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From Products Liability Law Daily, March 23, 2015

Generic drug makers loose bid for High Court review of Pa. preemption ruling

By Pamela C. Maloney, J.D.

The U.S. Supreme Court has denied a petition by a generic drug manufacturer challenging a Pennsylvania Superior Court ruling that claims against it in a mass tort litigation involving metoclopramide, the generic equivalent of the brand name drug Reglan, were not preempted by the federal Food, Drug, and Cosmetic Act (FDCA). The drug makers assert that a conflict among the appellate circuits requires resolution by the High Court. The Supreme Court’s decision lets stand that of the state superior court (Morton Grove Pharmaceuticals Inc. v. Adams, Docket No. 14-721, cert. filed December 16, 2014; cert. denied March 23, 2015). Two other petitions challenging the Superior Court’s decision are still pending (Teva Pharmaceuticals USA, Inc. v. Hassett, Docket No. 14-705, December 16, 2014; In re: Reglan®/Metoclopramide Litigation, Docket No. 14-711, December 16, 2014).

Background. The mass tort litigation involves the brand name drug Reglan® and its generic bioequivalent, metoclopramide, which were prescribed to treat chronic digestive problems, such as diabetic gastroparesis and gastroesophageal reflux. Following Food and Drug Administration (FDA) approval, long-term use of metoclopramide was linked to tardive dyskinesia, a severe and usually permanent neurological disorder characterized by involuntary and uncontrollable movements. The plaintiffs sought damages for personal injuries and deaths associated with use of the brand name drug or its generic equivalent. Manufacturers of the generic bioequivalent (generic manufacturers) sought dismissal of all claims, arguing that all state law claims asserted by the plaintiffs, regardless of the legal theory advanced and without consideration of the applicable state law, were failure-to-warn claims. The generic manufacturers claimed that all causes of action were indistinguishable from those held preempted by the U.S. Supreme Court in PLIVA, Inc. v. Mensing (131 S.Ct. 2567 (2011)). In addition, the generic manufacturer, Morton Grove Pharmaceuticals Inc., asserted that it remained a generic manufacturer entitled to the benefit of Mensingpreemption despite its designation by the FDA as the reference listed drug holder (RLD) for liquid syrup metoclopramide after the original RLD holder withdrew its drug.

Petition. In its petition, the manufacturer stated that the “firmly entrenched” principle in federal courts that the judiciary should defer to a federal agency’s reasonable interpretation of a statute or regulation that the agency administers has never been held to apply, by the Supreme Court, to state courts interpreting federal law. The petition asserted that absent clear direction from the Supreme Court, state courts have deferred to administrative interpretations of federal law inconsistently—many state courts following the doctrine of administrative deference articulated in Chevron and Auer, while other state courts “interpret federal law on their own, without looking for administrative guidance or, as in this case, by ignoring administrative guidance directly.” The petition argues that the Pennsylvania state courts, by ignoring the FDA’s guidance about the meaning of its own regulations, have “undercut the same federal regime that fosters the expansion of generic drugs.” The generic manufacturers in this petition state that in Bartlett and Mensing, the U.S. Supreme Court stepped in to protect that regime when federal courts failed to find state-law claims against generic drug makers preempted. The manufacturers contend that the Supreme Court “should grant certiorari to make clear that the same principles apply in state courts.”

Questions presented. Morton Grove Pharmaceuticals Inc. v. Adams (Docket No. 14-721) had ask the High Court the following question: “Under the doctrine of administrative deference this Court articulated in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and Auer v. Robbins, 519 U.S. 452 (1997), federal courts must defer to an administrative agency’s interpretation of a statute or regulation it administers unless that interpretation is plainly erroneous or unreasonable. Must a state court, like a federal court, defer to a federal agency’s reasonable interpretation of a federal statute or regulation that the agency administers in determining whether federal law conflicts with state law?”

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