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TRENTON, N.J. — (Mealey’s) A New Jersey state appeals court panel on Nov. 12 affirmed a lower court ruling that generic drug manufacturers can be sued for failure to update their labels with warnings added to the labels of the predecessor drug (In Re: Reglan Litigation, No. A-2014-13T4, N.J. Super., App. Div.).
(Opinion available. Document #28-141120-004Z.)
In 2010, plaintiffs filed an amended master long-form complaint in a multicounty litigation docket in the Atlantic County Superior Court against seven generic manufacturers of metoclopramide, the generic equivalent of the prescription heartburn drug Reglan. The plaintiffs claim that long-term use of the drug can cause tardive dyskinesia, a permanent neurological injury, and that the drug’s labels failed to warn of that risk.
Defendants are Actavis Elizabeth LLC, Barr Pharmaceuticals LLC, Mutual Pharmaceutical Co. Inc., PLIVA Inc., Teva Pharmaceuticals USA Inc., Watson Laboratories Inc. and United Research Laboratories Inc.
2 Nonpreemption Rulings
In May 2012, the trial court ruled that generic defendants had not shown that federal law prevented them from including on their labels additional warnings about tardive dyskinesia that were added to the Reglan label. It found that the defendants had a federal duty to adopt changes made to the Reglan label.
After the court allowed discovery into the dates that new warnings should have been included, some defendants argued that they did update their warning labels within a reasonable time. PLIVA argued that it had divested its metoclopramide product; Watson argued that when it bought the drug from PLIVA, it updated the label in a timely manner.
The trial court in May 2013 again ruled that plaintiffs’ failure-to-update claims are not preempted by federal law and that there was a genuine issue of material fact as to whether generic defendants added new warnings in a timely manner and if the warnings were adequate.
The New Jersey Superior Court Appellate Division denied the defendants’ motion to appeal. The defendants moved to appeal to the New Jersey Supreme Court, which granted the motion and remanded to the Appellate Division.
Mensing Doesn’t Foreclose
In its per curiam opinion, the appeals court panel said, “Here, the trial court correctly determined that Mensing [PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S. Ct. 2567 (2011) [enhanced opinion available to lexis.com subscribers] did not foreclose plaintiffs from pursuing certain state-law claims based on the alleged failure to provide adequate warnings concerning generic metoclopramide. . . . [T]he trial court correctly determined that plaintiffs' claims based on the Generic Defendants' failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.”
The panel said the trial court also “correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve in the Hatch-Waxman Amendments to the FDCA [Food, Drug and Cosmetic Act]. Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law. They are pursuing state-law products liability claims based on the Generic Defendants' alleged failure to provide adequate warnings concerning their products.”
The panel said its conclusion is supported by the Sixth Circuit U.S. Court of Appeals’ decision in Fulgenzi v. PLIVA, Inc. (711 F.3d 578, 581 [6th Cir. 2013] [enhanced opinion]). It acknowledged that the Fifth Circuit found preemption for failure to update but noted that other courts have not.
The New Jersey panel said it is persuaded by Fulgenzi.
No Fraud-On-FDA Question
The generic defendants argued that the New Jersey Supreme Court’s decision in Cornett v. Johnson & Johnson (211 N.J. 362 ) [enhanced opinion], a medical device preemption case, supported dismissal of failure-to-warn claims. The appeals court panel was not convinced.
“The claims at issue here do not involve a challenge to the adequacy of information provided to the FDA [Food and Drug Administration] or the label changes that federal agency approved in 2004 or 2009,” the panel held. “In addition, the claims do not involve any allegation of fraud on the FDA. They are grounded in state law and are not based solely upon a federal violation.”
“As in Cornett, plaintiffs' claims fall ‘within a traditional area of state concern and regulation,’” the panel concluded.
The panel consisted of Judges Joseph L. Yannotti, Douglas M. Fasciale and Mary Gibbons Whipple.
PLIVA, Barr Pharmaceuticals and Watson Laboratories are represented by Michael D. Shumsky of Kirkland & Ellis in Washington, D.C., Anita Hotchkiss and H. Lockwood Miller III of Goldberg Segalla in Princeton, N.J., and Joseph P. Thomas and Frederick M. Erny of Ulmer & Berne in Cincinnati.
Actavis Elizabeth, Teva Pharmaceuticals, Mutual Pharmaceutical and United Research Laboratories are represented by McElroy, Deutsch, Mulvaney & Carpenter in Morristown, N.J. Actavis is also represented by Harris Beach in New York.
Teva is also represented by Glenn S. Kerner of Goodwin Proctor in New York.
Mutual Pharmaceutical and United Research Laboratories are also represented by Archer & Greiner in Princeton.
The plaintiffs are represented by Louis M. Bograd and Jason L. Pullman of the Center for Constitutional Litigation in Washington.
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