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' "

Daimler AG v. Bauman

Holding that foreign corporations may not be subject to general jurisdiction "whenever they have an in-state subsidiary or affiliate"

Medtronic, Inc. v. Lohr

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"

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

Sprewell v. Golden State Warriors

Holding that unwarranted inferences are insufficient to defeat a motion to dismiss

Kearns v. Ford Motor Co.

Holding that circumstances constituting fraud must be stated with particularity

Norgart v. Upjohn Co.

Holding that the discovery rule "postpones accrual of a cause of action until the plaintiff discovers, or has reason to discover, the cause of action, until, that is, he at least suspects, or has reason to suspect, a factual basis for its elements"

Clemens v. DaimlerChrysler Corp.

Holding that "claims under the Magnuson–Moss Act stand or fall with express and implied warranty claims under state law"

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 9 - Pleading Special Matters

Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"

Section 335.1 - Assault, battery or injury or death caused by wrongful act or negligence

Imposing two-year statute of limitations for personal injury claims

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 337 - Proceedings in name of United States; provision as to subpoenas

Restricting FDCA enforcement to suits by the United States

Section 360e - Premarket approval

Granting FDA authority to conduct hearings regarding PMA withdrawal

Section 333 - Penalties

Defining civil and criminal penalties for violations of Section 331

Section 334 - Seizure

Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals

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 820.198 - [Effective until 2/2/2026] Complaint files

Requiring manufacturers to "establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit" including ensuring "timely" and "uniform" review of complaints

Section 814.44 - Procedures for review of a PMA