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.

Most of you have heard reports about the devastating effects of opioids. Millions of people have become addicted, and many of those people have overdosed and died while taking the addictive pain medication. Even in cases when death does not occur, addiction has caused job losses, ravaged families, and cost billions of dollars in treatment for victims.

Up to this point, most of the recent litigation involving opioids has involved lawsuits against the makers of opioids on behalf of states and local governments. The essential complaint is this: [Blank] State has incurred millions of dollars in losses because citizens in the state became addicted to opioids and required government assistance in the form of hospitalization, treatment programs, unemployment, welfare, and other governmental expenditures.

But what about individuals? It is plain to see how a state or county can articulate damages from the direct and indirect costs of widespread opioid addiction, but individuals have been injured as well. In 2018, do these individuals have valid claims? Increasingly, it appears the answer is yes. And if so, this litigation will eventually be massive.

Let’s take a look.

Individual Claims for Injuries Caused by Opioids

So when the opioid litigation shifts from states and counties to individuals, what kinds of injuries could these injured plaintiffs base their claims for compensation?

1. Opioid Addiction. It starts here. This claim must be established through the medical records, but it should not be difficult to prove. Doctors (and families of the victim) know addiction when they see it. It is estimated that over 2 million people suffer from opioid addiction in the United States.
2. Opioid Overdose. Opioid overdose can permanently injure the victim and cause years of required health care.
3. Opioid Overdose Causing Death. This tragic result is the most obvious and most painful of the potential injuries caused by opioids. The wrongful death claim would be brought by estate for the deceased victim and the victim’s family.
4. Neonatal Abstinence Syndrome (NAS). This condition occurs when a baby is born addicted to opioids. The newborn becomes addicted when the pregnant mother abuses the medication while pregnant. Some symptoms a newborn may experience when suffering from NAS include diarrhea, fever, sleep problems, seizures, trembling, birth defects, and many others.
5. Lost earnings and other financial losses. For this claim, the plaintiff must show the financial losses were directly caused by the opioid addiction, leading to lost jobs, lost savings, etc.

But What About the Learned Intermediary Defense?

Make no mistake, the manufacturers of opioids will present every defense they can find. Check out my post on Opioid Drug Company Defenses.

One of the more insidious of these potential defenses is the learned intermediary doctrine. I’ve written about this defense often on this site, but it essentially goes like this: if the drug company crafts a drug label detailing the risks of taking a medication, the company may rely on the patient’s doctor–the learned intermediary–to explain to the patient the risks and benefits of taking the drug. In this scenario, the doctor is expected to know (often in granular detail) the contents of the warning label and be able to give precise medical advice on whether the patient should take the medication. It’s a lot to ask of a general practitioner or a surgeon, but the defense has been used often by drug companies to escape liability for harm caused by dangerous medications.

But here is the reason the learned intermediary doctrine may not be the get-out-jail-free-card for drug companies in the new emerging opioid litigation:

1. The FDA and the medical community have learned much more about the devastating effects of opioids in recent years. This means that the medical community simply was not sufficiently informed (“learned”) about the serious risks until very recently, and so could not have been expected to give precise and proper caution to a patient taking the drug;
2. The FDA has recently added new “black box warnings” on opioid labels. The warnings have gotten stronger and more comprehensive. This means that individuals who were harmed by opioids prior to the latest warnings may not have to contend with the learned intermediary defense;
3. State medical boards have issued new guidelines for doctors who may prescribe opioids;
4. Doctors and their patients may overcome the learned intermediary defense by arguing that the drug companies informed doctors for years that opioids were not addictive. We now know that opioids are highly addictive and can be destructive to a person’s health. The drug companies’ representations in the past may eliminate or severely weaken the learned intermediary defense.

All that said, I believe many new individual claims for injuries caused by opioids will emerge over the next few years. In fact, the litigation could become huge over the next decade. You can read more about opioid litigation on this site. And you can always call me to discuss your potential opioid case at any time (919.830.5602). Good luck.

Osteoporosis is a disease where the human body’s bones become weaker. It is a common issue with women who have gone through menopause. The drug company Merck developed a drug called Fosamax (alendronate) hoping to prevent and treat osteoporosis in postmenopausal women.

As with all other drugs, Fosamax had side effects, one of which was actually increasing the risk of femoral (thigh) bone fractures. Thousands of users of Fosamax suffered this side effect and sued Merck.

Even though there were a lot of plaintiffs suing, many of their cases became consolidated into a multi-district litigation, or MDL, in New Jersey.

Initially, things didn’t go well for the injured plaintiffs, with Merck winning the first bellwether trial. Then things got worse for the plaintiffs when the trial court granted Merck’s motion for summary judgment to dismiss all the MDL lawsuits. However, this week plaintiffs won a big decision on appeal, restoring hundreds of cases.

But let’s back up.

The Fosamax Litigation

The crux of the plaintiffs’ argument against Merck was that under state law, Merck failed to issue revised drug warnings that would properly warn potential Fosamax users of the risk of femoral fractures. Merck’s primary defense was that the Food and Drug Administration (FDA) would not have approved the required revised warnings and therefore, Merck should not be liable for violating any state “failure-to-warn” laws.

Before we go any further, we’ll need to explain why the FDA would need to approve any revised drug warnings. It sounds odd, but drug companies are not allowed to add notice of possible problems with their drug unless the FDA approves the revised warnings.

There are two reasons for this. First, if a possible risk for using a drug is not supported by evidence, it may discourage the use of a useful drug. Second, by adding certain risks and side effects that are not supported by proper scientific evidence to a drug’s warning label, users of the drug may not recognize the more important and scientifically proven drug risk information. In other words, if there are too many meritless or marginal warnings for a particular drug, users of the drug will either ignore all the warnings or not properly consider the more serious ones.

What Happened at the Trial Court?

Before trial, Merck filed a motion for summary judgment. Merck’s primary argument was that plaintiffs’ lawsuits should be dismissed because their failure-to-warn claim was preempted by the FDA’s federal regulations. Preemption refers to the legal concept that where when a state law and federal law conflict, or where it’s impossible to comply with both laws, the federal law will apply and the state law will not.

The applicable FDA regulation had to do with approving a revised warning for Fosamax. Merck argued that it had discussed the risk of femoral fractures with the FDA and whether a revised warning was required. Merck claimed that the FDA told Merck during those discussions that a revised warning to reflect the risk of femoral fractures would not be approved.

Merck claimed that based on this discussion with the FDA, Merck believed that had they asked the FDA to approve a revised warning label warning users of the risk of femoral fractures, the FDA would never have approved it. Since FDA regulations overrode state laws thanks to preemption, and the FDA regulations would not have allowed a revised warning label about femoral fractures, Merck could not be in violation of state failure-to-warn laws.

Essentially, Merck’s position was: “We asked the FDA to let us revise the Fosamax warning label, but the FDA wouldn’t allow it. So we can’t be responsible.”

The trial court agreed with Merck and granted its motion for summary judgment, effectively dismissing every single Fosamax MDL lawsuit against Merck. Hundreds of people with severe femur fractures, many caused by low-stress activities like walking or getting into a car, were now, temporarily, dismissed from court.

What Happened on Appeal?

The appeals court acknowledged that the trial court was correct in that an FDA regulation could preempt a state law. However, in order for preemption to apply in this case, Merck had to prove it would be “highly probable” that the FDA would not have approved a change to Fosamax’s warnings.

According to the appeals court, Merck could not meet this high evidence standard and that such a decision was for a jury to decide, not a judge, who usually rules solely on issues of law, not fact. The appeals court concluded that plaintiffs had:

“…produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures…[this] is enough for Plaintiffs to defeat summary judgment and proceed to trial.”

Needless to say, this is a huge win for Fosamax plaintiffs. After years of delay, they may finally get their day before a jury.

What’s Next?

With Merck’s motion for summary judgment now dismissed, plaintiffs’ lawsuits can move forward to trial. There are also many other Fosamax lawsuits in New Jersey and California state courts. This federal appeals decision does not directly affect those state court cases, although it will surely influence the outcomes.

Note: Photos for illustration purposes only.

Boston Scientific is facing more than 36,000 product liability cases because of injuries the mesh has caused, including infections and erosion of surrounding tissue, according to the Minneapolis Star Tribune. Transvaginal slings are used as treatment for incontinence and surgical meshes are surgically implanted to strengthen tissue in women suffering from pelvic organ prolapse.

more New Warnings

The warnings include additional language to existing warnings concerning:

• “Erosion” and “ongoing pain” as possible side effects, and
• The company’s meshes and slings should be considered permanent implants because taking them out can be complicated or impossible but the new warnings also state treatment for erosion caused by the mesh may require at least an attempt at surgical removal of the device.

The company announced the warnings in June as part of “urgent” advisory letters sent in May to physicians worldwide. Those letters were followed by announcements from European regulators that publicized warning label changes. The changed warnings apply to:

• Five brands of transvaginal slings (Advantage, Lynx, Obtryx, Obtryx II and Solyx), and
• Three types of mesh (Uphold LITE, Pinnacle LITE, and Upsylon Y).

Boston Scientific states the changes to the warning label are a result of a review of data by company officials and Australian medical device regulators.

The patients harmed by Boston Scientific’s products make a number of legal claims including that its transvaginal mesh’s design and manufacturing are flawed, that it failed to warn of known dangers in the past, and that the company breached warranties and violated consumer protection laws.

Securities filings by Boston Scientific state it has settled about 11,000 of these cases without admitting liability or wrongdoing. One source estimates there are about 100,000 lawsuits by those harmed by vaginal mesh and more than 135,000 worldwide.

Counterfeit Raw Material

In addition to all the issues that arise when transvaginal mesh is manufactured to Boston Scientific’s specifications, the company may have used the wrong raw material in making some of its products, adding yet another complication for patients. The federal Food and Drug Administration (FDA) issued its own warning to physicians in April that it was investigating allegations Boston Scientific used counterfeit raw material for its transvaginal mesh, according to the Boston Globe.

FDA stated the company will conduct new tests on the safety and effectiveness of the product and the agency will review the results. Boston Scientific has denied that has used “‘counterfeit’ or ‘adulterated’ materials” in its medical devices.

The Takeaway

Warnings are a step in the right direction so patients can have a better idea as to the risks involved with TVM, but if the products are used anyway warnings won’t prevent harm to patients. Eliminating all risk of injury will occur only when transvaginal mesh is no longer used. That will only happen if:

• Manufacturers decide to step selling it,
• Doctors decide to stop implanting it,
• Patients refuse to use it, or
• The FDA decides to ban it.

Until then patients will continue to be injured by transvaginal mesh and lawsuits against manufacturers such as Boston Scientific will continue to be filed. These lawsuits not only compensate plaintiffs for the injuries they’ve suffered but they also increase the cost of doing business as usual for companies like Boston Scientific. They may eventually decide profits from selling transvaginal mesh aren’t worth the costs and stop selling these products.