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