Legal Basis for a Reglan and Tardive Dyskinesia Lawsuit
Tardive dyskinesia has long been known to be caused by the side effects of drugs known as dopamine antagonists, used to treat patients for certain forms of mental illness. However, one such drug, known as metoclopramide and marketed under the brand name Reglan, has also been used to treat individuals suffering from two specific digestive disorders: most commonly, gastroesophageal reflux disease (GERD) and diabetic gastroparesis (full or partial paralysis of the stomach).
Whether used to treat mental illness or digestive disorder however, the result is the same; a series of compulsive, involuntary muscular movements, contractions and tics that can be embarrassing and in some cases, disabling and/or even health and life-threatening.
Those who have experienced these symptoms as the result of using Reglan as it was intended have in legal terms been injured. Personal injury law, or torts, is a massive area of law, covering medical malpractice and auto accidents to dog bites and minor property damage. Reglan lawsuits fall under the category of product liability – which means that the manufacturer is responsible for any damage its product may cause to a consumer when used according to instructions.
The Basis of a Legal Claim
This last part is important. A claim must have a basis, which can cover several issues. One of these has to do with whether or not the claimant was misusing the product. This is highly unlikely to be the case in a Reglan lawsuit, since it is a prescription drug given to patients under a doctor's supervision. This only thing that might hurt a Reglan claim in this regard would be if the patient had taken a deliberate overdose on a regular basis or had otherwise abused the drug.
Assuming that the drug had been legitimately prescribed by a licensed medical professional and the claimant, or plaintiff, had taken the drug in the assigned dose for the purpose for which it was prescribed, the basis of the claim has to do with the manufacturer and its obligations toward the consumer.
Failure To Warn
Most product liability cases are based on the allegation that the manufacturer had known about the hazards of a given product and had failed to issue an adequate warning to the consumer. In this case, there is clear and convincing evidence, as dopamine antagonists have long been known to cause tardive dyskinesia.
Unlike other dopamine antagonists, metoclopramide was never widely used as an antipsychotic treatment, although it was initially developed for this purpose in the 1960s. Metoclopramide was found to be less effective than other neuroleptic drugs then being used to treat schizophrenia in mental patients; it was however effective in controlling nausea, vomiting and heartburn as well as GERD and gastroparesis.
In fact, the relationship between metoclopramide and tardive dyskinesia were known prior to the 1990s. At that time however, this drug was being supplanted by another substance known as cisapride (marketed under the brand name Propulsid). During this period, attention to the connections between the former drug and tardive dyskinesia among members of the medical community decreased. Although highly effective in increasing muscle tone in the digestive tract and treating gastroparesis as well as constipation, the long-terms side effects became apparent; the FDA issued a warning to doctors in 2000 and the drug was taken off the market – clearing the way for metoclopramide to make its comeback.
Researchers predicted at that time that an increase in tardive dyskinesia cases was likely as doctors returned to the use of metoclopramide, which was perceived as an "older, safer" form of medication. In fact, they turned out to be correct. The researchers published their findings in 2004 – but due to lax regulation and the fact that the federal government at that time was more interested in protecting the interests of the pharmaceutical corporations that the health and safety of citizens, no serious warnings were issued until February of 2009.
The bottom line – the manufacturers and the medical community knew, or should have known about the hazards associated with Reglan; they thus had duty of care toward the consumers of the drug to warn them of the side effects. Therein lies the basis of liability.
Those who believe they have a Reglan claim will need documentation as to who manufactured their prescription (it has been "generic" since 1982, therefore the drug may have been produced by any number of drug companies) as well as medical and prescription records.
© 2010 TardiveDyskinesia.com Last Modified Friday, April 23rd, 2010
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