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H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of Public Citizen

18 Cited authorities

  1. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,435 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 749 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. Conte v. Wyeth, Inc.

    168 Cal.App.4th 89 (Cal. Ct. App. 2008)   Cited 132 times   15 Legal Analyses
    Holding that, under California law, the brand-name manufacturer owes a duty of care to patients who ingest the generic drug

  4. Randi W. v. Muroc Joint Unified School Dist.

    14 Cal.4th 1066 (Cal. 1997)   Cited 124 times   3 Legal Analyses
    Holding that a party is “obliged to disclose all other facts which ‘materially qualify’ the limited facts disclosed.”

  5. Wyeth, Inc. v. Weeks

    159 So. 3d 649 (Ala. 2014)   Cited 45 times   7 Legal Analyses
    Holding that a brand-name manufacturer could be liable for failure to warn claims brought by plaintiffs who ingested the generic drug

  6. Huck v. Wyeth, Inc.

    850 N.W.2d 353 (Iowa 2014)   Cited 41 times   3 Legal Analyses
    Finding that "extending liability to brand manufacturers for harm caused by generic competitors would discourage investments necessary to develop new, beneficial drugs by increasing the downside risks"

  7. Garcia v. Superior Court

    50 Cal.3d 728 (Cal. 1990)   Cited 85 times
    Holding that although a parole officer had no duty to make disclosures about the dangerousness of a parolee, once he chose to do so, he "had a duty to use reasonable care"

  8. 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

  9. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,253 times   341 Legal Analyses
    Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

  10. Section 352 - Misbranded drugs and devices

    21 U.S.C. § 352   Cited 740 times   73 Legal Analyses
    Setting labeling requirements for drug products

  11. Section 6-5-530 - Liability for damages

    Ala. Code § 6-5-530   Cited 15 times

    (a) In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having

  12. Section 4073 - Substitution; "do not substitute"

    Cal. Bus. & Prof. Code § 4073   Cited 5 times

    (a) A pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined by the United States Adopted Names (USAN) and accepted by the federal Food and Drug Administration (FDA), of those drug products having the same active chemical ingredients. (b) In no case shall a selection be made pursuant to

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

    21 C.F.R. § 314.70   Cited 356 times   38 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

  14. Section 314.94 - Content and format of an ANDA

    21 C.F.R. § 314.94   Cited 224 times   37 Legal Analyses
    Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations

  15. Section 314.80 - Postmarketing reporting of adverse drug experiences

    21 C.F.R. § 314.80   Cited 114 times   7 Legal Analyses
    Requiring report of “serious and unexpected” adverse event within 15 days

  16. Section 314.108 - New drug product exclusivity

    21 C.F.R. § 314.108   Cited 28 times   33 Legal Analyses

    (a)Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section: Approved under section 505(b) means an NDA submitted under section 505(b) and approved on or after October 10, 1962, or an application that was "deemed approved" under section 107(c)(2) of Public Law 87-781 . Bioavailability study means a study to determine the bioavailability or the pharmacokinetics of a drug. Clinical investigation means any experiment other than a bioavailability study in which

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

    Cal. R. 8.520   Cited 3,191 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

  18. Rule 8.208 - Certificate of Interested Entities or Persons

    Cal. R. 8.208   Cited 17 times

    (a)Purpose and intent The California Code of Judicial Ethics states the circumstances under which an appellate justice must disqualify himself or herself from a proceeding. The purpose of this rule is to provide justices of the Courts of Appeal with additional information to help them determine whether to disqualify themselves from a proceeding. (b)Application This rule applies in appeals in civil cases other than family, juvenile, guardianship, and conservatorship cases. (Subd (b) adopted effective