§Why CasetextPricing

Rexina Mize et al v. Mentor Worldwide Llc et al

NOTICE OF MOTION AND MOTION to Dismiss Case Pursuant to 12

69 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 261,602 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 274,949 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 2,446 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. Cipollone v. Liggett Group, Inc.

    505 U.S. 504 (1992)   Cited 2,430 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 1,048 times   62 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 1,203 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

  7. In re Gilead Sciences

    536 F.3d 1049 (9th Cir. 2008)   Cited 2,988 times   4 Legal Analyses
    Holding that a court need not accept as true "allegations that are merely conclusory"

  8. Shwarz v. U.S.

    234 F.3d 428 (9th Cir. 2000)   Cited 815 times   1 Legal Analyses
    Holding that section 7433 is the "exclusive remedy" for recovering damages for improper inspection and disclosure of returns

  9. Estate of Tucker v. Interscope Records, Inc.

    515 F.3d 1019 (9th Cir. 2008)   Cited 398 times
    Listing lack of probable cause as a necessary element of a malicious prosecution claim

  10. In re Medtronic, Inc., Sprint Fidelis Leads

    623 F.3d 1200 (8th Cir. 2010)   Cited 315 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 355,868 times   945 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 161,044 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 301 - Short title

    21 U.S.C. § 301   Cited 2,448 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 1,037 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 798 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 681 times   21 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  17. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 503 times   18 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 411 times   28 Legal Analyses
    Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements

  19. Section 360j - General provisions respecting control of devices intended for human use

    21 U.S.C. § 360j   Cited 180 times   24 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)"

  20. Section 814.39 - PMA supplements

    21 C.F.R. § 814.39   Cited 156 times   5 Legal Analyses
    Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"

  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 47 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 812.20 - Application

    21 C.F.R. § 812.20   Cited 30 times   2 Legal Analyses

    (a)Submission. (1) A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent under § 50.24 of this chapter, or if FDA notifies the sponsor that an application is required for an investigation. (2) A sponsor shall not begin an investigation for which FDA's approval of an application is required until FDA has approved the application. (3) A sponsor shall

  24. Section 812.30 - FDA action on applications

    21 C.F.R. § 812.30   Cited 15 times   1 Legal Analyses

    (a)Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives the application at the address in § 812.19 for the investigation of a device other than a banned device, unless FDA notifies the sponsor that the investigation may not begin; or (2) FDA approves, by order, an IDE for the investigation

  25. Section 812.25 - Investigational plan

    21 C.F.R. § 812.25   Cited 14 times

    The investigational plan shall include, in the following order: (a)Purpose. The name and intended use of the device and the objectives and duration of the investigation. (b)Protocol. A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound. (c)Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized;

  26. 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

  27. Section 812.27 - Report of prior investigations

    21 C.F.R. § 812.27   Cited 4 times   2 Legal Analyses

    (a)General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation. (b)Specific contents. The report also shall include: (1) A bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the safety or effectiveness of the device, copies of all published and unpublished adverse information, and, if requested by