NJ Court Rules that Makers Reglan Failed to Warn of Harmful Side Effects
A New Jersey appellate court affirmed a 2013 judgment in favor of plaintiffs who were injured by the gastric reflux drug Reglan. The appellate court affirmed on November 12, 2014 the earlier decision of a New Jersey trial court, which had determined the plaintiffs’ failure-to-warn claims, based state law, can proceed against the manufacturers of Reglan and are not preempted by federal law.
Reglan, or metoclopramide, has various harmful side effects including tardive dyskinesia, which is a neurological syndrome characterized by repetitive, involuntary movements. Symptoms include lip smacking, grimacing, tongue protrusion and the puckering or pursing of lips. The plaintiffs, who are suing numerous pharmaceutical companies, allege that they sustained these personal injuries as a result of consuming Reglan or generic metoclopramide.
The plaintiffs have filed claims including:
- Negligent misrepresentation of the risk of physical harm.
- Defective design.
- Failure to warn.
- Breach of express warranties and breach of express and implied warranties.
- Negligence, negligent misrepresentation, and negligent infliction of emotional distress.
- Fraud, fraudulent concealment, and constructive fraud.
- Violation of consumer protection laws.
- Wrongful death.
The New Jersey trial court noted the plaintiffs’ claims tended to revolve more around products liability claims rather than a failure to provide adequate warnings regarding Reglan. The trial court further determined the multiple generic pharmaceutical defendants had not sufficiently shown any reason preventing them from including the additional warnings for their generic metoclopramide tablets.
The “Generic Defendants,” as the appellate court referred to them, had a duty under federal law to adopt the changes to the brand name warning labels on the drugs.
The New Jersey appellate court relied heavily on the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetics Act (“FDCA”). The FDCA states that a brand-name manufacturer seeking FDA approval of a new drug must ensure the accuracy and adequacy of the drug’s warnings and label.
Beyond this, the FDCA also requires that a manufacturer seeking approval of a generic drug must ensure its warning label is the same as the label for the equivalent brand-name drug.
Designed for short-term treatment
The FDA first approved metoclopramide in 1980, and the drug was marketed under the name Reglan. Metoclopramide was designed for short-term treatment of gastroesophagel reflux disease and it was available in both tablet and syrup form.
In February 2009, the FDA ordered a “black box warning,” its strongest label warning, to be placed on Reglan’s label. The newest label stated ”Treatment with metoclopramide for longer than 12 weeks should be avoided,” and that treatment with metoclopramide could cause tardive dyskinesia, “a serious movement disorder that is often irreversible.”
The Reglan plaintiffs will be able to proceed with their claims, now that the Appellate Court has affirmed the trial court’s decision that the Reglan plaintiffs’ claims are not preempted by federal law.
The case is Rosa Nunez and Carlos Garcia v. St. Mary's Hospital, Dr. Alina O. Libster, Paola Escobar, C.n.m., Wthel Hamech, R.N. and Jocelyn Grandchamp, R.N., Superior Court of New Jersey, Appellate Division, Docket No. A-0014-13t1.