§Why CasetextPricing

Kripke v. United States Food And Drug Administration et al

MOTION to Dismiss for Failure to State a Claim and for Standing

50 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 251,689 times   279 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 265,662 times   364 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. Lujan v. Defs. of Wildlife

    504 U.S. 555 (1992)   Cited 27,747 times   138 Legal Analyses
    Holding that the elements of standing "must be supported in the same way as any other matter on which the plaintiff bears the burden of proof"

  4. Kokkonen v. Guardian Life Ins. Co. of America

    511 U.S. 375 (1994)   Cited 18,896 times   5 Legal Analyses
    Holding that absent a reservation of jurisdiction in the stipulated dismissal order, federal courts lack jurisdiction to consider enforcement of a settlement agreement

  5. Summers v. Earth Island Inst.

    555 U.S. 488 (2009)   Cited 2,993 times   12 Legal Analyses
    Holding that supplementation of the district court record to receive affidavits from the organization's members was not permitted "in the circumstances here: after the trial is over, judgment has been entered, and a notice of appeal has been filed"

  6. Warth v. Seldin

    422 U.S. 490 (1975)   Cited 11,839 times   14 Legal Analyses
    Holding that Article III requires plaintiffs "to establish that, in fact, the asserted injury was the consequence of the defendants' actions"

  7. Whitmore v. Arkansas

    495 U.S. 149 (1990)   Cited 2,843 times   16 Legal Analyses
    Holding that a third party does not have "standing to challenge the validity of a death sentence imposed on a capital defendant who has elected to forgo his right of appeal"

  8. Norton v. Southern Utah Wilderness Alliance

    542 U.S. 55 (2004)   Cited 1,457 times   6 Legal Analyses
    Holding that agency can be compelled to act if time period is specified by law

  9. Massachusetts v. Environmental Protection Agency

    549 U.S. 497 (2007)   Cited 1,152 times   97 Legal Analyses
    Holding that denials of petitions for rulemaking are judicially reviewable

  10. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,181 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

  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 344,767 times   920 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 23 - Class Actions

    Fed. R. Civ. P. 23   Cited 34,840 times   1232 Legal Analyses
    Holding that, to certify a class, the court must find that "questions of law or fact common to class members predominate over any questions affecting only individual members"

  13. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,402 times   183 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  14. Section 551 - Definitions

    5 U.S.C. § 551   Cited 4,735 times   69 Legal Analyses
    Adopting the definition set out in the APA

  15. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,426 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

  16. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,241 times   334 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"

  17. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,165 times   158 Legal Analyses
    Defining “new drug”

  18. Section 555 - Ancillary matters

    5 U.S.C. § 555   Cited 1,118 times   13 Legal Analyses
    Providing that an agency's notice of denial "shall be accompanied by a brief statement of the grounds for denial"

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

    21 U.S.C. § 337   Cited 666 times   19 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  20. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 340 times   32 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

  21. Section 10.30 - Citizen petition

    21 C.F.R. § 10.30   Cited 139 times   35 Legal Analyses
    Describing the requirements for filing a citizens' petition

  22. Section 314.127 - Refusal to approve an ANDA

    21 C.F.R. § 314.127   Cited 62 times   14 Legal Analyses
    Listing reasons the FDA will refuse approval of an ANDA, none of which concern patent litigation under § 271(e)