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551 F.Supp.3d 27
E.D.N.Y.
2021
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Background

  • Relator CKD Project, LLC sued entities tied to Fresenius Medical Care under the False Claims Act, alleging a nationwide kickback scheme in violation of the Anti‑Kickback Statute.
  • Magistrate Judge Bulsara recommended dismissal under the FCA public‑disclosure bar, relying in part on Fresenius’s 2013 Form 20‑F disclosure describing joint‑venture risks and potential AKS/Stark exposure.
  • Relator argued the SEC filing did not disclose the specific alleged scheme (e.g., above‑market clinic purchases to induce referrals) and that relator is an "original source" based on information from an unnamed inside participant.
  • The amended complaint and objections failed to identify the source or detail how relator’s information was independent of, and materially added to, public disclosures; relator is an entity formed for the litigation and relied on some discovery materials.
  • The court denied leave to amend as futile, denied relator’s belated reply, adopted the R&R in full, and entered judgment dismissing the case.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Applicability of the FCA public‑disclosure bar SEC Form 20‑F did not disclose the specific fraud elements; public filing merely warned of risk 20‑F disclosed the substance of the allegations (joint‑venture referral risks) sufficient to trigger the bar Public disclosure bar applies — the 20‑F could alert enforcement to the likelihood of wrongdoing and exposed essential elements
Original‑source exception — independence Relator obtained independent inside information from an unnamed participant that predates or is independent of public disclosures Relator’s information is not shown to be independent; materials appear derived from discovery or public sources Relator is not an original source: complaint fails to show independent, material addition to public disclosures
Original‑source exception — materially adds Relator says its details (pricing, conduct) materially add to the SEC disclosure Defendants say added detail does not materially add when public disclosure already exposed essential elements Adding detail/color to publicly disclosed elements is insufficient; relator did not materially add to public record
Leave to amend Relator would offer additional independent information if permitted Defendants argue amendment is futile and untimely after six years and substantial discovery Leave to amend denied as futile given relator’s failure to identify new independent material information

Key Cases Cited

  • United States ex rel. Chorches for Bankr. Est. of Fabula v. American Medical Response, Inc., 865 F.3d 71 (2d Cir.) (defines public‑disclosure bar framework)
  • United States ex rel. Patriarca v. Siemens Healthcare Diagnostics, Inc., 295 F. Supp. 3d 186 (E.D.N.Y.) (two‑step public‑disclosure/original‑source inquiry)
  • United States ex rel. Vierczhalek v. MedImmune, Inc., 345 F. Supp. 3d 456 (S.D.N.Y.) (public disclosure must expose essential elements but need not disclose fraud word‑for‑word)
  • United States ex rel. Foreman v. AECOM, 454 F. Supp. 3d 254 (S.D.N.Y.) (material elements disclosure triggers bar even if fraud not fully disclosed)
  • United States ex rel. Kester v. Novartis Pharmaceuticals Corp., 43 F. Supp. 3d 332 (S.D.N.Y.) (public disclosures that alert enforcement can satisfy bar)
  • United States ex rel. Winkelman v. CVS Caremark Corp., 827 F.3d 201 (1st Cir.) (mere addition of detail/color does not satisfy original‑source "materially adds" requirement)
  • Holmes v. Grubman, 568 F.3d 329 (2d Cir.) (standards for denying leave to amend include futility)
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Case Details

Case Name: United States v. Fresenius Medical Care AG & Co. KGAA
Court Name: District Court, E.D. New York
Date Published: Jul 30, 2021
Citations: 551 F.Supp.3d 27; 1:14-cv-06646
Docket Number: 1:14-cv-06646
Court Abbreviation: E.D.N.Y.
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    United States v. Fresenius Medical Care AG & Co. KGAA, 551 F.Supp.3d 27