The New Jersey Supreme Court unanimously upheld a lower court’s 2014 ruling that consumers with state law claims blaming the manufacturers of generic versions of the heartburn drug Reglan for not adequately warning about neurological side effects, are not preempted by federal law.
The lawsuits claim that generics manufacturers, including Pliva Inc., Actavis Elizabeth LLC, and Teva Pharmaceuticals USA Inc., delayed changing the labels of generic Reglan, known chemically as metoclopramide so that it conformed with the brand-name version of the drug.
The New Jersey Supreme Court said that by not changing the labels to match that of the brand-name drug, the generics manufacturers violated the federal Food, Drug and Cosmetic Act.
“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 New Jersey Supreme 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.”
The lawsuit stems from a safety label update that the Food and Drug Administration (FDA) approved for Reglan in July 2004 that warned that using the drug for longer than 12 weeks could cause patients to develop a debilitating movement disorder known as tardive dyskinesia. In 2009, the safety label of Reglan was updated with a black box warning involving tardive dyskinesia risk.