Reglan, with the generic name metoclopramide, is a drug used to treat gastrointestinal issues and esophageal problems, like heartburn and ulcers. It was developed by Wyeth, but ultimately bought and controlled by Pfizer. Most people tolerate the medication well and it can prove essential for some who are suffering with very uncomfortable and even painful symptoms. Reglan also causes some side effects and very serious complications in some patients.
Reglan lawsuits have been filed over some of these complications, which include a movement disorder that can be debilitating, called tardive dyskinesia. Other possible issues include a neurological condition and depression. Some people have been left with permanent health problems after taking Reglan and this has spurred a number of lawsuits against Pfizer and other drug companies making similar medications.
What is Reglan?
Reglan is a medication used to treat conditions that affect the esophagus and gastrointestinal systems. The generic name for the drug is metoclopramide and there are a few different formulations. The patent that Pfizer owned ran out and now there are generic forms of Reglan available. There are several reasons that someone might be prescribed metoclopramide, but for some of these it is considered a drug of last resort, to be used when other treatments failed.
Reglan is used to treat heartburn and to treat the esophageal ulcers that form in people living with gastroesophageal reflux disease, or GERD. It can be used in people, typically with diabetes, whose stomachs empty too slowly. It helps to soothe the symptoms of slow emptying. Reglan can also be used as an antiemetic, and anti-nausea medication, and may be given to people with nausea from chemotherapy or radiation treatment, severe migraines, severe morning sickness, and a few other conditions.
Reglan Causes Tardive Dyskinesia
One of the main reasons for Reglan lawsuits that have been filed is a condition called tardive dyskinesia (TD). The U.S. Food and Drug Administration (FDA) warned about this condition in 2009. The official announcement stated that any medication containing metoclopramide had the potential to cause TD. The risk was considered great enough and the condition serious enough to require that these mediations carry a black box warning, the FDA’s strongest warning label.
TD is a movement disorder that is characterized by involuntary muscle movements, spasms, and twitches. These mostly occur in the lower half of the face, although the movements can be anywhere in the body. The main symptom of TD is experiencing muscle movements that can’t be controlled. Some of the most common of these are puffing of the cheeks, grunting, frowning, chewing, sticking out the tongue, blinking, and smacking lips.
Because the movements mostly occur in the face, the condition can be embarrassing and life-altering. Especially troubling is that the condition may become permanent. If signs are caught early, and use of the medication stopped, a patient has a decent chance of recovery, but if not caught soon, it can become a permanent disability. The debilitating nature of a permanent condition like this means that people may suffer lifelong medical expenses, shame, and an inability to work or maintain relationships.
The risk of developing TD while on metoclopramide is highest for patients taking it in higher doses and over a longer period of time. In the official warning, the FDA recommended that no one should be taking it for longer than 12 weeks at a time. Also at a greater risk are diabetics and older women.
Other Complications of Reglan
TD has gotten the most attention, but metoclopramide can cause other serious complications, including a condition called neuroleptic malignant syndrome. It is rare, but serious and can even become fatal if not treated. This condition causes an irregular heartbeat, stiff muscles, cognitive problems, sweating, and a fever. Another possible complication of using Reglan is depression. Some people who never had a problem before become suicidal while on the medication. Either of these issues could be the basis for a lawsuit against the drug maker.
Why People File Reglan Lawsuits
Metoclopramide lawsuits have been filed in the thousands, against Wyeth, Pfizer, and other drug companies that make versions of the generic drug. The main reason that they have been filed is because plaintiffs developed TD and had painful, uncomfortable, and lifelong outcomes because of it. Many of these patients have suffered with permanent neurological damage because of TD.
The plaintiffs making their cases claim that the drug companies did not adequately warn the public about the risks of TD. They say that the risk was downplayed and that the warning labels, before the FDA required a black box warning, made it seem as if TD were possible, but would easily disappear if use of the drug were discontinued. Plaintiffs also allege that the drug companies failed to test metoclopramide properly and to inform the FDA of all the risks.
Metoclopramide and Reglan Lawsuits
Of the thousands of lawsuits filed because of metoclopramide, none have been consolidated into multidistrict litigation, as is the case with many other drug lawsuits. The reason for this is that there are multiple defendants, the many companies that make and sell metoclopramide. Even without consolidation, many plaintiffs have made their way to court before a judge or jury to make their cases and some have won settlements.
Several plaintiffs won settlements in 2014, but many cases are still ongoing. In some individual cases judges ruled against the drug companies stating that the drug companies did fail to warn consumers about the severity of the risk of developing TD. Those drug companies fought hard to deny any negligence, often relying on the argument that makers of generic drugs should be protected from litigation.
If you have been harmed because of taking Reglan or another metoclopramide drug, you may still have time to make your case in court. The drug companies are largely being found to have failed to warn the public about how risky this medication can be. It has been on the market for decades and yet these manufacturers did not issue a serious warning until forced to by the FDA. If you feel you have a case, contact a lawyer to discuss your options.