59 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 198,437 times   262 Legal Analyses
    Holding that the sufficiency of the allegations is a legal question so appellate courts have jurisdiction to consider it on appeal from denial of qualified immunity
  2. Bell Atl. Corp. v. Twombly

    550 U.S. 544 (2007)   Cited 214,975 times   346 Legal Analyses
    Holding that conclusory allegations that the defendants acted unlawfully were insufficient to state a claim
  3. Medtronic, Inc. v. Lohr

    518 U.S. 470 (1996)   Cited 2,213 times   31 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 931 times   53 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 1,036 times   74 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. Swartz v. KPMG LLP

    476 F.3d 756 (9th Cir. 2007)   Cited 2,555 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”
  7. Kearns v. Ford Motor Co.

    567 F.3d 1120 (9th Cir. 2009)   Cited 1,920 times   4 Legal Analyses
    Holding that circumstances constituting fraud must be stated with particularity
  8. Fox v. Ethicon Endo-Surgery, Inc.

    35 Cal.4th 797 (Cal. 2005)   Cited 1,078 times   2 Legal Analyses
    Holding that "[r]esolution of the statute of limitations issue is normally a question of fact."
  9. Lazar v. Superior Court

    12 Cal.4th 631 (Cal. 1996)   Cited 1,507 times   3 Legal Analyses
    Holding that justifiable reliance is a required element of a fraud claim
  10. Norgart v. Upjohn Co.

    21 Cal.4th 383 (Cal. 1999)   Cited 1,177 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"
  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 272,120 times   788 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 124,344 times   187 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 32,322 times   261 Legal Analyses
    Requiring a party who alleged fraud or mistake to "state with particularity the circumstances constituting fraud of mistake"
  14. Section 335.1 - Assault, battery or injury or death caused by wrongful act or negligence

    Cal. Code Civ. Proc. § 335.1   Cited 1,677 times   4 Legal Analyses
    Imposing two-year statute of limitations for personal injury claims
  15. Section 360k - State and local requirements respecting devices

    21 U.S.C. § 360k   Cited 955 times   18 Legal Analyses
    Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause
  16. Section 360c - Classification of devices intended for human use

    21 U.S.C. § 360c   Cited 728 times   18 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 . . ."
  17. Section 337 - Proceedings in name of United States; provision as to subpoenas

    21 U.S.C. § 337   Cited 561 times   16 Legal Analyses
    Restricting FDCA enforcement to suits by the United States
  18. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 456 times   15 Legal Analyses
    Granting FDA authority to conduct hearings regarding PMA withdrawal
  19. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 310 times   24 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards
  20. Section 808.1 - Scope

    21 C.F.R. § 808.1   Cited 257 times   1 Legal Analyses
    Explaining that federal law preempts requirements "having the force and effect of law (whether established by statute, ordinance, regulation or court decision)."
  21. Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?

    21 C.F.R. § 803.50   Cited 127 times   6 Legal Analyses
    Requiring device manufacturers to report adverse medical device events to the FDA
  22. Section 814.80 - General

    21 C.F.R. § 814.80   Cited 102 times   1 Legal Analyses
    Prohibiting the production or labeling of any device in a manner inconsistent with any conditions of approval specified in the approval order
  23. Section 820.70 - Production and process controls

    21 C.F.R. § 820.70   Cited 41 times   2 Legal Analyses
    Requiring manufacturers, in general, to "establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications"
  24. Section 806.10 - Reports of corrections and removals

    21 C.F.R. § 806.10   Cited 16 times   6 Legal Analyses
    Requiring that "[e]ach device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device" including " description of the event giving rise to the information reported . . ."