United States Ex Rel. Schumann v. Astrazeneca Pharmaceuticals L.P.

769 F.3d 837, 2014 U.S. App. LEXIS 20116, 2014 WL 5315251
CourtCourt of Appeals for the Third Circuit
DecidedOctober 20, 2014
Docket13-1489
StatusPublished
Cited by325 cases

This text of 769 F.3d 837 (United States Ex Rel. Schumann v. Astrazeneca Pharmaceuticals L.P.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third 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. Schumann v. Astrazeneca Pharmaceuticals L.P., 769 F.3d 837, 2014 U.S. App. LEXIS 20116, 2014 WL 5315251 (3d Cir. 2014).

Opinion

OPINION

ROTH, Circuit Judge:

Plaintiff Karl S. Schumann, proceeding as a qui tam relator under the False Claims Act (FCA), 31 U.S.C. § 3729 et seq., and corresponding state laws, appeals the District Court’s orders granting motions to dismiss by defendants Bristol-Meyers Squib Company, E.I. du Pont de *840 Nemours and Company, and DuPont Pharmaceuticals Company (together, BMS), and defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP (together, AZ). Schumann alleges defendants (1) improperly induced Medco Health Solutions, Inc., his employer, to offer certain of defendants’ drugs in its mail-order pharmacies and in health plans it managed; (2) did not include those inducements when calculating the best price for their drugs, and thus submitted inaccurate best price reports to the government; (3) overcharged the government based on those inaccurate best prices; and (4) underpaid rebates owed based on those inaccurate best prices.

The District Court found it lacked subject matter jurisdiction over Schumann’s claims because he did not have the requisite direct and independent knowledge to satisfy the original source exception to the FCA’s public disclosure bar., As a result, the court dismissed Schumann’s claims with prejudice. We will affirm.

I. Background

A. FCA Statutory Framework

As we have previously explained in great detail, the FCA makes it unlawful to knowingly submit a fraudulent claim to the government. See, e.g., United States ex rel. Paranich v. Sorgnard, 396 F.3d 326, 331-32 (3d Cir.2005); United States ex rel. Dunleavy v. Cnty. of Del., 123 F.3d 734, 738 & n. 6 (3d Cir.1997); United States ex rel. Stinson, Lyons, Gerlin & Bustamante, P.A. v. Prudential Ins. Co., 944 F.2d 1149, 1153-54 (3d Cir.1991). “The qui tarn provision of the [FCA], permits, in certain circumstances, suits by private parties on behalf of the United States against anyone submitting a false claim to the Government. Prior to 1986, such suits were barred if the information on which they were based was already in the Government’s possession.” Hughes Aircraft Co. v. United States ex rel. Schumer, 520 U.S. 939, 941, 117 S.Ct. 1871, 138 L.Ed.2d 135 (1997).

In 1986, Congress amended the FCA to encourage private plaintiffs — relators, in FCA parlance — to bring civil cases if they had information that someone had defrauded the government. See False Claims Amendments Act (FCAA), Pub.L. No. 99-562, 100 Stat. 3153 (codified at 31 U.S.C. § 3729-33 (1988)); Graham Cnty. Soil & Water Conservation Dist. v. United States ex rel. Wilson, 559 U.S. 280, 293-95, 298, 130 S.Ct. 1396, 176 L.Ed.2d 225 (2010). But, “to strike a balance between encouraging private persons to root out fraud and stifling parasitic lawsuits,” Graham Cnty., 559 U.S. at 295, 130 S.Ct. 1396, Congress added the public disclosure bar to withdraw jurisdiction over, among other things, suits based on information that had been previously disclosed unless “the person bringing the action is an original source of the information.” FCAA § 3 (codified at 31 U.S.C. § 3730(e)(4)(A)); 1 *841 see also United States ex rel. Atkinson v. PA. Shipbuilding Co., 473 F.3d 506, 518-19 & n. 20 (3d Cir.2007) (describing purpose behind FCAA and public disclosure bar). Congress defined an “original source” as “an individual who has direct and independent knowledge of the information on which the allegations are based and has voluntarily provided the information to the Government before filing an action under this section which is based on the information.” FCAA § 3 (codified at 31 U.S.C. § 3730(e)(4)(B)).

B. Medicaid and Related Statutory Framework

Under the Medicaid Drug Rebate Program, a participating drug manufacturer agrees to pay rebates to state Medicaid programs in exchange for those programs covering the cost of a manufacturer’s drugs. See Omnibus Reconciliation Act of 1990, Pub.L. No. 101-508, § 4401, 104 Stat. 1388 (1990) (codified as amended at 42 U.S.C. § 1396r-8 (2012)); see also Astra USA, Inc. v. Santa Clara Cnty., — U.S. -, 131 S.Ct. 1342, 1345-46, 179 L.Ed.2d 457 (2011). The Department of Health and Human Services (HHS) determines the amount of the rebate using a statutory formula based on a manufacturer’s average and best prices for a particular drug. See, e.g., 42 U.S.C. § 1396r-8(c). Each manufacturer calculates these prices — which is “a complex enterprise requiring recourse to detailed information about the company’s sales and pricing,” Astra, 131 S.Ct. at 1346 (citing 42 U.S.C. § 1396r-8(k); 42 C.F.R. §§ 447.500-520) (2010) 2 — and submits them to HHS each quarter, 42 U.S.C. § 1396r-8(b)(3). HHS may not disclose a manufacturer’s reported prices except in certain circumstances. Astra, 131 S.Ct. at 1346 (citing 42 U.S.C. § 1396r-8(b)(3)(D) (2010)).

Pertinent here, a drug maker participating in Medicaid must also comply with Section 340B of the Public Health Service Act, 42 U.S.C. § 256b(a). That section prohibits a manufacturer from charging certain state-operated programs that receive federal funds more than the average price for its drugs, as defined by the Medicaid Drug Rebate Program, less a specified rebate percentage. See Astra, 131 S.Ct. at 1346. In addition, the federal anti-kickback statute (AKS) prohibits a drug, maker from knowingly offering any remuneration to induce others to cause the government to pay for its drugs. Medicare and Medicaid Patient Protection Act, Pub.L. No. 92-603, 86 Stat.

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769 F.3d 837, 2014 U.S. App. LEXIS 20116, 2014 WL 5315251, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-schumann-v-astrazeneca-pharmaceuticals-lp-ca3-2014.