A Delaware Superior Court Judge has allowed roughly 75,000 plaintiffs to be heard in Delaware courts regarding whether the drug Zantac caused cancer. This is a massive turn of events, as nearly 50,000 similar lawsuits were dismissed in federal courts just two years ago. In 2022, the federal judge in the multidistrict litigation in Florida determined that the expert witness reports and testimony were not based on adequate science. Judge Medinilla, by contrast, ruled that the expert testimony should be heard in court with regard to the causation between Zantac and cancer. Ultimately, she determined that the strength of each side’s scientific arguments should be heard and considered by juries. History of Zantac Regulation and Litigation The heartburn medication commonly known as Zantac has been available on the market for decades, and was once one of the world’s top selling drugs. It is used to treat many gastrointestinal disorders including heartburn, duodenal ulcers, gastroesophageal reflux disease, and esophagitis. Zantac is known to contain an active ingredient called ranitidine. This molecule has been shown to degrade into NDMA (N-Nitrosodimethylamine) over time and when exposed to heat. NDMA is a known carcinogen. In 2019, certain manufacturers and pharmacies stopped selling Zantac after NDMA was detected in a number of pills. Lawsuits began to pile up after this news began to spread, as plaintiffs argued that drug companies should have known that ranitidine was linked to cancer. These plaintiffs argued that companies failed to properly warn consumers about the risks of taking Zantac. In 2020, the FDA called for manufacturers and suppliers to remove the drug from the market. The injured parties are seeking compensation from former Zantac manufacturers, including GlaxoSmithKline, Pfizer, Sanofi, and Boehringer Ingelheim. Following Judge Medinilla’s ruling, these companies decided to appeal the decision, arguing that there is no reliable scientific evidence to prove that Zantac causes cancer.

The Zantac litigation initially included ten various types of cancers but has since been reduced to five: bladder, liver, esophageal, gastric, and pancreatic. Studies suggest that these cancers have the most clear linkage to Zantac usage. For more information on the specific cancers involved with this litigation, you can check out Attorney Clay Hodges’ previous Zantac post on this website. What this Decision Means For You

The drug companies have been successful in fighting these civil lawsuits over the past few years. Recently, these companies filed a motion to exclude expert testimony, and this motion was denied by Judge Medinilla. This means that plaintiffs’ experts will be permitted to present their findings to a jury, which had been denied the plaintiffs in the federal court Zantac MDL. You can read Judge Medinilla’s (lengthy) court order here. For the plaintiffs who developed certain cancers after takign Zantac for months or years, this is welcome news, particularly after the setback in the federal court MDL. Judge Medinilla currently presides over roughly 75,000 cases, with 4,000 cases also appearing in California state courts, and 2,000 cases in other state courts across the country. This ruling allows for more cases to be filed by new plaintiffs as well. If you or a loved one have been diagnosed with cancer following prolonged use of Zantac, you may now have a pathway to pursue legal action against the drug companies. First and foremost, please make sure to take care of your health and seek medical assistance. If you are interested in taking the time to discuss your legal options, now is a great time to do so. Please feel free to contact Attorney Clay Hodges at (919) 830-5602 for a discussion about your options..

In any product liability litigation, the injured person must ultimately prove that the injury was caused by the defective product (legal causation). A relatively easy example is when a lamp explodes and burns an individual, and in the post-explosion investigation the plaintiff discovers the lamp’s wiring was faulty and unreasonably dangerous. In the Zantac (ranitidine) multi-district litigation (MDL), thousands of plaintiffs have come forward alleging that use of the heartburn medication caused their various cancers. I discussed how Zantac is alleged to cause cancer in previous posts. You can start here if interested. In a nutshell, however, studies have shown that Zantac may contain potentially dangerous levels of NDMA (N-Nitrosodimethylamine), which is a likely carcinogen in humans.

There are several ways that NDMA is thought to be present in Zantac medication, which you can read about here. The larger point is simple: you do not want to ingest NDMA, and you certainly do not want to ingest large amounts of NDMA, especially for months or years. Remember, millions of people have taken Zantac or the generic ranitidine, some for many years, so the potential consumer-health risk is widespread. Zantac has been recalled.

Because these studies link Zantac to NDMA, plaintiffs who used Zantac and later developed one of several cancers (reasonably) came forward and filed lawsuits against the manufacturers of Zantac. The original Master Complaint listed at least sixteen different cancers, with indications that the list was not exhaustive.

Zantac Plaintiffs Have Filed Expert Reports on Five Cancers

On January 25, 2022, however, the Plaintiffs’ Leadership in the Zantac MDL filed disclosures with the Court indicating that the plaintiffs would provide general causation expert reports focused on five cancers: bladder, esophageal, gastric, liver, and pancreatic. Remember, the plaintiffs must have credible expert opinions on the link between a medication like Zantac and its likelihood of causing certain cancers. At this point it appears the plaintiffs’ experts will be able to make a viable connection between the use of Zantac and the onset of the above five cancers. If you have one of these cancers and you also took Zantac for a period of time prior to your cancer diagnosis, you should call me immediately ((919) 830-5602) to discuss your legal options.

The next step in the litigation is for both sides to take depositions of all experts providing reports in the litigation, and following that, the Court will hold hearings on the science supporting the expert reports (known as Daubert hearings). If the Court upholds the scientific viability of the plaintiffs’ experts, the cases will move closer to jury trials.

But What if I Have Been Diagnosed with a Different Cancer?

It’s a good question. At this point you will not be able to pursue your claim against the makers of Zantac in the Zantac MDL. Plaintiffs’ lawyers are still investigating the link between Zantac-use and other cancers, as well as looking for other possible venues to bring claims for those who suffered a different cancer than those five listed above. However, it bears repeating that an expert opinion is required for any successful product liability lawsuit.

If you have taken Zantac for a period of time and were subsequently diagnosed with bladder cancer, esophageal cancer, gastric cancer, liver cancer, or pancreatic cancer, it’s possible that your cancer was the result of your taking Zantac. Call me to discuss, and either way, good luck.

Note: The information contained in this post was developed from publicly available information, including court filings and media reports.

After news broke that Zantac (the brand name for ranitidine) was linked to cancer, a large wave of lawsuits started making their way into state and federal courts. Many of these cases have been consolidated into the Zantac multi-district litigation, or MDL 2924.

The Zantac MDL is still in the early stages of litigation, but the court just handed down two major decisions that could dramatically undermine a majority of the cases and claims.

We’ll go over these two decisions, but before we do, we need to provide a little context. We’ll start with outlining the defendants and claims in the Zantac MDL, then discuss a legal concept called “preemption.”

The Defendants in the Zantac MDL

There are five main groups of defendants in the Zantac MDL:

• Brand-Name Manufacturers of Zantac
• Generic Manufacturers of Ranitidine
• Distributors of Ranitidine Products
• Retailers of Ranitidine Products
• Repackagers of Ranitidine Products

To learn more about each of these defendants, you can check out my blog post, Zantac Litigation Master Complaint Key Points, Part 1: The Parties Involved.

The Allegations in the Zantac MDL

The plaintiffs in the Zantac MDL set out their allegations in the following three master complaints:

• Master Personal Injury Complaint (MPIC)
• Consolidated Consumer Class Action Complaint (CCCAC)
• Consolidated Third Party Payor Class Complaint (CTPPCC)

There is a fair amount of overlap concerning the overall gist of the allegations in these complaints. Causes of action among the complaints include various strict products liability claims, as well as claims relating to negligence, breach of warranties, violations of consumer-protection laws, violation of the Magnuson-Moss Warranty Act, and derivative claims (like loss of consortium and wrongful death).

The MPIC and CCCAC include both the generic manufacturers and repackagers of ranitidine as defendants. The CTPPCC includes generic manufacturers of ranitidine as defendants, but not repackagers of ranitidine.

After these complaints were filed, the generic manufacturer and repackager defendants (collectively, Generic Defendants) filed a motion to dismiss and the retailer and distributor defendants (collectively, Retailer Defendants) filed two motions to dismiss.

On December 31, 2020, the Zantac MDL court granted the Generic and Retailer Defendants’ motions to dismiss based largely on preemption grounds. These rulings have the potential to undermine and even end a majority of the Zantac MDL plaintiffs’ claims. But what is preemption and why does it matter?

Preemption and Why It’s Kind of a Big Deal in the Zantac MDL

Preemption is the legal principle that says federal law is the supreme law of the land. In other words, when federal law conflicts with state law, federal law wins (or “controls”). Preemption sometimes comes into play when plaintiffs sue generic drug makers (and related parties, like repackagers) for injuries from their products.

Most medicines and drugs sold in the United States are subject to regulation by the U.S. Food and Drug Administration (FDA). This includes rules about labeling, safety, effectiveness, when a drug can be sold as a generic and so on. But many personal injury claims involving pharmaceuticals arise from state law.

The FDA has established very specific rules about how generic drug manufacturers can sell a name-brand drug as a generic. After a name-brand drug is approved by the FDA (including how it’s labeled) generic drug companies who want to sell that name-brand drug are limited in what changes they can make to the drug. Without getting into the nitty-gritty, a generic drug company cannot substantially alter the drug or its label, including warnings placed on the packaging.

So let’s say a plaintiff uses state law to bring a personal injury lawsuit against a generic drug company claiming it didn’t properly warn patients of the risks when taking the drug. This puts the generic drug company in an unfair situation.

The generic drug company is being sued under state law for not changing the warning label of the drug. But federal law prohibits the generic drug company from making that label change. This is a conflict between state and federal law, so preemption comes into play and dismisses the failure to warn claims based on state law.

This means that the plaintiff’s legal case against the generic drug company is often effectively over because federal law overrides state law, leaving the plaintiff with few legal options to pursue a meaningful recovery.

This is largely what happened concerning the Generic and Retailer Defendants’ motions to dismiss. Now we can take a look at each motion more closely.

The Generic Defendants’ Motion to Dismiss

In its motion to dismiss, the Generic Defendants made the majority of their arguments relying on the theory of preemption. These arguments applied, at least in part, to the following plaintiffs’ claims:

• The generic drugs had labeling and product defects.
• The Generic Defendants should have conducted more testing of their generic drugs.
• The Generic Defendants should have adjusted the expiration date of the generic drugs.
• Ranitidine should have been stored and transported differently.
• The Generic Defendants should have warned the FDA about ranitidine’s cancer risk.
• The generic drugs had a manufacturing defect.
• The Generic Defendants violated the Magnuson-Moss Warranty Act
• The Generic Defendants have absolute liability for the harm plaintiffs suffered from taking ranitidine.
• Generic Defendant’s liability has led to derivative claims, including wrongful death and loss of consortium.

In deciding the motion to dismiss, the court sided with the Generic Defendants on every single point, largely relying on preemption. But that’s not the worst part for the plaintiffs.

The worst part is that not only did the court agree to dismiss all the claims, but it agreed that many of them should be dismissed “with prejudice.” That means that those claims cannot be rewritten and refiled and are lost forever.

Often, courts will grant a motion to dismiss, but give plaintiffs an opportunity to revise and adjust their legal arguments. This is called dismissing the claims “without prejudice.”

In this scenario, a court is telling plaintiffs that their arguments will not succeed as currently presented, but the plaintiffs might be successful if they replead the same legal arguments differently in an amended complaint.

In this Zantac MDL, the court only granted this “do-over” opportunity with the following plaintiffs’ claims:

• Expiration dates
• Testing
• Storage and transportation methods
• Warning the FDA
• Manufacturing defects
• Magnuson-Moss Warranty Act
• Derivative claims

Notice what’s missing: claims concerning product and labeling defects and absolute liability. These are among the strongest claims being made by the plaintiffs in the Zantac MDL.

The Retailer Defendants’ Motions to Dismiss

There were two motions to dismiss that were decided by the court.

In the first motion to dismiss, Retailer Defendants’ arguments were very similar to the Generic Defendants. Basically, Retailer Defendants argued that preemption required the court to dismiss the bulk of plaintiffs’ claims, including:

• Absolute liability
• Misbranding of products containing ranitidine
• General negligence
• Violations of the Magnuson-Moss Warranty Act
• Derivative claims, including wrongful death and loss of consortium

Just like with the Generic Defendants’ motion to dismiss, the court largely relied on preemption to dismiss every single one of the plaintiffs’ counts against the Retailer Defendants.

The court also allowed the counts to be dismissed with prejudice, except the plaintiffs’ claims for general negligence (to the extent they do not include arguments relating to the adequacy of the ranitidine label or the design of ranitidine), derivative claims and violations of the Magnuson-Moss Warranty Act. The plaintiffs were granted leave to amend their complaints to replead these claims.

Regarding the Retailer Defendants’ second motion to dismiss, the court denied it as moot, as it was based on arguments made in the first motion to dismiss.

Now What Happens in the Zantac MDL?

The court will soon release its decision concerning the Zantac brand-name manufacturers’ motion to dismiss. This is another very important court ruling that could have major implications on the Zantac MDL moving forward.

Plaintiffs will then have 30 days after the court releases that pending decision to file their amended complaints concerning the Generic and Retailer Defendants.

But the Zantac brand-name manufacturers’ motion to dismiss also relies heavily on preemption arguments. We still believe many viable and important claims will survive against the makers of Zantac, but recent court decisions have not been kind to certain plaintiffs in the Zantac litigation.

If you believe you have been harmed by Zantac, call me: (919) 830-5602.

Generic drugs are a big deal in the United States. According to the U.S. Food and Drug Administration (FDA), 90% of prescription medications are filled with a generic drug. One of the reasons so many people take generic medications is the cost savings. From 2007 to 2016, generic medications saved $1.67 trillion. A generic version of Zantac has been sold since 1997.

But how is a generic drug different from a brand-name drug? Does this difference matter in the Zantac litigation? If so, where does innovator liability come in? I’ll address these questions in the following blog post. But first, a brief update into the Zantac litigation.

Current Status of Zantac Litigation

In February 2020, the Zantac multi-district litigation (No. 2924) was created in the U.S. District Court for the Southern District of Florida. If a plaintiff sues the maker of Zantac and claims it gave her cancer, there’s a good chance that case will end up in this multi-district litigation, or MDL.

On June 22, 2020, the plaintiffs in the MDL filed their Master Personal Injury Complaint. To learn more about this lengthy legal document, check out my series of blog posts discussing it: Part 1, Part 2 and Part 3.

Right now, the MDL is currently in the pleadings stage and over the next few months, each side will present their arguments concerning the pending motions to dismiss.

What Is a Generic Drug?

A generic drug is a drug that is effectively the same as a name-brand drug, but is made by a company other than the name-brand drug maker.

Name-brand drugs are important in the pharmaceutical world because they give the brand-name holder exclusive rights to sell a medication in a given market. Depending on how popular the medication is, this can mean massive profits for the pharmaceutical company that created the name-brand drug.

How long this protection lasts is complicated, but it can last up to 20 years. After the protection is gone, other drug manufacturers can make a generic version of the drug.

The FDA approves generic medications to ensure that they:

• Contain the same active ingredient,
• Have the same strength,
• Are taken in the same way (injection, oral, etc.), and
• Have the same form (tablet, liquid, etc.).

A Brief History of Zantac

Zantac received patent protection in 1977 and got FDA approval in 1983. By 1988 Zantac became the world’s bestselling drug. In 1997, the patent protection expired and generic drug makers started making and selling ranitidine, the generic version of Zantac.

Why does this history matter? Because when consumers started taking ranitidine can make a difference in a potential lawsuit against a drug maker. That’s where the concept of innovator liability comes in.

What Is Innovator Liability and Why Does it Matter in the Zantac MDL?

Depending on the legal claims alleged, a plaintiff cannot sue the name-brand maker of a drug if he only took the generic version of the drug. So the plaintiff can go after the generic drug maker then, right? Well, that’s not always possible either, due to some oddities in how federal and state laws interact with one another.

This means that if a plaintiff only took ranitidine (and never took a Zantac branded product) and claims personal injuries, the court could potentially dismiss the plaintiff’s case. Given how Zantac became subject to generic competition in 1997, a lot of plaintiffs could be affected. But there’s a possible exception to this legal limitation in a few states: innovator liability.

Innovator liability is the legal theory that will hold the name-brand drug maker liable for injuries caused by the generic version of the drug. In other words, a plaintiff who took ranitidine could still sue the makers of Zantac (several companies have made name-brand Zantac over the years) despite never having taken that name-brand drug.

Because of innovator liability, a ranitidine consumer can still sue in the Zantac MDL, right? Probably not. Innovator liability is not a widely accepted legal theory, and so far is recognized only by the following four states:

• California
• Illinois
• Massachusetts
• Vermont

So to reiterate: if you took ranitidine, the generic version of Zantac, and never took name-brand Zantac, and later developed a qualifying cancer, you will not be able to invoke innovator liability to bring claims against the original makers of Zantac unless you live and developed cancer in the four states listed above.

However, and for further clarification, just because you took generic ranitidine doesn’t mean you can’t sue the name-brand pharmaceutical company. As long as you have taken Zantac, whether exclusively or in combination with ranitidine, you can still bring suit against the makers of Zantac without invoking innovator liability. And don’t forget that Zantac products continued to be widely available, even after generic versions became widespread. Don’t assume you don’t have a legal claim because you mainly took generic ranitidine.

Now What?

Right now we wait for the court to decide the motions to dismiss. There’s also a key study that should come out soon that may play a role in how the litigation proceeds depending on the study’s findings. When there’s a major update in the Zantac case, I’ll let you know. In the meantime, you can reach me at (919) 830-5602 if you have any questions about Zantac and cancer.

In Part 2 of this series we looked at the development of ranitidine (brand name Zantac), its rise as a hugely profitable heartburn drug, and the discovery that the carcinogen NDMA was found in rantidine, eventually leading to its recall and removal from the market. In this Part 3 I discuss how ranitidine can evolve into the cancer-causing chemical NDMA.

Nanitidine Can Form NDMA in the Stomach

When ranitidine enters the stomach, it can interact with “nitrites.” Nitrites are chemicals often found in spicy or salty foods. Food producers add nitrites to certain foods to prolong shelf life. All the way back in 1981, Dr. Silvio de Flora published a study showing that when ranitidine is introduced to nitrites it can lead to “toxic effects.” Dr. de Flora cautioned that if people take ranitidine, they should eat foods low in nitrites and avoid ranitidine near meal times.

Glaxo Smith Kline responded to this study, quickly and predictably. GSK stated that the levels of nitrite needed to cause such a reaction in the human body were unlikely in the real world. Instead, it continued selling Zantac and continuing not to warn consumers of the possible health risks. According to the Master Complaint, GSK “was involved in covering up the scientific data, offering illegal kickbacks to prescribing physicians, intimidating witnesses, and defrauding Medicare to profit from these medicines.” Pg. 63.

As GSK worked to get FDA approval for ranitidine (Zantac) it conducted several studies parsing out the findings that ranitidine can combine with nitrites in the stomach, thus mutating to NDMA, a known carcinogen. GSK repeatedly represented that the risk was low or unknown, and that patients would not be expected to take ranitidine for extended periods and so should not be exposed to risk of NDMA. In 1983, Dr. de Flora and other researchers confirmed in follow-up studies that mixing rantidine with nitrites can form NDMA. Subsequent studies have shown huge increases in NDMA in the human body after small amounts of rantidine are taken.

Valisure is an independent lab that conducted accredited studies on ranitidine in 2019. Valisure found that one ranitidine tablet produced 2,692,291 ng of NDMA. That’s a lot. According to these recent studies, a person who eats foods with nitrites would need to smoke 500 cigarettes to achieve similar levels of NDMA after taking one dose of 150mg ranitidine. It has become clear that ranitidine should never have been taken for extended periods while consuming foods high in nitrites. Nevertheless, the makers of Zantac advertised that it should be used when eating foods high in nitrites, such as tacos and pizza.

NDMA Can Form in Other Parts of the Body

NDMA can also form inside the human body but outside the stomach. Valisure lab found that an enzyme “DDAH” interacts with ranitidine to produce toxic levels of NDMA. This is complicated chemistry, but essentially the ranitidine binds to the DDAH enzyme, and together produces NDMA. So, where DDAH is most present in the body, more NDMA can be formed. DDAH is most commonly found in the kidneys, but also in the brain, colon, liver, intestine, stomach, bladder, and prostate. And, as we talked about in Part 2, NDMA can cross the blood-brain and placental barriers in a matter of hours, which means it reach most parts of the body.

NDMA Can Form When Ranitidine Exposed to Heat or Time

NDMA can also form when ranitidine or Zantac is exposed to heat or the passage of time. GSK confirmed this in its own studies in the 1980s. Valisure confirmed this finding decades later. These higher temperatures occur in normal conditions when the drug is stored in warehouses or shipped on trucks. Thus, ranitidine breaks down into NDMA in the days and weeks after manufacture under normal conditions when it sits in shipping trucks, or lingers in storage rooms. Even at room temperature, ranitidine can transform into NDMA within weeks.

NDMA Forms in the Ranitidine Manufacturing Process

This discovery was made in the context of other drugs found to contain NDMA, such as Valsartan. Eighty percent of the ingredients used to make drugs sold in the United States come from other countries, mainly China and India. NDMA was discovered in these ingredients, caused when these countries used less expensive solvents in the manufacturing process. As a result, NDMA has even been produced when manufacturing ranitidine or Zantac. Even without introducing nitrites, or enzymes, or heat, or time, the ranitidine tablets studied were found to contain high levels of NDMA.

Zantac has now been removed from the market, but the question is haunting: with all this scientific study about its connections to the cancer-causing NDMA, why did it take over thirty years?

Note: The statements in this blog post are allegations made by plaintiffs in the Zantac litigation. They have not yet been proven in court.

In Part 1 I discussed the concept of the Master Complaint in product liability multi-district litigation, and we also set the table with the plaintiffs and the many defendant-companies involved in the Zantac litigation. Now let’s keep grinding through the Zantac Master Complaint. The story of Zantac, the presence of the carcinogen NDMA, and the links to cancer can be found in the Factual Allegations, beginning on page 39 of the Master Complaint. (Note that I use the brand-name Zantac and its actual name ranitidine mostly interchangeably in this post.)

These are the key elements of the story:

Inventing and Selling Ranitidine

• Ranitidine is a medication relieves heartburn and acid indigestion.
• According to the Master Complaint, it was developed by GlaxoSmithKline (GSK) predecessors to compete with other “histamine H2-receptor antagonists” on the market, particularly Tagamet (cimetidine).
• A scientist working for a Glaxo subsidiary discovered ranitidine in 1976.
• In 1983, the FDA granted approval for Glaxo to sell Zantac.
• The prescription drug was a smash hit for Glaxo, the first drug to make $1 billion in sales.
• GSK turned Zantac into a blockbuster in part by driving sales. It added 800 salespersons to Zantac’s U.S. sales force.
• In 1993, GSK introduced an OTC version of Zantac, which it began selling a few years later.
• Over the next twenty-five years, other Defendants acquired the rights to sell OTC Zantac, including Pfizer, Boehringer Ingelheim, and Sanofi.
• GSK retained control of prescription Zantac in the U.S., which it sold until 2017.
• On October 18, 2019, Defendant Sanofi recalled all brand-name OTC Zantac in the U.S.
• In 1997, the original Zantac patent expired, allowing other companies to sell generic ranitidine products. Seventy-five companies eventually sold generic versions of ranitidine over the next two decades.
• The Brand-Name Manufacturer Defendants continued to sell prescription and OTC ranitidine.
• OTC Zantac antacid tablets had sales totaling $128.9 million in 2018.

Dangers of NDMA

• N-Nitrosodimethylamine (“NDMA”) is a toxic chemical and a danger to human health.
• NDMA is a carcinogen. As the Master Complaint puts it ominously, “its only use today is to cause cancer in laboratory animals.”
• Since 1980, companies have pulled all kinds of products from stores that were found to contain high levels of NDMA.
• In 2018, there have been recalls of several generic drugs to treat high blood pressure, including Valsartan and Losartan, (which I wrote about here).
• Scientists believe any amount of NDMA can increase risk for cancer or other health problems.
• In studies, laboratory animals taking NDMA orally developed liver, lung, bladder, kidney, pancreas, and stomach cancers.
• NDMA is a small particle, which means it can pass easily through the body, including into the brain and into placenta.
• But, studies also show that small amounts of NDMA can be fully metabolized in the liver, while larger amounts move throughout the body.
• In 1995, several studies showed an increased risk in cancer for humans after ingesting small amounts of NDMA.
• Studies in 1999, 2000, 2011, and 2014 reconfirmed the findings that NDMA can cause several cancers in humans.

NDMA Found in Ranitidine Products

• 

  In September 2019, an independent lab found significant levels of NDMA in ranitidine products. Four days later the FDA issued a warning that ranitidine (Zantac) may contain NDMA.
• In the next days and weeks, companies began voluntarily recalling their Zantac and generic-ranitidine products.
• On November 1, 2019, the FDA announced unacceptable levels of NDMA in ranitidine products based on recent testing, and requested that drug makers recall the medication.
• On December 4, 2019, the FDA issued a statement warning consumers who still take ranitidine to limit intake of nitrite-containing foods, like processed meats.
• The Complaint then throws a haymaker, noting that this was the same advice as the advice given by an Italian scientist . . . in 1981. Had GSK listened to the Italian scientists decades earlier, the Complaint argues, then millions of people may not have been exposed to dangerous levels of NDMA over thirty-eight years.
• In 2020 studies showed that ranitidine products can develop NDMA when exposed to temperature changes over time. The conclusion was that ranitidine is time and temperature sensitive, meaning the longer it sits or the more often it is exposed to temperature fluctuations, the more NDMA it is likely to develop.
• On April 1, 2020, the FDA recommended the removal of all ranitidine products.

In Part 3, we will look at the science behind the way ranitidine becomes NDMA.

Remember: These allegations come from the Master Complaint in the Zantac MDL and have not yet been proven in court.

If you truly want to learn about a particular litigation involving a defective product (such as Zantac), the best place to start is the Master Complaint. This is the lengthy comprehensive document filed by the plaintiffs in a multi-district litigation involving a defective product. This does not mean the case is a class action. Most product liability cases are not class action lawsuits but are rather individual lawsuits gathered together in a “multi-district litigation or MDL.” These cases are transferred from across the country in one court, where one federal court judge will oversee the litigation until either (1) a global settlement is reached or (2) the cases are ready to be returned to the their home courts for trial.

The multi-district litigation involving the drug Zantac is located in the Southern District of Florida (MDL No. 2924). On June 22, 2020 the plaintiffs filed their Master Personal Injury Complaint. It is a long and detailed document, and it is worth your time to read if you have taken Zantac over an extended period, and certainly if you have taken Zantac and later developed cancer.

Many people, understandably, are not thrilled to read a 158-page legal document. So today and in the days to follow I am going to write up key bullet points from the Zantac Master Complaint. First, a few general guidelines: a complaint is the document a plaintiff files in a court to start a civil case. It can be a single page, alleging that the neighbor’s dog bit the plaintiff and caused injuries, or it can be hundreds of pages long, involving many defendants and many claims. The key thing to remember is that the complaint involves allegations, not proven facts. It may well be that every word of a complaint is true and that the plaintiffs provide compelling evidence for every allegation at trial. But at the start of a civil case the complaint should be understood as a series of allegations, which the defendants are allowed to deny and which they often deny. And that’s where the courts and juries come in: to figure out which side has proven its case.

The Master Complaint in the Zantac MDL makes over one hundred pages of allegations against companies involved in the manufacture, sale, distribution, and repackaging of ranitidine, both with brand-name Zantac and its generic equivalents.

Let’s dive in. Before the Master Complaint can even get to the allegations connecting ranitidine to cancer-causing compounds, it must first set out the parties involved.

The Plaintiffs:

The Plaintiffs in the Zantac MDL are people who took prescription or over-the-counter (OTC) Zantac or generic ranitidine over a period of time, later developed certain cancers, and then brought a claim for damages. For MDL No. 2924, these plaintiffs must be residents of the United States, and they can include not only the individuals who were diagnosed with cancer, but also the spouses, children, heirs, and estates of other cancer-stricken plaintiffs. The cancers involved include “bladder, brain, breast, colorectal, esophageal or throat, intestinal, kidney, liver, lung, ovarian, pancreatic, prostate, stomach, testicular, thyroid, and uterine.” Master Complaint, p. 5. Other cancers may well be involved in this litigation, and this list should not be taken as exhaustive. The bottom-line is this: if you took Zantac and later developed any cancer, you should have a competent attorney investigate your possible case.

The Defendants: Brand-Name Manufacturers. These are the multi-national pharmaceutical companies that manufactured and sold brand-name Zantac for decades:

• Boehringer Ingelheim Pharmaceuticals, Inc.
• GlaxoSmithKline (GSK)
• Pfizer
• Sanofi-Aventis

Generic Manufacturers. These are the companies that manufactured, marketed and sold generic ranitidine. There are dozens of these companies, from Acic Pharmaceuticals to Zydus Pharmaceuticals (literally A to Z). I won’t list them all here, but you can access all of them in the Master Complaint if interested.

Distributor Defendants. These are the companies that purchase ranitidine products from manufacturers and then sell to Retailers. The following distributor defendants control 92% of the total volume of ranitidine distribution:

• AmerisourceBergen
• Cardinal Health, Inc.
• McKesson Corporation

Retailer Defendants. Retail Defendants are those companies with drugstores you can walk into, or online pharmacies from which you can purchase medications like Zantac. These companies may also repackage ranitidine and place their own individual labels. As you can imagine there are dozens of these companies. I won’t list them all here, but Retailer Defendants include Amazon, Costco, CVS, RiteAid, Walgreens, Walmart, and many smaller companies.

Repackager Defendants. These defendants include several defendants referenced above, but this class of defendants is simple enough: repackagers take a generic ranitidine product and place different labels on the medication and sell as their own product. For example, when you buy Costco or CVS brand ranitidine, you are buying from a repackager. Other Repackager Defendants include Denton Pharma, Golden State Medical Supply, and Precision Dose.

So these are the players in the Zantac litigation as identified in the Master Complaint. In Part 2, I will work to simplify the factual allegations involving Zantac and ranitidine, focusing on the key allegations connecting the medication to N-Nitrosodimethylamine (“NDMA”), which is a cancer-causing compound, and which, according to the Complaint, has caused hundreds of thousands of people to be afflicted with many types of cancer.

As always, if you took Zantac or a generic and have further questions, you can always call me to discuss further: (919) 830-5602. Good luck.

Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.

A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.

Why Did the FDA Ask for a Recall?

The FDA based this decision on its findings that the levels of NDMA could increase over time when stored at higher than room temperatures. The FDA’s new testing found that “NDMA levels increase in ranitidine even under normal storage conditions.” The FDA also discovered that “the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.”

There is debate on how the NDMA makes its way into medications such as Zantac. The FDA sometimes seems to take the approach that the NDMA is an impurity found in medications with ranitidine. However, the major theory is that as ranitidine breaks down in the human body, it creates very high levels of NDMA.

One study from 2016 supports this theory. Ten adults each took just 150mg of ranitidine (the recommended dose is 150mg, twice a day) with scientists analyzing their urine for 24 hours. They found that NDMA levels in the urine increased by a factor of 400.

Despite this massive increase, it’s still a conservative number. That’s because the human body will metabolize some of the NDMA before it can be removed through urine.

Regardless of how the NDMA finds its way into the human body, it’s clear that NDMA is something that people should avoid, especially for its increased cancer risks.

How Does NDMA Cause Cancer in Humans?

The World Health Organization explains that NDMA causes cancer when a particular enzyme converts NDMA into a methyldiazonium ion. This ion then leads to DNA damage, which can turn healthy cells into cancerous cells.

The U.S. Environmental Protection Agency (EPA) classifies NDMA as a “B2 (probable human) carcinogen.” This is based on studies that have found cancer in the liver, kidney and lungs of several different types of laboratory animals. Other studies have potentially linked NDMA to other cancers, such as pancreatic cancer, stomach cancer and bladder cancer.

Currently, there is the fear that Zantac and other medications containing ranitidine can lead to many types of cancers, including:

• Small intestine cancer
• Colorectal cancer
• Esophageal cancer
• Throat cancer
• Nasal cancer
• Thyroid cancer
• Liver cancer
• Brain cancer
• Colorectal cancer
• Kidney cancer
• Breast cancer
• Lung cancer
• Ovarian cancer
• Prostate cancer
• Testicular cancer
• Uterine cancer
• Multiple myeloma
• Non-Hodgkin lymphoma

It’s thought that this cancer risk is cumulative, which means the more someone takes ranitidine, the higher that person’s risk of developing cancer. The problem is that until last year, the widespread view by medical professionals was that ranitidine was an extremely safe drug. This means potentially millions of people were taking ranitidine non-stop for years and even decades.

Currently, more research is underway to better understand the links between NDMA and cancer, including exactly what types of cancers are the result of medications containing ranitidine.

If you have taken Zantac or any other drug with ranitidine for an extended period of time and have been diagnosed with any of the above cancers, it’s possible that your cancer was the result of you taking ranitidine.

As scientists complete their research and learn more, I’ll be sure to provide additional updates and information. In the meantime, feel free to call me at (919) 830-5602 if you have any questions, and if you took Zantac for an extended period and later developed cancer, call me to discuss your potential case against the pharmaceutical company Sanofi.

Many of us suffer from heartburn, and one of the most popular ways to treat it is by taking Zantac. Until recently, Zantac was considered a very safe medication and was available without a prescription.

Given how well it worked, along with its affordable price and the perception of safety, hundreds of thousands of people, if not millions, took Zantac. In the fall of last year, the US Food and Drug Administration (FDA) reported that this popular drug might contain N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance.

The past few months have resulted in mass voluntary recalls and a rush of FDA updates and reports about the possible dangers of taking Zantac and what it means for consumers. This blog post will attempt to summarize what’s going on and briefly discuss what happens next.

What Is Zantac?

Zantac is the brand name of a popular H2 histamine receptor antagonist called ranitidine. In plain English, Zantac is an antacid. It works by reducing the amount of stomach acid your body produces. Zantac is most commonly used to treat heartburn, ulcers and acid reflux.

What Is NDMA?

Before you ask, no, Zantac won’t get you high. Though the initials might seem similar, Zantac does not contain the active ingredient found in ecstasy. Ecstasy is 3,4-methyl​enedioxy​methamphetamine or MDMA. The possible carcinogen in Zantac is NDMA, not MDMA. Confusion is understandable given how an “N” not only looks like an “M,” but it sounds that way, too.

The FDA considers NDMA a “probable carcinogen” as it has caused cancer in laboratory animals. NDMA, in very small doses, is possibly not harmful as it’s often found in cured and grilled meats. But with enough exposure, NDMA may cause cancer in humans, such as in the bladder and stomach. NDMA can also be harmful to your liver.

How Much NDMA Is in Zantac?

One of the first publicized instances of NDMA causing cancer was the Citizen Petition sent by Valisure to the FDA on September 9, 2019. In this petition, Valisure explained that in its testing, it found alarming levels of NDMA in ranitidine.

Per the FDA, humans can acceptably consume up to 96 nanograms (ng) of NDMA per day. Valisure tested various types of over-the-counter 150 mg ranitidine medications found at stores like Walmart, Walgreens and CVS.

Valisure discovered that the amount of NDMA found in each 150mg dose ranged from 2.2 to 3.2 million ng. So by taking just one 150mg pill each day, a person was potentially consuming about 30,000 times the amount of NDMA the FDA says is acceptable.

Even when using modified testing methods that should better simulate the human body, Valisure found that each 150mg pill had between 23,600 and 304,500 ng of NDMA. This still vastly exceeds the FDA’s recommendation.

Things get complicated when you look at the FDA’s ranitidine testing results, which found far lower levels than Valisure did. The levels, while elevated, did not alarm the FDA enough to stop the sale of ranitidine.

What’s the FDA Doing About Zantac?

The FDA hasn’t done much besides issue Statements, Press Releases and Updates. However, they did complete their own testing of ranitidine and have asked ranitidine manufacturers to test for NDMA before their products hit store shelves. The following is a recent timeline of events:

September 13, 2019: the FDA publishes a Statement that announces it had become aware of possible problems with ranitidine. The FDA mentions that concerned consumers may ask for a different prescription or take an alternative over-the-counter antacid.

September 24, 2019: the FDA publishes a Press Release announcing the voluntary recall of prescription ranitidine capsules distributed by Sandoz, Inc.

September 26, 2019: the FDA alerts consumers and medical professionals that generic over-the-counter ranitidine made by Apotex Corp was being voluntarily recalled.

October 2, 2019: the FDA discusses more effective methods of ranitidine testing. Specifically, lower temperature testing methods should be used to avoid artificially raising NDMA levels.

October 23, 2019: the FDA further discusses NDMA testing procedures.

October 28, 2019: FDA announces more voluntary recalls.

November 1, 2019: the FDA publishes its ranitidine testing results for NDMA in an Update and issues a Statement. The overall conclusion is that NDMA levels were somewhat higher than what the FDA recommends, but not high enough to require all sales of the drug to stop. In fact, the FDA states that:

“FDA has determined that the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

November 8, 2019: the FDA alerts the public about a voluntary recall for ranitidine medications manufactured by Aurobindo Pharma USA.

November 22, 2019: the FDA mentions more voluntary recalls for ranitidine medications.

December 4, 2019: the FDA asks manufacturers to test for ranitidine before shipping to retailers.

December 18, 2019: the FDA announces a voluntary recall for ranitidine medications manufactured by Glenmark Pharmaceutical Inc.

January 8, 2020: the FDA announces that Appco Pharma LLC and Northwind Pharmaceuticals (for tablets manufactured by Glenmark Pharmaceutical Inc.) were issuing voluntary recalls of ranitidine.

For a complete list of FDA recall announcements involving ranitidine, please go to the FDA’s Recalls, Market Withdrawals, & Safety Alerts page.

Zantac Lawsuits Emerge

Given how popular Zantac has been and how long it’s been on the market in the US, we’re probably going to see a large wave of litigation against various ranitidine pharmaceutical companies. The lawsuits have already begun. A few of them include:

• Coggins v. Sanofi Case No. 3:19-cv-20060
• Rodriguez v. Sanofi, Case No. 1:19-cv-09527-AT
• Garza v. Sanofi, Case No. 5:19-cv-05772-NC
• Melillo v. Sanofi, Case No. 1:19-cv-06376

What’s important to note is that these lawsuits do not focus on cancer or other personal injuries due to the NDMA. These lawsuits were filed in late 2019 after news broke about the NDMA risks. Therefore, they are mostly suing on the basis of consumer fraud, breach of expressed and implied warranties and other unfair competition laws.

It’s only a matter of time before the personal injury class action lawsuits begin. One reason why they haven’t arrived yet is because they’re far more involved legal cases.

In most of the current cases in litigation now, plaintiffs are basically saying, “the defendant deceived me by not telling me of the health risks in taking ranitidine.” This is a lot easier to prove than saying, “ranitidine caused my cancer.”

Cancer is a complicated disease. Plaintiffs must figure out how much ranitidine was needed to cause cancer. This isn’t to say it’ll be impossible to prove ranitidine caused injuries in people, but it’ll take time to build a case.

What Does the Future Hold for Zantac?

These are still very new developments, so it’ll take some time to create a personal injury lawsuit against the makers and distributors of ranitidine. But there is huge potential for massive litigation. For instance, from 2007 to 2017, ranitidine was prescribed about 15 million times . . . per year . . . in just the US. And this doesn’t even count over-the-counter sales.

As more lawsuits get filed, it’s possible we can expect them to be placed into a multi-district litigation, or MDL. This will hopefully allow for more efficient litigation and maybe even a possible settlement that avoids decades of time in the courts.

Right now, it’s probably best to avoid taking anything containing ranitidine without at least talking to your doctor first. And as I get more information, I’ll post the updates in this blog. If you want to discuss Zantac, call me: (919) 830-5602.