Generic Reglan Labels Not Preempted by Federal Regulations

Washington, DCA spate of lawsuits have been lodged against generic and brand-name manufacturers of Reglan for their perceived failure to provide consumers with adequate information about Reglan side effects on the drug labels.

According to the January 12 issue of Drug Industry Daily, the US Court of Appeals for the Fifth Circuit ruled in a liability case against Actavis, a generic manufacturer of Reglan, that such suits are not preempted by federal regulations.

The ruling, along with a similar ruling by the US Court of Appeals for the Eighth Circuit in December, may help guide generic drug makers to a new line of defense against product liability lawsuits.

Actavis argued that it was unable to change the labeling for its generic version of Reglan, since the US Food and Drug Administration (FDA) requires that the labeling for generic drugs be identical to that of its brand-name counterpart. The court held that Actavis could have used FDA procedures to make any changes the company deemed necessary, or asked the FDA to forward communiqués to physicians alerting them to risks associated with the drug.

In a different Reglan suit, the Eighth Circuit Court decreed that the generic manufacturers couldn't use federal preemption as a shield against liability claims. Actavis, Teva Pharmaceuticals USA, Alpharma Pharmaceuticals and Actavis Elizabeth were all named as defendants in the suit.

"The regulatory framework makes clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug," said the Eighth Circuit court.

With regard to the Fifth Circuit decision, plaintiff Julie Demahy had been prescribed Reglan for gastroesophageal reflux disease but was given the generic version made by Actavis. After remaining on the drug for an extended period of time, Demahy developed tardive dyskinesia, a condition characterized by uncontrolled movement of facial muscles and other extremities.

Demahy is suing Actavis for failing to warn of the risks associated with long-term use of the drug. The Fifth Circuit decision upheld a ruling from the US District Court for the Eastern District of Louisiana in Demahy's lawsuit.

The US Supreme Court took a similar view in the case Wyeth v. Levine (Wyeth being the manufacturer of a brand-name drug). The ruling held that drug makers are not prohibited from revising drug labeling to include new warnings for which they may seek FDA approval.