41 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 254,776 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 268,550 times   366 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. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,434 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
  4. Robbins v. Oklahoma

    519 F.3d 1242 (10th Cir. 2008)   Cited 5,751 times   1 Legal Analyses
    Holding that collective allegations do not satisfy a plaintiff's "burden . . . to provide fair notice of the grounds for the claims made against each of the defendants"
  5. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 749 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
  6. Vess v. Ciba-Geigy Corp. USA

    317 F.3d 1097 (9th Cir. 2003)   Cited 4,223 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
  7. Swartz v. KPMG LLP

    476 F.3d 756 (9th Cir. 2007)   Cited 2,883 times   3 Legal Analyses
    Holding that “[t]o the extent Swartz seeks a declaration of defendants' liability for damages sought for his other causes of action,” claim must be dismissed as “merely duplicative”
  8. Mut. Pharm. Co. v. Bartlett

    570 U.S. 472 (2013)   Cited 416 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"
  9. Lazar v. Superior Court

    12 Cal.4th 631 (Cal. 1996)   Cited 1,664 times   3 Legal Analyses
    Holding that justifiable reliance is a required element of a fraud claim
  10. Neilson v. Union Bank of California, N.A.

    290 F. Supp. 2d 1101 (C.D. Cal. 2003)   Cited 692 times
    Holding that plaintiffs could prevail if they could prove at trial that certain transfers made pursuant to a Ponzi scheme were made within the limitations period of California's UFTA
  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 348,046 times   927 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 8 - General Rules of Pleading

    Fed. R. Civ. P. 8   Cited 157,353 times   196 Legal Analyses
    Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."
  13. Rule 9 - Pleading Special Matters

    Fed. R. Civ. P. 9   Cited 39,076 times   320 Legal Analyses
    Requiring that fraud be pleaded with particularity
  14. Rule 201 - Judicial Notice of Adjudicative Facts

    Fed. R. Evid. 201   Cited 28,497 times   26 Legal Analyses
    Holding "[n]ormally, in deciding a motion to dismiss for failure to state a claim, courts must limit their inquiry to the facts stated in the complaint and the documents either attached to or incorporated in the complaint. However, courts may also consider matters of which they may take judicial notice."
  15. 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"
  16. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,169 times   165 Legal Analyses
    Defining “new drug”
  17. Section 352 - Misbranded drugs and devices

    21 U.S.C. § 352   Cited 740 times   73 Legal Analyses
    Setting labeling requirements for drug products
  18. Section 377.60 - Persons who may assert action

    Cal. Code Civ. Proc. § 377.60   Cited 481 times   1 Legal Analyses
    Creating a "cause of action for the death of a person caused by the wrongful act or neglect of another"
  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 314.70 - Supplements and other changes to an approved NDA

    21 C.F.R. § 314.70   Cited 356 times   38 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"
  21. Section 314.50 - Content and format of an NDA

    21 C.F.R. § 314.50   Cited 150 times   16 Legal Analyses
    Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications
  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 314.71 - Procedures for submission of a supplement to an approved application

    21 C.F.R. § 314.71   Cited 12 times   2 Legal Analyses

    (a) Only the applicant may submit a supplement to an application. (b) All procedures and actions that apply to an application under § 314.50 also apply to supplements, except that the information required in the supplement is limited to that needed to support the change. A supplement is required to contain an archival copy and a review copy that include an application form and appropriate technical sections, samples, and labeling; except that a supplement for a change other than a change in labeling