34 Cited authorities

Ashcroft v. Iqbal
556 U.S. 662 (2009) Cited 252,784 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
Bell Atl. Corp. v. Twombly
550 U.S. 544 (2007) Cited 266,697 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' "
Neitzke v. Williams
490 U.S. 319 (1989) Cited 55,792 times
Holding that "an in forma pauperis pro se complaint may only be dismissed as frivolous ... when the petitioner cannot make any claim with a rational or arguable basis in law or in fact"
Swierkiewicz v. Sorema N.A.
534 U.S. 506 (2002) Cited 16,766 times 20 Legal Analyses
Holding with regard to a 67-year-old plaintiff and a 59-year-old comparator that " difference of eight years between the age of the person discharged and his replacement . . . is not insignificant"
Scheuer v. Rhodes
416 U.S. 232 (1974) Cited 22,288 times 3 Legal Analyses
Holding that executive branch officers had qualified immunity
Conley v. Gibson
355 U.S. 41 (1957) Cited 58,508 times 25 Legal Analyses
Holding that "a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief"
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"
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
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
English v. General Electric Co.
496 U.S. 72 (1990) Cited 1,315 times 8 Legal Analyses
Holding that a tort arising from whistleblower retaliation at a nuclear facility was insufficiently related to radiological safety aspects in the facility's operation
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 345,982 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
Rule 15 - Amended and Supplemental Pleadings
Fed. R. Civ. P. 15 Cited 90,557 times 91 Legal Analyses
Finding that, per N.Y. C.P.L.R. § 1024, New York law provides a more forgiving principle for relation back in the context of naming John Doe defendants described with particularity in the complaint
Section 355 - New drugs
21 U.S.C. § 355 Cited 2,245 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"
Section 1782 - Notice and demand to correct, repair, replace or rectify goods or services
Cal. Civ. Code § 1782 Cited 285 times 5 Legal Analyses
Providing that no action for damages on behalf of a class of consumers may be maintained if a person alleged to have violated section 1770 shows that he or she has identified and notified the members of the class that he or she will remedy the violations upon request and he or she has ceased or will cease to engage in the violations
Section 21 - Registered futures associations
7 U.S.C. § 21 Cited 41 times 1 Legal Analyses
Stating that decisions of the Commodity Futures Trading Commission are reviewed by filing a petition in a court of appeals
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"
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
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
Section 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in Section 201.56(b)(1)
21 C.F.R. § 201.80 Cited 85 times 5 Legal Analyses
Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”

Stephanie Patton et al v. Forest Laboratories, LLC

34 Cited authorities

Holding that a claim is plausible where a plaintiff's allegations enable the court to draw a "reasonable inference" the defendant is liable

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' "

Holding that "an in forma pauperis pro se complaint may only be dismissed as frivolous ... when the petitioner cannot make any claim with a rational or arguable basis in law or in fact"

Holding with regard to a 67-year-old plaintiff and a 59-year-old comparator that " difference of eight years between the age of the person discharged and his replacement . . . is not insignificant"

Holding that executive branch officers had qualified immunity

Holding that "a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief"

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"

Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

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

Holding that a tort arising from whistleblower retaliation at a nuclear facility was insufficiently related to radiological safety aspects in the facility's operation

Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

Finding that, per N.Y. C.P.L.R. § 1024, New York law provides a more forgiving principle for relation back in the context of naming John Doe defendants described with particularity in the complaint

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"

Stating that decisions of the Commodity Futures Trading Commission are reviewed by filing a petition in a court of appeals

Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations

Requiring products to be withdrawn from the market where the FDA revokes approval

Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”