Supreme Court to Hear Generic Drug Side Effects Label Exemption Case

The U.S. Supreme Court has decided to hear an appeal filed by generic drug makers, who say that federal laws requiring their labels to match those of the original medication should allow them to escape liability from product liability lawsuits that allege they failed to properly warn about dangerous drug side effects. 

The case involves a generic Reglan lawsuit brought by Gladys Mensing, of Minnesota. Mensing sued generic drug makers after she was diagnosed with tardive dyskinesia, a rare movement disorder that has been linked to Reglan and its generic equivalent; metaclopramide. The case has worked its way through the federal court system and the Supreme Court announced on Friday that it would hear the case.

The decision to hear the case comes after the U.S. Solicitor General asked the Supreme Court to decline the appeal, arguing that an 8th Circuit Court of Appeals decision rejecting generic drug manufacturers’ arguments should be upheld, and stressing that the lawsuit over generic Reglan is a poor test case for preemption involving generic drugs.

At issue in the appeal is whether a generic drug manufacturer can change the label or otherwise warn the public of a health risk that was not placed on the label by the original manufacturer of the drug. FDA regulations require that generics seeking approval have the same label as the brand name manufacturer, and it also stipulates that the generic’s label has to remain consistent with the brand name label. However, the lower appeals court ruled that the regulations do not prevent generics from requesting a label change to warn of a health risk, nor do they prevent the drug company from other methods of warning the public, such as sending out a “Dear Healthcare Professionals” letter to warn of potential risks.

Reglan (metoclopramide) was originally introduced by Wyeth in 1989, and the drug company continued to market and distribute the drug through late December 2001, when Schwarz acquired the rights to Reglan. Schwarz continued to manufacture and distribute the drug until 2008, when they ceased production, leaving only generic metoclopramide versions. Since the mid-eighties metoclopramide generic has been manufactured by a number of companies, including the defendants in this case.

In February 2009, the FDA required that the manufacturers of all metoclopramide-containing drugs add a “black box” warning about the risk of tardive dyskinesia from Reglan. In addition, the manufacturers were required to develop a mitigation and risk evaluation strategy to help ensure that patients are made aware of the potential side effects of metoclopramide.

Tardive dyskinesia is a neurological disorder that causes repetitive and involuntary movements of the lower face and limbs. Symptoms can include repeated grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment for the condition, and the involuntary movements often persist even after use of the drug has stopped, contrary to what was previously suggested on the warning labels for Reglan and generic metoclopramide drugs.

While metoclopramide is only approved for short-term treatment of gastrointestinal disorders, like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying, it is often prescribed for longer periods of time given the chronic persistence of those ailments. Use of metoclopramide for more than 12 weeks has been shown to increase the risk of tardive dyskinesia and other movement disorders, and plaintiffs allege that the generic drug makers failed to adequately research their medications and attempted to minimize the risk.

The outcome of this case could impact hundreds of Reglan lawsuits over generic metoclopramide, which are pending in state and federal courts throughout the country. More than 70 Reglan suits are pending in New Jersey state court, with other cases scattered across the United States. Given the number of different generic drug makers involved in the Reglan litigation, the U.S. Judicial Panel on Multidistrict Litigation has declined to centralize the lawsuits. Therefore, all of the cases in federal court are proceeding as individual claims, with different judges sometimes ruling in conflicting ways on pretrial motions.