Source: http://healthdrugpdf.com/c/curtis-lawgroup.com1.html
Timestamp: 2019-04-21 12:46:24+00:00

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Late last year the Supreme Court of the United States granted certiorari in two (2) consolidated generic pharmaceutical product liability cases to answer the question of whether state tort personal injury claims by individuals against generic pharmaceutical manufacturers are preempted by federal laws and/or regulations. See Demahy v. Actavis, Inc., certiorari granted No. 09-1501, and Mensing v. Wyeth, Inc., certiorari granted Nos. 09-993 and 09-1039 (the consolidated cases before the Supreme Court are hereinafter referred to as “Mensing”). To understand how we have arrived at the point where the Supreme Court is going to ultimately decide the issue of generic pharmaceutical manufacturer liability, an exploration of past decisions in the context of generic pharmaceutical liability is worthwhile and necessary. Foster v. American Home Products Corp.
Mensing and Demahy are both Circuit Court cases involving Reglan/metoclopramide (“MCP”). Both were decided in the last two (2) years regarding generic manufacturers’ claims of federal preemption – efforts by the generic drug companies to seek immunity from liability. In both cases the generic manufacturers argued that at the time of first approval of the generic drug, their drugs’ labels had to follow an FDA requirement that they be identical to the brand name label, therefore, state law failure-to-warn tort claims were preempted. In Mensing and Demahy, the Eighth and Fifth Circuit Courts of Appeal, respectively, rejected that argument. Both courts acknowledged that although Levine concerned a brand name manufacturer, the holding in Levine did carry “important implications” regarding the courts’ consideration of preemption in relation to the duties of generic drug manufacturers. Demahy v. Actavis, Inc., 593 F.3d 428, 433 (5th Cir.2010); Mensing v. Wyeth, Inc., 588 F.3d 603, 607 (8th Cir. 2009). Of course, now the Supreme Court will now review and decide the rulings of the Courts of Appeal in Mensing and Demahy.
them from taking steps to warn their customers of new safety hazards, federal law requires such action.” Id. 588 F.3d at 614.
When the Mensing Court issued its opinion, the Fifth Circuit had pending before it a case which presented the same issues regarding a generic manufacturer’s responsibilities regarding the labeling of its products. In 2010, the Fifth Circuit joined the Fourth and Eighth Circuits in holding that generic manufacturers have a duty to provide an accurate label in the case of Demahy v. Actavis. In its opinion, the Demahy Court initially notes that the fact that currently 7 out of 10 prescriptions are filled with generic drugs argues strongly in favor of holding a generic manufacturer responsible for the information provided in their labeling. Demahy, at 432. In discussing the responsibilities of a generic drug manufacturer, the Court stated: “[M]anufacturers – name brand and generic alike – must act to warn customers when they learn that they may be marketing an unsafe drug. For their part, generic manufacturers are subject to the requirement that their labeling “be revised… as soon as there is reasonable evidence of an association of a serious hazard with a drug.”” Id. at 437 (citing Wyeth v. Levine, 129 S.Ct. at 1197-98; 21 C.F.R. §201.80(e)). The Demahy court also followed Mensing in finding that generic drug manufacturers had the same recordkeeping and reporting requirements as branded manufacturers. Id. at 437-8 (citing Mensing and 57 Fed. Reg. 17950). The Court went even further to acknowledge that the higher risk associated with long-term use of MCP was noted in the medical literature in the 1980s and 1990s, and that there was nothing to indicate that monitoring such literature would result in significant additional expense to a generic drug manufacturer. Id. at 448.

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