§Why CasetextPricing

Sara Ebrahimi v. Mentor Worldwide Llc et al

NOTICE OF MOTION AND MOTION to Dismiss Case for Failure to State a Claim

53 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 267,813 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 280,791 times   369 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 2,473 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 2,444 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 1,062 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 1,219 times   84 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 3,063 times   4 Legal Analyses
    Holding that a court need not accept as true "allegations that are merely conclusory"

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

    623 F.3d 1200 (8th Cir. 2010)   Cited 320 times   5 Legal Analyses
    Holding in medical-device context that potential additional warnings were "precisely the type of state requirement that is 'different from or in addition to' the federal requirement and therefore preempted" (quoting 21 U.S.C. § 360k)

  9. Shaw v. Hahn

    56 F.3d 1128 (9th Cir. 1995)   Cited 504 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

  10. Quiroz v. Seventh Ave. Center

    140 Cal.App.4th 1256 (Cal. Ct. App. 2006)   Cited 358 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 362,607 times   962 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 164,455 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 2,474 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 1,049 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 805 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 695 times   22 Legal Analyses
    Providing that suits to enforce the FDCA generally must be brought "by and in the name of the United States"

  17. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 506 times   19 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 416 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 315 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 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)"

  21. Section 814.80 - General

    21 C.F.R. § 814.80   Cited 103 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 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

  23. 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

  24. 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

  25. 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