfort, or numbness in a testicle or the scrotum, with or without swelling. ●      Change in the way a testicle feels or a feeling of heaviness in the scrotum. ●      A dull ache in the lower abdomen or groin	●      Tender breasts ●      Lower back pain, ●      shortness of breath, ●      chest pain, and ●      bloody sputum or phlegm ●      Swelling of 1 or both legs or shortness of breath from a blood clot ●      Sudden buildup of fluid in the scrotum
Pancreatic Cancer	●      Inflamed pancreas ●      Abdominal pain ●      No appetite	●      Fatigue ●      Jaundice
Blood Cancer	●      Vitamin B-12 deficiency ●      Reduced platelet levels ●      Hemolytic anemia (red blood cells are being destroyed more quickly than they can be restored) ●      Pancytopenia (low red, white, and platelet levels)	●      Low levels of neutrophils and/or granulocytes (types of white blood cells) ●      Blood vessel inflammation ●      Fever ●      Weakness ●      Fatigue
Lung Cancer (non-smokers)	●      Impaired lung function ●      Coughing up blood ●      Chest pain or discomfort ●      Trouble breathing ●      Wheezing ●      Recurrent lung infections, including pneumonia	●      Hoarseness ●      Loss of appetite ●      Weight loss for no reason ●      Fatigue ●      Trouble swallowing ●      Swelling in the face and/or the neck
Breast Cancer	●      New lump in the breast or underarm (armpit). ●      Thickening or swelling of part of the breast. ●      Irritation or dimpling of breast skin. ●      Redness or flaky skin in the nipple area or the breast.	●      Pulling in of the nipple or pain in the nipple area. ●      Nipple discharge other than breast milk, including blood. ●      Any change in the size or the shape of the breast. ●      Pain in any area of the breast.
Ovarian Cancer	●      Abdominal bloating or swelling ●      Quickly feeling full when eating ●      Weight loss	●      Discomfort in the pelvis area ●      Changes in bowel habits, such as constipation ●      A frequent need to urinate
Prostate Cancer	●      Trouble urinating ●      Decreased force in the stream of urine ●      Blood in the urine ●      Blood in the semen	●      Bone pain ●      Losing weight without trying ●      Erectile dysfunction
Thyroid Cancer	●      A lump in the front of the neck, near the Adam’s apple ●      Hoarseness ●      Swollen glands in the neck ●      Difficulty swallowing	●      Difficulty breathing ●      Pain in the throat or neck ●      A cough that persists and is not caused by a cold
Uterine cancer	●      unusual vaginal discharge, which can be foul-smelling, pus-like or blood-tinged ●      pain during intercourse ●      pelvic pain or pressure ●      pain or feeling of tension in the pelvis, lower abdomen, back, or legs ●      pain during urination, difficult urination, or blood in the urine	●      pain during bowel movements, difficult bowel movements, or blood in the stool ●      bleeding from the bladder or rectum ●      buildup of fluid in the abdomen (called ascites) or in the legs (called lymphedema) ●      weight loss ●      lack of appetite ●      difficulty breathing

Zantac Recall List

ZANTAC  RECALL LIST
Recall Date	Brand Name	Recalled Product	Company
02/27/2020	American Health Packaging	Ranitidine Tablets, USP 150mg	American Health Packaging
01/08/2020	Mylan Pharmaceuticals Inc.	Nizatidine Capsule 150 mg and 300mg (similar to Ranitidine)	Mylan N.V.
01/08/2020	Northwind	Ranitidine Tablets, USP 150mg and 300 mg	Denton Pharma, Inc. dba Northwind Pharmaceuticals
01/07/2020	ANI Pharmaceuticals	Ranitidine Tablets, USP 150mg and 300 mg	Appco Pharma LLC
12/17/2019	Glenmark	Ranitidine Tablets, USP 150mg and 300 mg	Glenmark Pharmaceuticals, Inc.
11/22/2019	Amneal	Ranitidine Tablets, USP 150mg, and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/ml	Amneal Pharmaceuticals, LLC
11/19/2019	Precision Dose	Ranitidine Oral Solution, USP 150 mg/10mL	Precision Dose Inc.
09/25/2019	Apotex Corp.	Ranitidine Tablets 75 mg and 150mg	Apotex Corp
09/23/2019	Sandoz Inc.	Ranitidine Hydrochloride Capsules	Sandoz Inc.
11/15/2019	GMS Incorporated	Ranitidine HCl 150mg and 300mg Capsules	GSMS, Inc.
11/08/2019	AHP	Ranitidine Liquid Unit Dose Cups	American Health Packaging
11/06/2019	Aurobindo & D.G. Health	Ranitidine	Aurobindo Pharma USA, Inc.
10/25/209	Novitium Pharma	Ranitidine Hydrochloride Capsules 150mg and 300mg	Novitium Pharma
10/25/2019	Lannett Company, Inc.	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL	Lannett Company, Inc.
10/23/2019	Dr. Reddy’s, Kroger, Walgreens, and others	Ranitidine Tablets & Capsules	Dr. Reddy’s Laboratories Ltd.
10/23/2019	Sanofi	Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products)	Sanofi
10/23/2019	Perrigo Company  plc	Ranitidine (all pack  sizes)	Perrigo Company plc

 

Who are the Defendants in the Zantac lawsuit?

GlaxoSmithKline is, of course, the main defendant.  But you would be stunned at the number of defendants in Zantac litigation.  Why?  Because plaintiffs’ lawyers are bringing claims against retailers and pharmacies.  So the defendants include:

• Albertsons Companies
• com
• B.J.’s Wholesale Club Holdings
• Costco
• CVS Pharmacy, Inc.
• Dolgencorp
• Dollar Tree/Family Dollar
• Duane Reade
• Express Scripts
• Giant Eagle
• Grocery Outlet
• HEB
• Humana Pharmacy
• Hy-Vee
• Kaiser
• Kmart
• Kroger
• Medicine Shoppe International
• OptumRx
• Price Chopper
• Publix Super Markets
• Rite Aid
• Safeway
• Sam’s Club
• ShopRite Supermarkets
• Southeastern Grocers
• Target
• Vitamin Shoppe Industries
• Vons Companies
• Walgreen Co.
• Walgreens Boot Alliance
• Walmart
• Wakefern Food
• Winn-Dixie Stores
• Wholesale Corporation

We have 50,000 claimants and counting.  Glaxo’s net worth is $100 billion. Some plaintiffs used generic Ranitidine.  So plaintiffs’ lawyers want to hold every entity in the supply chain accountable for the harm Zantac has caused.

Why are supply chain companies and retailers named Defendants?

Emery’s Citizen Petition outlined its substantial concern that Ranitidine is a time- and temperature-sensitive pharmaceutical product that develops NDMA when exposed to heat. However, because the pharmaceutical companies failed to disclose such information, ranitidine drugs were exposed to heat, as it is a common occurrence during the shipping, handling, and storage process. NDMA accumulated in the ranitidine products at unsafe rates when exposed to heat levels that would commonly occur during transportation and drug storage.

What are my chances of developing cancer if I have taken Zantac?

NDMA exposure has been linked to several cancers, including tongue, esophagus, lung, pancreas, liver, kidney, and bladder cancers. Any concerns about cancer from Zantac should be addressed with your primary physician.  It is important to note that there is no exact formula to determine your risk of cancer.

Recently, animal testing has discovered that the higher doses and the longer exposures to NDMA increase the risk of animals getting cancer. In lab rodents, life expectancy decreased, survival rates fell, and liver tumors were more persistently found.

What will happen to Zantac?

Tens of thousands of Zantac lawsuits will likely be filed over the next few years alleging Zantac causes cancer. Our firm is currently taking Zantac cancer cases.

As of recently, Zantac and other related ranitidine suits are moving forward quickly.  Many lawyers suspect that a settlement of the Zantac lawsuit could be worth many billions of dollars.

How Much Will Zantac Cases Be Worth?

The Zantac litigation will most likely be resolved with a global settlement of all cases. The cases will be ranked into settlement tiers based on the severity of the plaintiff’s injuries and the strength of the claim. The following are the expected tiers for the settlement:

• Cases in the top tier could be worth around $500,000.
• Second-tier cases may be in the $250,000 range.
• The lowest tier cases will likely be worth $100,000 or less.

Again, this is just an estimate. Attorneys in the Zantac litigation cannot determine at this moment what would be a person’s compensation. It also assumes, as our lawyers believe, that this litigation will be very successful.

When Will The Zantac Lawsuits Settle?

A global settlement in the Zantac litigation will probably not happen soon. Significant mass tort cases involving thousands of plaintiffs always take a long time to settle. Right now, the litigation is at the beginning of the consolidated discovery phase, with hundreds of new plaintiffs every week.  The excellent news is Zantac is off-the-market. This helps facilitate a more speedy settlement.

What is the key to global Zantac settlement?

The most crucial goal of handling these Zantac mass tort litigation cases is getting them to trial.

How close are we to that goal?

On January 15, 2021, lawyers representing Zantac victims in California filed a motion to remove these cases to state court because the victims also sued California defendants, which usually defeats federal court jurisdiction.  Having these cases in California state court would give Zantac lawyers another opportunity and perhaps a better chance to push these cases to trial.  The sooner we get trial dates, the greater the likelihood of getting to a global settlement.

Do You Qualify For A Zantac Lawsuit?

Based on previous plaintiffs, Zantac cases for anyone who meets the following essential criteria:

• You took Zantac (or another ranitidine product) on a daily or regular basis for at least six months.
• S. Residency and used Zantac (Ranitidine) in the United States
• Used the following drugs:
  • Zantac Prescription,
  • Zantac over the counter,
  • Ranitidine/Generic version?
• Did not primarily use Ranitidine (Zantac) in or live in Kentucky, Louisiana, Michigan, Tennessee, Puerto Rico.
• Used Zantac from 2006 to the present, we may not be able to obtain your medical records if you used Zantac before 2006 unless you were seen at a research hospital or if you have a copy of your medical records or can obtain them.
• Was diagnosed with qualifying cancer at least one year after the date of first use or up to 10 years from the date of last use.
• After taking Zantac, you were diagnosed with any of the following cancers:
  • Bladder cancer
  • Breast cancer (No familial history or BRCA gene)
  • Colon, rectal cancer, or colorectal cancer
  • Esophageal cancer (Not throat cancer) (No Achalasia as pre-existing)
  • Intestinal cancer
  • Gastric cancer (No H. Pylori as pre-existing)
  • Kidney cancer (No Hep B or C as pre-existing)
  • Liver cancer (No Hep B or C as pre-existing)
  • Lung cancer (If primary cancer, must not have a history of smoking for at least 20 years before lung cancer diagnosis)
  • Pancreatic cancer
  • Prostate cancer (Under age 69 at time of diagnosis)
  • Stomach cancer (No H. Pylori as a pre-existing condition)

Is There a New Zantac Class Action MDL?

As with many other multi-district litigations or mass tort litigation, it is unsurprising that many legal experts are predicting a mass wave of Zantac lawsuits getting filed over the next few years.

Numerous cancer cases have been filed in federal court. The exact current cases are unknown, but it is expected to be over 50,000. However, this is likely only the beginning, and there are many more cases to follow because Zantac and its generic equivalents were widely used. Fifteen million people annually in the U.S. used over-the-counter ranitidine medicines regularly for heartburn. This means that the size of potential claimants could be more extensive than any other defective drug cases.

As a result, a group of lawyers representing Zantac victims has filed a motion to consolidate all pending cases in federal court to a single federal court. This motion was granted in February 2020, and MDL No. 2924 was formed.

What does this mean practically for Zantac cancer claims?

In federal court, it means all the individual claimants are now consolidated in Florida under Judge Robin L. Rosenberg for coordinated or consolidated pretrial proceedings.

This also means that  MDL class action for pretrial discovery gives the plaintiffs’ lawyers a chance to pool their efforts to learn more about what the creators and manufacturers knew about NDMAs in Zantac products and how that impacted a person’s cancer risk.  The plaintiff’s lawyers may team up to each handle a part of the litigation, such as discovery, reviewing advertisements, deposing past employees, deposing experts, reviewing emails, etc.

What is the current status of the MDL case in Florida?

In two recent rulings, U.S. District Court Judge Robin L Rosenberg dismissed a series of claims against Zantac defendants based on federal pre-emption. Essentially, preemption is a doctrine that shields drug manufacturers from liability in some instances where they followed the FDA requirements for an approved drug or medication.

In Judge Rosenberg’s rulings, she held that pre-emption blocks liability against both name-brand and generic manufacturers for labeling claims brought by injured plaintiffs. Preemption protects defendants because the defendants cannot alter brand-name drug labels or designs that have been approved by the U.S. Food and Drug Administration.

Judge Rosenberg stated, “a claim based on allegations that a generic drug’s labeling renders the drug misbranded is a preempted claim because the drug’s manufacturer cannot independently and lawfully change FDA approved labeling. Likewise, a claim based on an allegation that a generic drug’s formulation renders the drug misbranded is a preempted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA has approved.” Judge Rosenberg rejected plaintiffs’ arguments that claims should not be preempted because of misbranding as NDMA was not disclosed by the drugmaker.

State Lawsuits for High NDMA Levels

There are cases also pending in state court. Some cases have been filed in state courts throughout the country. A large percentage of these state court cases were filed in California courts. Currently, there are 40 pending cases in the state of California. The plaintiffs are seeking to merge their cases in California in a manner similar to multidistrict litigation.

The number of additional lawsuits being filed reveals the dangers of Zantac and how the risks may be far more significant than initially thought. In one of the pending California cases,  a woman claims that taking Zantac while pregnant caused her son to develop testicular cancer as an eight-year-old child. The new lawsuits are alleging a wide range of cancers traced back to the use of Zantac. Stomach cancer, liver cancer, bladder cancer, and kidney cancer are a few of the named cancers in these suits.

Ranitidine Drugs Lawsuits May Grow Larger

There is still research being performed about the exact effects of Zantac. The FDA recall just occurred within the past year, so we are still learning about the dangers of Zantac. Besides, many of the Zantac cases are still being filed.

The Zantac litigation still has the potential to become a multi-billion dollar lawsuit. Based on the FDA’s estimates, one in every 8,000 people who took the maximum dosage of Zantac may develop cancer. Of course, the FDA has a history of understating the dangers of Zantac, and its initial attempt to minimize the damage did not accurately depict the extent of the contamination. Private testing has shown that the contamination is much higher than the public was initially told.

What Will Zantac Victims Have to Do to be Included in the MDL?

It’ll be important for victims to fill out a comprehensive information sheet setting out their medical history.

Why are mass tort cases, like Zantac cases, so challenging to resolve?

There are two reasons why mass tort litigation cases are often so difficult to resolve.

First, there are several factual and legal issues raised by latent injuries.

Secondly, it is pretty difficult to establish direct causation for latent injuries. The scientific research and evidence of a causal link between product use or exposure and the harm claimed are uncertain. Some obstacles arise from how judges and juries will respond to and evaluate whatever scientific evidence is available. Additionally, plaintiffs’ attorneys must establish that the defendants are legally responsible for the plaintiffs’ injuries.

How will the Zantac settlements work?

 Negotiations

Mass tort cases such as Zantac resolve through either: (1) global settlements or (2) inventory settlements.

Global (or matrix) settlements

A global settlement is a dollar amount that covers all the outstanding claims. In the Zantac litigation, there may very well be tens of thousands of shares. There is also a “matrix” of criteria to decide which plaintiff gets how much.

For instance, stage 1 cancer patients who get cured may receive less than stage 4 cancer patients who are terminal. And people who had one surgery may receive less than people who had multiple surgeries.

Therefore, each settlement may depend on how injured you were.

 Inventory settlements

With inventory settlements, plaintiffs’ law firms evaluate their cases individually. (Most plaintiffs’ firms have multiple Zantac clients.)

Each plaintiff agrees to an acceptable settlement amount. Then the plaintiffs’ firm adds together each client’s good minimum. This is called the aggregate minimum.

The defense attorneys offer each plaintiffs’ firm a settlement to cover all its clients. If a plaintiffs’ firm scores a larger payment than the aggregate minimum, each client will get a percentage of the extra money.

Ultimately up to each plaintiff to accept or reject the settlement.

Attorney Compensation

The standard legal fee for plaintiffs’ attorneys is 40% plus expenses. In mass tort cases like Zantac with thousands of plaintiffs, “expenses” tend to be minimal as multiple firms share litigation costs.  If plaintiffs were to bring individual cases, the expenses may be very high as only that plaintiff would be shouldering all the litigation costs.

So if a plaintiff gets a $100,000 settlement, the plaintiff can expect to receive close to $60,000 (60% of the total).

An attorney’s retainer agreement spells out all the terms of the legal fee.

People are advised never to hire an attorney who charges a fee upfront. People are also advised never to hire an attorney who charges a fee if he/she loses the case.

What if I do not agree to a settlement?

For plaintiffs who do not wish or agree to take the settlement offers, such plaintiffs may take the case to trial. However, as with any case, there is no guarantee the plaintiff will win at trial. If the plaintiff does win at trial, there is no guarantee the court will award more than the settlement amount.

Ultimately, plaintiffs should always discuss with their attorneys whether a settlement is fair or not and their chances of success at trial. A plaintiff should never feel pressured to accept a payment.