Reglan (metoclopramide), which is used to treat nausea and gastrointestinal disorders, has been linked to a serious neurological syndrome called tardive dyskinesia. Although product liability lawsuits involving Reglan have been going on for a number of years, a U.S. Food and Drug Administration (FDA) warning in 2009 spurred a new crop of Reglan litigation.
Here's the latest on Reglan's side effects and the current status of Reglan litigation.
What Is Reglan?
Reglan is the brand name for metoclopramide, a prescription drug that has been on the market for over thirty years. Other brand names for metoclopramide include Octamide and Maxolon. Reglan can be taken as a pill or liquid or can be administered by injection. 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 nausea and vomiting caused by migraine and cluster headaches and morning sickness in pregnant women. The FDA has never approved this off-label use.
The FDA estimates that over two million people nationwide use Reglan or another brand name drug containing metoclopramide.
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:
- 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 over time. For others, the symptoms persist indefinitely. There is no known treatment for tardive dyskinesia.
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 twenty percent 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.
The FDA's Black Box Warning
In February 2009, the FDA required manufacturers of Reglan and other brand name drugs containing metoclopramide to use a black box warning. A black box warning appears on the package insert of a pharmaceutical drug and warns consumers that the drug may have serious adverse effects. A black box warning -- so named because of the black border surrounding the text -- is the strongest warning the FDA can require.
The required FDA black box warning for Reglan and other metoclopramide drugs 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.
- Metoclopramide should not be used for longer than 12 weeks in all but rare cases.
In the past few years, over 70 Reglan lawsuits have been filed around the country. Of these, 14 are scheduled for trial from April 2010 to January 2011. Some experts believe that the 2009 FDA black box warning has prompted (and will continue to prompt) new Reglan litigation.
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 by the drug 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. (To learn more about the elements in a product liability claim, see Nolo's article Proving a Defective Product Liability Claim.)
The facts surrounding Reglan may 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-market uses, like treating nausea for cluster headaches and migraines, but did not warn doctors that these uses were not approved by the FDA.
Consolidation of Reglan Lawsuits
In 2009, plaintiffs' lawyers in a number of federal lawsuits tried to consolidate their litigation into one federal case for purposes of pretrial motions and discovery. That effort was rejected by the court. Plaintiffs in these and other federal lawsuits continue to litigate their cases individually in courts throughout the country.
In July 2010, 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. In addition, all new New Jersey state court Reglan lawsuits must be filed in Judge Higbee's court.
The legal and medical issues in Reglan cases are usually sophisticated and complex. Depending on the circumstances of your case, you may want to hire a lawyer who specializes in products liability litigation (or, even better, one who has experience with Reglan cases). You may also consider joining an existing class action lawsuit, if there is one. (To learn more about class actions, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)
For help on choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer. Or go straight to Nolo's Lawyer Directory for a list of personal injury attorneys in your geographical area.