United States ex rel. Colquitt v. Abbott Labs.
| Decision Date | 24 August 2012 |
| Docket Number | No. 3:06–cv–1769–M.,3:06–cv–1769–M. |
| Citation | 864 F.Supp.2d 499 |
| Parties | UNITED STATES of America ex rel. Kevin N. COLQUITT, Plaintiff, v. ABBOTT LABORATORIES f/k/a Guidant Corporation, Abbott Vascular Solutions, Inc., Boston Scientific Corporation, Johnson & Johnson, Cordis Corporation, Defendants. |
| Court | U.S. District Court — Northern District of Texas |
OPINION TEXT STARTS HERE
Sean Robert McKenna U.S. Attorney's Office, Laura Jean Baughman, Baron & Budd PC, Dallas, TX, Michael F. Hertz, Andrew M. Beato, David U. Fierst, Stein Mitchell & Muse, Jacob A. Stein, Stein Mitchell & Mezines LLP, Kelly Bagby, Stacy J. Canan, AARP Foundation Litigation, Washington, DC, for Plaintiff.
Michael E. McCue, Meadows Collier Reed Cousins & Blau LLP, Wayne B. Mason, Katherine W. Binns, Sedgwick LLP, Joseph P. Griffith, Greenberg Traurig LLP, Joel S. Allen, Elizabeth M. Bedell, Morgan Lewis & Bockius LLP, Dallas, TX, Geoffrey E. Hobart, Kathryn C. Arnold, Covington & Burling LLP, Mitchell J. Lazris, Logan Lovells U.S. LLP, Kathleen McDermott, Morgan Lewis & Bockius LLP, Washington, DC, Andrea W. Trento, Stephen J. Immelt, Hogan Lovells U.S. LLP, Baltimore, MD, for Defendants.
Before the Court are Motions to Dismiss filed by Boston Scientific Corporation [Docket Entry # 110], Cordis Corporation and Johnson & Johnson (collectively, “Cordis”) [Docket Entry # 112], and Abbott Laboratories and Abbott Vascular Solutions, Inc. (collectively, “Abbott”) [Docket Entry # 115]. For the reasons stated below, the Motions to Dismiss filed by Boston Scientific and Cordis are GRANTED, and the Motion to Dismiss filed by Abbott is GRANTED in part and DENIED in part. As explained below, the Relator is granted leave to amend some of the dismissed claims.
Relator Kevin Colquitt brings this qui tam action, under the federal False Claims Act (“FCA”) and several analogous state false claims statutes, against the Defendants, who are medical device manufacturers. The crux of Colquitt's suit is that the Defendants engaged in a scheme to thwart the FDA approval process for vascular stentsby fraudulently obtaining FDA clearance for their devices as biliary stents, when in fact the Defendants intended to and did market and promote them as vascular stents. Colquitt argues that this scheme led or was material to false claims for reimbursement submitted to federal payer programs, such as Medicare and Medicaid. The Defendants move to dismiss Colquitt's claims under Rules 12(b)(1) and 12(b)(6), arguing that the FCA's public disclosure jurisdictional bar deprives the Court of jurisdiction over Colquitt's claims, see31 U.S.C. § 3730(e)(4), that Colquitt has failed to state a plausible claim for relief as required by Rule 8, and that Colquitt has not pleaded fraud with particularity as required by Rule 9(b).
Defendants are medical device manufacturers who make and sell biliary stents. Colquitt held the position of Territory Manager for Abbott, successor-in-interest to Guidant Corporation, from February 2004 to July 2006. Colquitt alleges that during this period he witnessed and participated in a scheme through which Abbott promoted the off-label use of its biliary stents, and induced physicians and hospitals to seek reimbursement from federal payer programs for such off-label use. Although Colquitt never worked for Boston Scientific or Cordis, he alleges that through his employment with Abbott he witnessed similar off-label promotion by them as well.
The allegations in the Third Amended Complaint (“TAC”) can be divided into four categories: (1) allegations concerning false statements allegedly made by the Defendants to the FDA in obtaining market clearance for their stents; (2) allegations that the Defendants promoted and marketed their biliary stents for off-label, vascular applications; (3)...
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