56 Cited authorities

Bell Atl. Corp. v. Twombly
550 U.S. 544 (2007) Cited 269,239 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' "
Tellabs v. Makor Issues Rights
551 U.S. 308 (2007) Cited 9,200 times 104 Legal Analyses
Holding that a strong inference is one that is "cogent and at least as compelling as any opposing inference"
Dura Pharmaceuticals v. Broudo
544 U.S. 336 (2005) Cited 3,567 times 67 Legal Analyses
Holding that the securities statutes have a private of action “not to provide investors with broad insurance against market losses, but to protect them against those economic losses that misrepresentations actually cause”
Stoneridge Investment Partners, LLC v. Scientific-Atlanta, Inc.
552 U.S. 148 (2008) Cited 1,184 times 80 Legal Analyses
Holding that the fraud-on-the-market presumption did not apply because business partners' "deceptive acts were not communicated to the public"
ATSI Communications, Inc. v. Shaar Fund, Ltd.
493 F.3d 87 (2d Cir. 2007) Cited 3,902 times 6 Legal Analyses
Holding that because "a plaintiff must show . . . a primary violation by the controlled person" in order to "establish a prima facie case of control[-]person liability," a plaintiff who "fails to allege any primary violation . . . cannot establish control[-]person liability"
In re Silicon Graphics Inc.
183 F.3d 970 (9th Cir. 1999) Cited 1,419 times 8 Legal Analyses
Holding that stock sales of individual defendants are only indicative of scienter where they are "dramatically out of line with prior trading practices" (quoting In re Apple Computer Sec. Litig., 886 F.2d 1109, 1117 (9th Cir. 1989))
Southland Securities v. Inspire Ins. Solutions
365 F.3d 353 (5th Cir. 2004) Cited 1,154 times 8 Legal Analyses
Holding that when determining whether a statement made by a corporation was made with scienter it is “appropriate to look to the state of mind of the individual corporate official or officials who make or issue the statement ... rather than generally to the collective knowledge of all the corporation's officers and employees”
Lentell v. Merrill Lynch Co., Inc.
396 F.3d 161 (2d Cir. 2005) Cited 1,003 times 20 Legal Analyses
Holding that to prove loss causation, a plaintiff must allege "that the misstatement or omission concealed something from the market that, when disclosed, negatively affected the value of the security"
Securities & Exchange Commission v. First Jersey Securities, Inc.
101 F.3d 1450 (2d Cir. 1996) Cited 1,237 times 5 Legal Analyses
Holding that owner-officer who collaborated in unlawful conduct of firm may be held jointly and severally liable with firm for disgorgement of unlawful gains received
Acito v. Imcera Group, Inc.
47 F.3d 47 (2d Cir. 1995) Cited 1,133 times 1 Legal Analyses
Holding that selling stock, by itself, insufficient to plead scienter, absent allegations that "stock sales were 'unusual'"
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 348,810 times 931 Legal Analyses
Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss
Rule 9 - Pleading Special Matters
Fed. R. Civ. P. 9 Cited 39,136 times 321 Legal Analyses
Requiring that fraud be pleaded with particularity
Section 78j - Manipulative and deceptive devices
15 U.S.C. § 78j Cited 12,542 times 165 Legal Analyses
Granting SEC power to establish rules to further statute forbidding manipulative or deceptive devices in connection with purchase or sale of securities
Section 78u-4 - Private securities litigation
15 U.S.C. § 78u-4 Cited 7,505 times 50 Legal Analyses
Granting courts authority to permit discovery if necessary "to preserve evidence or to prevent undue prejudice to" a party
Section 78t - Liability of controlling persons and persons who aid and abet violations
15 U.S.C. § 78t Cited 3,990 times 20 Legal Analyses
Holding liable any person "who, directly or indirectly, controls any person liable under any provision of this chapter or of any rule or regulation thereunder"
Section 355 - New drugs
21 U.S.C. § 355 Cited 2,253 times 341 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 78t-1 - Liability to contemporaneous traders for insider trading
15 U.S.C. § 78t-1 Cited 298 times
Granting an explicit right of private action under Rule 10b-5 pursuant to the Insider Trading and Securities Fraud Enforcement Act of 1988
Section 314.101 - Filing an NDA and receiving an ANDA
21 C.F.R. § 314.101 Cited 31 times 9 Legal Analyses
Providing that an "NDA may be filed" once the "FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review"
Section 314.108 - New drug product exclusivity
21 C.F.R. § 314.108 Cited 28 times 33 Legal Analyses
(a)Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section: Approved under section 505(b) means an NDA submitted under section 505(b) and approved on or after October 10, 1962, or an application that was "deemed approved" under section 107(c)(2) of Public Law 87-781 . Bioavailability study means a study to determine the bioavailability or the pharmacokinetics of a drug. Clinical investigation means any experiment other than a bioavailability study in which
Section 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
21 C.F.R. § 314.510 Cited 4 times 2 Legal Analyses
FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that the applicant study

Corwin v. Seizinger et al

56 Cited authorities

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 a strong inference is one that is "cogent and at least as compelling as any opposing inference"

Holding that the securities statutes have a private of action “not to provide investors with broad insurance against market losses, but to protect them against those economic losses that misrepresentations actually cause”

Holding that the fraud-on-the-market presumption did not apply because business partners' "deceptive acts were not communicated to the public"

Holding that because "a plaintiff must show . . . a primary violation by the controlled person" in order to "establish a prima facie case of control[-]person liability," a plaintiff who "fails to allege any primary violation . . . cannot establish control[-]person liability"

Holding that stock sales of individual defendants are only indicative of scienter where they are "dramatically out of line with prior trading practices" (quoting In re Apple Computer Sec. Litig., 886 F.2d 1109, 1117 (9th Cir. 1989))

Holding that to prove loss causation, a plaintiff must allege "that the misstatement or omission concealed something from the market that, when disclosed, negatively affected the value of the security"

Holding that owner-officer who collaborated in unlawful conduct of firm may be held jointly and severally liable with firm for disgorgement of unlawful gains received

Holding that selling stock, by itself, insufficient to plead scienter, absent allegations that "stock sales were 'unusual'"

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

Requiring that fraud be pleaded with particularity

Granting SEC power to establish rules to further statute forbidding manipulative or deceptive devices in connection with purchase or sale of securities

Granting courts authority to permit discovery if necessary "to preserve evidence or to prevent undue prejudice to" a party

Holding liable any person "who, directly or indirectly, controls any person liable under any provision of this chapter or of any rule or regulation thereunder"

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"

Granting an explicit right of private action under Rule 10b-5 pursuant to the Insider Trading and Securities Fraud Enforcement Act of 1988

Providing that an "NDA may be filed" once the "FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review"