§Why CasetextPricing

Streed et al V Wyeth Pharmaceuticals, Inc. et Al.,

MOTION to Dismiss for Lack of Jurisdiction

98 Cited authorities

  1. Ashcroft v. Iqbal

    556 U.S. 662 (2009)   Cited 252,709 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 266,625 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. Daimler AG v. Bauman

    571 U.S. 117 (2014)   Cited 5,616 times   236 Legal Analyses
    Holding that foreign corporations may not be subject to general jurisdiction "whenever they have an in-state subsidiary or affiliate"

  4. Goodyear Dunlop Tires Oper. v. Brown

    564 U.S. 915 (2011)   Cited 5,203 times   86 Legal Analyses
    Holding "the sales of petitioners' tires sporadically made in North Carolina through intermediaries" insufficient to support general jurisdiction

  5. Burger King Corp. v. Rudzewicz

    471 U.S. 462 (1985)   Cited 16,823 times   46 Legal Analyses
    Holding that a defendant has "fair warning" if he purposefully directs his activities at residents of the forum and if the litigation results from alleged injuries arising out of or relating to those activities.

  6. Medtronic, Inc. v. Lohr

    518 U.S. 470 (1996)   Cited 2,417 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"

  7. Int'l Shoe Co. v. Washington

    326 U.S. 310 (1945)   Cited 22,588 times   109 Legal Analyses
    Holding that states may exercise personal jurisdiction over out-of-state defendants with "certain minimum contacts with [the forum] such that the maintenance of the suit does not offend ‘traditional notions of fair play and substantial justice’ " (quoting Milliken v. Meyer , 311 U.S. 457, 463, 61 S.Ct. 339, 85 L.Ed. 278 (1940) )

  8. 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”

  9. 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

  10. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 746 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

  11. Section 636 - Jurisdiction, powers, and temporary assignment

    28 U.S.C. § 636   Cited 500,353 times   39 Legal Analyses
    Holding that when a party fails to object to a magistrate judge's report and recommendation, our review of the district court's resulting decision is for plain error so long as the party "has been served with notice that [this consequence] will result from a failure to object"

  12. 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 345,885 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

  13. Rule 72 - Magistrate Judges: Pretrial Order

    Fed. R. Civ. P. 72   Cited 166,548 times   20 Legal Analyses
    Granting a party fourteen days to object to a Magistrate Judge's non-dispositive order

  14. Rule 8 - General Rules of Pleading

    Fed. R. Civ. P. 8   Cited 156,205 times   193 Legal Analyses
    Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."

  15. Rule 26 - Duty to Disclose; General Provisions Governing Discovery

    Fed. R. Civ. P. 26   Cited 94,988 times   653 Legal Analyses
    Adopting Fed.R.Civ.P. 37

  16. Rule 4 - Summons

    Fed. R. Civ. P. 4   Cited 68,973 times   122 Legal Analyses
    Holding that if defendant is not served within 90 days after the complaint is filed, the court—on a motion, or on its own following notice to the plaintiff—must dismiss the action without prejudice against that defendant or order that service be made by a certain time

  17. Rule 9 - Pleading Special Matters

    Fed. R. Civ. P. 9   Cited 38,923 times   316 Legal Analyses
    Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"

  18. Rule 201 - Judicial Notice of Adjudicative Facts

    Fed. R. Evid. 201   Cited 28,281 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."

  19. Section 17200 - Unfair competition defined

    Cal. Bus. & Prof. Code § 17200   Cited 17,837 times   315 Legal Analyses
    Prohibiting unlawful business practices

  20. Section 1631 - Transfer to cure want of jurisdiction

    28 U.S.C. § 1631   Cited 7,656 times   16 Legal Analyses
    Granting courts authority to transfer action to court with proper jurisdiction

  21. Section 314.70 - Supplements and other changes to an approved NDA

    21 C.F.R. § 314.70   Cited 353 times   37 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

  22. 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

  23. 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

  24. Section 314.80 - Postmarketing reporting of adverse drug experiences

    21 C.F.R. § 314.80   Cited 113 times   7 Legal Analyses
    Requiring report of “serious and unexpected” adverse event within 15 days

  25. 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

  26. Section 314.81 - Other postmarketing reports

    21 C.F.R. § 314.81   Cited 45 times   26 Legal Analyses
    Requiring transmittal of the advertisement with Form FDA-2253

  27. 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

  28. Section 314.98 - Postmarketing reports

    21 C.F.R. § 314.98   Cited 16 times   1 Legal Analyses
    Imposing a duty on generic manufacturers to report adverse drug experiences to the FDA