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Generic Providers of Reglan Failed to Warn of Harmful Side Effects

A 2013 judgment in favor of plaintiffs who were injured by the gastric reflux drug Reglan was recently affirmed in the Superior Court of New Jersey Appellate Division.

The appellate court affirmed the decision of New Jersey's trial court on November 12, 2014, which had determined the plaintiffs' state law failure-to-warn claims can proceed against the manufacturers of Reglan and are not preempted by federal law.

For more information concerning In re: Reglan Litigation, view the Appellate per curium opinion.

Tardive dyskinesia

Reglan, or metoclopramide, has various harmful side effects. It can cause 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 a wide array of pharmaceutical companies, allege that they sustained these personal injuries as a result of consuming Reglan or generic metoclopramide.

The plaintiffs, who are seeking both compensatory and punitive damages for their experiences with Reglan side effects, 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. In affirming the trial court's reasoning, the appellate court said,

[I]f labels belonging to generic manufacturers of tablets did not match the brand-name manufacturers of tablets, then there are [at] least some changes to their labels that federal law would allow, or even require, these defendants to make, and state tort law in this situation does not conflict with federal law. Consequently, . . . to the extent that generic manufacturers of metoclopramide tablets failed to update the labels to be the same as the brand-name label, they are excluded from preemption.

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. The appellate court stated, "The FDA has interpreted its regulations as imposing upon generic drug manufacturers an ongoing federal duty 'sameness,' meaning that their warning labels must always be the same as those of the 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.

Five years after the FDA approved Reglan, generic manufacturers began marketing the drug. Evidence thereafter arose indicating that that long-term users of metoclopramide faced a significant risk of developing tardive dyskinesia, the severe neurological disorder described above.

The original Reglan label stated that "therapy longer than 12 weeks has not been evaluated and cannot be recommended." In 1985, the warnings were changed to say, "tardive dyskinesia may develop in patients treated with metoclopramide.” In 2004, the label was again changed to boldly state that "therapy should not exceed 12 weeks in duration."

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."

Plaintiffs proceed

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 based on the generic defendants' failure to update their warnings to conform to changes made by the brand-name drug warnings are not preempted by federal law, The Reglan plaintiffs' claims have been determined to be grounded in state law and are not based solely upon a federal violation because these claims fall "within a traditional area of state concern and regulation."

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