Failure-to-Warn Claims Dismissed in Generic Reglan Lawsuit

Shay Morrigan | January 4th, 2012 | Posted in Reglan Lawsuit News

Plaintiffs Joshua A. Whitener, Sr., and his wife, Lindsey C. Whitener, originally brought a Reglan lawsuit against manufacturer Pliva Inc. and makers of the generic Reglan (metoclopramide), claiming serious Reglan side effects, including Reglan tardive dyskinesia. They also asserted that the manufacturing companies failed to warn of the serious health risks.

Generic Reglan side effects lawsuit claims dismissed by judge

In a December 6, 2011 order, Judge Eldon Fallon of the U.S. District Court for the Eastern District of Louisiana ruled that the failure-to-warn claims in the Whitener’s generic Reglan lawsuit are federally preempted because the generic versions of Reglan must follow exactly the warning labels of the brand-name drug.

In addition, the judge granted the Reglan side effects lawsuit plaintiffs leave to amend their complaint so that it contains sufficient facts to show that the defendants marketed or promoted the anti-nausea medication for off-label purposes in a manner that violated federal law.

Reglan side effects include Reglan tardive dyskinesia

According to the Whiteners’ Reglan side effects lawsuit, plaintiff Lindsey Whitener was prescribed metoclopramide to treat nausea and morning sickness during her pregnancy. As a result, she claims to have developed Reglan tardive dyskinesia.

Reglan tardive dyskinesia is a movement disorder characterized by uncontrollable muscle movements like grimacing, lip smacking, rapid eye blinking, chewing and sucking motions. The risk of Reglan tardive dyskinesia increases the longer a patient takes the drug.

Reglan side effects lawsuit also claims birth defects

In addition to Lindsey Whitener’s Reglan tardive dyskinesia, she and her husband also claim in their Reglan side effects lawsuit that the drug caused their son, Lucas, to be born with severe developmental disabilities and spend the first six months of his life in the hospital.

A year later Mrs. Whitener saw a television commercial about Reglan side effects, and learned the drug was not approved by the FDA for use during pregnancy. In her lawsuit, she claimed not only that the manufacturers had failed to warn of the risks, but that in spite of the allegedly known risks of Reglan birth defects, the manufacturers marketed and/or promoted it for off-label prescription to pregnant women.

Reglan side effects lawsuit may be amended

Though the Whiteners’ claims of failure-to-warn in their Reglan side effects lawsuit have been dismissed by the court due to federal preemption, they still have a chance to recover damages if they can gather sufficient facts to support a claim that the manufacturers promoted metoclopramide for off-label use during pregnancy.

To win compensation for Reglan side effects, the plaintiffs will have to show what marketing or promotional representations were made by the defendants, and how they violated federal law.