United States ex rel. Solis v. Millennium Pharm., Inc.
885 F.3d 623
9th Cir.2018Background
- Frank Solis, a former pharmaceutical sales rep for Millennium and later Schering/ Merck, sued in 2009 under the False Claims Act (FCA) and various state laws alleging off-label promotion of Integrilin and kickbacks (also alleging kickbacks for Avelox).
- The U.S. and 24 states declined to intervene after a three-year investigation.
- The district court dismissed Solis's FCA claims under Rule 12(b)(1) as barred by the FCA public-disclosure bar and declined supplemental jurisdiction over state-law claims; Solis appealed.
- The district court found Integrilin claims substantially similar to prior public complaints (a 2006 state complaint and several 2007 federal complaints) and held Solis failed the court’s earlier "hand-in-the-public-disclosure" original-source requirement.
- The district court also found Avelox claims publicly disclosed (though Avelox was not mentioned in the cited prior complaints) and did not resolve Rule 9(b) leave-to-amend issues; the Ninth Circuit reviewed jurisdiction de novo.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Solis's Integrilin claims are barred by the FCA public-disclosure bar (based on prior complaints) | Solis: his allegations are not "based upon" the prior public disclosures (adds more detail and alleges fraud vs. prior negligence pleadings) | Defendants: prior public complaints disclosed the same actors, conduct, and risks so Solis's claims are substantially similar | Held: Integrilin claims are substantially similar to prior disclosures; public-disclosure bar applies as to those claims (dismissal vacated only to allow original-source inquiry) |
| Whether Solis qualifies as an original source to overcome the public-disclosure bar | Solis: claims direct, independent knowledge and provided info to government pre-filing | Defendants: Solis did not meet original-source requirements (district court relied on a now-repudiated third prong) | Held: Remanded — Ninth Circuit repudiated the "hand-in-the-public-disclosure" prong (Hartpence); district court must decide original-source status under the two statutory prongs (direct/independent knowledge and prior voluntary disclosure) |
| Whether Avelox kickback claims were publicly disclosed | Solis: Avelox claims are part of his complaint and not covered by the prior disclosures | Defendants: Avelox claims were publicly disclosed as part of broader disclosures | Held: Reversed — district court clearly erred treating Avelox as publicly disclosed because the prior complaints did not mention Avelox; but Avelox claims fail Rule 9(b) pleading particularity so dismissal is affirmed on that alternative ground |
| Whether Avelox claims meet Rule 9(b) and whether leave to amend should be allowed | Solis: can amend and plead missing links to federal claims submission | Defendants: complaint lacks particularity linking alleged kickback scheme to any submitted federal claims | Held: Avelox claims do not satisfy Rule 9(b) (no specific false claims or reliable indicia that claims were submitted); district court should decide in the first instance whether to grant leave to amend on remand |
Key Cases Cited
- United States ex rel. Hartpence v. Kinetic Concepts, Inc., 792 F.3d 1121 (9th Cir. 2015) (en banc) (rejects extra-textual "hand-in-the-public-disclosure" original-source requirement)
- United States ex rel. Mateski v. Raytheon Co., 816 F.3d 565 (9th Cir. 2016) (public-disclosure "based upon" requires substantial similarity; prior disclosure can put government on notice)
- Malhotra v. Steinberg, 770 F.3d 853 (9th Cir. 2014) (interpreting the public-disclosure bar elements)
- A-1 Ambulance Serv., Inc. v. California, 202 F.3d 1238 (9th Cir. 2000) (material transactions in a prior disclosure can trigger the public-disclosure bar even absent explicit wrongdoing language)
- United States v. Alcan Elec. & Eng'g, Inc., 197 F.3d 1014 (9th Cir. 1999) (similar principle regarding public disclosure of material transactions)
- United States v. UnitedHealthcare Ins. Co., 848 F.3d 1161 (9th Cir. 2016) (Rule 9(b) requires particularity: "who, what, when, where, and how" paired with reliable indicia that claims were submitted)
- Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993 (9th Cir. 2010) (Rule 9(b) standards applied to FCA claims)
- Wang ex rel. United States v. FMC Corp., 975 F.2d 1412 (9th Cir. 1992) (original-source test earlier adopted by Ninth Circuit and later limited by Hartpence)
- United States ex rel. Kelly v. Serco, Inc., 846 F.3d 325 (9th Cir. 2017) (appellate courts may affirm on any ground supported by the record)
- J.B.D.L. Corp. v. Wyeth-Ayerst Labs., Inc., 485 F.3d 880 (6th Cir. 2007) (explains that a drug being "on formulary" means availability/coverage, not proof of submission of claims)