The New Jersey Supreme Court ruled that 1,000 lawsuits filed against the generic makers of Reglan, a gastric reflux drug, can proceed in state court and that the claims are not pre-empted by federal law. The manufacturers failed to match the warnings in brand-name labeling that long-term use of the drug causes severe neurological disorders.
For the third time in two years, the New Jersey courts have denied defense arguments that claims brought under the New Jersey Product Liability law are pre-empted by federal law, and ruled that the holding in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) does not apply.
The case is In Re: Reglan Litigation, Case No. 075269 (August 22, 2016). The defendants include PLIVA Inc., Barr Pharmaceuticals, LLC, Barr Laboratories, Inc., Watson Laboratories, Inc., Actavis-Elizabeth LLC, Teva Pharmaceuticals USA, Inc., Mutual Pharmaceutical Company, Inc., and United Research Laboratories, Inc.
“Federal preemption is inapplicable because defendants did not have to violate federal law in order to comply with state law, and it was not impossible to comply with both federal and state law,” the court said. “Plaintiffs’ state law claims highlight the inadequacy of the warnings for a drug, which if used for a prolonged period, could cause grave harm.”
“No law prevented defendants from giving the same warnings that appeared on the labeling of the brand-name drug — the warnings that plaintiffs contend the [New Jersey Product Liability Act] required,” the NJ Supreme Court said. “Defendants did not have to violate federal law to comply with state law.”
In 2004, the brand-name manufacturer of Reglan, known generically as metoclopramide, received approval from the FDA to publish new label warnings about the dangers of the long-term use of the drug. The plaintiffs took metoclopramide, the generic form of Reglan. The generic drug manufacturers did not timely upgrade their label warnings to match the FDA-approved brand-name labeling. Due to the allegedly inadequate generic drug warnings, the plaintiffs took metoclopramide beyond the prescribed period, causing them to develop tardive dyskinesia, a neurological disorder characterized by involuntary, repetitive body movements.
The plaintiffs filed failure-to-warn product-liability actions against defendants in New Jersey state court. The defendants argued that federal law preempts plaintiffs’ state-law claims. The trial court denied the defendants’ motion to dismiss and denied their motions for summary judgment. The Appellate Division upheld the ruling and now the Supreme Court affirmed as well.
“Defendants have managed to delay this litigation for years through endless rounds of interlocutory appeals,” Louis Bograd of Motley Rice LLC, who argued for the consumers, told Law360.
“Had defendants provided the same labeling as the brand-name manufacturers, as required by federal law, defendants would have enjoyed a safe harbor. Here, however, defendants did not provide the same warning labels that the FDA approved for the brand-name manufacturers. As alleged, defendants’ inadequate labeling breached a duty of care under the New Jersey Product Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11,” the NJ Supreme Court ruled.
An appellate split
The ruling creates a split among appellate courts, according to Law360:
- In a 2013 decision, a Fifth Circuit panel decided not to revive failure-to-warn claims against generic makers, finding that they didn’t have a duty to warn about the health risks of Reglan because brand-name manufacturers didn’t take action.
- Similarly, the Sixth Circuit in the same year also ruled that such claims against generic-drug makers over Reglan labeling were preempted.
- However, the Pennsylvania Supreme Court ruled in 2014 that state law claims over generic Reglan labels weren’t necessarily preempted.
- Last year, the U.S. Supreme Court denied three petitions by drugmakers to review the ruling.