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From Products Liability Law Daily, January 29, 2014

PLIVA USA, Inc. escapes additional Reglan® products liability claims

By Greg Hammond, J.D.

Maryland state law claims asserted by a patient who took the generic drug Reglan® over a 10-month period, and subsequently sustained damages from it, against the drug’s manufacturer, PLIVA, Inc., were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), the U.S. Court of Appeals for the Fourth Circuit held. The appellate court determined that it was proper to dismiss the state law claims against the generic drug manufacturer because the company would have been required to change either the drug’s warning or its formulation, in violation of the FDCA, or would have been required to exit the market or accept state tort liability, in violation of recent U.S. Supreme Court decisions (Drager v. PLIVA USA, Inc., January 28, 2014, Duncan, A).

Background. Shirley Gross was prescribed Reglan, a generic prescription drug that treats gastroesophageal reflux disease. After long-term use of the drug, Gross developed permanent injuries and movement disorders. She subsequently filed suit against PLIVA USA, Inc. (PLIVA) and brand name producers of the drug, bringing state law claims of negligence, breach of warranty, fraud, misrepresentation, strict liability, and failure to warn. A federal district court in Maryland granted PLIVA’s motion for judgment on the pleadings, holding that Gross’s state law claims were preempted by the FDCA requirements that applied to generic drug manufacturers, pursuant to the U.S. Supreme Court’s decision in PLIVA, Inc. v Mensing, 131 S.Ct. 2567 (2011). Gross subsequently passed away before the Fourth Circuit Court heard her appeal, but Arthur L. Drager continued with the case as her estate’s representative.

On appeal, Drager argued that (1) the district court abused its discretion in denying Gross’s request for leave to amend her complaint and (2) the district court erred in finding that the state tort claims were preempted by the FDCA.

Amendment. According to Drager, Gross never filed an actual motion to amend her complaint. Because a proper motion was not made, the Fourth Circuit determined that the district court did not abuse its discretion in denying Gross’s request for leave to amend her complaint. Consequently, the court affirmed the trial court’s decision.

Preemption. According to the Fourth Circuit, the Supreme Court, in both Mensing and Mutual Pharmaceutical Co., Inc. v. Bartlett, --- U.S. ---, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (June 24, 2013), established that under the FDCA and the Hatch-Waxman amendments thereto, a generic drug company “may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability.” Consequently, a state law is preempted in the event a generic drug manufacturer must take one of the aforementioned actions in order to comply with a state-law duty.

Pursuant to the FDCA and the Supreme Court’s Mensing and Bartlett decisions, the Fourth Circuit found that Gross’s remaining individual state law tort claims were preempted by the FDCA, since compliance with Maryland’s state laws would require PLIVA to either: (1) change its Reglan warnings; (2) change the formulation of Reglan; (3) exit the market; or (4) accept state tort liability. Therefore, the court of appeals affirmed the lower court’s dismissal of Gross’s state- law causes of action.

The case number is 12-1259.

Attorneys: Louis Martin Bograd (Center for Constitutional Litigation, PC) for Arthur L. Drager. John K. Crisham (Kirkland & Ellis, LLP) for PLIVA USA, Inc.

Companies: PLIVA USA, Inc.

MainStory: TopStory PreemptionNews WarningsNews DrugsNews MarylandNews NorthCarolinaNews SouthCarolinaNews VirginiaNews WestVirginiaNews

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