§Why CasetextPricing

Rexina Mize et al v. Mentor Worldwide Llc et al

NOTICE OF MOTION AND MOTION to Dismiss Case Pursuant to FRCP 12

66 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 255,413 times   280 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 269,161 times   367 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. Daimler AG v. Bauman

    571 U.S. 117 (2014)   Cited 5,704 times   236 Legal Analyses
    Holding that foreign corporations may not be subject to general jurisdiction "whenever they have an in-state subsidiary or affiliate"

  4. Goodyear Dunlop Tires Oper. v. Brown

    564 U.S. 915 (2011)   Cited 5,275 times   86 Legal Analyses
    Holding "the sales of petitioners' tires sporadically made in North Carolina through intermediaries" insufficient to support general jurisdiction

  5. Walden v. Fiore

    571 U.S. 277 (2014)   Cited 4,359 times   49 Legal Analyses
    Holding that “the mere fact that [defendant's] conduct affected plaintiffs with connections to the forum State does not suffice to authorize jurisdiction.”

  6. Medtronic, Inc. v. Lohr

    518 U.S. 470 (1996)   Cited 2,420 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"

  7. Cipollone v. Liggett Group, Inc.

    505 U.S. 504 (1992)   Cited 2,406 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

  8. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,034 times   62 Legal Analyses
    Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

  9. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,188 times   80 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

  10. Swartz v. KPMG LLP

    476 F.3d 756 (9th Cir. 2007)   Cited 2,885 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”

  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 348,708 times   930 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 157,731 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. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,430 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

  14. Section 360k - State and local requirements respecting devices

    21 U.S.C. § 360k   Cited 1,027 times   21 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 789 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 . . ."

  16. Section 337 - Proceedings in name of United States; provision as to subpoenas

    21 U.S.C. § 337   Cited 671 times   19 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  17. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 494 times   17 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 405 times   28 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 305 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 178 times   21 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 801.109 - Prescription devices

    21 C.F.R. § 801.109   Cited 82 times   4 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

  22. Section 814.82 - Postapproval requirements

    21 C.F.R. § 814.82   Cited 46 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

  23. 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

  24. Section 878.3530 - Silicone inflatable breast prosthesis

    21 C.F.R. § 878.3530   Cited 6 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