§Why CasetextPricing

Bertroch v. Smith & Nephew

MOTION to Dismiss Based upon Plaintiffs claims are preempted

60 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 262,570 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 275,856 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. Phillips v. County of Allegheny

    515 F.3d 224 (3d Cir. 2008)   Cited 17,302 times   2 Legal Analyses
    Holding that a district court need not permit a curative amendment if such amendment would be futile

  4. 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"

  5. Cipollone v. Liggett Group, Inc.

    505 U.S. 504 (1992)   Cited 2,432 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

  6. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,049 times   62 Legal Analyses
    Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

  7. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,205 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

  8. Malleus v. George

    641 F.3d 560 (3d Cir. 2011)   Cited 2,703 times   1 Legal Analyses
    Holding inquiry is normally broken into three parts: identifying the elements of a claim, reviewing the complaint to strike conclusory allegations, and then looking at the well-pleaded components of the complaint and evaluating whether all of the elements identified in part one of the inquiry are sufficiently alleged.

  9. 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."

  10. Wolicki-Gables v. Arrow International, Inc.

    634 F.3d 1296 (11th Cir. 2011)   Cited 158 times   3 Legal Analyses
    Holding that medical device's pre-market approval “imposes specific requirements on it that are sufficient to preempt a state law claim”

  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 356,916 times   947 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 161,536 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 2,453 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 1,039 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 799 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 685 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 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"

  19. 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

  20. Section 814.20 - Application

    21 C.F.R. § 814.20   Cited 72 times   1 Legal Analyses

    (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identify the representative's name and address. (b) Unless the applicant justifies an omission in accordance with paragraph (d) of this section, a PMA shall include in electronic format: (1) The name and address

  21. Section 820.30 - [Effective until 2/2/2026] Design controls

    21 C.F.R. § 820.30   Cited 59 times   39 Legal Analyses
    Requiring manufacturers, in general, to establish maintain "procedures to control the design of the device" in order to ensure that specified design requirements are met

  22. Section 820.100 - [Effective until 2/2/2026] Corrective and preventive action

    21 C.F.R. § 820.100   Cited 46 times   14 Legal Analyses
    Requiring manufacturers, in general, to "establish and maintain procedures for implementing corrective and preventive action"

  23. Section 820.80 - [Effective until 2/2/2026] Receiving, in-process, and finished device acceptance

    21 C.F.R. § 820.80   Cited 19 times   5 Legal Analyses
    Requiring manufacturers, in general, to "establish and maintain procedures for acceptance activities"