§Why CasetextPricing

Morgan v. Medtronic, Inc.

MOTION for Rule 12

50 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 254,033 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. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,032 times   62 Legal Analyses
    Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

  3. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,187 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

  4. Funk v. Stryker Corp.

    631 F.3d 777 (5th Cir. 2011)   Cited 850 times   1 Legal Analyses
    Holding court lacked jurisdiction to consider district court's denial of plaintiff's postjudgment motions because he did not file an amended, or separate, notice of appeal

  5. Airborne v. AT&T

    499 F.3d 663 (7th Cir. 2007)   Cited 846 times
    Finding that defendant suffered real prejudice by endless amendments and motion practice regarding the complaint

  6. American Tobacco Co. Inc. v. Grinnell

    951 S.W.2d 420 (Tex. 1997)   Cited 1,113 times   1 Legal Analyses
    Holding that Texas law does not recognize claims based on a duty to act to prevent risk once prior conduct is found to be dangerous and noting that such claims "are particularly ill-suited for application to what are essentially products liability claims because they impose liability even when the manufacturer provides adequate warnings"

  7. Torrington Co v. Stutzman

    46 S.W.3d 829 (Tex. 2001)   Cited 531 times
    Holding that general-negligence findings in the context of premises liability are immaterial

  8. Bass v. Stryker Corp.

    669 F.3d 501 (5th Cir. 2012)   Cited 237 times   3 Legal Analyses
    Holding that an entire device, including its component parts, satisfied the first step of Riegel when the FDA reviewed those components during the PMA process

  9. McKay v. Novartis Pharm. Corp.

    751 F.3d 694 (5th Cir. 2014)   Cited 148 times
    Holding that the notice must “inform the seller that the transaction is claimed to involve a breach, and thus open the way for normal settlement through negotiation”

  10. In re Medtronic, Inc. Sprint Fedelis Leads Prods.

    592 F. Supp. 2d 1147 (D. Minn. 2009)   Cited 123 times   2 Legal Analyses
    Holding that claims for breach of an express warranty of a medical device's safety would require a jury to determine that the device was unsafe

  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 347,250 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 201 - Judicial Notice of Adjudicative Facts

    Fed. R. Evid. 201   Cited 28,407 times   26 Legal Analyses
    Holding "[n]ormally, in deciding a motion to dismiss for failure to state a claim, courts must limit their inquiry to the facts stated in the complaint and the documents either attached to or incorporated in the complaint. However, courts may also consider matters of which they may take judicial notice."

  13. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,428 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 1,026 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 788 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 352 - Misbranded drugs and devices

    21 U.S.C. § 352   Cited 740 times   73 Legal Analyses
    Setting labeling requirements for drug products

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

    21 U.S.C. § 337   Cited 670 times   19 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  18. Section 360e - Premarket approval

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

  19. Section 360 - Registration of producers of drugs or devices

    21 U.S.C. § 360   Cited 405 times   28 Legal Analyses
    Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements

  20. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 340 times   32 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

  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 814.80 - General

    21 C.F.R. § 814.80   Cited 102 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

  23. Section 814.84 - Reports

    21 C.F.R. § 814.84   Cited 87 times   5 Legal Analyses
    Providing that the FDA may require such reports

  24. Section 814.82 - Postapproval requirements

    21 C.F.R. § 814.82   Cited 46 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