New York v. Amgen Inc.
2011 U.S. App. LEXIS 15036
| 1st Cir. | 2011Background
- Westmoreland and state intervenors allege Amgen, INN, and ASD used kickbacks to induce Aranesp prescriptions, aiming to increase Medicaid reimbursements.
- Alleged kickbacks include excess Aranesp overfill in vials and sham consulting, honoraria, and retreats orchestrated with INN and ASD.
- Claims are brought under seven state False Claims Acts (CA, GA, IL, IN, MA, NM, NY) and the federal FCA, with district court dismissing state claims on 12(b)(6) grounds.
- District court largely applied Hutcheson’s framework, treating false claims as factually or legally false via express/implied certification theories.
- This Court holds state FCAs are substantively similar to the federal FCA and analyzes false claims under Hutcheson rather than the district court framework.
- Georgia lacks a state anti-kickback analogue to AKS; no precondition-of-payment precludes Medicaid payments based on alleged kickbacks.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Do the Medicaid claims misrepresent preconditions of payment under the seven state FCAs? | Westmoreland argues kickbacks render claims false as they violated preconditions of payment. | Amgen argues framework is limited to factually/legally false claims and does not recognize implied warranties arising from kickbacks. | Claims may be false under six states; Georgia rejected. |
| Does Hutcheson govern the false-claim analysis for state FCAs here? | Hutcheson controls, allowing non-express certification theories and materiality/sciable considerations. | District framework should apply; kickbacks do not create false claims under some states. | Hutcheson controls; district framework rejected to the extent inconsistent. |
| Are California and New Mexico provider agreements sufficient to render claims false? | Provider agreements require compliance with anti-kickback laws; alleged kickbacks make claims false. | Participation conditions do not equate to payment preconditions for all states; concerns about scope. | Yes for CA and NM; agreements render claims false. |
| Did Georgia's regime establish a precondition of payment via kickbacks? | Ga. law and cases suggest kickbacks are fraudulent and preconditions of payment exist. | Georgia lacks AKS analogue; no clear precondition of payment identified. | No false-claim basis under Georgia FCA; district dismissal affirmed for GA. |
| Should the court apply a uniform analysis across state FCAs given statutory similarities to the federal FCA? | State laws align with federal FCA; uniform analysis should apply. | States may differ in definitions and preconditions; careful state-by-state analysis needed. | Yes; analysis aligned with Hutcheson and federal guidance. |
Key Cases Cited
- United States ex rel. Hutcheson v. Blackstone Medical, Inc., 647 F.3d 377 (1st Cir. 2011) (rejects narrow express/implied certification framework; adopts materiality/sciter standard)
- Pharma Research & Mfrs. of Am. v. Walsh, 538 U.S. 644 (Supreme Court, 2003) (states have substantial discretion over Medicaid requirements)
- United States v. Sci. Applications Int'l Corp., 626 F.3d 1257 (D.C. Cir. 2010) (discusses preconditions of payment and false-claim theories)
- Massachusetts v. Mylan Labs., 608 F.Supp.2d 127 (D. Mass. 2008) (considers construction of state FCA against federal FCA framework)