Reglan is used to treat disorders including acid reflux, migraines, heartburn, and gastroparesis, a condition sometimes associated with diabetes in which the stomach empties too slowly.
According to complaints filed in federal court, the defendant drug companies were accused of negligence, fraud and deceptive marketing practices. According to the plaintiffs, the defendant companies failed to adequately warn patients and doctors and published misleading information about the risk of developing neurological disorders when using Reglan.
Plaintiffs say they suffered permanent neurologic damage and disfigurement as a result of the negligence of drug companies.
Plaintiffs say that because of the negligence of drug companies, they suffered permanent neurologic damage — including tardive dyskinesia and other nervous system disorders — disfigurement and aggravation of preexisting conditions.
The injured people who filed lawsuits demanded compensation for medical expenses, lost wages and earning capacity, and loss of quality of life. The plaintiffs also demanded punitive damages.
Millions Paid in Reglan Lawsuits
A Pennsylvania-based watchdog group, the Institute for Safe Medication Practices, named Reglan and metoclopramide the most litigated drug in 2011, with more than 11,000 litigation-related adverse event reports received by the Food and Drug Administration that year. In the second quarter alone, the organization said there were 4,237 new reports from legal cases involving the drug. In Philadelphia alone, the Complex Litigation Center has more than 2,000 Reglan cases on its docket.
To date, companies have paid millions in compensation to those suffering from tardive dyskinesia after taking Reglan/metoclopramide.
Drugmakers Accused of Concealing Side Effects
The Food and Drug Administration warns that use of Reglan for longer than 12 weeks carries a significant risk of tardive dyskinesia, a painful, socially crippling, neurological disorder. Other potential serious side effects include depression, suicide, Parkinson’s disease and Neuroleptic Malignant Syndrome, a rare, but serious condition that can be fatal.
People who were diagnosed with tardive dyskinesia or suffered other side effects as a result of taking Reglan have filed lawsuits against the drug’s manufacturer for concealing the side effects of the drug and failing to warn the public. Much of the litigation has been mired in issues related to whether the manufacturers of the generic form of the drug or the brand-name makers can be held liable. This has led to a number of confusing and seemingly contradictory court rulings.
Reglan litigation has been reported as the largest mass-tort program in Philadelphia.
Global Settlement Reached
In January 2017, Teva Pharmaceuticals, Pliva and Watson Laboratories, manufacturers of generic forms of Reglan, reached a tentative, global settlement to resolve thousands of cases around the United States related to claims the drugs caused tardive dyskinesia.
Details of the settlement, including the amount of money involved, were not made public because of the confidential nature of the agreement. The following month, Teva Pharmaceuticals, maker of a generic version of Reglan, reported to the U.S. Securities and Exchange Commission that it had agreed to settle the majority of approximately 4,000 lawsuits it faced over the drug.
Laws, Rulings Limit Reglan Lawsuits
As in all cases, people who think they have a claim against Reglan makers have to be mindful of the statutes of limitations, or the legal deadlines for filing lawsuits, which can vary from jurisdiction to jurisdiction. The limit has caused problems for some people who were injured by the drug. For example, in August 2016, a Nebraska federal court dismissed a fraud suit against Pfizer Inc., Wyeth LLC and Schwarz Pharma Inc., because the plaintiffs had taken more than 10 years too long to sue.
Courts have also handed down rulings severely limiting cases against generic drug makers. It’s believed that about 95 percent of Reglan patients take a generic version, something that is encouraged by insurance companies for most drugs. Consequently, many law firms across the country have stopped taking Reglan cases.
However, some attorneys are representing people who were injured after taking Reglan for at least three months and developed serious side effects, such as tardive dyskinesia. The awards have ranged from small amounts to more than $1 million. Thousands of cases have been resolved through confidential settlements. The lawsuits seek compensation for pain and suffering, as well as lost income.
A 69-year-old woman in Rhode Island won a verdict totaling $2.95 million against her physician over his prescribing her Reglan for years.
In one case that reached a jury in 2007, a 69-year-old woman in Rhode Island won a jury verdict of $1.25 million – plus $1.7 million in interest – against her physician over his prescribing her Reglan for years, beginning in the early 1990s. According to a report in Lawyer’s Weekly, in 1995, the woman switched pharmacies, and the new pharmacist refused to fill the prescription because he believed she was having a reaction to the Reglan. The pharmacist contacted the physician about his concerns that the patient had developed a movement disorder. The note in the doctor’s office record was, “Thank you continue Reglan.”
In 2000, the woman was diagnosed with tardive dyskinesia, and after that, she filed suit against her doctor and pharmacy. The case against the pharmacy settled before the trial for a confidential amount.
Various courts, including the U.S. Supreme Court, have issued differing decisions about whether the drug makers could be sued for failing to adequately warn patients of the potential dangers of taking the medication. The U.S. Supreme Court has held that the makers of brand-name Reglan could be subject to such litigation, while manufacturers of generic versions could not. But some state courts have held their laws are different and not covered by the U.S. Supreme Court decision in this respect.
Some of the seemingly conflicting rulings:
- In August 2016, the New Jersey Supreme Court ruled unanimously that generic Reglan failure-to-warn lawsuits were not barred by federal law. The ruling allowed hundreds of claims against the generic makers, including Pliva Inc., Actavas Elizabeth LLC, and Teva Pharmaceuticals USA Inc., to move forward.
- The U.S. Supreme Court, in March 2015, declined to consider a Pennsylvania appeals court ruling that the maker of a generic version of Reglan had to face failure-to-warn claims in state court.
- In January 2015, a Mississippi federal judge ruled that brand-manufacturers Wyeth and Alaven Pharmaceuticals could not be sued for the suicide of a patient who took a generic form of the drug that they did not make. The makers of the generic form of the drug had earlier been dismissed from the case because of a 2011 Supreme Court ruling that spared generic drug companies from state failure-to-warn claims. The patient’s mother, Diane Truddle, had filed the lawsuit without the aid of an attorney.
- But in January 2013, the Alabama Supreme Court ruled that a patient could sue brand-named manufacturer, Wyeth, even though he had taken the generic form of the drug. A lawyer for Pfizer, which owned Wyeth, told The New York Times that the decision ran counter to more than 70 other court decisions that had gone the other way. The state Legislature in 2015 changed the law to prevent such lawsuits.
- In 2011, the U.S. Supreme Court ruled in a generic Reglan case, held that generic drug manufacturers could not be sued for failing to warn of potential serious side effects. In 2008, the same court had ruled that makers of brand-name drugs could be sued under state law for failing to warn about potential serious side effects.
Elaine Silvestrini is a career journalist with a strong desire to learn, explain, and help people. While working at Drugwatch, Elaine has reported on breaking news involving prescription drugs and medical devices and has written pieces on several large pharmaceutical companies and other topics. She is dedicated to telling people what they need to know about developments in the news, and helping consumers understand what they can do when something goes wrong with their drugs and medical devices.