§Why CasetextPricing

Denise Harrison v. Bayer Corporation et al

NOTICE OF MOTION AND MOTION to Dismiss Case /Plaintiff's First Amended Complaint; Memorandum of Points and Authorities in Support Thereof

44 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. 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"

  4. 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”

  5. 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

  6. Sprewell v. Golden State Warriors

    266 F.3d 979 (9th Cir. 2001)   Cited 5,069 times   4 Legal Analyses
    Holding that unwarranted inferences are insufficient to defeat a motion to dismiss

  7. Kearns v. Ford Motor Co.

    567 F.3d 1120 (9th Cir. 2009)   Cited 2,257 times   5 Legal Analyses
    Holding that circumstances constituting fraud must be stated with particularity

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

    623 F.3d 1200 (8th Cir. 2010)   Cited 308 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."

  9. Stengel v. Medtronic Inc.

    704 F.3d 1224 (9th Cir. 2013)   Cited 227 times   12 Legal Analyses
    Holding that "the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA"

  10. Fields v. Legacy Health System

    413 F.3d 943 (9th Cir. 2005)   Cited 228 times
    Upholding statute against substantive due process challenge on rational basis review; recognizing a distinction between vested and non-vested property rights only in the context of petitioner's procedural due process 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 346,412 times   923 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 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. . . ."

  13. Rule 9 - Pleading Special Matters

    Fed. R. Civ. P. 9   Cited 38,956 times   317 Legal Analyses
    Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"

  14. 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

  15. 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 . . ."

  16. 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

  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 333 - Penalties

    21 U.S.C. § 333   Cited 436 times   39 Legal Analyses
    Defining civil and criminal penalties for violations of Section 331

  19. Section 334 - Seizure

    21 U.S.C. § 334   Cited 374 times   5 Legal Analyses
    Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals

  20. Section 332 - Injunction proceedings

    21 U.S.C. § 332   Cited 268 times   6 Legal Analyses
    Granting the district court jurisdiction to restrain violations of FDCA

  21. Section 814.39 - PMA supplements

    21 C.F.R. § 814.39   Cited 152 times   4 Legal Analyses
    Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"

  22. 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

  23. 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

  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