United States Ex Rel. Colquitt v. Abbott Laboratories, 858 F.3d 365

Background

Relator Kevin Colquitt, a former Guidant/Abbott salesman, sued Abbott under the False Claims Act (FCA) alleging off‑label promotion of biliary stents for vascular use led to false Medicare claims.
He pursued three theories: (1) fraudulent inducement via misrepresentations in FDA 510(k) submissions, (2) claims rendered false by Anti‑Kickback Statute violations, and (3) false presentment caused by promotional activity inducing ineligible Medicare claims.
The government declined to intervene. The district court dismissed the Anti‑Kickback claim for failure to satisfy Rule 9(b) and dismissed the fraudulent‑inducement claim under the public‑disclosure bar; the false‑presentment claim survived but was limited to periods when Colquitt worked for Guidant/Abbott.
At trial the jury found for Abbott; Colquitt appealed, arguing errors in dismissal/summary judgment rulings, exclusion of evidence, and jury instructions.
The Fifth Circuit affirmed, upholding: Rule 9(b) dismissal of kickback allegations, dismissal of fraudulent‑inducement claims under the public‑disclosure/original‑source rules, the temporal limitation on the false‑presentment theory, evidentiary exclusions, and rejection of proposed jury instructions.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Anti‑Kickback allegations met Rule 9(b) particularity	Colquitt asserted schemes (discounts, dinners, fellowships) caused certified Medicare claims to be false	Abbott argued complaint lacked specifics on who submitted claims, when, and how kickbacks produced claims	Dismissed: complaint failed Grubbs standard; allegations too vague and not tied to specific submitted claims
Whether fraudulent‑inducement claim is barred by public‑disclosure rule and whether Colquitt is an original source	Colquitt argued his insider observations gave independent knowledge of defendants’ intent and facts beyond public records	Abbott pointed to public 510(k) summaries, ads, and an FDA letter disclosing the core allegations	Dismissed: public materials disclosed the substance; Colquitt lacked direct, independent knowledge of FDA submissions to be an original source
Whether false‑presentment claim could be tried for periods before/after Colquitt’s employment or against Abbott independently of Guidant	Colquitt contended his knowledge and later materials supported broader timeframe and liability of Abbott post‑acquisition	Abbott contended Colquitt lacked firsthand knowledge outside his tenure and could not be original source for other periods/Abbott acts	Affirmed limitation: claim confined to periods when Colquitt had direct, first‑hand knowledge and to Guidant conduct as successor evidence was insufficient
Whether evidentiary exclusions and jury instruction refusals prejudiced Colquitt	Colquitt sought admission of FDA warning/compliance letters and Guidant felony conviction for impeachment; requested instructions on Medicare "reasonable and necessary" and that government knowledge is not a defense	Abbott argued letters were irrelevant or prejudicial (outside allowed timeframe); conviction was remote/prejudicial; proposed instructions misstated law or were unsupported	No reversible error: trial court did not abuse discretion in excluding evidence; refused instructions were legally incorrect or not required, and any error was not prejudicial

Key Cases Cited

Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (distinguishing 510(k) clearance and PMA process)
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006) (premarket approval process discussion)
Williams v. WMX Tech., Inc., 112 F.3d 175 (5th Cir. 1997) (Rule 9(b) "who, what, when, where, and how" standard)
Grubbs v. Kanneganti, 565 F.3d 180 (5th Cir. 2009) (flexible Rule 9(b) in qui tam suits; scheme-plus-indicia rule)
Fed. Recovery Servs., Inc. v. United States, 72 F.3d 447 (5th Cir. 1995) (three‑part public‑disclosure/original‑source test)
Little v. Shell Exploration & Prod. Co., 690 F.3d 282 (5th Cir. 2012) (public‑disclosure synthesis test)
Jamison v. McKesson Corp., 649 F.3d 322 (5th Cir. 2011) (public‑disclosure merits overlap; summary‑judgment treatment)
Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899 (5th Cir. 1997) (FCA claims plead with Rule 9(b) rigor)
Bollinger Shipyards, Inc. v. United States, 775 F.3d 255 (5th Cir. 2014) (government knowledge can negate FCA scienter)