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United States of America et al v. Takeda Pharmaceutical Company Limited et al

MEMORANDUM in Support re MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

69 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 254,855 times   280 Legal Analyses
    Holding that a claim is plausible where a plaintiff's allegations enable the court to draw a "reasonable inference" the defendant is liable

  2. Bell Atl. Corp. v. Twombly

    550 U.S. 544 (2007)   Cited 268,629 times   367 Legal Analyses
    Holding that a complaint's allegations should "contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face' "

  3. Mine Workers v. Gibbs

    383 U.S. 715 (1966)   Cited 17,845 times   2 Legal Analyses
    Holding that supplemental jurisdiction is a "doctrine of discretion"

  4. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,188 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

  5. U.S. ex Rel. Clausen v. Laboratory Corp.

    290 F.3d 1301 (11th Cir. 2002)   Cited 821 times   14 Legal Analyses
    Holding Rule 9(b) applies to False Claims Act claims

  6. Pharmaceutical Research and Mfrs. of America v. Walsh

    538 U.S. 644 (2003)   Cited 234 times   5 Legal Analyses
    Holding that Maine may impose regulatory burdens on drug manufacturers who do not have a rebate agreement with the state

  7. S.E.C. v. Tambone

    597 F.3d 436 (1st Cir. 2010)   Cited 533 times   7 Legal Analyses
    Reinstating portions of withdrawn panel opinion

  8. Ruiz Rivera v. Pfizer

    521 F.3d 76 (1st Cir. 2008)   Cited 541 times   2 Legal Analyses
    Holding that to establish a prima facie case of disability discrimination under the ADA, a plaintiff must prove: “ that [he] was ‘disabled’ within the meaning of the ADA; that [he] was able to perform the essential functions of [his] job with or without accommodation; and that [he] was discharged or adversely affected, in whole or in part, because of [his] disability”

  9. Weinberger v. Hynson, Westcott Dunning

    412 U.S. 609 (1973)   Cited 364 times
    Holding that the FDA has primary jurisdiction to determine that a product is a ‘new drug,’ subject to review in the court of appeals

  10. U.S. ex Rel. Wilkins v. United Health Group

    No. 10-2747 (3d Cir. Jun. 30, 2011)   Cited 370 times   5 Legal Analyses
    Holding that plaintiffs "need not allege a relationship between the alleged [anti-kickback] violations and the claims ... submitted to the Government"

  11. Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing

    Fed. R. Civ. P. 12   Cited 348,148 times   929 Legal Analyses
    Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

  12. Rule 9 - Pleading Special Matters

    Fed. R. Civ. P. 9   Cited 39,081 times   320 Legal Analyses
    Requiring that fraud be pleaded with particularity

  13. Section 1001 - Statements or entries generally

    18 U.S.C. § 1001   Cited 7,360 times   303 Legal Analyses
    Making false statements

  14. Section 3729 - False claims

    31 U.S.C. § 3729   Cited 6,766 times   630 Legal Analyses
    Holding liable "any person" who knowingly causes false claims to be presented

  15. Section 3730 - Civil actions for false claims

    31 U.S.C. § 3730   Cited 5,400 times   430 Legal Analyses
    Granting the government primary responsibility for conducting suit

  16. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,430 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

  17. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,252 times   340 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"

  18. Section 337 - Proceedings in name of United States; provision as to subpoenas

    21 U.S.C. § 337   Cited 671 times   19 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  19. Section 333 - Penalties

    21 U.S.C. § 333   Cited 439 times   39 Legal Analyses
    Defining civil and criminal penalties for violations of Section 331

  20. 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

  21. 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

  22. 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

  23. Section 314.105 - Approval of an NDA and an ANDA

    21 C.F.R. § 314.105   Cited 94 times   5 Legal Analyses
    Explaining that a "tentative" approval is the same as a final approval with a delayed effective date

  24. 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

  25. Section 314.81 - Other postmarketing reports

    21 C.F.R. § 314.81   Cited 46 times   27 Legal Analyses
    Requiring transmittal of the advertisement with Form FDA-2253

  26. Appendix A to Part 199 - Acronyms

    32 C.F.R. § 199 app A to Part 199   Cited 16 times

    AFR-Air Force Regulation AR-Army Regulation ASD (HA)-Assistant Secretary of Defense (Health Affairs) CCLR-Claims Collection Litigation Report CEOB-CHAMPUS Explanation of Benefits CFR-Code of Federal Regulations CHAMPUS-Civilian Health and Medical Program of the Uniformed Services CRD-Chronic Renal Disease CT-Computerized Tomography DASD (A)-Deputy Assistant Secretary of Defense (Administration) D.D.S.-Doctor of Dental Surgery DEERS-Defense Enrollment Eligibility Reporting System DHHS-Department of

  27. Section 199.21 - TRICARE Pharmacy Benefits Program

    32 C.F.R. § 199.21   Cited 10 times   4 Legal Analyses

    (a) General- (1)Statutory authority. Title 10, U.S. Code, Section 1074g requires that the Department of Defense establish an effective, efficient, integrated pharmacy benefits program for the Military Health System. This law is independent of a number of sections of Title 10 and other laws that affect the benefits, rules, and procedures of TRICARE, resulting in changes to the rules otherwise applicable to TRICARE Prime, Standard, and Extra. (2)Pharmacy benefits program. (i)Applicability. The pharmacy

  28. Section 1.1 - General

    21 C.F.R. § 1.1   Cited 3 times

    (a) The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done. (b) The definitions and interpretations of terms contained in sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 and 387 ) shall be applicable also to such terms when used in regulations promulgated under that act. (c) The definition of package in § 1.20 and of principal display