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H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of AARP and AARP Foundation

12 Cited authorities

  1. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,432 times   101 Legal Analyses
    Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

  2. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 745 times   143 Legal Analyses
    Holding that state tort law that required generic drug manufacturers to provide adequate warning labels was preempted where federal law required manufacturers to use the same labels as their brand-name counterparts

  3. In re Reglan Litig.

    226 N.J. 315 (N.J. 2016)   Cited 20 times   3 Legal Analyses
    In Reglan, the FDA had approved new warning labels in 2004, id. at 729, but the plaintiffs alleged that the defendant ANDA holders had not updated their labels to match the FDA-approved warnings until 2009, long after those new warnings were issued, id. at 730.

  4. Klein v. Children's Hospital Medical Center

    46 Cal.App.4th 889 (Cal. Ct. App. 1996)   Cited 23 times

    Docket No. A072286. June 20, 1996. Appeal from Superior Court of Alameda County, No. 751340-2, Sandra Lynn Margulies, Judge. COUNSEL Steel, Clarence Buckley, Thomas Steel and Kate Dyer for Plaintiffs and Appellants. Craddick, Candland Conti, Judy S. Craddick, Phillip J. Maddux, Jean L. Perry, Anderson, Galloway Lucchese, G. Patrick Galloway and Karen A. Sparks for Defendants and Respondents. OPINION HANING, J. Plaintiffs and appellants Joel and Cynthia Klein appeal the dismissal of their action for

  5. T. H. v. Novartis Pharms. Corp.

    245 Cal.App.4th 589 (Cal. Ct. App. 2016)   Cited 1 times   2 Legal Analyses

    D067839 03-09-2016 T.H., a Minor, etc., et al., Plaintiffs and Appellants, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and Respondent. Thorsnes Bartolotta McGuire, Benjamin I. Siminou and Kevin F. Quinn, San Diego, for Plaintiffs and Appellants. Hollingsworth, Eric G. Lasker; Morrison & Foerster, Erin M. Bosman and Julie Y. Park, San Diego, for Defendant and Respondent. McCONNELL, P.J. Thorsnes Bartolotta McGuire, Benjamin I. Siminou and Kevin F. Quinn, San Diego, for Plaintiffs and Appellants

  6. Section 352 - Misbranded drugs and devices

    21 U.S.C. § 352   Cited 739 times   73 Legal Analyses
    Setting labeling requirements for drug products

  7. Section 314.70 - Supplements and other changes to an approved NDA

    21 C.F.R. § 314.70   Cited 353 times   37 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

  8. Section 10.30 - Citizen petition

    21 C.F.R. § 10.30   Cited 140 times   35 Legal Analyses
    Describing the requirements for filing a citizens' petition

  9. Section 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in Section 201.56(b)(1)

    21 C.F.R. § 201.80   Cited 85 times   5 Legal Analyses
    Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”

  10. Section 10.25 - Initiation of administrative proceedings

    21 C.F.R. § 10.25   Cited 77 times   3 Legal Analyses
    Including forms under 21 C.F.R. § 314.50 among the forms that constitute a "petition"

  11. Section 10.3 - Definitions

    21 C.F.R. § 10.3   Cited 5 times
    Defining administrative record for FDA decisions

  12. Rule 8.520 - Briefs by parties and amici curiae; judicial notice

    Cal. R. 8.520   Cited 3,160 times

    (a)Parties' briefs; time to file (1) Within 30 days after the Supreme Court files the order of review, the petitioner must serve and file in that court either an opening brief on the merits or the brief it filed in the Court of Appeal. (2) Within 30 days after the petitioner files its brief or the time to do so expires, the opposing party must serve and file either an answer brief on the merits or the brief it filed in the Court of Appeal. (3) The petitioner may file a reply brief on the merits or