Drug Injury Lawyer Case: Reglan Side Effect

DRUG INJURY LAWYER CASE EXPLORES WHETHER U.S. LAW OVERRULES N.J. LAW

Here’s a digest of a recent drug injury lawyer case. In 2004, the manufacturer of Reglan received approval from the FDA to publish new label warnings about the dangers of the long-term use of the drug. (“FDA” stands for the Food and Drug Administration, a federal agency.)

The generic name of Reglan is metoclopramide. It is a prescription drug. Doctors prescribe the drug for ggastroesophageal reflux. They also prescribe it for relief  of symptoms associated with diabetic gastroparesis. (Gastroparesis, also called delayed gastric emptying, is a disorder that slows or stops the movement of food from the stomach to the small intestine.) Reglan speeds the movement of food through the digestive system.

Patients Claim Faulty Warning Labels on Generic Reglan Harmed Them

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Many people who took the generic form claimed that the generic drug manufacturers didn’t promptly upgrade their label warnings. Due to the allegedly defective drug warnings, people took metoclopramide beyond the prescribed period.  Consequently, they developed severe neurological disorders.

Drug Companies Claim U.S. Law Overrules N.J. Law

These victims’ drug injury lawyer filed product liability actions against the drug manufacturers in New Jersey state court. However, relying on a 2011 United States Supreme Court Ruling, the manufacturers argued that federal law precluded these New Jersey claims.

In its ruling, the Supreme Court explained that, under federal law, generic drug manufacturers must provide the same warning labels as those provided by the brand-name manufacturer. Therefore, the Supreme Court concluded that federal law preempted any state law claims against generic drug manufacturers for failing to give warnings exceeding those on brand-name labels. The rationale being that generic drug manufacturers could therefore not comply with state law without violating federal law.

The issue, however,  in the New Jersey case was whether a state-law failure-to-warn claim is precluded when a generic drug manufacturer gives warnings that are inferior to the manufacturer’s FDA-approved brand-name warnings.

The trial judge denied the manufacturer’s motions to dismiss the victims’ failure-to-warn claims.  The judge ruled that the federal preemption rule didn’t apply because the manufacturers had a separate duty under state law to provide adequate labeling. And their labeling did not match the brand-name labeling.

An appeals court upheld the trial judge’s ruling. The appeals court similarly ruled that the victims’ claims didn’t involve violations of federal law. Rather, the claims asserted that the drug companied failed to give adequate warnings under New Jersey’s product-liability law.

N.J. Supreme Court Rules for Victims.

The manufacturers appealed again to the New Jersey Supreme Court. That court upheld the appeals court’s ruling.  The victims’ failure-to-warn claims did not put state law and federal law in conflict.

Had the drug companies merely provided the same labeling as the brand-name manufacturers, as required by federal law, the victims could not have sued them. However, the companies did NOT provide the same warning labels that the FDA approved for the brand-name manufacturers.

No Contradiction Between U.S. and N.J. Law

Thus, the manufacturers inadequate labeling breached a duty of care under the New Jersey Product Liability Act.  Clearly, complying with both federal and state law was possible. The companies could have updated their labeling without violating the FDA’s “sameness” requirement.

I agree with these rulings. A good drug injury lawyer victory.

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