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Case 6:10-cv-00886-TLM-CMH Document 99 Filed 11/15/11 Page 4 of 6 PageID #: 756 drug’s label upon generic drug manufacturers. After the Supreme Court rendered its decision, the Fifth Circuit vacated and remanded its decision for the entry of judgment in th favor of defendant-appellant, Actavis. Demahy v. Actavis, Inc., 650 F.3d 1045 (5 Cir. Aug. 22, 2011). Here, plaintiff alleged in her second amended complaint that defendant had failed to warn of the risks of taking metoclopramide on its labels and package inserts. [rec. doc. 60, 6, 21-32]. This is precisely the type of claim that Mensing held was pre-empted by federal law. Moreover, while plaintiff attempts to assert a design defect claim in her third amended complaint without alleging any defect in Pliva’s metoclopramide [rec. doc. 82, 47] , to the extent plaintiff properly states a claim, the reasoning in Mensing compels dismissal. Under the same federal law analyzed in Mensing [21 U.S.C. § 355(j)], a generic pharmaceutical product must be the same as the referenced listed drug (typically a brand- name drug) in active ingredients, safety and efficacy and hence, as was the case with labeling, federal law pre-empts state laws imposing the duty to change a drug’s design upon 3 generic drug manufacturers. See Mensing, 131 S.Ct. at 2574. As required by federal law, 3 The Court reasoned as follows: Under this law, “generic drugs” can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA.[Fn.2] 21 U.S.C. § 355(j)(2)(A). This allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug. A generic drug application must also “show that the [safety and efficacy] labeling proposed . . . is the same as the labeling approved for the [brand-name] drug.” § 355(j)(2)(A)(v); see also § 355(j)(4)(G); Beers §§ 3.01, 3.03[A]. In footnote 2, the Court noted: As we use it here, “generic drug” refers to a drug designed to be a copy of a reference listed drug 4
Case 6:10-cv-00886-TLM-CMH Document 99 Filed 11/15/11 Page 5 of 6 PageID #: 757 Pliva submitted the referenced listed drug’s “design” and obtained FDA approval before marketing. Considering the Supreme Court’s opinion, and the lack of opposition to Pliva’s motion, the undersigned finds that plaintiff’s claims are preempted by federal law. Accordingly, I recommend that the motion to dismiss plaintiff’s claims be GRANTED. Conclusion Based on the foregoing reasons, the undersigned recommends that the Motion to Dismiss be GRANTED. Under the provisions of 28 U.S.C. § 636(b)(1)(C) and F.R.Civ.Proc. 72(b), parties aggrieved by this recommendation have fourteen (14) days from service of this Report and Recommendation to file specific, written objections with the Clerk of Court. A party may respond to another party’s objections within fourteen (14) days after being served with a copy thereof. Counsel are directed to furnish a courtesy copy of any objections or responses to the District Judge at the time of filing. (typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy. See, e.g., United States v. Generix Drug Corp., 460 U.S. 453, 454–455, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983); 21 CFR § 314.3(b) (2006) (defining “reference listed drug”). As a result, brand-name and generic drug manufacturers have different federal drug labeling duties. A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. See, e.g., 21 U.S.C. §§ 355(b)(1), (d); Wyeth, supra, at 570–571, 129 S.Ct. 1187. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's. See, e.g., § 355(j)(2)(A)(v); § 355(j)(4)(G); 21 CFR §§ 314.94(a)(8), 314.127(a)(7). 5
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