§Why CasetextPricing

Lefaivre v. KV Pharmaceutical Company, et al.

MEMORANDUM in Opposition re MOTION to Dismiss Case Defendants' Rule 12

60 Cited authorities

  1. Medtronic, Inc. v. Lohr

    518 U.S. 470 (1996)   Cited 2,416 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"

  2. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,432 times   101 Legal Analyses
    Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

  3. 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”

  4. 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

  5. Hillsborough County v. Automated Medical Labs

    471 U.S. 707 (1985)   Cited 1,191 times   3 Legal Analyses
    Holding local health ordinance not preempted because "the regulation of health and safety matters is primarily, and historically, a matter of local concern"

  6. Mylan Laboratories, Inc. v. Matkari

    7 F.3d 1130 (4th Cir. 1993)   Cited 4,021 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"

  7. Jones v. Rath Packing Co.

    430 U.S. 519 (1977)   Cited 1,187 times   3 Legal Analyses
    Holding that the presumption is weaker, if triggered at all, where there is not a tradition of state legislation

  8. Fla. Avocado Growers v. Paul

    373 U.S. 132 (1963)   Cited 1,567 times   3 Legal Analyses
    Holding federal regulation concerning maturity of avocados did not preempt California regulation, where it was not impossible for growers to comply with both regulations

  9. Rice v. Santa Fe Elevator Corp.

    331 U.S. 218 (1947)   Cited 2,165 times   11 Legal Analyses
    Holding that the clear statement rule may be satisfied where "the Act of Congress ... touch[es] a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject."

  10. Roth Steel Products v. Sharon Steel Corp.

    705 F.2d 134 (6th Cir. 1983)   Cited 613 times   3 Legal Analyses
    Holding that if "the underlying contractual obligation is predicated on an illusory promise," the resulting "contract" is not valid

  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 345,805 times   922 Legal Analyses
    Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

  12. Section 1051 - Application for registration; verification

    15 U.S.C. § 1051   Cited 3,788 times   123 Legal Analyses
    Requiring a filing of a Statement of Use to register a mark

  13. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,427 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 1,025 times   21 Legal Analyses
    Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause

  15. 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

  16. Section 333 - Penalties

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

  17. Section 334 - Seizure

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

  18. 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

  19. Section 601 - Definitions

    21 U.S.C. § 601   Cited 178 times   10 Legal Analyses
    Defining "misbranded" meat product in part as one with "labeling is false or misleading in any particular"

  20. Section 360h - Notification and other remedies

    21 U.S.C. § 360h   Cited 56 times   3 Legal Analyses
    Granting FDA authority over device recall orders and timetables