United States ex rel. Colquitt v. Abbott Laboratories, 864 F. Supp. 2d 499

Relator Colquitt sues Abbott, Cordis, and Boston Scientific under FCA and analogous state false-claims statutes for promoting biliary stents for off-label vascular use and inducing false reimbursements.
Colquitt alleges the Defendants fraudulently obtain FDA clearance by misclassifying biliary stents as vascular stents, enabling cheaper 510(k) clearance.
Allegations include false statements to the FDA, off-label promotion, inducement of reimbursement, and kickbacks.
Relator asserts these activities caused false claims submitted to Medicare/Medicaid; Government/States decline to intervene; Court considers motions to dismiss under 12(b)(1)/12(b)(6) with government interests.
Procedural posture: motions to dismiss granted in part; public-disclosure bar issues addressed; Colquitt granted leave to amend some claims; Abbott’s motion granted in part and denied in part.
Court addresses public-disclosure jurisdiction, Rule 9(b) pleading standards, and state-law claims; decision ultimately that fraudulent-inducement and some off-label-promotion claims are dismissed for lack of jurisdiction; AKS claims dismissed without prejudice; leave to amend granted.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Public-disclosure bar applicability	Claims based on public disclosures can be pursued if Colquitt is an original source.	Disclosures in 510(k) summaries, FDA letters, and ads publicly disclose the alleged fraud; relator may be barred.	Fraudulent inducement claims lack jurisdiction; Colquitt not an original source; off-label-promotion claims partly based on disclosures; AKS survives.
Pleading of off-label-promotion claims under Rule 9(b)	TAC provides detailed promotional scheme and reimbursement guides.	Cordis/Boston Scientific lack specific false statements; Boston Scientific/ Cordis insufficiently pleaded.	Off-label-promotion claims against Abbott adequate; against Cordis and Boston Scientific not sufficiently pleaded.
State-law claims under public-disclosure bars	States have similar public-disclosure bars; should survive with original-source analysis.	Same jurisdictional bars apply; states lack independent basis.	State fraudulent-inducement/off-label claims dismissed for lack of jurisdiction; AKS-related state claims dismissed without prejudice.
Antikickback statute (AKS) viability	AKS theory supports FCA false claims via kickbacks and false certifications.	Insufficient 9(b) pleading tying kickbacks to actual submitted false claims or certifications.	AKS claims dismissed without prejudice for failure to adequately plead under Rule 9(b).

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (federal preemption of misrepresentation claims in regulatory approvals)
Rockwell Int’l Corp. v. United States, 549 U.S. 457 (U.S. 2007) (original-source analysis for FCA jurisdiction under public disclosure)
United States ex rel. Jamison v. McKesson Corp., 649 F.3d 322 (5th Cir. 2011) (public-disclosure bar analyzed; amending complaint cannot retroactively create jurisdiction)
United States ex rel. Reagan v. E. Tex. Med. Cent. Reg’l Healthcare Sys., 384 F.3d 168 (5th Cir. 2004) (three-part test for public-disclosure bar: public disclosure, basis, and original-source)
Minn. Ass’n of Nurse Anesthetists v. Allina Health Sys. Corp., 276 F.3d 1032 (8th Cir. 2002) (original-source requirement and public-disclosure interplay)
Gear v. Emergency Med. Assoc. of Ill., Inc., 436 F.3d 726 (7th Cir. 2006) (industry-wide disclosures and identifiable defendants rule)
Baltazar v. Warden, 635 F.3d 866 (7th Cir. 2011) (industry-wide disclosures not identifying a defendant do not trigger FCA bar)
Schindler Elevator Corp. v. United States ex rel. Kirk, 131 S. Ct. 1885 (S. Ct. 2011) (broad interpretation of ‘news media’ and statutory disclosures)
Springfield Terminal Ry. v. Quinn, 14 F.3d 645 (D.C.Cir. 1994) (fraud element structure for public-disclosure analysis)