Ashcroft v. Iqbal

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

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

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

Wyeth v. Levine

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

Buckman Co. v. Plaintiffs' Legal Committee

Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

Lormand v. US Unwired, Inc.

Holding that warnings "d[id] not qualify as meaningful cautionary language" because they "did not disclose that defendants knew from past experience that the [risks] posed an imminent threat of business and financial ruin and that some damage from these risks had already materialized"

Mut. Pharm. Co. v. Bartlett

Holding "state-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA"

Wolcott v. Sebelius

Holding "§ 405(h) does not preclude § 1361 jurisdiction"

Funk v. Stryker Corp.

Holding court lacked jurisdiction to consider district court's denial of plaintiff's postjudgment motions because he did not file an amended, or separate, notice of appeal

Plotkin v. IP Axess Inc.

Holding that a plaintiff must plead with “specificity as to the statements (or omissions) considered to be fraudulent, the speaker, when and why the statements were made, and an explanation of why they were fraudulent.”

Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing

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

Section 1332 - Diversity of citizenship; amount in controversy; costs

Holding district court has jurisdiction over action between diverse citizens "where the matter in controversy exceeds the sum or value of $75,000"

Rule 9 - Pleading Special Matters

Requiring that fraud be pleaded with particularity

Rule 201 - Judicial Notice of Adjudicative Facts

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."

Section 1404 - Change of venue

Granting Class Plaintiffs' motion to transfer action in order to "facilitate a unified settlement approval process together with the class action cases in" In re Amex ASR

Section 301 - Short title

Section 355 - New drugs

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 201 - Bribery of public officials and witnesses

Using "proceeding" to refer to trials, hearings, or the like "before any court, any committee of either House or both Houses of Congress, or any agency, commission, or officer"

Section 262 - Regulation of biological products

Providing that a license shall issue "only upon a showing" by the manufacturer

Section 82.001 - Definitions

Defining seller as a "person who is engaged in the business of distributing or otherwise placing, for any commercial purpose, in the stream of commerce for use or consumption a product or any component part thereof"

Section 314.125 - Refusal to approve an NDA

Requiring FDA to reject application when proposed labeling is "false or misleading in any particular"