Reglan Lawsuits Lead to Debate Over Corporate Immunity for Generic Drug Makers

Washington, DCLawsuits stemming from Reglan side effects have prompted a new round of debate over federal laws that provide complete immunity from state lawsuits even when cases of serious harm have been linked to their products.

The US Supreme Court has called on the Obama administration to take a stand in the situation, which grew out of the Eighth Circuit court decision in last November's Mensing v. Wyeth suit. The state court's ruling found the generic manufacturer, Mensing, responsible for the mislabeling of generic Reglan (metoclopramide), a controversial judgment given that federal regulation seemingly preempts lawsuits in lower courts.

Generic forms of Reglan were singled out in a 2009 FDA ruling that linked the medication to tardive dyskinesia, a debilitating movement disorder characterized by involuntary gyrations and movements, prompting the organization to issue a black box warning on all boxes of Reglan, name brand and generic alike.

The FDA's action was the first warning to appear on the drug's labeling that expressed the potential severity of the drug's side effects, prompting numerous lawsuits for makers of the three decade-old drug.

In 2008 the Supreme Court ruled that Wyeth, the name brand manufacturer of Reglan, was responsible for the adequate labeling of its products, and since then makers of generic Reglan have campaigned for immunity from prosecution on lawsuits related to the medication.