27 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 255,123 times   280 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 268,865 times   367 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. Tellabs v. Makor Issues Rights

    551 U.S. 308 (2007)   Cited 9,191 times   104 Legal Analyses
    Holding that a strong inference is one that is "cogent and at least as compelling as any opposing inference"
  4. 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
  5. Dorsey v. Portfolio Equities Inc.

    540 F.3d 333 (5th Cir. 2008)   Cited 1,131 times
    Holding that to satisfy Rule 9(b), a plaintiff pleading fraud must "specify the statements contended to be fraudulent, identify the speaker, state when and where the statements were made, and explain why the statements were fraudulent. Put simply, Rule 9(b) requires the complaint to set forth the who, what, when, where, and how of the events at issue."
  6. U.S. ex Rel. Willard v. Humana Health Plan

    336 F.3d 375 (5th Cir. 2003)   Cited 959 times
    Holding that the district court did not abuse its discretion in not allowing the plaintiff to amend its complaint because the plaintiff had already had two opportunities to amend their complaint
  7. Lovelace v. Software Spectrum Inc.

    78 F.3d 1015 (5th Cir. 1996)   Cited 1,116 times
    Holding that courts may take judicial notice of public disclosure documents in securities fraud causes, but "only for the purpose of determining what statements the documents contain, not to prove the truth of the documents’ contents"
  8. Lone Star Ladies Inv. Club v. Schlotzsky's

    238 F.3d 363 (5th Cir. 2001)   Cited 315 times
    Holding that the district court erred in denying plaintiffs leave to file their amended securities complaint
  9. Frith v. Guardian Life Ins. Co. of America

    9 F. Supp. 2d 734 (S.D. Tex. 1998)   Cited 276 times
    Holding that "[c]laims . . . asserting fraud, fraudulent inducement, fraudulent concealment . . . are subject to the requirements of Rule 9(b)"
  10. Roberts v. Williamson

    111 S.W.3d 113 (Tex. 2003)   Cited 206 times
    Holding pediatrician qualified to testify on neurological injuries given pediatrician's study on effects of pediatric neurological injuries and advising parents about effects of those injuries
  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 348,416 times   930 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 157,557 times   196 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 39,105 times   320 Legal Analyses
    Requiring that fraud be pleaded with particularity
  14. Section 331 - Prohibited acts

    21 U.S.C. § 331   Cited 1,518 times   105 Legal Analyses
    Prohibiting the sale of adulterated foods
  15. Section 352 - Misbranded drugs and devices

    21 U.S.C. § 352   Cited 740 times   73 Legal Analyses
    Setting labeling requirements for drug products
  16. Section 2.313 - Express Warranties By Affirmation, Promise, Description, Sample

    Tex. Bus. & Com. Code § 2.313   Cited 137 times
    Describing the ways in which a seller creates express warranties
  17. Section 2.315 - Implied Warranty: Fitness for Particular Purpose

    Tex. Bus. & Com. Code § 2.315   Cited 82 times
    Requiring seller to have "reason to know any particular purpose for which the goods are required and that the buyer is relying on the seller's skill or judgment to select or furnish suitable goods"
  18. Section 336 - Report of minor violations

    21 U.S.C. § 336   Cited 27 times   2 Legal Analyses

    Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning. 21 U.S.C. § 336 June 25, 1938, ch. 675, §309, formerly §306, 52 Stat. 1045; renumbered §309, Pub. L. 102-282, §2, May 13, 1992, 106 Stat. 150. EXECUTIVE DOCUMENTS TRANSFER OF FUNCTIONSFor transfer of

  19. Section 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in Section 201.56(b)(1)

    21 C.F.R. § 201.57   Cited 253 times   27 Legal Analyses
    Listing requirements for different subsections for indications, dosage, and clinical studies
  20. Section 201.128 - Meaning of "intended uses"

    21 C.F.R. § 201.128   Cited 47 times   36 Legal Analyses

    The words intended uses or words of similar import in §§ 201.5 , 201.115 , 201.117 , 201.119 , 201.120 , 201.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising