United States ex rel. Patriarca v. Siemens Healthcare Diagnostics, Inc., 295 F. Supp. 3d 186

Background

Relator Rey C. Patriarca (qui tam) alleged Siemens marketed an “ADVIA Centaur Intact PTH Assay” (a Second‑Generation PTH test) that produced systematically inflated PTH values from 2006–2010, causing medically unnecessary treatments reimbursed by Medicare.
Relator’s evidence relied principally on ~20 in‑house parallel comparisons between the Siemens test and Scantibodies’ Third‑Generation test, showing ~42% higher Siemens readings, and on clinical anecdotes (dialysis centers/doctors).
Published studies (notably the 2006 and 2009 Souberbielle studies) and a 2009 Cantor study had already reported substantial inter‑assay variability and a Siemens→Scantibodies differential near Relator’s figure. KDOQI guidance and later NKF updates also warned of test variability and advised using single labs and trends.
Relator alleged Siemens knew of the misalignment (internal testing, communications with Cantor, Spectra lot‑testing incident) and made affirmative/misleading statements in IFUs, bulletins, website and labeling. He asserted FCA claims for false claims (lack of medical necessity), sale of defective/nonconforming devices, misbranding, and a conspiracy count.
Siemens moved to dismiss. The court applied the FCA public‑disclosure bar (pre‑ and post‑2010 framework), concluded Relator’s core allegations were publicly disclosed, found Relator was not an original source, and dismissed the complaint (conspiracy claim dismissed for failure to state a claim).

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Applicability of the FCA public‑disclosure bar	Relator claimed his parallels revealed Siemens’ previously undisclosed misalignment (≈42%) causing false claims	Siemens argued published studies and guidelines already disclosed the assay differentials and variability, so Relator’s claims are based on public disclosures	Court held the public‑disclosure bar applies: prior studies and guidance publicly disclosed the same core information, barring the qui tam claims
Original‑source exception to the public‑disclosure bar	Relator argued his direct, independent parallel testing and insider communications rendered him an original source	Siemens argued Relator’s data tracked publicly available studies and added no independent, material information	Held: Relator is not an original source — his information did not materially add to public disclosures
Conspiracy claim sufficiency	Relator alleged Siemens manipulated calibrations/lots to conceal discrepancies, causing false claims	Siemens argued alleged conduct was either publicly linked to the already disclosed assay variability or was plausible routine calibration activity	Held: Conspiracy count dismissed for failure to state a plausible claim; allegations equally consistent with benign explanations
Reliance on published studies and guidelines as public disclosures	N/A (implicates scope of public‑disclosure bar)	Siemens relied on KDOQI guidelines, Souberbielle studies, Cantor study, and professional literature as qualifying public disclosures	Held: Those publications qualify as public disclosures (including scholarly journals) and disclosed material elements underlying Relator’s claims

Key Cases Cited

Kellogg Brown & Root Servs., Inc. v. U.S. ex rel. Carter, 135 S.Ct. 1970 (2015) (defining FCA liability for presenting false claims)
Graham County Soil & Water Conservation Dist. v. U.S. ex rel. Wilson, 559 U.S. 280 (2010) (public‑disclosure bar context and purpose)
United States ex rel. Chorches for Bankr. Estate of Fabula v. Am. Med. Response, Inc., 865 F.3d 71 (2d Cir. 2017) (public‑disclosure bar and procedural effect after 2010 amendment)
John Doe Corp. v. United States, 960 F.2d 318 (2d Cir. 1992) (public disclosure doctrine; information accessible to non‑parties is in the public domain)
Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility pleading standard)
Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading standard for conspiracy and plausible claims)