Bell Atl. Corp. v. Twombly

Holding that allegations of conduct that are merely consistent with wrongdoing do not state a claim unless "placed in a context that raises a suggestion of" such wrongdoing

Tellabs v. Makor Issues Rights

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

Papasan v. Allain

Holding that Ex parte Young would not support a suit against a state for ongoing liability for an alleged past breach of trust, since "continuing payment of the income from the lost corpus is essentially equivalent in economic terms to a one-time restoration of the lost corpus itself"

Riegel v. Medtronic, Inc.

Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

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

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

U.S. ex Rel. Willard v. Humana Health Plan

Holding that the district court did not abuse its discretion in not allowing the plaintiff to amend its complaint because the plaintiff had already had two opportunities to amend their complaint

Lovelace v. Software Spectrum Inc.

Holding that courts may take judicial notice of public disclosure documents in securities fraud causes, but "only for the purpose of determining what statements the documents contain, not to prove the truth of the documents’ contents"

Rios v. City of Del Rio

Holding that there can be no supervisory liability where there is no underlying constitutional violation

In re Medtronic, Inc., Sprint Fidelis Leads

Holding in medical-device context that potential additional warnings were "precisely the type of state requirement that is 'different from or in addition to' the federal requirement and therefore preempted" (quoting 21 U.S.C. § 360k)

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

Rule 8 - General Rules of Pleading

Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."

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 360k - State and local requirements respecting devices

Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause

Section 360c - Classification of devices intended for human use

Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."

Section 360e - Premarket approval

Granting FDA authority to conduct hearings regarding PMA withdrawal

Section 360 - Registration of producers of drugs or devices

Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements

Section 9:2800.54 - Manufacturer responsibility and burden of proof

Stating that a manufacturer is liable only when an injury "arose from a reasonably anticipated use of the product"

Section 9:2800.51 - Short title

Section 9:2800.52 - Scope of this Chapter

Noting that "`fault' within the meaning of Civil Code Article 2315" triggers LPLA liability

Section 814.39 - PMA supplements

Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"

Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?

Requiring device manufacturers to report adverse medical device events to the FDA

Section 814.84 - Reports

Providing that the FDA may require such reports

Section 801.109 - Prescription devices

Requiring labels to include such information as indications, effects, routes, methods, frequency and duration of administration, relevant hazards, contraindications, side effects, and precautions

Section 814.44 - Procedures for review of a PMA

Section 806.10 - Reports of corrections and removals

Requiring that "[e]ach device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device" including " description of the event giving rise to the information reported . . ."

Section 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?

Requiring KLS to report to the FDA information that is “reasonably known” to KLS, including “[a]ny information that [KLS] can obtain by analysis, testing, or other evaluation of the device, ” or to provide an explanation in the event that no evaluation was performed