Reglan (Metoclopramide) Litigation

Reglan (metoclopramide), used to treat nausea and gastrointestinal disorders, has been linked to serious neurological problems, including tardive dyskinesia (TD) and a potentially fatal condition called neuroleptic malignant syndrome (NMS). Although product liability lawsuits involving Reglan have been going on for many years, a U.S. Food and Drug Administration (FDA) warning in 2009 spurred a new crop of Reglan litigation.

Owing largely to a 2011 United States Supreme Court decision, Reglan litigation appears to have mostly run its course. New cases continue to be filed, but Reglan attorneys are mostly interested in those where the patient took metoclopramide for more than three months. In the wake of the first wave of Reglan lawsuits, those cases are quite rare.

Here's the latest on Reglan's side effects and the current status of Reglan litigation.

What Is Reglan?

Reglan is a brand name for metoclopramide, a prescription drug that has been on the market for over forty years. Other brand names for metoclopramide include Octamide and Maxolon. Originally available as a pill, liquid, or injection, today Reglan is only available in pill form. Generic versions can still be found in liquid or injectable formulations.

The FDA has approved Reglan and other metoclopramide drugs to treat:

• post-surgery nausea
• nausea caused by chemotherapy
• gastrointestinal disorders, such as acid reflux and heartburn, and
• diabetic gastroparesis (a condition in which the stomach loses the ability to contract and empty).

However, doctors also regularly prescribe Reglan to treat migraine and cluster headaches and morning sickness in pregnant women. The FDA has never approved these or other off-label uses.

Who Owns Reglan?

If you're considering a claim or a lawsuit for injuries you suffered while taking Reglan, you'll need to know who owned it when you took it. Because Reglan was so commercially successful, ownership has changed hands many times.

In 1979, when it was first introduced in the United States, Reglan was owned by A.H. Robins Company. Robins sold the rights to Reglan to American Home Products, Inc. (AHP) in 1989. In 2001, AHP (which later changed its name to Wyeth Pharmaceuticals, Inc.) sold Reglan to Schwarz Pharma AG. Schwarz later sold Reglan to Alavan Pharmaceutical L.L.C., its present owner.

Generic versions of Reglan are made by several companies, including Teva Pharmaceutical Industries, Ltd., Impax Laboratories, Inc., Strides Pharma Science, Ltd. (formerly known as Strides Shasun, Ltd.), IPCA Labs, Ltd., and Aiping Pharmaceutical, Inc.

Side Effects of Reglan and Its Generics

Reglan and its generics belong to a class of drugs that work by temporarily slowing down or inhibiting receptors that use dopamine, a chemical messenger that influences how the brain works. Among other things, dopamine plays an important role in body movement. When dopamine receptors are impaired by metoclopramide, severe neurological problems sometimes follow.

Reglan and Tardive Dyskinesia

Research has linked Reglan with an increased risk of developing tardive dyskinesia, a neurological syndrome characterized by repetitive, involuntary movements. Symptoms of tardive dyskinesia include:

• grimacing
• tongue protrusion
• lip smacking
• puckering and pursing lips
• rapid eye blinking
• rapid movements of the arms, legs, and trunk, and
• finger movements that look like the patient is playing an invisible guitar or piano.

Symptoms of tardive dyskinesia may develop over time, even after the patient has stopped taking the drug. For some patients, the symptoms subside once the drug is discontinued. For others, symptoms persist indefinitely.

The risk of developing tardive dyskinesia increases with higher doses and longer use (usually more than three months) of Reglan. According to one FDA study, over 20% of patients who took Reglan were on the medication for longer than three months. Elderly patients, especially elderly women, are also at increased risk of developing tardive dyskinesia.

Reglan and Neuroleptic Malignant Syndrome

Metoclopramide is also associated with NMS, a much less common but potentially fatal neurologic disorder. NMS symptoms include:

• high fever
• sweating
• unstable blood pressure
• an inability to move, speak, or respond to stimuli
• muscular rigidity, and
• a variety of autonomic nervous system problems like a rapid heartbeat or heart arrhythmia, vomiting or diarrhea, urinary problems, dizziness, headache, mood swings, and fainting.

If it isn't caught in time and properly treated, NMS can lead to death.

The FDA's Black Box Warning

In February 2009, the FDA required manufacturers of Reglan and other brand name drugs containing metoclopramide to include a "black box" warning on consumer packaging materials. A black box warning—so named because of the black border surrounding the text—is the strongest warning the FDA can require. It appears on the package insert of a pharmaceutical drug and warns users that the drug may have serious adverse effects.

The FDA black box warning for Reglan and other metoclopramide drugs—which is still required—states that:

• treatment with metoclopramide (Reglan) can cause tardive dyskinesia, a serious movement disorder that is often irreversible and for which there is no known treatment
• the risk of developing tardive dyskinesia increases with the duration of treatment and total cumulative doses, and
• metoclopramide should not be used for longer than 12 weeks in all but rare cases.

Note that while the warning still appears to say that there's no treatment for TD, the FDA has approved medications that have been shown to be effective in treating some cases of TD. Ask your doctor for details.

History and Present Status of Lawsuits

Since its introduction in 1979, thousands of Reglan lawsuits have been filed around the country. What began as a trickle of cases grew to a steady stream of lawsuits after the FDA's 2009 FDA black box warning requirement. While each case is different, in general, plaintiffs (injured patients who file a lawsuit) claim that the makers of Reglan and its generics knew of adverse side effects, downplayed or tried to ignore them, and failed to warn users about them.

Specific Claims

The Reglan lawsuits rely on a legal theory called "product liability." In product liability claims involving pharmaceutical drugs, plaintiffs typically argue that they were injured because:

• the drug caused unreasonably dangerous side effects, and
• the manufacturer, doctor, or pharmacy did not adequately warn the consumer (or prescribing physician) of these dangers. (Learn more about proving the elements of a product liability case.)

The facts surrounding Reglan can give rise to several different kinds of product liability claims. Plaintiffs in these cases might argue that:

• Reglan manufacturers were aware that Reglan was linked to tardive dyskinesia, but did not adequately warn consumers of that danger.
• Reglan manufacturers knew that doctors often prescribed Reglan for periods longer than three months, but did not warn doctors and consumers that this greatly increased the risk of developing tardive dyskinesia.
• Reglan manufacturers knew doctors regularly prescribed Reglan for off-label uses, like treating nausea for cluster headaches and migraines, but did not warn doctors that these uses were not approved by the FDA.

No Reglan Multidistrict Litigation

Litigating product liability cases is costly and time consuming for all involved. Quite often, it's possible to save both time and money by grouping factually similar cases into something called multidistrict litigation (MDL). Mass tort cases are consolidated in one federal court, where a single judge presides over pretrial matters like motions and discovery.

In 2009, plaintiffs' lawyers in several federal Reglan lawsuits asked the court to consolidate the litigation into a Reglan MDL. The court denied that request, handing a significant win to manufacturers. As a result, plaintiffs in these and other federal lawsuits had to litigate their cases individually in courts throughout the country.

The End of Generic Failure to Warn Claims

Failure to warn is a key type of product liability claim. In drug product liability cases, plaintiffs argue that drug makers failed to warn patients about known risks associated with use of the drug. These were important claims in suits against companies that made Reglan and it generic equivalents.

But in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), the Supreme Court ruled that failure to warn claims against generic metoclopramide manufacturers were preempted—meaning prohibited—by federal law. While plaintiffs can assert other kinds of product liability claims against the makers of generics, those claims are much more difficult to prove. Failure to warn is still a viable theory in cases involving Reglan and other brand name drugs.

Litigation in State Courts

With federal multidistrict litigation off the table, plaintiffs' lawyers turned to state courts, particularly in California, Pennsylvania, and New Jersey. The volume of Reglan litigation prompted these state courts to centralize Reglan lawsuits into what's sometimes called "multi-county litigation" or "mini-MDLs."

In July 2010, for example, the New Jersey Supreme Court ordered that all Reglan lawsuits filed in New Jersey state courts be centralized for case management purposes before Superior Court Judge Carol E. Higbee. This multi-county litigation was dissolved by the state supreme court in November, 2021.

In Pennsylvania, the Philadelphia County Complex Litigation Center handles mass tort claim cases. Pennsylvania Reglan cases were consolidated at the Center. A global settlement—the terms of which are confidential—was finalized in 2018, resulting in the disposition of about 2,000 claims.

Can You Still File a Lawsuit?

Possibly so. New metoclopramide cases are still being filed, most involving claims related to Reglan, in both state and federal courts. Your lawyer might decide to bring a product liability case against the manufacturer, a medical malpractice case against your prescribing physician, or both.

Keep in mind that you're up against the statute of limitations, a law that puts a deadline on the time you have to file your case in court. Miss that deadline and your case probably won't survive a motion to dismiss. You'll lose the right to collect compensation ("damages") for your injuries.

Getting Help With Your Reglan Claim

The legal and medical issues in Reglan cases are usually sophisticated and complex. It's not the type of case you should consider handling on your own, without expert legal help. Give serious thought to hiring a lawyer who specializes in products liability litigation. Or, even better, one who has experience with Reglan cases.

If you're ready to move forward with your Reglan or metoclopramide case, here's how to find a personal injury attorney who's right for you.