Overview

It is undeniable that pharmacological innovation has always created a favorable impact on human life expectancy. Drugs and medical devices save the lives of millions of people every year. Pharma businesses around the world have social duties and they fulfill these commitments by investing in illness research drug development.

Pharmaceutical behemoths such as Johnson & Johnson, Pfizer, Merck, Gilead, Amgen, and AbbVie have their headquarters in the U.S which reflects that drug research and marketing is a potential business in the US. However we cannot turn a deaf ear towards the fact that, unethical and illegal actions by some pharma companies endanger public health, costing the government billions of dollars as restitution. We are about to talk about one of them in this blog- Zantac Lawsuits.

Let’s start with some biology and chemistry before getting into the sum and substance of this blog.

What is in a Zantac?

Zantac, with the generic name ranitidine, belongs to the histamine-2 blocker class of medicines. They act as antagonists to the histamine (H2) receptors that mediate gastric secretion in the human body. The active ingredient in Zantac is ranitidine hydrochloride (HCl). Each oral Zantac 150 Tablet contains 168 mg of ranitidine HCl, which is equivalent to 150 mg of ranitidine. In addition to that, it also contains FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin, and yellow iron oxide.

The IUPAC name of ranitidine is [1-({2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulfanyl]ethyl}amino)-2-nitroethenyl](methyl)amine hydrochloride and the chemical formula is C13H22N4O3S. It is available in the form of tablets, injections, and effervescent tablet preparations.

Did you know? The average adult human stomach secretes 1.5 liters of gastric acid every day.

This is not just another fact about the human body. It has something to do with the mechanism of action and the use of Zantac. Gastrin, produced by the stomach lining cells stimulates the histamine release, especially after a meal. Histamine then binds to histamine H2 receptors, leading to the secretion of gastric acid.  Ranitidine acts as a competitive inhibitor to the H2 receptors, thereby inhibiting the binding of histamine. The end reaction of this process is a decrease in gastric acid secretion within around 60 minutes of the intake of the drug.

Zantac has long been used to treat and prevent peptic ulcer disease, Gastroesophageal Reflux Disease (GERD), and Zollinger-Ellison syndrome.  GERD is the condition where the gastric juice flows back into the esophagus. Zollinger-Ellison syndrome is a disorder in which the stomach produces high amounts of gastric acid.

zantac-lawsuits

The Highs and Lows in the ‘Big Drug’ Era

Let’s find out what made the game change? Why and when were Zantac lawsuits filed?

Glaxo Holdings Ltd (GSK or GlaxoSmithKline) was the first Zantac manufacturer in the year 1983. With 15 million prescriptions written each year, it was the 50th most commonly prescribed medicine. Zantac was first approved by the FDA only for short-term use to treat ulcers.

The literature points out two medical studies conducted during that period, which indicated the carcinogenic molecule N- Nitrosodimethylamine (NDMA) in Zantac. In the first study, “Genotoxicity of Nitrosated Ranitidine,” it was found that the acid in stomachs caused the NDMA to appear in rat, mouse, and human livers, which did not occur in fasting test subjects. The results of the second study, “Genotoxic Effects in Rodents Given High Oral Doses of Ranitidine and Sodium Nitrite” were confirming the findings of the first study. It was identified that NDMA had the potential to mutate the cellular DNA of the gastric cells, making them cancerous. However, these studies did not affect the marketing and usage of the drug.

By 1988, Zantac became the world’s best-selling drug to treat ulcers, heartburn, and gastroesophageal reflux disease (GERD). Beyond doubt, Glaxo’s marketing techniques and millions of investments in product promotion had propelled the success of Zantac in the global market. When the company’s patent for the drug was expired in 1997, other pharmaceutical companies also came up with generic alternatives to Zantac. In 2004, companies like Sanofi SA, Johnson & Johnson, Boehringer, and Ingelheim Pharmaceuticals started selling Zantac in the U.S.

The breakthrough, which determined the fate of Zantac, was in September 2019 when Valisure reported to the FDA about the high composition of NDMA in ranitidine products. However, the study did not create much impact as the FDA cited a lack of research existing to recall the drug from the market.

In October 2019, the FDA initiated studies to identify the carcinogenic effects of NDMA. It was identified that ranitidine degrades into NDMA under heat, humidity, and time. In April 2020, the FDA released an official request to stop marketing all the over-the-counter (OTC) ranitidine drugs with an immediate effect. Consumers taking OTC ranitidine should cease taking any tablets or liquid were advised to properly dispose the drug they have and not acquire more. Individuals who prefer to continue treating their disease were recommended to consider using other approved OTC medicines.

Zantac Lawsuits

After the announcement from the FDA regarding the carcinogenic property of NDMA, people who took ranitidine-based Zantac started filing Zantac cancer lawsuits after being diagnosed with cancer. Zantac lawsuits claim that ranitidine, the active molecule in Zantac is highly unstable and the manufacturers did not warn the public about its carcinogenic potential. In Zantac (Ranitidine) Cancer Lawsuits, each plaintiff’s case is distinct. However, to speed the legal process, all of the lawsuits are consolidated into an MDL (multi-district litigation).

As per the data of April 16, 2022,there are 2,100 Zantac cancer lawsuits filed in federal court in the U.S. The actual figure would exceed 75,000.

Do You Qualify for a Zantac Lawsuit?

NDMA is listed as one of the potential compounds with carcinogenic properties by the World Health Organization (WHO). Studies by the Centers for Disease Control and Prevention (CDC) indicates that NDMA is highly carcinogenic even at a low concentration.

NDMA is classified as a group 2A carcinogen by the International Agency for Research on Cancer (IARC). This indicates it’s “probably carcinogenic to humans”.  NDMA has a wide range of negative health impacts. Once ingested, the chemical enters the bloodstream and reaches the organs, inducing organ damage and carcinogenic effects.

Cancers that qualify for Zantac lawsuits are mentioned below.

  • Bladder cancer and bladder removal
  • Breast cancer
  • Ovarian cancer
  • Colon cancer
  • Esophageal cancer
  • Kidney cancer and kidney removal
  • Stomach cancer
  • Liver cancer
  • Melanoma
  • Prostate cancer

The most common cancers among Zantac litigants are breast, colon, and prostate cancer. In Zantac lawsuits, the majority of the physicians who diagnose the plaintiffs with Zantac cancer indicate that there is no family history or genetic indication. They claim that an external carcinogenic substance is involved, which they indicate could be NDMA. Other than cancer, certain other disease conditions like Primary Pulmonary Hypertension (PPH) and Crohn’s disease are also covered under Zantac lawsuits.

Legal Requirements for a Zantac Cancer Lawsuit

The following are the legal necessities to be fulfilled to file a Zantac lawsuit.

  • The illness in the plaintiff should have a direct association with the intake of the drug.
  • The plaintiff should have used the drug for a certain period before receiving a cancer diagnosis. In some states, it should be a minimum of one year.
  • The plaintiff should produce the prescription of the drug.
  • Plaintiffs who had taken the drug over-the-counter should produce receipts or doctor’s statements.
  • Medical records should be presented as evidence of the drug intake and the resulting medical condition.
  • Like any other lawsuit, Zantac lawsuits also have a statute of limitation to file the claim. It may vary between different states. For instance, in Illinois, the plaintiff should file the lawsuit within two years after the diagnosis of cancer.
  • The claim should rule out genetic as well as other causes related to cancer with supporting medical proof.
  • If the damages cannot be substantiated in a court of law, courts will not enable people to file Zantac lawsuits or other proceedings.

Zantac cancer claims have been merged into a multidistrict litigation (MDL) in Case MDL No. 2924 in the United States District Court’s Southern District of Florida. Zantac lawsuits are currently in the consolidated discovery phase, with hundreds of new plaintiffs joining the MDL every week. COVID pandemic had further delayed the legal process.

The two cancer forms with the most vital relationship to NDMA in Zantac are now being identified, based on the scientific evidence linking them to Zantac.

The class action lawsuit filed in California against Zantac makers is the first to have a trial date set. October 10, 2022 is declared as the start date for the bellwether test trials in the California Ranitidine Product Cases JCCP 5150 by the Superior Court of Alameda Judge Evelio Grillo.

The Pretrial Order # 75 was issued on April 15, 2022. The order indicated the modified responsibilities of the Special Master appointed in the Zantac MDL.

The Zantac MDL Judge issued the latest Pretrial Order #77 in May 2022, which established realistic deadlines for summary judgement motions prior to trial. Defense motions must be filed by June 13, 2022, with hearings scheduled on September 20, 2022. The plaintiffs have until July 6 to file their own motions, with hearings scheduled for September 28, 2022.

Illinois, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, and  Washington would also start the Zantac cases before the trial date in California.

Email Deletion by Sanofi

Sanofi has been accused of deleting “massive” employee emails linked to the 2019 recall of the drug. The plaintiff accuses that the deleted emails could have been used as strong evidence for NDMA contamination of Zantac. They argue that the mishandling of the emails relating to Zantac recall “resulted in the delay and/or postponement of many key Sanofi depositions”.

Going through the words of Ashleigh Koss, a US spokeswoman for Sanofi, “Although Sanofi has already provided hundreds of thousands of pages of relevant discovery to the plaintiffs, Sanofi has voluntarily disclosed that certain emails requested by plaintiffs were not preserved as intended. There was no intentional destruction of data. Sanofi is working to obtain as much of the data as possible from alternative sources. This issue has no impact on the strong defenses Sanofi has in this litigation, and the company remains fully confident in the safety of Zantac”.

The plaintiffs wanted to examine the Sanofi IT employee for the alleged email deletions. Magistrate Judge Reinhart granted the motion in May 2022, giving the MDL plaintiffs one hour to examine the IT employee during his deposition.

Settlement from Zantac Lawsuits

Till now, there is no settlement of any pending Zantac lawsuits. Compensation in these lawsuits would cover economic damages, including the past and future medical expenses related to the drug intake, lost wages, loss of consortium, and non-economic damages such as pain & suffering. Funeral expenses may also be covered in Zantac lawsuits involving the death of the victims.

Zantac and generic ranitidine medications are formulated and marketed by different pharmaceutical companies. As a result, a number of separate Zantac lawsuit settlements may occur on different dates. When will the Zantac lawsuit be settled? This is the most frequent query of the plaintiffs in Zantac lawsuits. Expert Zantac lawyers opine that settlement in Zantac lawsuits need not be anticipated for at least a couple of years.

The ranitidine lawsuit settlement amounts may be through global (matrix) settlements or inventory settlements. There would be a matrix of criteria in the global settlement, depending on which the settlement amount would be fixed. The higher the severity of the damages, the higher the settlement amount. The criteria in Zantac lawsuits would be the stage of cancer sustained by the plaintiff, need for surgery, etc.

Under inventory settlement in Zantac lawsuits, each plaintiff would admit to an acceptable settlement called the aggregate minimum. The plaintiff law firm would receive the settlement amount from the defendant to cover all its clients. Experienced lawyers predict that Zantac lawsuits will eventually end up in a global settlement.

The amount of the Zantac settlement will be determined by several factors, including

  1. The number of Zantac litigation pending at the time
  2. The strength of the causation evidence,
  3. The outcomes of the first bellwether ranitidine trials.

Based on the ongoing Zantac lawsuits  the Zantac lawsuit attorneys are expect the claim to be worth more than $10 billion. The speculation is that the plaintiffs can expect to receive Zantac lawsuit settlement amounts anywhere from $20,000 to $400,000, depending upon the severity of the damages sustained.

Is Zantac Back to the Shelf?

Without describing the present state of Zantac in the market, this blog about Zantac lawsuits would be incomplete. You will be distressed to learn that it has returned to the market. Sanofi launched Zantac 360 in April 2021, a new over-the-counter medication that doesn’t carry the same cancer risks. Famotidine is the active ingredient, which is not included in the Zantac recall.

Conclusion

Zantac lawsuit is an active one and most legal experts believe that a large number of Zantac lawsuits will be filed over the following few years.  If Zantac had harmed you or your loved ones, there may be a class action lawsuit for you. There are plentiful law firms currently reviewing Zantac lawsuits brought by victims. The medical records of the victim, if reviewed by an experienced medical record review outsourcing company, would make the claim easy for the attorney.

You may be compensated with a significant financial return for your damages. Even if you are not eligible for a Zantac cancer lawsuit, you may be eligible for a Zantac class-action lawsuit if you have used the drug unaware of the carcinogenic component. Have a case evaluation with an experienced Zantac class action lawyer and join the class action lawsuit. It’s the right time to take on those pharmaceutical magnates who have made a fortune off of your health and lives.