November 13, 2014 — An appeals court in New Jersey has ruled that failure-to-warn lawsuits involving generic Reglan (metoclopramide) are not preempted by federal law, according to the New Jersey Law Journal.
The issue has been contentious since 2011, when the Supreme Court ruled in Pliva v. Mensing that generic drug-makers cannot be held liable for failing to warn about side effects.
However, the three-judge panel ruled that generic drug-makers should make timely updates to their labels after new side effects are discovered. They are only immune from lawsuits if generic products carry the same warning labels as the brand-name drug.
Therefore, people who were injured when the labels on Reglan were different can pursue failure-to-warn claims.
Reglan is used for short-term treatment for heartburn and generic version have been available since 1985. In 2004, the label on brand-name Reglan was updated to warn that it should not be used any longer than 12 weeks. In 2009, the FDA required a “Black Box” warning about tardive dyskinesia.
Attorneys have filed more than 650 lawsuits on behalf of people who were injured by tardive dyskinesia, a chronic involuntary-movement disorder that causes repetitive chewing, blinking, tongue-thrusting, lip-smacking, and facial grimacing.
Nearly all of the lawsuits involve generic Reglan. Lawyers allege that generic drug-makers should be liable for failing to warn about side effects after the brand-name label was updated — some waited 6-8 months to update the label, another waited 13 months, and one did not make any changes until after the boxed warning was added in 2009.