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.

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.