53 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. Cipollone v. Liggett Group, Inc.

    505 U.S. 504 (1992)   Cited 2,253 times   9 Legal Analyses
    Holding that an express warranty was not a "requirement ... imposed under State law" because the obligation was imposed by the warrantor
  5. 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”
  6. 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
  7. In re Gilead Sciences

    536 F.3d 1049 (9th Cir. 2008)   Cited 2,211 times   3 Legal Analyses
    Holding that a court need not accept as true "allegations that are merely conclusory"
  8. Shaw v. Hahn

    56 F.3d 1128 (9th Cir. 1995)   Cited 442 times   1 Legal Analyses
    Finding privity when the interests of the party in the subsequent action were shared with and adequately represented by the party in the former action
  9. In re Medtronic, Inc., Sprint Fidelis Leads

    623 F.3d 1200 (8th Cir. 2010)   Cited 263 times   5 Legal Analyses
    Holding that a design-defect claim was properly dismissed as preempted because the FDA accepted the design of a Class III medical device in granting pre-market approval of the device
  10. Quiroz v. Seventh Ave. Center

    140 Cal.App.4th 1256 (Cal. Ct. App. 2006)   Cited 292 times   1 Legal Analyses
    Holding it was "irrelevant" that "fact" in separate statement of undisputed facts was undisputed by opposing party because "fact" was a legal conclusion
  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. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,269 times   40 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

  14. 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
  15. 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 . . ."
  16. 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
  17. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 456 times   15 Legal Analyses
    Granting FDA authority to conduct hearings regarding PMA withdrawal
  18. Section 360 - Registration of producers of drugs or devices

    21 U.S.C. § 360   Cited 372 times   22 Legal Analyses
    Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements
  19. Section 1507 - Filing document as constructive notice; publication in Federal Register as presumption of validity; judicial notice; citation

    44 U.S.C. § 1507   Cited 280 times   1 Legal Analyses
    Stating that notice by publication in the Federal Register "is sufficient to give notice of the contents of the document to a person subject to or affected by it"
  20. Section 360j - General provisions respecting control of devices intended for human use

    21 U.S.C. § 360j   Cited 170 times   13 Legal Analyses
    Providing that a custom device "is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated)"
  21. 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
  22. Section 801.109 - Prescription devices

    21 C.F.R. § 801.109   Cited 71 times   3 Legal Analyses
    Requiring labels to include such information as indications, effects, routes, methods, frequency and duration of administration, relevant hazards, contraindications, side effects, and precautions
  23. Section 814.82 - Postapproval requirements

    21 C.F.R. § 814.82   Cited 44 times   1 Legal Analyses

    (a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device: (1) Restriction of the sale, distribution, or use of the device as provided by section 515(d)(1)(B)(ii) or 520(e) of the act. (2) Continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. FDA

  24. Section 814.44 - Procedures for review of a PMA

    21 C.F.R. § 814.44   Cited 33 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 communicate

  25. Section 878.3530 - Silicone inflatable breast prosthesis

    21 C.F.R. § 878.3530   Cited 5 times

    (a)Identification. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast. (b)Classification. Class III. (c)Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with