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Zantac Cancer Lawsuits September 2020 Update

Zantac Truck InfographicThousands of Zantac lawsuits will likely be filed over the next few years alleging Zantac causes cancer. Our law firm is currently reviewing Zantac lawsuits brought by former Zantac users diagnosed with cancer.

These suits have just begun. But plaintiffs' lawyers speculate that a settlement of the Zantac class action lawsuit could be worth many billions of dollars. Our attorneys are vigorously investigating these lawsuits. The basis for these suits is based in part on this drawing on your right. The Zantac defendants had opportunities to protect consumers along the way. But they drove through every stop sign. Why? Maximizing profits.

Zantac is a very popular antacid drug that has been around since the 1980s. Millions of people have been using the drug and generic equivalents daily for years for acid reflux. Recent lab testing of ranitidine (the active ingredient in Zantac) found that these pills contain very high levels of a chemical called NDMA. This contaminant is known to cause cancer.

In September 2019, the U.S. Food and Drug Administration issued a public safety warning about possible cancer risks from Zantac. In the wake of the FDA safety warning, there has been a Zantac recall and ranitidine has been abruptly pulled from shelves across the country.

This page talks about what our lawyers expect from these claims and we speculate about their ultimate settlement value.

About Zantac

Zantac (ranitidine) belongs to a family of drugs known as histamine-2 or H2 blockers. Ranitidine and other H2 blockers work by decreasing the amount of acid produced in the stomach. H2 blockers like Zantac are often called "antacids" and the OTC versions are commonly used to treat and prevent heartburn (gastroesophageal reflux disease or GERD). Prescription-strength Zantac is used for the treatment of very severe heartburn and more serious conditions such as stomach/intestinal ulcers and Zollinger-Ellison syndrome.

Zantac was first released as a prescription drug in the U.S. in the early 1980s. Zantac and generic ranitidine were available in both prescription and over-the-counter form. This drug was originally developed and patented by the European pharmaceutical company Glaxo (n/k/a GlaxoSmithKline). It was first approved and released as a prescription drug in the United States in 1983. Glaxo invested millions in aggressively promoting the drug both to doctors and the general public.

Zantac then went on to become one of the best-selling drugs in pharmaceutical history. This medication was the first drug to reach $1 billion in annual U.S. sales. Drugmakers made a fortune. One of the keys to the marketing strategy that made sales of this medicine take off was the emphasis that the drug was worked well - which it did - and was totally safe and harmless. The latter contention proved untrue.

Discovery of NDMA in Zantac

N-Nitrosodimethylamine ("NDMA") is an unstable organic chemical that is usually is created unintentionally as a byproduct of certain industrial processes. NDMA is very toxic to the human body (especially the liver) and it has been recognized as a human carcinogen since the 1970s. Dimethylhydrazine, the "D" in NDMA, is a component of rocket fuel.

The evidence that NDMA causes cancer is overwhelming. No Zantac lawsuit defendant will dispute that this contaminant is a carcinogen. NDMA has repeatedly caused cancer in basically every single animal lab test performed on it over the last 40 years.

NDMA is listed as a potent human carcinogen by the World Health Organization (WHO), the International Agency for Research on Cancer (IARC), the U.S. Environmental Protection Agency (EPA) and various other organizations. The CDC has always pointed out the risks of NDMA even at relatively low doses.

Most recently studies by WHO have definitively linked NDMA to gastric and colorectal cancer. Calling this contaminant a "probable carcinogen" is dramatically understating the case.

Over the years, the presence of NDMA in consumer products has prompted massive safety recalls, both voluntary and at the direction of the FDA. The most recent round of NDMA contamination recalls impacted the popular blood pressure drug, Valsartan. In the summer of 2018, several Chinese manufacturers of generic Valsartan discovered that their drug compounds were contaminated with unsafe levels of NDMA. The NDMA contamination was caused by a change in the manufacturing process and led to a massive recall of generic Valsartan.

The discovery of NDMA in generic Valsartan in 2018 caught the attention of Valisure, a pharmaceutical lab in Connecticut that performs quality testing on consumer drugs. In the spring of 2019, Valisure decided to perform independent testing of various antacid drugs because of prior reports suggesting that they might contain NDMA. The results of this testing came as a shock to many. But is should not have. Ranitidine was suspected back in the 1980s of reacting with nitrite in the stomach to make NDMA.

The Valisure testing found that ranitidine contained levels of NMDA that were off the charts. According to the FDA, the maximum safe level of daily NDMA exposure is 96 nanograms (ng). The Valisure testing found that one OTC Zantac tablet contained 2,511,469 ng of NDMA. This equated to roughly 26,000 times the maximum daily limit of NDMA! Valisure immediately reports its testing results to the FDA in July 2019 in a Citizen Petition. It said in the petition that the formation of NDMA is likely a chemical reaction caused by the inherent instability of the ranitidine molecule.

In September 2019, the FDA announced that it had conducted its own recent tests on ranitidine. The FDA's laboratory tests also found NDMA in ranitidine medications, but at much lower levels than the Valisure tests. (The FDA tests were flawed. They did not use sodium nitrate.) Even the "low levels" of NDMA found in the FDA testing were considered "unacceptable" and led to a public safety warning.

The FDA safety warning prompted an immediate reaction from retailers and manufacturers. CVS, Walgreens, Rite Aid, Walmart, and other major stores have all suspended sales of Zantac and its generic equivalents. Generic manufacturers have also voluntarily recalled their products in response to the FDA warning. The FDA, leading from behind as the often do, finally ordered a Zantac voluntary recall.

Zantac Recalls Infographic
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 strength of claim. 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.

When Will The Zantac Lawsuits Settle?

A global settlement in the Zantac litigation will probably not happen until at least the end of 2022 or later. Big mass tort cases involving thousands of plaintiffs always take a long time to settle. Right now the litigation is in the begging of the consolidated discovery phase, with hundreds of new plaintiffs being added every week.

Do You Qualify For A Zantac Lawsuit?

We are currently accepting new Zantac cases for anyone who meets the following basic criteria:

  • You took Zantac (or another ranitidine product) on a daily or regular basis for a period of 6 months or longer.
  • After taking Zantac you were diagnosed with any of the following cancers: liver cancer, stomach cancer, bladder cancer, intestinal cancer, colorectal cancer, esophageal cancer.

If you meet these criteria you qualify for a Zantac lawsuit and we want to hear from you as soon as possible. FILE A ZANTAC LAWSUIT.

What is the Risk of NDMA in Zantac?

People taking Zantac might have unknowingly been ingesting incredibly high levels of NDMA into their system on a daily basis. Even the lower levels of NDMA found in the FDA testing are alarming high, and much more than the accepted safe daily limits for NDMA. Given the known potential of NDMA to cause cancer in lab animals, Zantac users may be a significantly increased risk of various types of cancers.

NDMA ingestion from the use of Zantac can cause all types of cancer. But there are certain cancers that are specifically linked this cancer causing chemical. These include liver cancer, and cancers involving the gastrointestinal system: stomach cancer, colorectal cancer, and intestinal cancer. Are many more types of cancer involved? Probably. We just do not know yet.

Is There a New Zantac Class Action MDL?

Most legal experts are predicting a mass wave of Zantac lawsuits getting filed over the next few years. There are now 140 cancer cases that have been filed in federal court as of March 2020. We do not have the current number of cases but it would not be a surprise if it was now over 1,000.

Our Zantac lawsuit attorneys believe that these claims are the tip of a gigantic mass-tort iceberg. Zantac and its generic equivalents were widely used. Literally millions of people in the U.S. used over-the-counter ranitidine medicines regularly for heartburn. This means that the size of potential claimants could be larger than any other defective drug cases.

As a result, a group of plaintiffs' lawyers have filed a motion to consolidate all of the pending cases in federal court to a single federal court. As the motion points out, the Zantac cases will "almost certainly dwarf the Valsartan litigation" (another NDMA MDL) because of the "ubiquity of Zantac and because the NDMA in Zantac is not an impurity that only recently made its way into the drug through shoddy manufacturing but is instead inherent to the drug’s molecular structure." This motion was granted in February 2020 and MDL No. 2924 was formed.

What does this mean practically for your Zantac cancer claim? It means individual lawsuits like yours in federal court claim are now consolidated in Florida under Judge Robin L. Rosenberg for coordinated or consolidated pretrial proceedings.

What can we expect from Judge Rosenberg?

We do not know. This is the first MDL for Judge Rosenberg, who was appointment to the bench by President Obama in 2014. We should learn more on March 20, 2020 after the first status conference before Judge Rosenberg, assuming the coronavirus does not cause a cancellation of that court date.

The good news is this MDL class action for pretrial discovery gives the plaintiffs' lawyers a chance to pool our efforts to learn more about what Sanofi and Boehringer knew about NDMAs in Zantac products and how that impacted your cancer risk.

The MDL is moving forward well, with a few hiccups.  Hopefully, these cases will be ready to begin a few test trials in the near future. 

What will you have to do in the MDL?

Not much. You would have to fill out a comprehensive information sheet setting out your medical history. From there, for most victims, you pretty much just wait and hope to get a settlement offer.

Preemption Defense

Drug companies fight back hard when their drugs are under attack, particularly when they are as profitable as things like Zantac. You can expect the drug manufacturers, particularly the generic manufacturers, to argue that there is preemption of any lawsuits because generic drugs have been held by the Supreme Court to be preempted in many cases. Why? The reason is that generic drugs must have a warning that is identical to their brand-name counterpart.

We don't think preemption will be a valid defense in the Zantac cases. Federal preemption is only a valid legal defense when the victims are claiming that the drug was defectively designed. But the Zantac cases are significantly different because they will not involve typical design defect allegations. Rather the primary theory in these cases will be defective manufacture of the drug as opposed to the typical duty to warn theory that lawyers usually pursue in these types of lawsuits.

Discovery against generic manufacturers in this litigation has already begun.

Who Will Be in This Zantac Class Action?

Prospective Zantac plaintiffs will include anyone who used Zantac on a regular basis for any extended period of time and was subsequently diagnosed with cancer. The highest individual payouts in these cases will be those diagnosed with specific types of cancer that are closely linked to NDMA and the gastrointestinal system which the drug impacts. These include

  • Liver cancer
  • Stomach Cancer
  • Bladder Cancer
  • Intestinal Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Breast Cancer

The evidence will also be stronger with prescription Zantac because the history of the use of the drug will be strong.

There is a spate of research now on NDMA and the type of cancer this compound can cause. The Sloane Memorial Cancer Center in particular is expected to come out with research that will narrow down the cancers we are at greatest risk for with NDMA exposure.

Zantac Settlement Value

If you or a family member has gotten cancer from the use of Zantac and are thinking of joining these lawsuits, you naturally want to know what the speculation is have to want to know what the settlement value of these cases might be and the possible range of individual payouts.

Let's start by saying we have no real idea. There has been no pre-trial discovery. The MDL petition was just granted in February 2020. But we can look at other class action lawsuits and speculate and the possible financial compensation victims will receive in these cases if they are successful.

The most natural starting point is the Roundup lawsuits. This is a good comparable because the injury is cancer and liability is hotly contested with good lawyer in those cases just like it will be in these. You can expect these defendants to trot our expert witnesses who will say ranitidine is not harmful just like experts testified passionately defending Roundup. But our feeling is the results may very well be the same.

The Roundup cases have not resolved. But the settlement value of those cases is likely to come in at an average payout of around $500,000. If the ranitidine cases go well, an average settlement in this range would not be surprising.

You might be asking why only a half a million dollars for a cancer wrongful death case. It is a good question. The settlement value of any mass tort cases is always likely to be less than the trial value of the case. The Roundup claims are again a good case in point. The verdicts in those cases have been in the millions. One was $1 billion. But for cases that settle without going to trial, you can expect a lesser amount.

FDA Orders Zantac Off Shelves

In April 2020, after months of mounting evidence that Zantac has been causing cancer, the U.S. Food and Drug Administration ordered that the popular heartburn drug be removed from retail shelves across the country. Of course Zantac had already started disappearing from shelves months before this latest pronouncement from the FDA. In fact, when the news first broke that Zantac contained dangerous levels of NDMA (a notorious human carcinogen) major retailers like Walmart, CVS, Rite Aid and others voluntarily decided to pull the product.

Despite the widespread voluntary removals of Zantac by retailers, the drug was still available by prescription and over the counter at some stores. The recent FDA recall means that now Zantac and other ranitidine products will not be available for new or existing prescriptions or OTC anywhere in the U.S. Back in September 2019, the FDA issued a public safety warning about potential NDMA contamination in Zantac. At that time, however, the FDA did not have adequate information to determine whether a mandatory recall was warranted. Since then the FDA has conducted its own investigation and lab testing which confirmed the alarming results of earlier 3rd party testing. The recent FDA testing found that even under normal storage conditions, the levels of NDMA in Zantac gradually increase over time. The testing found that the older a Zantac product is and the longer its been on the shelf, the greater the level of NDMA. The FDA testing results showed NDMA levels in Zantac well above above the acceptable daily intake limit.

The FDA testing and resulting recall are significant and should pave the way for the building Zantac mass tort litigation. When these cases first started getting filed, there was some question about the credibility of the 3rd party testing that initially found NDMA in Zantac. But now the FDA has done its own independent testing and the results have totally confirmed the initial fears about NDMA in Zantac.

Claim Census Ordered in Zantac MDL

The Federal judge handling the Zatac MDL cases has ordered a 2-part census of all filed and unfiled Zantac cancer claims. There are already thousands of individual plaintiff claims in the Zantac MDL and thousands of additional claims are expected. The Zantac cases have been consolidated into an MDL and assigned to Judge Robin Rosenberg in the Southern District of Florida.

In April 2020, Judge Rosenberg issued an order that will require a 2 tiered census of all the Zantac claims. The initial part of the claim census is designed to give the court an accurate pictue of exactly how many individual cases are in the MDL. This information will be used to help Judge Rosenberg select lawyers with the most clients to serve on the plaintiff leadership committee in the MDL.

The second part of the claim census will require attorneys to submit information on all individual plaintiff claims that are being investigated but have not yet been filed. The second census form will also require plaintiffs with filed cases to provide additional detailed information about their alleged Zantac usage and their physical injuries. This information will be used to help create a broad picture of the scope of alleged usage and injuries. This will eventually form the basis for grouping these individual cases into tiers for purposes of settlement.

Beyond this paperwork, plaintiffs in this litigation simply have to wait and see how these case play out. They have few, if any, other obligations.

Contact Miller & Zois About Zantac Cancer Lawsuits

Our firm is currently evaluating new Zantac cancer cases. If you used Zantac and were diagnosed with cancer, particularly any of the specific cancers listed above, we can give you free legal advice and explain your options to you. Contact our lawyers at 800-553-8082 or fill out this contact form online for a free case evaluation.

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