41 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 252,544 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. Bell Atl. Corp. v. Twombly

    550 U.S. 544 (2007)   Cited 266,461 times   365 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. 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
  4. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 745 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
  5. Swartz v. KPMG LLP

    476 F.3d 756 (9th Cir. 2007)   Cited 2,864 times   3 Legal Analyses
    Holding that “[t]o the extent Swartz seeks a declaration of defendants' liability for damages sought for his other causes of action,” claim must be dismissed as “merely duplicative”
  6. Mut. Pharm. Co. v. Bartlett

    570 U.S. 472 (2013)   Cited 415 times   67 Legal Analyses
    Holding "state-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA"
  7. Marshall Cty. Bd. of Educ. v. Marshall Cty

    992 F.2d 1171 (11th Cir. 1993)   Cited 998 times
    Finding that under Rule 12(b), dismissal of a complaint is appropriate "when, on the basis of a dispositive issue of law, no construction of the factual allegations will support the cause of action."
  8. Horne v. Potter

    392 F. App'x 800 (11th Cir. 2010)   Cited 288 times
    Holding that the district court properly took judicial notice of court filings in a previous case at the motion to dismiss stage
  9. Drager v. PLIVA USA, Inc.

    741 F.3d 470 (4th Cir. 2014)   Cited 235 times   1 Legal Analyses
    Holding that district court did not abuse its discretion in denying motion to amend when plaintiff did not file motion to amend or proposed amended complaint
  10. Germain v. Teva Pharmaceuticals

    756 F.3d 917 (6th Cir. 2014)   Cited 145 times   7 Legal Analyses
    Holding that brand-name manufacturers cannot be held liable for damages caused by ingestion of generic drugs under negligent misrepresentation law of 22 states
  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 345,715 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. Rule 8 - General Rules of Pleading

    Fed. R. Civ. P. 8   Cited 156,116 times   193 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 38,911 times   316 Legal Analyses
    Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"
  14. Rule 201 - Judicial Notice of Adjudicative Facts

    Fed. R. Evid. 201   Cited 28,265 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."
  15. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,244 times   337 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"
  16. Section 6-5-101 - Fraud - Misrepresentations of material facts

    Ala. Code § 6-5-101   Cited 320 times
    Providing misrepresentation of material fact constitutes legal fraud
  17. Section 314.94 - Content and format of an ANDA

    21 C.F.R. § 314.94   Cited 224 times   37 Legal Analyses
    Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations
  18. Section 314.50 - Content and format of an NDA

    21 C.F.R. § 314.50   Cited 148 times   16 Legal Analyses
    Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications
  19. Section 314.150 - Withdrawal of approval of an application or abbreviated application

    21 C.F.R. § 314.150   Cited 87 times   4 Legal Analyses
    Requiring products to be withdrawn from the market where the FDA revokes approval