November 13, 2014 — New Jersey Law Journal reports that a New Jersey appeals court has ruled that some failure-to-warn claims involving generic Reglan (metoclopramide) are not preempted by federal law and can proceed.
There has been confusion about what types of claims can be pursued against generic drug-makers since the 2011 Supreme Court decision Pliva Inc. v. Mensing, which held that generic drug-makers cannot be held liable for failing to warn about side effects.
However, immunity does not apply when generic drug-makers fail to make timely updates to the label after a brand-name manufacturer updates the label, according to a three-judge panel.
The decision means that generic drug-makers are only protected from lawsuits if their labels are the same as those used on the brand-name drug, according to Law360.
The plaintiffs took generic Reglan and were injured by tardive dyskinesia, an involuntary-movement disorder that can cause repetitive and uncontrollable lip smacking, chewing, blinking, and tongue-thrusting.
The original label on Reglan did not include warnings about tardive dyskinesia. In 2004, it was updated to say that Reglan should not be used for more than 12 weeks. In February 2009, the FDA ordered a “Black Box” warning about tardive dyskinesia.
Generic drug-makers did not change the label immediately. Some waited 6-8 months to update the label after the brand-name drug was updated. Others waited 13 months, and one did not make any changes until after the “Black Box” was added in 2009.
As a result, lawsuits are allowed from plaintiffs who took Reglan and were injured by side effects while the labels differed. The decision has significant implications for about 650 lawsuits, nearly all involving generic versions of Reglan that have been on the market since 1985.