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Amarin Pharma, Inc. et al v. United States Food & Drug Administration et al

MEMORANDUM OF LAW in Support re: 5 MOTION for Preliminary Injunction . . Document

27 Cited authorities

  1. Winter v. Natural Res. Def. Council, Inc.

    555 U.S. 7 (2008)   Cited 16,853 times   56 Legal Analyses
    Holding that a plaintiff must establish "that he is likely to suffer irreparable harm"

  2. Nken v. Holder

    556 U.S. 418 (2009)   Cited 3,310 times   7 Legal Analyses
    Holding that "courts must be mindful that the Government's role as the respondent in every removal proceeding does not make the public interest in each individual one negligible"

  3. Elrod v. Burns

    427 U.S. 347 (1976)   Cited 4,230 times   7 Legal Analyses
    Holding that local government could not constitutionally base public employment opportunities on political affiliation or nonaffiliation

  4. Buckley v. Valeo

    424 U.S. 1 (1976)   Cited 3,418 times   37 Legal Analyses
    Holding that a public financing law does not "abridge, restrict, or censor" expression

  5. Central Hudson Gas Elec. v. Public Serv. Comm'n

    447 U.S. 557 (1980)   Cited 2,052 times   105 Legal Analyses
    Holding that a restriction on commercial speech must directly advance a substantial governmental interest

  6. 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"

  7. 44 Liquormart, Inc. v. Rhode Island

    517 U.S. 484 (1996)   Cited 502 times   9 Legal Analyses
    Holding advertising limits on liquor retailers violated First Amendment, explaining that state decision to license its liquor retailers did not permit it to condition license on "surrender of a constitutional right"

  8. Milavetz, Gallop & Milavetz, P.A. v. United States

    559 U.S. 229 (2010)   Cited 282 times   3 Legal Analyses
    Holding that Bankruptcy Abuse Prevention and Consumer Protect Action of 2005 plainly covers lawyers as “debt relief agencies”

  9. Thompson v. Western States Medical Center

    535 U.S. 357 (2002)   Cited 213 times   14 Legal Analyses
    Holding that a ban on advertising the compounding of pharmaceuticals violated the First Amendment

  10. N.Y. Progress & Prot. Pac v. Walsh

    733 F.3d 483 (2d Cir. 2013)   Cited 140 times
    Holding that an aggregate limit on an individual's contributions is unconstitutional as applied to contributions to groups for independent expenditures

  11. Section 3729 - False claims

    31 U.S.C. § 3729   Cited 6,746 times   628 Legal Analyses
    Holding liable "any person" who knowingly causes false claims to be presented

  12. Section 3730 - Civil actions for false claims

    31 U.S.C. § 3730   Cited 5,385 times   430 Legal Analyses
    Granting the government primary responsibility for conducting suit

  13. Section 331 - Prohibited acts

    21 U.S.C. § 331   Cited 1,513 times   105 Legal Analyses
    Prohibiting the sale of adulterated foods

  14. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,168 times   165 Legal Analyses
    Defining “new drug”

  15. Section 1395x - Definitions

    42 U.S.C. § 1395x   Cited 1,161 times   40 Legal Analyses
    Stating that the regulations "may provide for using different methods in different circumstances"

  16. Section 352 - Misbranded drugs and devices

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

  17. Section 333 - Penalties

    21 U.S.C. § 333   Cited 436 times   39 Legal Analyses
    Defining civil and criminal penalties for violations of Section 331

  18. Section 332 - Injunction proceedings

    21 U.S.C. § 332   Cited 268 times   6 Legal Analyses
    Granting the district court jurisdiction to restrain violations of FDCA

  19. Section 1396r-8 - Payment for covered outpatient drugs

    42 U.S.C. § 1396r-8   Cited 221 times   32 Legal Analyses
    Listing as approved “compendia” the American Hospital Formulary Service Drug Information, the United States Pharmacopeia–Drug Information (or its successor publications), and the DRUGDEX Information System

  20. Section 201.100 - Prescription drugs for human use

    21 C.F.R. § 201.100   Cited 47 times   9 Legal Analyses
    Exempting certain approved and new drugs from the FDCA's labeling requirements for adequate directions for use

  21. Section 202.1 - [Effective until 5/20/2024] Prescription-drug advertisements

    21 C.F.R. § 202.1   Cited 42 times   29 Legal Analyses
    Defining labeling to include virtually any type of audio, visual or printed matter descriptive of a drug and supplied by a manufacturer