Recent Reglan Litigation News: Reglan Lawsuit Goes to the Supreme Court

Branden Samuels | March 31st, 2011 | Posted in Reglan Lawsuit News

In recent Reglan litigation news, a Reglan lawsuit being heard this week by the United States Supreme Court could have seismic repercussions on the way the pharmaceutical industry does business.

On Wednesday, the highest court in the country heard arguments from both sides of the litigation in Pliva Inc. v. Mensing, which pits a woman struck by Reglan side effects against the makers of a generic Reglan.

Plaintiff Gladys Mensing continues to live out a nightmare with generic Reglan that echoes the experience of millions of generic drug users across the US.

Generic Reglan use led to tardive dyskinesia

A former waitress from Minnnesota, Ms. Mensing was prescribed generic Reglan (metoclopramide) in 2001 to treat heartburn and acid reflux. After 4 years of use, she developed Reglan-induced tardive dyskinesia, a severe neurological disorder that has long been linked to metoclopramide.

Yet it wasn’t until 2009 that the FDA required brand-name Reglan carry a “black box” warning for tardive dyskinesia. Federal law dictated the boxed warning would carry over to generic forms of the medication as well.

But lawyers for the plaintiff in this Reglan lawsuit say makers of the generic Reglan were required by state law to warn about Reglan tardive dyskinesia sooner. The risk was well established. The generic drugmakers we’re responsible for communicating that risk with doctors and patients.

Defense lawyers counter that federal law prevents generic drugmakers from using a label that was never used by the brand name drug or approved by the FDA.

Justice Antonin Scalia summarized the disconnect at the center of the generic vs. brand-name conflict. Generic makers don’t “know anything about science.” A generic maker “knows how to replicate this pill exactly. That’s all he really knows.”

And that’s what makes generics considerably cheaper than their brand-name counterparts.

Justice Sonia Sotomayor voiced doubt that state and federal laws ever meant for the pharmaceutical industry to be two-pronged.

“Do you think Congress really intended to create a market in which consumers can only sue brand-named products? Because if that’s the case, why would anybody ever take [a generic]?”

Louis M. Bograd, attorney for the plaintiffs in the Reglan lawsuit, said during the Wednesday proceedings that generic prescriptions make up 70 percent of all prescriptions filled in the US. Many have no brand-name counterparts.

“If generics are not responsible, in many of these cases no one is responsible.”

It is believed the Supreme Court will rule on the Reglan lawsuit by late June.