EL DORADO, Ark. Ã¯Â¿Â½ After a year of taking a drug to combat a medical condition involving paralysis of stomach muscles, an Arkansas resident started exhibiting abnormal muscle movements throughout her body.
Kecia Neal has filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., the manufacturers of the drug Reglan and its generic equivalent metoclopramide. The product liability suit was filed on May 27, 2009, in the El Dorado Division of the Western District of Arkansas.
The drug Reglan is used to treat gastrointestinal disorders but has been linked to an increase risk of tardive dyskinesia, a condition that results in involuntary and repetitive movements of the body. Currently, there is no known treatment for tardive dyskinesia. In some patients, the syndrome's symptoms may be reduced in the weeks or months following the cessation of the drug.
Neal was taking the drug for treatment of gastroparesis.
The Food and Drug Administration required the drug's manufacturers to provide the addition of a boxed warning in February 2009. The new warning stated "chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement that is often irreversible."
In addition, the new warning stated "prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases."
The plaintiff states that she did not have access to these warnings and therefore, took the drug for more than a year. She states her use of the drug as prescribed resulted in overexposure and caused her to suffer serious, permanent and disabling injuries.
According to the lawsuit, nearly one-third of all patients who used the drug received a prescription for 12 months or longer, rather than 12 weeks or less. Those patients who took the drug for longer than 12 weeks are at a 100 times greater risk for the disorder and other similar side effects.
Neal argues that the defendants failed to warn doctors and patients of information within their knowledge and possession regarding the increased risk of debilitating side effects.
Further, the plaintiff argues that the defendants "encouraged the long term use of these drugs, misrepresented the effectiveness of these drugs and concealed the drug's dangerous side effects."
Causes of action filed against the defendants include negligence, strict liability, misrepresentation, fraud and breach of implied and express warranties.
The lawsuit alleges that the defendants failed to use due care in developing, testing, designing and manufacturing the drug, failing to provide proper or adequate warnings regarding the adverse side effects, failing to conduct adequate pre-clinical and clinical testing, and failing to adequately train medical providers regarding the appropriate use.
"Defendants breached these warranties (both express and implied) as the Reglan/metoclopramide was not merchantable, was unfit for its intended use and was unreasonably dangerous when comparing the benefits to the risks associated with its use," the complaint states.
The plaintiff is seeking damage for past and future medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, disability, psychological injury, loss of ability to provide household services, loss of earnings, and loss of earning capacity.
Arguing that the defendants "had actual, subjective awareness of the risks involved, but nevertheless proceeded with conscious indifference to the rights, safety or welfare of Plaintiff," the plaintiff is seeking punitive damages in excess of $75,000.
With the potential for numerous litigations against the drug, the case is expected to become part of a multi-district litigation (MDL-2049).
Little Rock attorney George Wise Jr. of The Brad Hendricks Law Firm and Dallas attorney William B. Curtis of Miller, Curtis and Weisbrod LLP, represent the plaintiff.
U.S. District Judge Harry F. Barnes is assigned to the litigation.
Case No 1:09cv01027