§Why CasetextPricing

De La Paz v. Bayer AG et al

MOTION to Dismiss Plaintiff's First Amended Complaint and Notice of Renewed Motion; Memorandum of Points and Authorities in Support

78 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 263,477 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 276,716 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 2,451 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 1,051 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 1,207 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

  6. Sprewell v. Golden State Warriors

    266 F.3d 979 (9th Cir. 2001)   Cited 5,226 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 2,334 times   5 Legal Analyses
    Holding that circumstances constituting fraud must be stated with particularity

  8. Fox v. Ethicon Endo-Surgery, Inc.

    35 Cal.4th 797 (Cal. 2005)   Cited 1,272 times   2 Legal Analyses
    Holding that "[r]esolution of the statute of limitations issue is normally a question of fact."

  9. Norgart v. Upjohn Co.

    21 Cal.4th 383 (Cal. 1999)   Cited 1,326 times   1 Legal Analyses
    Holding that the discovery rule "postpones accrual of a cause of action until the plaintiff discovers, or has reason to discover, the cause of action, until, that is, he at least suspects, or has reason to suspect, a factual basis for its elements"

  10. Clemens v. DaimlerChrysler Corp.

    530 F.3d 852 (9th Cir. 2008)   Cited 930 times   5 Legal Analyses
    Holding that "claims under the Magnuson–Moss Act stand or fall with express and implied warranty claims under state law"

  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 357,835 times   950 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 162,084 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. Rule 9 - Pleading Special Matters

    Fed. R. Civ. P. 9   Cited 39,880 times   331 Legal Analyses
    Requiring that fraud be pleaded with particularity

  14. Section 335.1 - Assault, battery or injury or death caused by wrongful act or negligence

    Cal. Code Civ. Proc. § 335.1   Cited 2,347 times   6 Legal Analyses
    Imposing two-year statute of limitations for personal injury claims

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

    21 U.S.C. § 360k   Cited 1,041 times   21 Legal Analyses
    Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause

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

    21 U.S.C. § 360c   Cited 801 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 . . ."

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

    21 U.S.C. § 337   Cited 687 times   21 Legal Analyses
    Providing that suits to enforce the FDCA generally must be brought "by and in the name of the United States"

  18. Section 15-3-530 - Three years

    S.C. Code § 15-3-530   Cited 576 times   1 Legal Analyses
    Applying three-year statute of limitations to actions for, among other things, breach of contract and fraud

  19. Section 360e - Premarket approval

    21 U.S.C. § 360e   Cited 504 times   18 Legal Analyses
    Granting FDA authority to conduct hearings regarding PMA withdrawal

  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 803.50 - If I am a manufacturer, what reporting requirements apply to me?

    21 C.F.R. § 803.50   Cited 151 times   8 Legal Analyses
    Requiring device manufacturers to report adverse medical device events to the FDA

  22. Section 814.84 - Reports

    21 C.F.R. § 814.84   Cited 88 times   5 Legal Analyses
    Providing that the FDA may require such reports

  23. Section 2-30.001 - Written Statement Explaining Consumer Rights Under Chapter 681, Florida Statutes; Hearings Before Florida New Motor Vehicle Arbitration Board

    Fla. Admin. Code R. 2-30.001   Cited 58 times

    (1) The following documents are incorporated into these rules by reference and can each be obtained by visiting the applicable web address shown below, where available, or by contacting the address shown in subsection (4): (a) The form entitled "Manufacturer's Answer, " DLA/LL-006 (rev. 2/06), effective 2-1-06. (b) The forms entitled "Consumer's Prehearing Information Sheet DLA/LL-007, (rev. 02/2023), effective 2-1-2023, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-14995 and Manufacturer's

  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