§Why CasetextPricing

Priest v. Sandoz Inc.

MOTION for Summary Judgment and Incorporated Memorandum of Law

41 Cited authorities

  1. Anderson v. Liberty Lobby, Inc.

    477 U.S. 242 (1986)   Cited 237,021 times   38 Legal Analyses
    Holding that summary judgment is not appropriate if "the dispute about a material fact is ‘genuine,’ that is, if the evidence is such that a reasonable jury could return a verdict for the nonmoving party"

  2. Celotex Corp. v. Catrett

    477 U.S. 317 (1986)   Cited 217,007 times   40 Legal Analyses
    Holding that a movant's summary judgment motion should be granted "against a [nonmovant] who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial"

  3. Daubert v. Merrell Dow Pharmaceuticals, Inc.

    509 U.S. 579 (1993)   Cited 26,436 times   228 Legal Analyses
    Holding that a trial judge must ensure that all admitted expert testimony "is not only relevant, but reliable"

  4. Little v. Liquid Air Corp.

    37 F.3d 1069 (5th Cir. 1994)   Cited 12,436 times   5 Legal Analyses
    Holding that a mere scintilla of evidence does not create a genuine issue of material fact

  5. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,188 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. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 749 times   143 Legal Analyses
    Holding that state tort law that required generic drug manufacturers to provide adequate warning labels was preempted where federal law required manufacturers to use the same labels as their brand-name counterparts

  7. Boudreaux v. Swift Transp. Co., Inc.

    402 F.3d 536 (5th Cir. 2005)   Cited 2,137 times   1 Legal Analyses
    Explaining non-moving party's burden is not satisfied by "some metaphysical doubt as to the material facts, by conclusory allegations, by unsubstantiated assertions, or by only a scintilla of evidence"

  8. Transportation Ins. Co. v. Moriel

    879 S.W.2d 10 (Tex. 1994)   Cited 1,047 times   4 Legal Analyses
    Holding that evidence of defendant's allegedly "reckless" conduct was legally insufficient to support award of punitive damages in civil lawsuit

  9. U-Haul Int'l v. Waldrip

    55 Tex. Sup. Ct. J. 1345 (Tex. 2012)   Cited 358 times
    Holding actual knowledge cannot be imputed to a corporation absent actual proof by management

  10. Ford Motor Co. v. Ledesma

    242 S.W.3d 32 (Tex. 2007)   Cited 337 times
    Holding that a fire was a “condition” when, hours after it was extinguished, a person slipped and fell trying to close a valve on the site of the fire

  11. Rule 56 - Summary Judgment

    Fed. R. Civ. P. 56   Cited 329,902 times   158 Legal Analyses
    Holding a party may move for summary judgment on any part of any claim or defense in the lawsuit

  12. Rule 702 - Testimony by Expert Witnesses

    Fed. R. Evid. 702   Cited 26,822 times   260 Legal Analyses
    Adopting the Daubert standard

  13. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,252 times   340 Legal Analyses
    Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

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

    21 U.S.C. § 337   Cited 671 times   19 Legal Analyses
    Restricting FDCA enforcement to suits by the United States

  15. Section 41.001 - Definitions

    Tex. Civ. Prac. & Rem. Code § 41.001   Cited 609 times   6 Legal Analyses
    Defining the standard for gross negligence

  16. Section 41.003 - Standards for Recovery of Exemplary Damages

    Tex. Civ. Prac. & Rem. Code § 41.003   Cited 583 times   4 Legal Analyses
    Permitting recovery of exemplary damages if the claimant proves that fraud, malice, or gross negligence caused the harm at issue

  17. Section 208.24 - Distributing and dispensing a Medication Guide

    21 C.F.R. § 208.24   Cited 40 times
    Requiring drug manufacturers to make Medication Guides available for distribution to each patient with each prescription, by providing them—or the means to produce them—to distributors, packers, or authorized dispensers of the drug

  18. Section 208.1 - Scope and purpose

    21 C.F.R. § 208.1   Cited 13 times   2 Legal Analyses

    (a) This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. It applies primarily to human prescription drug products used on an outpatient basis without direct supervision by a health professional. This part shall apply to new prescriptions and refill prescriptions

  19. Section 208.20 - Content and format of a Medication Guide

    21 C.F.R. § 208.20   Cited 5 times

    (a) A Medication Guide shall meet all of the following conditions: (1) The Medication Guide shall be written in English, in nontechnical, understandable language, and shall not be promotional in tone or content. (2) The Medication Guide shall be scientifically accurate and shall be based on, and shall not conflict with, the approved professional labeling for the drug product under § 201.57 of this chapter, but the language of the Medication Guide need not be identical to the sections of approved

  20. Section 208.3 - Definitions

    21 C.F.R. § 208.3   Cited 4 times

    For the purposes of this part, the following definitions shall apply: (a)Authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice. (b)Dispense to patients means the act of delivering a prescription drug product to a patient or an agent of the patient either: (1) By a licensed practitioner or an agent of a licensed practitioner, either directly