§Why CasetextPricing

Bertroch v. Smith & Nephew

REPLY BRIEF re MOTION to Dismiss Based upon Plaintiffs claims are preempted

72 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 253,227 times   279 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 267,097 times   365 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. Phillips v. County of Allegheny

    515 F.3d 224 (3d Cir. 2008)   Cited 16,859 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 2,417 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. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,031 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 1,184 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

  7. Francis v. Giacomelli

    588 F.3d 186 (4th Cir. 2009)   Cited 3,910 times
    Holding that the defendant was entitled to qualified immunity since "his actions were not clearly unlawful when performed"

  8. Mylan Laboratories, Inc. v. Matkari

    7 F.3d 1130 (4th Cir. 1993)   Cited 4,023 times   2 Legal Analyses
    Holding that the plaintiff's "claims that the defendants falsely represented that their drugs had been ‘properly approved by the FDA’ must fail"

  9. Puerto Rico v. Franklin Cal. Tax-Free Tr.

    136 S. Ct. 1938 (2016)   Cited 180 times   10 Legal Analyses
    Holding that, when the "statute 'contains an express pre-emption clause,' we do not invoke any presumption against pre-emption but instead 'focus on the plain wording of the clause, which necessarily contains the best evidence of Congress' pre-emptive intent'"

  10. Bausch v. Stryker Corp.

    630 F.3d 546 (7th Cir. 2010)   Cited 631 times   7 Legal Analyses
    Holding that tort law claims based on manufacturing defects were not impliedly preempted

  11. Rule 8 - General Rules of Pleading

    Fed. R. Civ. P. 8   Cited 156,480 times   194 Legal Analyses
    Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."

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

    21 U.S.C. § 360k   Cited 1,025 times   21 Legal Analyses
    Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause

  13. Section 360c - Classification of devices intended for human use

    21 U.S.C. § 360c   Cited 787 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 . . ."

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

    21 U.S.C. § 337   Cited 667 times   19 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  15. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 494 times   17 Legal Analyses
    Granting FDA authority to conduct hearings regarding PMA withdrawal

  16. Section 36-2-313 - Express warranties by affirmation, promise, description, sample

    S.C. Code § 36-2-313   Cited 37 times

    (1) Express warranties by the seller are created as follows: (a) Any affirmation of fact or promise, including those on containers or labels, made by the seller to the buyer, whether directly or indirectly, which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods conform to the affirmation or promise. (b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to

  17. Section 10.30 - Citizen petition

    21 C.F.R. § 10.30   Cited 140 times   35 Legal Analyses
    Describing the requirements for filing a citizens' petition

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

    21 C.F.R. § 820.30   Cited 59 times   38 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

  19. 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"

  20. Section 820.198 - [Effective until 2/2/2026] Complaint files

    21 C.F.R. § 820.198   Cited 37 times   12 Legal Analyses
    Requiring manufacturers to "establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit" including ensuring "timely" and "uniform" review of complaints

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

    21 C.F.R. § 820.80   Cited 18 times   5 Legal Analyses
    Requiring manufacturers, in general, to "establish and maintain procedures for acceptance activities"

  22. Section 820.120 - [Effective until 2/2/2026] Device labeling

    21 C.F.R. § 820.120   Cited 2 times   1 Legal Analyses

    Each manufacturer shall establish and maintain procedures to control labeling activities. (a)Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use. (b)Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier