Sixth Circuit Rules Generic Reglan Manufacturer Failed to Update Label – Fulgenzi v. PLIVA

By March 20, 2013 July 10th, 2019 Dangerous Drugs, Reglan

As a pharmaceutical liability lawyer, I’ve written several posts here recently about generic Reglan lawsuits. Generic versions of Reglan, a drug for gastroesophageal reflux disease, have been the subjects of multiple lawsuits recently because Reglan and its generics can cause an irreversible neurological disorder called tardive dyskinesia. Reglan has also been in the news because it was the basis for 2011’s PLIVA v. Mensing, the U.S. Supreme Court decision that barred most generic drug lawsuits based on claims that the manufacturer failed to warn patients about the drugs’ risks. Since then, many if not most generic lawsuits have been dismissed, no matter how meritorious they might be. But in Fulgenzi v. PLIVA, the Sixth U.S. Circuit Court of Appeals reversed dismissal of Eleanor Fulgenzi’s tardive dyskinesia lawsuit, finding that the manufacturer failed to change its label when required to by the FDA.
Fulgenzi took Reglan (metoclopramide) at the end of 2004 and again for more than a year from 2006 to 2007. Scientists now believe that taking Reglan for an extended period substantially increases the risk of tardive dyskinesia, which causes uncontrollable movements, particularly of the face, and cannot be cured. But the only warning on the drug’s label before 2004 said taking it for more than 12 weeks has not been evaluated and cannot be recommended. The FDA approved a label change in 2004 that stated, in bold, “Therapy should not exceed 12 weeks in duration.” While that change went on to the name-brand label, it apparently did not get on the label of the PLIVA-manufactured generic taken by Fulgenzi. Her 2009 lawsuit alleged that this failure violated PLIVA’s federal “duty of sameness” and thus violated Ohio products liability law.
The federal district court in northern Ohio dismissed Fugenzi’s case, saying they were preempted by Mensing and also that there’s no private cause of action for failure to follow FDA regulations.
On appeal, however, the Sixth Circuit reinstated the lawsuit, finding no federal preemption. It said in Mensing, the Supreme Court’s decision rested on the idea that it would be impossible to comply with federal law and also state courts’ judgments in product liability lawsuits. Thus, it said, the question is whether PLIVA could independently update its label without consulting the FDA—and in fact, it said, PLIVA not only could have done so, but had a legal duty to do so. Thus, there is no impossibility preemption that would dismiss the case. The Sixth then found no purposes-and-objectives preemption in federal law. Finally, it found there was no need for a private right of action in federal drug regulations, because Fulgazi’s claim was premised on a violation of a state-law duty to warn. Thus, she does not fail to state a claim, the court said, and may proceed with her lawsuit.
As a dangerous drug attorney, I’m pleased to see that the court permitted this case to go forward. To rule otherwise would be to give drug manufacturers even more free rein than they already have to ignore basic safety. The fact that the manufacturer violated FDA rules by failing to update means that the FDA could have penalized it—but the agency apparently did not. Indeed, in my experience as a defective drug lawyer, the FDA frequently does not hold drug manufacturers to strict enough safety standards. That’s why so many patients like Fulgazi end up pursuing defective drug lawsuits in court. I’m pleased that people in her (hopefully unusual) situation will continue to be able to pursue justice.


If you believe an unreasonably dangerous drug or medication caused a serious injury, illness or death in your family, you should talk to Carey, Danis & Lowe about your legal rights. For a free, confidential case evaluation, send us an email or call 1-877-678-3400 today.
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