New Legislation May Impact Generic Reglan Lawsuits

Ava Lawson | February 24th, 2013 | Posted in Reglan Lawsuit News

Courthose Thumbnail 1In recent years, both state and federal courts have dismissed lawsuits involving allegations of injuries caused by generic equivalents of Reglan and other medications. Based on a landmark Supreme Court ruling in Pliva v Mensing, which was handed down in 2011, generic drug manufacturers cannot be held responsible for failing to provide side effect warnings, on condition that their product labeling mirrors that of the brand-name medication.

As a result of this Supreme Court decision, plaintiffs have had little legal recourse if injured by generic forms of Reglan and other drugs, as the manufacturers were absolved of legal liability in cases where their warning labels complied. However, in recent Reglan lawsuit news, federal regulators are contemplating new legislation for generic warning labels, which may have the potential of reversing the effects of Pliva v Mensing.

Pending legislation may impact lawsuits filed by Reglan lawyer

For many plaintiffs seeking Reglan settlements or jury awards after suffering serious injuries from the generic medication, the Pliva v Mensing decision seemed unjust. Approved by the FDA for the treatment of heartburn caused by gastroesophageal reflux, Reglan (metoclopramide) and its generic versions have been linked to a slew of neurological side effects such as tardive dyskinesia, cervical dystonia and neuroleptic malignant syndrome. A black box warning regarding tardive dyskinesia was added to Reglan labeling in 2009 at the insistence of the FDA, but before the drug label was updated, hundreds of patients took the medication and its generic form without full knowledge of potential side effects. The updated Reglan black box warning states:

“Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.”

Many who developed tardive dyskinesia filed claims through a Reglan lawyer only to discover that makers of generic drugs were protected under the 2011 Supreme Court ruling.

FDA considers regulatory change that may affect future generic Reglan lawsuits

In a January 2013 amicus brief in Mutual Pharmaceutical v. Bartlett, a brief annotation indicates that the FDA is taking into consideration new rules that would hold manufacturers of generic medications accountable for including adequate warnings of drug side effects and risks. The footnote says, “This Office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.”

This new legislation was mentioned in another milestone case, where a jury awarded Karen Bartlett – a New Hampshire resident – $21 million in a personal injury/product liability lawsuit, after she developed Stevens-Johnson Syndrome and toxic epidermal necrolysis from taking a generic form of Clinoril (an anti-inflammatory). Only time will tell if the FDA passes these new laws affecting liability of generic drug manufacturers indicted in current and future Reglan lawsuits.