Supreme Court Argument Begins in Dangerous Drugs Lawsuit Against Generic Drugmaker

Supreme Court Trial Starts in Dangerous Drugs Lawsuit Against Generic DrugmakerThe U.S. Supreme Court has begun hearing arguments relating to the dangerous drugs lawsuit filed by a Louisiana woman who claims she developed involuntary body movements after taking an acid reflux drug.

According to the Times-Picayune, 61-year-old Julie DeMahy of Slidell says she first began experiencing heartburn in 2001 and visited her doctor, who gave her a prescription for generic Reglan, also known as metoclopramide. She stopped taking the drug when the heartburn went away, but found she was developing a new symptom – parts of her body were moving uncontrollably and shaking, the dangerous drugs lawsuit says. She was then diagnosed with tardive dyskinesia, a permanent disorder marked by uncontrollable body twitches.

At the time of DeMahy's consumption of the drug, defendant Actavis, Inc. ran a label describing tardive dyskinesia as a rare side effect of generic Reglan. According to the news source, the generic drugmaker immediately asked the court to dismiss DeMahy's lawsuit on the grounds that they were legally required to include the same warning label as the brand-name drugmaker, which they had allegedly done.

The dangerous drugs lawsuit was not dismissed however, as both a district court judge and judges for the 5th Circuit U.S. Court of Appeals upheld the suit. According to MedPage Today, lawyers for the departments of Justice and Health and Human Services argued that generic drugmakers have an obligation to propose changes to the warning label that both they and the brand-name manufacturer are subject to if they become aware that the drug carries hazards not explained on the existing label.

According to the news source, the high court's decision could be a landmark ruling that decides if generic drugmakers could be held liable for side effects even if their warning labels are made identical to those of the brand name manufacturer.