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370 F. Supp. 3d 483
E.D. Pa.
2019
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Background

  • Relators SMSPF, LLC and Panzey Belgium Harris (a former Pfizer employee) filed a qui tam suit under the False Claims Act alleging that pharmaceutical companies (EMD Serono, Pfizer) and vendors (Quintiles IMS/IQVIA, RXC) engaged in "white coat marketing" and provided allegedly unlawful free nursing/reimbursement support that violated the Anti‑Kickback Statute.
  • The government investigated for ~18 months, reviewed documents, interviewed witnesses, met with defendants and relators, and consulted multiple OIG and DOJ components.
  • After investigation, the United States declined to intervene and moved to dismiss the relators’ suit under 31 U.S.C. § 3730(c)(2)(A), explaining the allegations lacked sufficient legal and factual support and that litigation costs and policy considerations counseled dismissal.
  • Relators objected, arguing the government’s decision was arbitrary, inadequately investigated, and that the matter could yield large recoveries; they also alleged animus toward the corporate relator.
  • The court considered conflicting circuit standards and adopted the Ninth/Tenth Circuit "rational relationship" test for evaluating a government motion to dismiss under § 3730(c)(2)(A).
  • Applying that test, the court found the government articulated legitimate interests (resource conservation and policy-based views that the challenged practices were permissible/beneficial) and that the investigation was adequate; relators failed to show dismissal was arbitrary, fraudulent, or illegal. The court granted the government’s motion and dismissed the action.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Standard of review for government motion to dismiss under 31 U.S.C. § 3730(c)(2)(A) Relators urged judicial review to prevent arbitrary dismissal Government urged deference / limited review of dismissal decision Court adopted Ninth/Tenth Circuit "rational relationship" test (government must show dismissal serves a valid governmental purpose and is rationally related to that purpose)
Adequacy of government's investigation before dismissing Investigation was insufficient; government failed to do due diligence and ignored potential large recoveries Government conducted extensive multi‑office investigation over 18 months and collected substantial materials Court found investigation adequate and not arbitrary
Legitimacy of government reasons (costs, policy) for dismissal Cost concerns are generic and do not justify dismissal; free services were inducements violating AKS Preservation of resources and policy judgments about permissible educational/support services are legitimate governmental interests Court held resource conservation and policy concerns are legitimate and rationally related to dismissal
Relators' claim that dismissal was fraudulent, arbitrary, or an abuse of discretion Relators asserted arbitrariness and possible animus toward corporate relator Government denied improper motive; presented investigatory record and rationale Court found relators did not present colorable evidence of fraud, illegality, or arbitrary conduct; dismissal affirmed

Key Cases Cited

  • United States ex rel. Sequoia Orange Co. v. Baird‑Neece Packing Corp., 151 F.3d 1139 (9th Cir. 1998) (articulates "rational relationship" test for gov't dismissal under § 3730(c)(2)(A))
  • Ridenour v. Kaiser‑Hill Co., 397 F.3d 925 (10th Cir. 2005) (adopts Sequoia standard and emphasizes test is not exacting)
  • Swift v. United States, 318 F.3d 250 (D.C. Cir. 2003) (holds government has virtually unfettered right to dismiss under § 3730(c)(2)(A))
  • Heckler v. Chaney, 470 U.S. 821 (1985) (executive prosecutorial discretion and limited judicial review)
  • Kellogg Brown & Root Servs. v. United States ex rel. Carter, 135 S. Ct. 1970 (2015) (government need not intervene to move to dismiss under § 3730(c)(2)(A))
  • Graham County Soil & Water Conservation Dist. v. United States ex rel. Wilson, 545 U.S. 409 (2005) (relator procedures and government intervention rights under the FCA)
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Case Details

Case Name: United States v. EMD Serono, Inc.
Court Name: District Court, E.D. Pennsylvania
Date Published: Apr 3, 2019
Citations: 370 F. Supp. 3d 483; CIVIL ACTION NO. 16-5594
Docket Number: CIVIL ACTION NO. 16-5594
Court Abbreviation: E.D. Pa.
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    United States v. EMD Serono, Inc., 370 F. Supp. 3d 483