Filed October 7, 2015
73 Fed.Reg. at 49606. Thus, even under the umbrella of the 2008 Final Rule, GSK would have had an obligation to revise its label based on the knowledge in its possession concerning the suicidality risks – See also Levine, 555 U.S. at 569 (refusing to decide whether the 2008 Final Rule was consistent with the FDCA, but holding that, even under the 2008 Rule, the manufacturer has a duty to issue warnings that are based upon new analysis of previously submitted data – “If the sponsor submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to FDA, the sponsor meets the requirement for ‘newly acquired information.’ ”).
Filed August 26, 2009
The Supreme Court also remarked: “In keeping with Congress’ decision not to preempt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation.” 129 S. Ct. at 1202. Wyeth thus makes clear that conflict preemption does not bar Mr. Lefaivre’s claims.
Filed July 7, 2009
The Supreme Court also remarked: “In keeping with Congress’ decision not to preempt common- law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation.” 129 S. Ct. at 1202. Wyeth thus makes clear that conflict preemption does not bar Mr. Lefaivre’s claims.
Filed November 21, 2012
Finally, Abbott argues that the FDA’s desire to have a class-wide section of TNF-inhibitor labels somehow absolves Abbott of its duty to “ensur[e] that its warnings remain adequate as long as the drug is on the market.” Levine, 555 U.S. at 571. This is contrary to Levine, as a district court in Minnesota recently observed.
Filed October 5, 2015
See Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 706 (1984) (“Since the [state] law . . . compels conduct that federal law forbids, the state [law] clearly ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives’ of the federal regulatory Case: 1:12-cv-06403 Document #: 306 Filed: 10/05/15 Page 35 of 42 PageID #:18545 30 scheme.”); see also Levine, 555 U.S. at 581 (recognizing that “some state-law claims might well frustrate the achievement of congressional objectives”). For over thirty years, FDA’s regulations have required that warnings be based on “reasonable evidence … [of] an association between a drug and a serious hazard.”
Filed October 22, 2009
Accordingly, Plaintiffs’ claim for malicious prosecution is “plausible on its face,” and the supporting evidence is sufficient to sustain a verdict in Plaintiffs favor. Ashcroft, 129 S. Ct. at 1949. Therefore, the motion to dismiss should be denied.
Filed February 17, 2017
_57- As a result, an untold numberof children were needlessly injured from prenatal Brethine exposure between at least 2002 and 2011. And yet, because every subsequent Brethine manufacturer would have invariably been stuck with a warning regarding risks to fetal health had Novartis added one (see Wyeth, supra, 555 U.S. at p. 568; 21 C.F.R. § 314.70(c)(6)Gii)(A)-(C)), Novartis could have prevented that cavalcade of injury at its source by adding a such a warning to the Brethine label while it still owned the drug. As this case thus demonstrates, a brand-name manufacturer who sells the rights to a mislabeled drug to a successor manufacturer on the assumption that the successorwill “clean up the mess” is taking a serious gamble with consumers’ well-being.
Filed December 15, 2016
16 In fact, Appellants’ theory of liability acts alongside existing federal statutory schemes intended to ensure patient safety. As the U.S. Supreme Court noted in Wyeth, “failure to warn” claims similar to Appellants’ claims actually “lend force to the [Food, Drug, and Cosmetics Act’s] premise that manufacturers, not the FDA,bear primary responsibility for their drug labeling...” Wyeth, 555 U.S. at 579. Congress further “determined that widely available state rights of action provided appropriate relief for injured consumers” and “mayalso have recognized that state-law remedies further consumerprotection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.”
Filed February 24, 2011
See Wyeth, 129 S.Ct. at 1199-1202; accord Lefaivre v. KV Pharmaceutical Co., — F.3d —, No. 10-1326, 2011 WL 148730, at *5 (8th Cir. Jan. 19, 2011) (state law claims not an obstacle to congressional purposes because “state law is complementary to federal drug regulation”). Far from serving as an additional “layer of consumer protection,” Wyeth, 129 S. Ct. at 1202, the State conduct in this case is directly contrary to the protections of federal law. See Order of March 2, 2010 (Doc. 72), at 9-10 (“If the statutes apply to lethal injection, ignoring those safeguards, as Plaintiffs allege Defendants intend to do, places Plaintiffs at risk.”).
Filed May 15, 2017
Under federal law, “[a] brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label.” Mensing, 564 U.S. at 613 (citing 21 U.S.C. §§ 355(b)(1), (d)); Levine, 555 U.S. at 570-71. Federal regulations state that “the holder of an approved application” may make changes to “add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under 201.