53 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 263,477 times   281 Legal Analyses
    Holding court need not credit "mere conclusory statements" in complaint
  2. Bell Atl. Corp. v. Twombly

    550 U.S. 544 (2007)   Cited 276,716 times   369 Legal Analyses
    Holding that allegations of conduct that are merely consistent with wrongdoing do not state a claim unless "placed in a context that raises a suggestion of" such wrongdoing
  3. Medtronic, Inc. v. Lohr

    518 U.S. 470 (1996)   Cited 2,451 times   35 Legal Analyses
    Holding that the presence of a state-law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but "merely provides another reason for manufacturers to comply with . . . federal law"
  4. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,051 times   62 Legal Analyses
    Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”
  5. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,207 times   82 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
  6. Sprewell v. Golden State Warriors

    266 F.3d 979 (9th Cir. 2001)   Cited 5,226 times   4 Legal Analyses
    Holding that unwarranted inferences are insufficient to defeat a motion to dismiss
  7. Fox v. Ethicon Endo-Surgery, Inc.

    35 Cal.4th 797 (Cal. 2005)   Cited 1,272 times   2 Legal Analyses
    Holding that "[r]esolution of the statute of limitations issue is normally a question of fact."
  8. Norgart v. Upjohn Co.

    21 Cal.4th 383 (Cal. 1999)   Cited 1,326 times   1 Legal Analyses
    Holding that the discovery rule "postpones accrual of a cause of action until the plaintiff discovers, or has reason to discover, the cause of action, until, that is, he at least suspects, or has reason to suspect, a factual basis for its elements"
  9. Jolly v. Eli Lilly & Co.

    44 Cal.3d 1103 (Cal. 1988)   Cited 1,018 times   3 Legal Analyses
    Holding that a plaintiff who suspects wrongdoing but is unaware of any specific facts establishing wrongful conduct on the part of the defendant, may not delay bringing an action until she discovers such facts or their legal significance
  10. In re Medtronic, Inc., Sprint Fidelis Leads

    623 F.3d 1200 (8th Cir. 2010)   Cited 317 times   5 Legal Analyses
    Holding "[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is pre-empted."
  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 357,835 times   950 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 162,084 times   197 Legal Analyses
    Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."
  13. Section 335.1 - Assault, battery or injury or death caused by wrongful act or negligence

    Cal. Code Civ. Proc. § 335.1   Cited 2,347 times   6 Legal Analyses
    Imposing two-year statute of limitations for personal injury claims
  14. Section 337 - Proceedings in name of United States; provision as to subpoenas

    21 U.S.C. § 337   Cited 687 times   21 Legal Analyses
    Providing that suits to enforce the FDCA generally must be brought "by and in the name of the United States"
  15. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 504 times   18 Legal Analyses
    Granting FDA authority to conduct hearings regarding PMA withdrawal
  16. Section 360 - Registration of producers of drugs or devices

    21 U.S.C. § 360   Cited 412 times   28 Legal Analyses
    Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements
  17. Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?

    21 C.F.R. § 803.50   Cited 151 times   8 Legal Analyses
    Requiring device manufacturers to report adverse medical device events to the FDA
  18. Section 7.3 - Definitions

    21 C.F.R. § 7.3   Cited 12 times   4 Legal Analyses

    (a)Agency means the Food and Drug Administration. (b)Citation or cite means a document and any attachments thereto that provide notice to a person against whom criminal prosecution is contemplated of the opportunity to present views to the agency regarding an alleged violation. (c)Respondent means a person named in a notice who presents views concerning an alleged violation either in person, by designated representative, or in writing. (d)Responsible individual includes those in positions of power

  19. Section 7.49 - Recall communications

    21 C.F.R. § 7.49   Cited 12 times

    (a)General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey: (1) That the product in question is subject to a recall. (2) That further distribution or use of any remaining product should cease immediately

  20. Section 7.50 - Public notification of recall

    21 C.F.R. § 7.50   Cited 1 times

    The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was Food and Drug Administration-requested or firm-initiated, and the specific action being taken by the recalling firm. The Food and Drug Administration will intentionally delay public notification of recalls of certain drugs and devices where the agency determines that public notification may cause unnecessary