United States ex rel. Solis v. Millennium Pharm., Inc.

885 F.3d 623
CourtCourt of Appeals for the Ninth Circuit
DecidedMarch 15, 2018
DocketNo. 15-16953; No. 15-17055; No. 15-17057
StatusPublished
Cited by26 cases

This text of 885 F.3d 623 (United States ex rel. Solis v. Millennium Pharm., Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States ex rel. Solis v. Millennium Pharm., Inc., 885 F.3d 623 (9th Cir. 2018).

Opinion

WALLACE, Circuit Judge:

*625Frank Solis appeals from the dismissal of his False Claims Act action against three pharmaceutical companies. We have jurisdiction under 28 U.S.C. § 1291, and we affirm in part and vacate and remand in part.

I.

Millennium Pharmaceuticals, Inc. hired Solis to promote sales of a cardiovascular drug, Integrilin. He moved to Schering-Plough Corp. after Schering acquired the right to market Integrilin. There, he also promoted an antibiotic drug, Avelox. Schering later merged with Merck & Co., and Merck fired Solis a year later.

Solis filed this action in 2009. He alleged that his former employers violated state laws and the False Claims Act (FCA) by promoting dangerous off-label uses of Integrilin and by paying physicians kickbacks to prescribe Integrilin and, in the case of Schering and Merck (collectively, Schering), Avelox. Following a three-year investigation, the United States and all twenty-four states named in Solis's initial complaint chose not to intervene.

The district court dismissed Solis's FCA claims under Federal Rule of Civil Procedure 12(b)(1), finding them foreclosed by the FCA's so-called public disclosure bar. After dismissing Solis's federal claims, the district court declined to exercise supplemental jurisdiction over his state law claims. Solis appealed.

II.

We review de novo the district court's dismissal for lack of subject matter jurisdiction. United States ex rel. Hartpence v. Kinetic Concepts, Inc. , 792 F.3d 1121, 1126 (9th Cir. 2015) (en banc). Plaintiff bears the burden to establish subject matter jurisdiction by a preponderance of the evidence. United States ex rel. Mateski v. Raytheon Co. , 816 F.3d 565, 569 (9th Cir. 2016). We review for clear error the findings of fact underlying the subject matter jurisdiction determination. Hartpence , 792 F.3d at 1126-27.

III.

The FCA allows whistleblowers, known as relators, to bring an action on the government's behalf against companies that "knowingly present[ ], or cause[ ] to *626be presented ... a false or fraudulent claim for payment or approval" to the federal government. 31 U.S.C. § 3729(a)(1) (2006)1 ; see Mateski , 816 F.3d at 569. The statute, however, deprives federal courts of subject matter jurisdiction over FCA suits when the alleged fraud has already been publicly disclosed, unless the relator is deemed an original source. See 31 U.S.C. § 3730(e)(4) (2006) (amended 2010). This public disclosure bar is triggered if three conditions are met: "(1) the disclosure at issue occurred through one of the channels specified in the statute; (2) the disclosure was 'public'; and (3) the relator's action is 'based upon' the allegations or transactions publicly disclosed." Mateski , 816 F.3d at 570, quoting Malhotra v. Steinberg , 770 F.3d 853, 858 (9th Cir. 2014). Solis challenges only the third condition, as he contends his allegations are not based upon a prior public disclosure.

"Under our case law, for a relator's allegations to be based upon a prior public disclosure, the publicly disclosed facts need not be identical with, but only substantially similar to, the relator's allegations." Id. at 573 (internal quotation marks and citation omitted). A prior disclosure and an allegation may be substantially similar when the prior public disclosure put the government "on notice to investigate the fraud before the relator filed his complaint." Id. at 574.

IV.

We first consider Solis's Integrilin claims. These claims, brought in 2009, fall into three categories: combination use claims, other off-label claims, and kickback claims. The district court held the combination use claims were substantially similar to those in a complaint filed in state court by an unrelated plaintiff in 2006. It further held the other off-label use and kickback claims were substantially similar to those in five complaints filed in federal court by unrelated plaintiffs in 2007.

We compare Solis's combination use claims to those in the 2006 complaint to determine whether they are substantially similar. Solis alleged that Millennium and Schering fraudulently promoted the use of Integrilin in combination with the drugs tenecteplase and heparin, which was "extremely dangerous" and "increased bleeding risk." He also alleged that publicly available studies identified this increased bleeding risk and that Schering managers gave those studies to its sales representatives. By comparison, the 2006 complaint alleged that Schering and Millennium were negligent in (1) failing to warn adequately physicians who would prescribe Integrilin about the "danger of causing intracranial bleeds," (2) failing to warn physicians about the "dangers of using [Integrilin ] in combination with tenecteplase and heparin," and (3) "marketing [Integrilin ] for use in combination with tenecteplase and heparin."

The publicly disclosed allegations from the 2006 complaint are substantially similar to Solis's 2009 combination use claims. Both sets of allegations point to the same actors (Schering and Millennium), the same conduct (marketing Integrilin for use in combination with tenecteplase and heparin ), and the same risk (increased bleeding). While there may be some differences in the focus and framing of the 2006 complaint compared with Solis's 2009 combination use claims, the degree of overlap is sufficient to show substantial similarity.

*627

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885 F.3d 623, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-solis-v-millennium-pharm-inc-ca9-2018.