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H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of The Atlantic Legal Foundation

49 Cited authorities

  1. Citizens United v. Fed. Election Comm'n

    558 U.S. 310 (2010)   Cited 1,583 times   71 Legal Analyses
    Holding that disclaimer and disclosure requirements are subject to exacting scrutiny

  2. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,429 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

  3. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,180 times   80 Legal Analyses
    Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

  4. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 744 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

  5. Vess v. Ciba-Geigy Corp. USA

    317 F.3d 1097 (9th Cir. 2003)   Cited 4,190 times   3 Legal Analyses
    Holding that the Rule 9(b) pleading standards apply to California CLRA, FAL, and UCL claims because, though fraud is not an essential element of those statutes, a plaintiff alleges a fraudulent course of conduct as the basis of those claims

  6. English v. General Electric Co.

    496 U.S. 72 (1990)   Cited 1,312 times   8 Legal Analyses
    Holding that a tort arising from whistleblower retaliation at a nuclear facility was insufficiently related to radiological safety aspects in the facility's operation

  7. Gregory v. Ashcroft

    501 U.S. 452 (1991)   Cited 987 times   2 Legal Analyses
    Holding Missouri's judicial age limitation of 70 rationally related to such legitimate purposes as avoiding laborious testing of older judges' physical and mental acuity, promoting orderly attrition of judges, and recognizing that judges' remoteness from public view makes determination of competency, and removal from office, more difficult than for other office-holders

  8. Va. Pharmacy Bd. v. Va. Consumer Council

    425 U.S. 748 (1976)   Cited 1,730 times   5 Legal Analyses
    Holding society and consumers both have a strong interest "in the free flow of commercial information"

  9. Sorrell v. IMS Health Inc.

    564 U.S. 552 (2011)   Cited 502 times   66 Legal Analyses
    Holding that a restriction on "speech result[ing] from an economic motive" is not "a mere commercial regulation"

  10. Gade v. National Solid Wastes Management Ass'n

    505 U.S. 88 (1992)   Cited 887 times   10 Legal Analyses
    Holding that "nonapproved state regulation of occupational safety and health issues for which a federal standard is in effect is impliedly preempted" by OSHA's standard

  11. Section 17200 - Unfair competition defined

    Cal. Bus. & Prof. Code § 17200   Cited 17,785 times   315 Legal Analyses
    Prohibiting unlawful business practices

  12. Section 271 - Infringement of patent

    35 U.S.C. § 271   Cited 6,026 times   1043 Legal Analyses
    Holding that testing is a "use"

  13. Section 8 - Powers of Congress

    U.S. Const. art. I, § 8   Cited 6,955 times   27 Legal Analyses
    Granting Congress the power to “provide for the common Defence,” to “regulate Commerce with foreign Nations,” and to “establish an uniform Rule of Naturalization”

  14. Section 501 - Exemption from tax on corporations, certain trusts, etc

    26 U.S.C. § 501   Cited 3,215 times   283 Legal Analyses
    Granting tax-exempt status to qualified pension plans

  15. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,241 times   333 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"

  16. Section 156 - Extension of patent term

    35 U.S.C. § 156   Cited 202 times   173 Legal Analyses
    Granting five-year extension of patent term based upon regulatory review of the product Abilify® (aripiprazole) by the FDA

  17. Section 396 - Practice of medicine

    21 U.S.C. § 396   Cited 83 times   12 Legal Analyses
    Contemplating off-label uses of devices by physicians

  18. Section 355g - Utilizing real world evidence

    21 U.S.C. § 355g   Cited 14 times   12 Legal Analyses

    (a) In general The Secretary shall establish a program to evaluate the potential use of real world evidence- (1) to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and (2) to help to support or satisfy postapproval study requirements. (b) Real world evidence defined In this section, the term "real world evidence" means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical

  19. 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"

  20. Section 312.2 - Applicability

    21 C.F.R. § 312.2   Cited 5 times   5 Legal Analyses

    (a)Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)). (b)Exemptions. (1) The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements of this part if all the following apply: (i) The investigation