61 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 260,142 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 273,590 times   368 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 2,439 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 1,043 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 1,200 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. Daniels-Hall v. National Educ. Ass'n

    629 F.3d 992 (9th Cir. 2010)   Cited 2,147 times   3 Legal Analyses
    Holding information made publicly available on official government websites appropriate for judicial notice
  7. Fox v. Ethicon Endo-Surgery, Inc.

    35 Cal.4th 797 (Cal. 2005)   Cited 1,264 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 1,321 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 1,014 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 313 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 354,229 times   943 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 160,289 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 201 - Judicial Notice of Adjudicative Facts

    Fed. R. Evid. 201   Cited 29,078 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."
  14. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,441 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

  15. Section 335.1 - Assault, battery or injury or death caused by wrongful act or negligence

    Cal. Code Civ. Proc. § 335.1   Cited 2,320 times   6 Legal Analyses
    Imposing two-year statute of limitations for personal injury claims
  16. Section 360k - State and local requirements respecting devices

    21 U.S.C. § 360k   Cited 1,033 times   21 Legal Analyses
    Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause
  17. Section 360c - Classification of devices intended for human use

    21 U.S.C. § 360c   Cited 794 times   22 Legal Analyses
    Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."
  18. Section 337 - Proceedings in name of United States; provision as to subpoenas

    21 U.S.C. § 337   Cited 680 times   21 Legal Analyses
    Restricting FDCA enforcement to suits by the United States
  19. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 500 times   18 Legal Analyses
    Granting FDA authority to conduct hearings regarding PMA withdrawal
  20. Section 360 - Registration of producers of drugs or devices

    21 U.S.C. § 360   Cited 409 times   28 Legal Analyses
    Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements
  21. Section 814.44 - Procedures for review of a PMA

    21 C.F.R. § 814.44   Cited 35 times   1 Legal Analyses

    (a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42 . FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. If FDA refers an application to a panel, FDA will forward the PMA, or relevant portions thereof, to each member of the appropriate FDA panel for review. During the review process, FDA may

  22. Section 10.33 - Administrative reconsideration of action

    21 C.F.R. § 10.33   Cited 11 times   7 Legal Analyses

    (a) The Commissioner may at any time reconsider a matter, on the Commissioner's own initiative or on the petition of an interested person. (b) An interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under § 10.25 . Each request for reconsideration must be submitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition