Ashcroft v. Iqbal

Holding court need not credit "mere conclusory statements" in complaint

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

Allison Engine Co. v. U.S. ex Rel. Sanders

Holding that an action under subsection requires a relater to allege "that the defendant intended that the false record or statement be material to the Government's decision to pay or approve the false claim"

In re Schering Plough Corp. Intron/Temodar Consumer Class Action

Holding that the "Complaint's federal and New Jersey RICO Claims parallel each other, and because the two RICO statutes are intended to be coextensive, we follow the District Court's approach and analyze the two claims concurrently"

U.S. ex Rel. Grubbs v. Kanneganti

Holding that defendants received adequate notice in a False Claims Act case where the complaint alleged a scheme to submit false claims and enough details that the defendants—who "will be in possession of the most relevant records, such as patients’ charts, doctors’ notes, and internal billing records"—could adequately investigate and defend the claims

United States ex rel. Nathan v. Takeda Pharms. N. Am., Inc.

Holding that the district court did not abuse its discretion in denying plaintiff leave to file a fourth amended complaint after repeated prior dismissals for failure to sufficiently plead his claim

Seville Indus Machinery v. Southmost Machinery

Holding that Rule 9(b) does not requires a plaintiff to plead date, place, or time of alleged fraud

U.S. ex Rel. Lusby v. Rolls-Royce Corp.

Holding that a plaintiff need not allege a specific individual claim to satisfy Rule 9(b)

U.S. v. Pfizer

Holding that a complaint does not meet the requirements of Rule 9 when the complaint did not “give notice to [the defendant] of false claims submitted by others for federal reimbursement of off-label uses, only of illegal practices in promotion of the drug”

Kaiser Found. Health Plan, Inc. v. Pfizer, Inc. (In re Neurontin Mktg. & Sales Practices Litig.)

Holding plaintiff presented "ample evidence" of reliance where summary judgment facts showed plaintiff "received [defendant's] misrepresentations through [defendant's] contacts" with plaintiffs’ Drug Information Service ("DIS") "which disseminated information throughout [plaintiff's] organization" and that plaintiffs’ "physicians received and acted upon [defendant's] misrepresentations, both through information sent through the DIS and information provided to them at [defendant's] events"

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

Requiring that fraud be pleaded with particularity

Section 3729 - False claims

Holding liable "any person" who knowingly causes false claims to be presented

Section 301 - Short title

Section 1320a-7b - Criminal penalties for acts involving Federal health care programs

Prohibiting the solicitation or receipt of "remuneration" in exchange for referrals

Section 1395y - Exclusions from coverage and medicare as secondary payer

Granting the government subrogation rights

Section 1395pp - Limitation on liability where claims are disallowed

In 42 U.S.C. § 1395pp, Congress specifically allows providers to exercise the rights of individuals under certain sections of the statute "after the Secretary determines that the individual will not exercise such rights under such sections."