Defendant Wins False Claims Act Trial After the Government Kills $8.9M Settlement Agreement Negotiated By Relator; Affirmed By Fourth Circuit

In United States ex rel. Ubl v. IIF Data Solutions, Case No. 09-2280, 2011 WL 1474783 (4th Cir. 2011), the Fourth Circuit affirmed a verdict for a defendant in a False Claims Act trial in a case where the Government declined to intervene and held the following:  (1) the district court properly refused to enforce a settlement agreement; (2) the district court correctly admitted “government knowledge” evidence at trial; and (3) the district court erred in awarding attorneys’ fees to the defendant.

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Civil Investigative Demands & The False Claims Act

Prior to 1983, the government relied primarily on two sources to investigate civil FCA cases: the work of agency Inspector Generals and material developed in criminal investigations, usually through the use of grand jury subpoenas. In United States v. Sells Engineering, Inc., 463 U.S. 418 (1983), the Supreme Court held that Rule 6(e) of the Federal Rules of Criminal Procedure prohibits the use of grand jury materials for civil use without a court order. After Sells, if the government wants to use grand jury materials for civil use, it must make a showing of particularized need for the materials, which is an extremely tough burden.

In light of the Sells decision, Congress determined that there was a need for an investigative tool to aid the government in obtaining information relating to possible violations of the civil False Claims Act. Accordingly, in 1986, Congress amended the FCA to include a provision which enables the government to serve civil investigative demands (“CID”) in FCA investigations. Congress intended that this CID authority would permit the DOJ’s civil division to gain access to evidence of fraud which might be otherwise unavailable to it under Rule 6(e). See S. Rep. No. 345, 99th Cong. 2d Sess. 33 (1986), reprinted in 1986 U.S.C.C.A.N. at 5298; see also United States v. Markwood, 48 F.3d 969, 984 (6th Cir. 1995) (discussing legislative history of the FCA's CID provision).

Under 31 U.S.C. § 3733(a)(1), the Attorney General or a designee may issue CIDs to “any person [who] may be in possession, custody, or control of any ... information relevant to a false claims law investigation.” CIDs may seek documents as well as interrogatory responses and oral testimony. See 31 U.S.C. § 3733(a)(1)(A)-(D). CIDs may only be used during the pre-litigation investigatory phase of an FCA matter. Once the government files an FCA complaint or makes an election to intervene (or to decline intervention), it may no longer issue CIDs. 31 U.S.C. § 3733(a)(1).

The 2009 FERA amendments to the FCA expressly permit the government to share any information obtained via a CID with qui tam relators. See 31 U.S.C. § 3733(a)(1) (“Any information obtained by the Attorney General or a designee of the Attorney General under this section may be shared with any qui tam relator if the Attorney General or designee determine it is necessary as part of any false claims act investigation.”). Accordingly, defense counsel should be aware that to the extent the government is relying on a relator and relator’s counsel to assist the government in reviewing a defendant’s document production in response to a CID, a relator may be selective about the documents it chooses to show to the government. For example, a relator may bring only those documents supporting the relator’s claims to the government’s attention, while failing to point out that there are documents in a defendant’s production that negate or weaken the relator’s claims.  To counter the bias that may occur as a result of a relator cherry-picking through a defendant’s CID production, defense counsel should consider informing the government of helpful documents in a response letter at the time the defendant makes its production or in a face-to-face presentation to the government shortly thereafter.

Can a Qui Tam Relator Prosecute a False Claims Act Case Pro Se?

Qui tam relators cannot prosecute False Claims Act cases pro se after the United States declines to intervene, says the District Court in Nebraska in dismissing the relator’s FCA claim.  See Malone v. Omaha Housing Authority, Case No. 4:09CV3208, 2011 WL 1435257 (D. Neb. April 14, 2011).  The court held that the FCA is silent on the issue, but the law is well-established in the Eighth Circuit.  As the Eighth Circuit explained in United States v. Onan, 190 F.2d 1, 6-7 (8th Cir. 1951):

[W]e do not think that Congress could have intended to authorize a layman to carry on such suit as attorney for the United States but must have had in mind that such a suit would be carried on in accordance with the established procedure which requires that only one licensed to practice law may conduct proceedings in court for anyone other than himself…it is unthinkable that Congress by this Act intended to license laymen to practice law. The practice of law is affected with a public interest and an attorney at law as distinguished from a layman, has both public and private obligations, being sworn to act with all good fidelity toward both his client and the court.

The Eighth Circuit is in agreement with the Second, Seventh, Ninth, Eleventh, and D.C. Circuits.  See Jones v. Jindal, No. 10-7124, 2011 WL 588062, at *1 (D.C. Cir. Feb. 10, 2011); Meidinger v. Healthcare Indus. Oligopoly, 391 F. App’x 777, 780 (11th Cir. 2010); United States ex rel. Mergent Servs. v. Flaherty, 540 F.3d 89, 93-94 (2d Cir. 2008); Timson v. Sampson, 518 F.3d 870, 873-74 (11th Cir. 2008); Stoner v. Santa Clara County Office of Educ., 502 F.3d 1116, 1126-28 (9th Cir. 2007); United States ex rel. Lu v. Ou, 368 F.3d 773, 775-76 (7th Cir. 2005), overruled on other grounds, 129 S.Ct. 2230 (2009). 

S.D.N.Y. Dismisses FCA Case Against Lab Testing Companies Because Complaint Was Based On Client Confidential Information Disclosed By Former General Counsel

In United States ex rel. Fair Laboratory Practices Associates v. Quest Diagnostics, Inc., Unilab Corp. et al., 05-CV-5393 (S.D.N.Y. April 5, 2011), the Southern District of New York dismissed a qui tam action against laboratory testing companies Quest Diagnostics and Unilab because the qui tam complaint was based on confidential information disclosed by Unilab's former general counsel. The relator, Fair Laboratory Practices Associates (“FLPA”), is a general partnership formed by Unilab’s former general counsel, CEO, and CFO for the sole purpose of commencing a qui tam action against the lab companies. All three senior executives started working at Unilab in the early to mid 1990s and had left the company by early 2000. Unilab was acquired by a Quest Diagnostics subsidiary in 2003. The relator filed the qui tam complaint in 2005, and an amended complaint was unsealed in 2010. The government has not yet decided whether it will intervene in the action.

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Court in Southern District of New York Dismisses Relator's False Claims Act Complaint Because No Law or Regulation Prohibited Hospital's Billing Method

A former independent consultant to Beth Israel Medical Center (“BIMC”), Cleuza Colucci, brought a False Claims Act action against the hospital, alleging that it billed for and received inflated Medicare payments by purchasing Kings Highway and Doctors Hospital and then taking advantage of rate increases resulting from consolidation with BIMC for purposes of billing Medicare. The Government did not intervene, and the District Court for the Southern District of New York dismissed the case on defendants’ motion to dismiss. See United States ex rel. Colucci v. Beth Israel Medical Center, et al., Case No. 06 Civ. 5033, 2011 WL 1226267 (S.D.N.Y. Mar. 31, 2011). The District Court held that “[taking] advantage of the uncertainty in the regulations to maximize its Medicare billings..is not fraud.”

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Georgia District Court Dismisses FCA Claim Based On A Theory Of Promissory Fraud

After being fired as its CEO, Angela Parato filed a False Claims Act action against her former employer, Unadilla Health Care Center, Inc. (UnaHealth). Parato alleged, among other things, that UnaHealth, a Federally Qualified Health Center, made false certifications in its applications for grants under Section 330 of the Public Health Service Act to the Department of Health and Human Services. Essentially, Parato claimed that UnaHealth promised, in its application, that it would prohibit future conduct by employees constituting a conflict of interest. On UnaHealth’s summary judgment motion, the court dismissed this “promissory fraud” claim. The court did permit Parato’s claims against UnaHealth for retaliation under the FCA and breach of contract under state law to survive. See United States ex rel. Parato v. Unadilla Health Care Center, Inc., Case No. 5:07-CV-76 (MTT), 2011 WL 1196067 (M.D. Ga. Mar. 28, 2011)

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OIG Determines that 24 State False Claims Acts Do Not Comply with Federal Requirements

The Office of Inspector General for the Department of Health and Human Services (OIG) completed its review of 24 individual state false claims acts for compliance with Section 1909 of the Social Security Act.  This section, made effective on January 1, 2007, is intended to encourage states to enact or update existing state false claims act (FCA) legislation to facilitate the prosecution of state false claims act cases.  Specifically, federal law provides a financial incentive to a state with legislation that is in compliance by increasing that state’s share of monetary recovery from any lawsuit brought under the state's false claims act by 10 percent. 

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Defining Off-Label Marketing Of Prescription Drugs: Conduct Likely To Trigger Government Scrutiny

Here is a copy of the off-label marketing presentation that I prepared for ACI's conference on Fraud and Abuse in the Sale and Marketing of Drugs held last week in New York.  The presentation slides include:

  • A summary chart of off-label marketing settlements with drug companies between 2004 and 2010. (Slide Nos. 1-4)
     
  • A summary chart showing which U.S. Attorney's Offices have been most active in pursuing off-label marketing investigations against drug companies, and the success rates of each office (as measured by felony pleas, misdemeanor pleas, and settlement amounts).  (Slide Nos. 5-6)
     
  • Recent government interventions and subpoenas in off-label marketing investigations. (Slide Nos. 7-11)
     
  • The pipeline for future off-label marketing cases based on information about sealed qui tam cases recently disclosed by the DOJ. (Slide No. 12)
     
  • 18 different types of conduct that are likely to trigger an off-label marketing investigation by the government.  (Slide Nos. 13-38)