144 So. 3d 898
La.2014Background
- Louisiana AG sued Janssen/Johnson & Johnson alleging misrepresentation in marketing Risperdal and violations of MAPIL (La. Rev. Stat. 46:438.3) based on off‑label statements in a November 10, 2003 DHCP letter and subsequent sales calls.
- FDA required a class warning (Sept. 2003) about hyperglycemia/diabetes for atypical antipsychotics; defendants sent a DHCP that included additional, arguably reassuring, statements about Risperdal’s risk profile.
- FDA DDMAC issued a warning letter (Apr. 2004) and defendants sent a corrective letter (July 2004); FDA closed the matter in Oct. 2004.
- At trial the jury found defendants violated MAPIL subsections (A), (B), and (C), counted 35,146 violations (letters + sales calls), and awarded large civil penalties, fees, and costs; trial and appellate courts entered and affirmed judgment for the State.
- Louisiana Supreme Court granted writs and reversed, holding the AG failed to prove that defendants presented or caused the presentment of any false or fraudulent claim for payment from Louisiana medical assistance programs as required by MAPIL.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Scope of §46:438.3(A): whether causing a physician to prescribe (via misleading marketing) can constitute "presenting or causing to be presented a false or fraudulent claim" | Misleading marketing caused providers to prescribe and bills to be submitted to Medicaid, so defendants caused false claims | MAPIL requires proof a person caused a health‑care provider or billing agent to present a claim that the provider knew was false; no evidence of such knowing presentment here | Rejected plaintiff: §46:438.3(A) does not reach marketing statements absent proof a provider knowingly submitted a false claim caused by defendant |
| Scope of §46:438.3(B): whether off‑label misstatements constitute "misrepresentation to obtain payment" | Misrepresentations were intended to and did lead to Medicaid purchases/payments for Risperdal; thus defendants attempted to obtain payment | "Misrepresentation" applies to failures/ concealment of information required on a claim/provider agreement or false statements to the department; AG’s expansive reading would reach too broadly and is inconsistent with MAPIL's purpose | Rejected plaintiff: §46:438.3(B) does not apply because defendants did not attempt to obtain payment via a claim nor fail to disclose information on a claim/provider agreement or to the department |
| Scope of §46:438.3(C): whether conspiracy/attempt to defraud via marketing is covered absent a causal link to claims for payment | The statute prohibits attempts to defraud the medical assistance programs through misrepresentation; off‑label marketing satisfies the attempt element | Liability under (C) requires a causal link between misrepresentation and a false/fraudulent claim or attempt to obtain payment under a claim; record lacks that link | Rejected plaintiff: §46:438.3(C) not proven because no causal connection to false/ fraudulent claims or attempts to obtain payment was shown |
| Proper statutory interpretation and remedial reach of MAPIL | MAPIL’s broad purpose to protect program integrity justifies applying it to harmful promotional conduct that leads to Medicaid payments | Statute’s text and definitions limit liability to conduct tied to claims/payment attempts; cannot expand by policy argument | Majority adopted the narrower textual reading limiting MAPIL to claim‑related misconduct; reversed judgment for AG |
Key Cases Cited
- First Nat. Bank, USA v. DDS Const., LLC, 91 So.3d 944 (La. 2012) (standard of review for questions of law)
- Broussard v. Hilcorp Energy Co., 24 So.3d 813 (La. 2009) (de novo review of legal questions)
- McLane Southern, Inc. v. Bridges, 84 So.3d 479 (La. 2012) (statutory interpretation principles; apply clear text)
- Pumphrey v. City of New Orleans, 925 So.2d 1202 (La. 2006) (contextual meaning of words; general terms limited by specific ones)
- M.J. Farms, Ltd. v. Exxon Mobil Corp., 998 So.2d 16 (La. 2008) (start with statutory text when interpreting statutes)
- United States v. Southland Mgmt. Corp., 288 F.3d 665 (5th Cir. 2002) (describing federal False Claims Act liability as submission or causing submission of false claims)