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H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of Washington Legal Foundation

25 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. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,031 times   62 Legal Analyses
    Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

  3. 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

  4. Mut. Pharm. Co. v. Bartlett

    570 U.S. 472 (2013)   Cited 415 times   67 Legal Analyses
    Holding "state-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA"

  5. U.S. v. Oakland Cannabis Buyers' Cooperative

    532 U.S. 483 (2001)   Cited 371 times   9 Legal Analyses
    Holding that there is no medical-necessity exception to the Controlled Substances Act's prohibitions on manufacturing and distributing marijuana

  6. Cuomo v. Clearing House Ass'n, L. L.C.

    557 U.S. 519 (2009)   Cited 157 times   9 Legal Analyses
    Holding that states cannot informally subpoena national banks through their "capacity as supervisor of corporations"

  7. City of Hope Nat. Medical Center v. Genentech, Inc.

    43 Cal.4th 375 (Cal. 2008)   Cited 387 times
    Holding that when "ascertaining the intent of the parties at the time the contract was executed depends on the credibility of extrinsic evidence, that credibility determination and the interpretation of the contract are questions of fact that may properly be resolved by the jury"

  8. O'Neil v. Crane Co.

    53 Cal.4th 335 (Cal. 2012)   Cited 201 times   27 Legal Analyses
    Holding that product manufacturer is not liable under any theory for harm caused by a third party's products

  9. People v. Rubalcava

    23 Cal.4th 322 (Cal. 2000)   Cited 257 times
    Holding that the intent to use a dagger as a stabbing weapon is not an express element of California Penal Code § 12020

  10. Germain v. Teva Pharmaceuticals

    756 F.3d 917 (6th Cir. 2014)   Cited 145 times   7 Legal Analyses
    Holding that brand-name manufacturers cannot be held liable for damages caused by ingestion of generic drugs under negligent misrepresentation law of 22 states

  11. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,427 times   48 Legal Analyses

    This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 301 June 25, 1938, ch. 675, §1, 52 Stat. 1040. STATUTORY NOTES AND RELATED SUBSIDIARIES EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:"[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this

  12. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,244 times   337 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"

  13. Section 352 - Misbranded drugs and devices

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

  14. 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

  15. Section 314.150 - Withdrawal of approval of an application or abbreviated application

    21 C.F.R. § 314.150   Cited 87 times   4 Legal Analyses
    Requiring products to be withdrawn from the market where the FDA revokes approval