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Page 498 DEFENSE COUNSEL JOURNAL–October 2012NATIONWIDE FLUX: MENSING’SIMPACT ON STATE TORT CLAIMPRE-EMPTION AND GENERICPHARMACEUTICALSBy: Debra M. Perry andSara F. MerinThis article originally appeared in theAugust 2012 Drug, Device andBiotechnology Committee Newsletter.Since the United States SupremeCourt’s holding in PLIVA v. Mensing 1that federal regulations governinggeneric pharmaceuticals pre-empt statelaw failure-to-warn tort claims, the lawgoverning pre-emption in regard togeneric pharmaceuticals has been influx within United States courts. Thisarticle addresses Mensing itself, lowercourt decisions interpreting Mensing,and recent legislation proposed as aresponse to Mensing, which wouldchange the framework of the U.S. Foodand Drug Administration’s (FDA)regulation of generic pharmaceuticalmanufacturers.Mensing was the consolidation oftwo cases in which plaintiffs allegedstate law failure to warn claims againstgeneric pharmaceutical manufacturers. 2Each plaintiff claimed that her longtermuse of metoclopramide “caused hertardive dyskinesia and that the [genericmanufacturers of the metoclopramide]were liable under state law (specificallythat of Minnesota and Louisiana) for1 __ U.S. __, 131 S. Ct. 2567, 180 L. Ed. 2d580 (2011).2 Id. at 2573.Debra M. Perry is aPartner at McCarter &English, LLP in thefirm’s Newark, NewJersey office. Herpractice focusesprimarily on the areaof products liabilitylitigation with an emphasis on thenational defense of pharmaceuticalproducts and the coordination of masstort products liability litigationinvolving occupational exposures. SaraF. Merin is anassociate at McCarter& English, LLP in thefirm’s Newark, NewJersey office. Sheconcentrates herpractice in productliability litigation atthe trial and appellate levels and alsohandles other complex civil litigationmatters ranging from two-partydisputes to complex class actions,including multidistrict litigation.failing to provide adequatewarning labels.” 3 They argued that thegeneric drug manufacturers should haveand failed to change their labels in lightof “mounting evidence” showing thattardive dyskinesia was a larger risk thanwas stated on the metoclopramidelabel. 4 The generic manufacturerdefendants argued that plaintiffs’ statelaw tort claims were pre-empted byfederal statutes and FDA regulationsthat “required them to use the samesafety and efficacy labeling as their3 Id.4 Id.
Newsletters Page 499brand-name counterparts and that it wasimpossible to simultaneously complywith both federal law and any state tortlawduty that required them to use adifferent label.” 5In an opinion delivered by JusticeThomas, the Supreme Court held that“federal drug regulations applicable togeneric pharmaceutical manufacturersdirectly conflict with, and thus preempt,”state law failure to warn claims. 6Pre-emption occurs where “it is‘impossible for a private party tocomply with both state and federalrequirements.’” 7 As discussed below,there remains uncertainty as to thebreadth of the holding in Mensing,namely whether it is limited to failure towarn claims or if it causes state lawdesign defect product liability claims tobe pre-empted as well.The pre-emption question inMensing was framed as applying togeneric pharmaceutical manufacturersonly, because regulations governinglabeling for brand-name and genericmanufacturers differ. 8 “A brand-namemanufacturer seeking new drugapproval is responsible for the accuracyand adequacy of its label. ”9 “A5 Id.6 Id. at 2572.7 Mensing, 131 S. Ct. at 2577 (quotingFreightliner Corp. v. Myrick, 514 U.S. 230,287, 115 S. Ct. 1483, 131 L. Ed. 2d 385(1995)).8 Id. at 2574 (citations omitted); see also id.at 2581 (explaining how the state tort failureto warn claim in Wyeth v. Levine, 555 U.S.555, 559-560, 129 S. Ct. 1187, 173 L. Ed.2d 41 (2009), differed because a brand-namepharmaceutical manufacturer could complywith both federal and state law).9 Id. at 2574 (citations omitted).manufacturer seeking generic drugapproval, on the other hand, isresponsible for ensuring that its warninglabel is the same as the brand name’s.” 10Thus, federal regulations preventgeneric pharmaceutical manufacturers“from independently changing theirgeneric drugs’ safety labels.” 11The conflict in Mensing arosebecause, despite the federal regulations,the state tort law at issue (which hascorollaries throughout the country)“place[d] a duty directly on all drugmanufactures to adequately and safelylabel their products.” 12 As a result, itwas impossible for the genericpharmaceutical manufacturer defendantto comply with both federal and statelaw:If the [generic pharmaceuticalm]anufacturers had independentlychanged their labels to satisfy theirstate law duty, they would haveviolated federal law. . . . [S]tate lawimposed on the [genericpharmaceutical m]anufacturers aduty to attach a safer label to theirgeneric [pharmaceutical at issue].Federal law, however, demandedthat generic drug labels be the sameat all times as the correspondingbrand-name drug labels. See, e.g.,21 C.F.R. § 314.510(b)(10). Thus,it was impossible for the genericpharmaceutical manufacturers tocomply with both their state-lawduty to change the label and their10 Id. at 2574 (citations omitted).11 Id. at 2577.12 Id. at 2577.
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