UNITED STATES of America, ex rel. Karl S. SCHUMANN, and on Behalf of the States of California, Delaware, the District of Columbia, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Nevada, Tennessee, Texas and Virginia; Karl S. Schumann v. ASTRAZENECA PHARMACEUTICALS L.P.; Astrazeneca LP; Bristol-Myers Squibb Company; E.I. DuPont De Nemours & Company; DuPont Pharmaceuticals Company Karl S. Schumann, Appellant.
No. 13-1489.
United States Court of Appeals, Third Circuit.
Argued Nov. 6, 2013. Opinion filed: Oct. 20, 2014.
769 F.3d 837
Mark E. Haddad, Esquire, (argued), Collin P. Wedel, Esquire, Sidley Austin LLP, Los Angeles, CA, Michael P. Doss, Esquire, Sidley Austin LLP, Chicago, IL, Counsel for Appellees AstraZeneca LP and AstraZeneca Pharmaceuticals L.P.
Catherine E. Stetson, Esquire, (argued), Jessica L. Ellsworth, Esquire, David M. Ginn, Esquire, Hogan Lovells U.S. LLP, Washington, D.C., Thomas M. Gallagher, Esquire, Pepper Hamilton, Philadelphia, PA, Counsel for Appellees Bristol-Myers Squibb Company, DuPont Pharmaceuticals, Company, and E.I. DuPont De Nemours & Company.
Before: GREENAWAY, JR., VANASKIE and ROTH, Circuit Judges.
OPINION
ROTH, Circuit Judge:
Plaintiff Karl S. Schumann, proceeding as a qui tam relator under the False Claims Act (FCA),
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 tam 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 (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
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
Pertinent here, a drug maker participating in Medicaid must also comply with
At all relevant times, BMS participated in Medicaid‘s Drug Rebate Program with regard to its anticoagulant Coumadin, and AZ participated in the program with regard to its proton pump inhibitors (PPIs) Nexium and Prilosec. Both companies also participated in the Section 340B program with those drugs, and sold those drugs to government health care programs. Therefore, the companies were prohibited from, and subject to liability
C. Facts and Procedural History
From 1999 to 2003, Schumann was Vice President of Pharmaceutical Contracting for Medco, a large national pharmacy benefit manager (PBM). As a PBM, Medco manages mail-order pharmacies and pharmacy benefits for health plans, including those offered by various federal and state government entities to qualifying employees, and contracts with drug makers, including BMS and AZ, to offer their products in the health plans Medco manages. Health plans retain PBMs such as Medco “to efficiently manage their benefit plans and to achieve cost savings” by “negotiating discounts or rebates from drug manufacturers, providing mail order prescription service to plan members, contracting with retail pharmacies for reimbursement when prescriptions are filled for plan members, and electronic processing and paying of claims.” In re Pharmacy Benefit Mgrs. Antitrust Litig., 582 F.3d 432, 434 (3d Cir.2009). As a result, Medco had the power to determine whether BMS‘s and AZ‘s products would be available to patients covered by plans it managed, to negotiate the price at which such products would be available, and to influence the average and best prices for BMS and AZ products.
Schumann filed his initial Complaint under seal in the Eastern District of Pennsylvania on September 26, 2003, on behalf of the federal government, eleven states, and the District of Columbia. Schumann subsequently filed under seal a First Amended Complaint on November 9, 2005, and a Second Amended Complaint on November 22, 2006. On June 15, 2009, after the government declined to intervene, the District Court lifted the seal for all matters occurring on or after that date and accepted Schumann‘s Third Amended Complaint (TAC) for filing.
BMS moved to dismiss the TAC under
In the CFAC, Schumann alleges that, from December 1997 until March 2003, BMS induced Medco to make Coumadin the exclusive anticoagulant in its mail-order pharmacies by paying sham data fees and rebates up to 63% off Coumadin‘s wholesale price. Schumann further alleges BMS improperly omitted those payments when calculating Medco‘s cost for Coumadin, thereby avoiding setting a new best price for the drug and inaccurately reporting its best price to the government.
Schumann states that he learned of BMS‘s conduct through his job at Medco. More precisely, he pleads facts indicating
Schumann further alleges that from 1996 through 2007, AZ used improper rebates and payments to induce Medco to offer Prilosec and Nexium as the exclusive PPIs in Medco‘s mail-order pharmacies, and to prefer those drugs in the formularies of two health plans Medco managed. Specifically, Schumann alleges AZ withheld Prilosec rebates unless Medco placed Nexium on its preferred formulary, paid post-patent rebates on Prilosec if Medco preferred Nexium over generic PPIs, reduced Medco‘s cost of Prilosec and Nexium to match the cost of generics, and charged Medco the cost of a generic if Medco substituted Prilosec for a generic prescription. In addition, Schumann alleges AZ improperly paid Medco and health plans it managed $100 million under two disease-management agreements, $500,000 via an educational grant to “push Prilosec,” $1.2 million to market Nexium, and $200,000 to subsidize use of the AZ data-analysis program Rational Med. Finally, Schumann alleges AZ improperly failed to incorporate these rebates and payments into its best-price calculations, and thereby submitted false best-price reports and caused the government to overpay for AZ drugs. Schumann states that he learned about AZ‘s improper activity in his role at Medco. Specifically, he says he gained the knowledge by reviewing contracts between Medco and AZ and internal Medco documents describing the history of the companies’ dealings; discussing rebates, formulary placement, disease-management agreements, and other payment vehicles with Medco colleagues and AZ officials; negotiating extensions of various agreements and structuring them to entice health plans managed by Medco to favor AZ PPIs; and, at AZ‘s behest, encouraging those plans to favor AZ PPIs. In addition, he asserts that it was AZ‘s intent to bribe Medco and plans it managed to favor AZ PPIs and to structure deals to evade best-price reporting obligations.
Based on these allegations, the CFAC brings four FCA claims against each defendant, under AKS-violation and inaccurate best-price theories of liability.4 First, Schumann contends defendants knowingly presented or caused to be presented to the government false claims for payment. See
Defendants separately moved to dismiss the CFAC with prejudice. BMS again moved under
Schumann timely moved for reconsideration as to claims against BMS, arguing that he satisfied the FCA‘s original source exception.5 In support of his motion, Schumann submitted a twelve-page declaration purporting to add facts that he had omitted from the CFAC. In pertinent part, he stated he had learned of BMS‘s conduct by reviewing existing agreements and internal documents in Medco files, discussing them with Medco colleagues, negotiating rebate and data fee agreements with BMS, and comparing the terms of those agreements with others he had seen in his years in the pharmacy-benefits industry. He further stated that in negotiations that had occurred before he arrived at Medco, and in those in which he participated, BMS officials had expressed concern about setting a new best price for Coumadin. Finally, he stated that he had deduced, based on his “cumulative knowledge” and the supposed irrationality of the terms to which BMS had agreed, that BMS was illegally paying kickbacks to Medco and misreporting Coumadin‘s best price. In a written decision, the court declined to consider Schumann‘s supplemental declaration, because it was not new evidence, and denied his motion for reconsideration.
AZ then moved to dismiss the CFAC under
II. Discussion
A. Jurisdiction
Schumann brought his FCA claims in federal court pursuant to
B. Standard of Review
This Court exercises plenary review over a district court‘s dismissal for lack of subject matter jurisdiction. Paranich, 396 F.3d at 331 (citing Stinson, 944 F.2d at 1152).
The parties agree that AZ‘s motion to dismiss was a factual attack on jurisdiction, but they disagree about whether BMS‘s motion to dismiss was a facial or factual attack. The distinction is theoretically important because a court may consider matters outside the pleadings in a factual challenge, but must take the complaint at face value and construe it as true in a facial challenge. See Atkinson, 473 F.3d at 514 (citing Gould Electronics Inc. v. United States, 220 F.3d 169, 176-78 (3d Cir.2000)). Here, however, the distinction makes no difference: as we detail below, neither the CFAC‘s allegations alone, nor those allegations plus Schumann‘s supplemental declarations, meet his burden to satisfy that he is an original source of his claims against either BMS or AZ. See Atkinson, 473 F.3d at 515 (noting relator‘s burden to plead or prove jurisdiction).
C. Original Source Exception6
We have previously expounded on what it means to have both “direct and independent knowledge” under the original source exception to the FCA‘s public disclosure bar. See Stinson, 944 F.2d at 1160 (noting conjunctive “and” indicates “direct” and “independent” each impose distinct requirements). “‘Direct knowledge’ is knowledge obtained without any ‘intervening agency, instrumentality, or influence: immediate.‘” Atkinson, 473 F.3d at 520 (quoting Stinson, 944 F.2d at 1160). Such knowledge has also been described as “first-hand, seen with the relator‘s own eyes, unmediated by anything but [the relator‘s] own labor, and by the relator‘s own efforts, and not by the labors of others, and ... not derivative of the information of others.” Paranich, 396 F.3d at 336 & n. 11 (internal quotation marks and citations omitted); see also Stinson, 944 F.2d at 1161 (citing with approval cases finding information is not direct if learned from “a whistleblowing insider” or by “stumbl[ing] across an interesting court file“). The independent knowledge requirement means that “knowledge of the fraud cannot be merely dependent on a public disclosure.” Paranich, 396 F.3d at 336 (quoting United States ex rel. Hafter v. Spectrum Emergency Care, Inc., 190 F.3d 1156, 1160 (10th Cir.1999)). In other words, “a relator who would not have learned of the information absent public disclosure [does] not have ‘independent’ information” under the FCA. Stinson, 944 F.2d at 1160.
We have also described the type of information a relator must know directly and independently. In Stinson, for example, we explained that:
Undoubtedly, it is not necessary for a relator to have all the relevant information in order to qualify as “independent.” Nonetheless, the relator must possess substantive information about the particular fraud, rather than merely background information which enables a putative relator to understand the significance of a publicly disclosed transaction or allegation. If the latter were enough to qualify the relator as an “original source,” then a cryptographer who translated a ciphered document in a public court record would be an “original source,” an unlikely interpretation of the phrase.
Although not previously discussed in the original source context, the algebraic expression we have used to aid our analysis of whether the information underlying a relator‘s claim has been publicly disclosed also serves as a helpful guidepost for understanding what information a relator must know directly and independently. As we laid out in Atkinson:
“[I]f X + Y = Z, Z represents the allegation of fraud and X and Y represent its essential elements. In order to disclose the fraudulent transaction publicly, the combination of X and Y must be revealed, from which readers or listeners may infer Z, i.e., the conclusion that fraud has been committed.” To draw an inference of fraud, both a misrepresented [X] and a true [Y] state of facts must be publicly disclosed. So, if either Z (fraud) or both X (misrepresented facts) and Y (true facts) are disclosed ... then a relator is barred from bringing suit under § 3730(e)(4)(A) unless he is an original source.
Atkinson, 473 F.3d at 519 (quoting Dunleavy, 123 F.3d at 741). Extending this reasoning into the analysis under Section 3730(e)(4)(B), a relator must have direct and independent knowledge of either Z, the alleged fraud, or both X and Y, the false and true sets of facts, to qualify under the FCA‘s original source exception. See Atkinson, 473 F.3d at 519; see also Springfield Terminal, 14 F.3d at 657.
D. Application
Having outlined the contours of the original source exception, we now apply that law to the facts at bar to determine whether Schumann is an original source of the information underlying each of his claims. See Rockwell Int‘l Corp. v. United States, 549 U.S. 457, 476 (2007) (“Section 3730(e)(4) does not permit jurisdiction in gross just because a relator is an original source with respect to some claim.“); see also United States ex rel. Merena v. SmithKline Beecham Corp., 205 F.3d 97, 101-02 (3d Cir.2000) (noting FCA‘s reference to “action” may reasonably be read to mean “claim” because the statute envisions a single-claim complaint).
1. Claims Against BMS
Schumann alleges he obtained direct and independent knowledge of his AKS and best-price claims against BMS in the same fashion. Specifically, he states
None of these allegations is sufficient for Schumann to plead that he is an original source of the key components of his claims against BMS. First, knowledge of a scheme is not direct when it is gained by reviewing files and discussing the documents therein with individuals who actually participated in the memorialized events. See Paranich, 396 F.3d at 335-36; Stinson, 944 F.2d at 1160-61. Second, Schumann‘s description of his involvement in Medco‘s business with BMS, including negotiating rebate and data fee agreements and recognizing that BMS was aware of its best-price reporting obligations, does not evince direct and independent knowledge of any improper kickback or inaccurate best-price report. See Paranich, 396 F.3d at 336 & n. 11 (noting such knowledge gained when relator‘s involvement constituted filing false claims on defendant‘s behalf); Houck on Behalf of the United States v. Folding Carton Admin. Comm., 881 F.2d 494, 505 (7th Cir.1989) (finding relator‘s knowledge direct when he was involved by helping others file false claims); see also In re Pharmacy Benefit Mgrs. Antitrust Litig., 582 F.3d at 434 (explaining PBMs negotiate discounts and rebates from drug makers). Finally, Schumann‘s conclusions that BMS intended to pay kickbacks to Medco and to submit false claims to the government, based on his experience in and understanding of the PBM industry, do not qualify as independent knowledge under the FCA. See, e.g., United States ex rel. Zizic v. Q2Administrators, LLC, 728 F.3d 228, 240 (3d Cir.2013) (“[W]e have repeatedly rejected the argument that a relator‘s knowledge is independent when it is gained through the application of expertise to information publicly disclosed under § 3730(e)(4)(A).” (citing Atkinson, 473 F.3d at 526 n. 27; Stinson, 944 F.2d at 1160)); see also Rockwell, 549 U.S. at 475-76 (rejecting FCA claim premised on relator correctly predicting submission of a false claim); United States ex rel. Vuyyuru v. Jadhav, 555 F.3d 337, 353 (4th Cir.2009) (“[M]ere suspicion that there must be a false or fraudulent claim lurking around somewhere simply does not carry [relator‘s] burden of proving that he is entitled to original source status.“).
At bottom, then, the facts alleged in Schumann‘s CFAC and supplemental declaration do not indicate he has direct and independent knowledge of BMS‘s actual best price for Coumadin or how it was calculated; the inaccurate best price BMS reported to the government or how it was calculated, or any improper payments made to Medco or its health plans; or any false or fraudulent claim submitted or caused to be submitted by BMS. See Atkinson, 473 F.3d at 519-20. Therefore, Schumann does not qualify as an original source of his FCA claims against BMS.
2. Claims Against AZ
Schumann also purports to show direct and independent knowledge of the information underlying his AKS and best-
Under the now-familiar case law, these allegations are insufficient to plead original source status. As discussed above, Schumann‘s knowledge is not direct because it came from reviewing documents and discussing them with colleagues who participated in the underlying events. See Paranich, 396 F.3d at 335-36; Stinson, 944 F.2d at 1160-61. In addition, although he has direct and independent knowledge of AZ‘s business strategies, and of certain payments made by AZ to Medco and health plans it managed (which he pejoratively terms “Special Deals“), he does not have such knowledge that those strategies or payments involved kickbacks or submission of inaccurate best-price reports. And his knowledge that AZ was aware of its best-price obligations does not indicate AZ intended to evade such obligations. Instead, Schumann substitutes experience-based belief that misconduct was occurring for the requisite direct and independent knowledge. This is plainly insufficient to qualify as an original source under the FCA. See, e.g., Zizic, 728 F.3d at 240 (citing Atkinson, 473 F.3d at 526 n. 27; Stinson, 944 F.2d at 1160-61); see also Rockwell, 549 U.S. at 475-76.
Therefore, Schumann fails to aver facts indicating he has direct and independent knowledge of any improper kickbacks from AZ to Medco or to health plans Medco managed; AZ‘s actual best price for Prilosec or Nexium; AZ‘s reported best price for those drugs; how AZ calculated the actual or reported best prices for Prilosec or Nexium; or any false or fraudulent claim submitted or caused to be submitted by AZ. See Atkinson, 473 F.3d at 519-20. Accordingly, he is not an original source of the information underlying his FCA claims against AZ.8
E. Denial of Schumann‘s Motion For Reconsideration As To BMS
The Court reviews “a denial of a motion for reconsideration for abuse of discretion, but we review the District Court‘s underlying legal determinations de novo and factual determinations for clear error.” Howard Hess Dental Labs. Inc. v. Dentsply Int‘l, Inc., 602 F.3d 237, 246 (3d Cir.2010).
“The purpose of a motion for reconsideration ... is to correct manifest errors of law or fact or to present newly discovered evidence.” Max‘s Seafood Café v. Quinteros, 176 F.3d 669, 677 (3d Cir.1999). “Accordingly, a judgment may be altered or amended if the party seeking reconsideration shows at least one of the following grounds: (1) an intervening
In support of his motion for reconsideration, Schumann submitted his twelve-page supplemental declaration in an attempt to plead the facts the District Court had found the CFAC lacked. The court followed Third Circuit precedent and declined to consider such “new” evidence, which Schumann could have submitted in opposition to BMS‘s motion to dismiss. See id. The court therefore did not abuse its discretion in disregarding Schumann‘s supplemental declaration. See Howard Hess Dental Labs., 602 F.3d at 251-52 (citing Harsco Corp. v. Zlotnicki, 779 F.2d 906, 909 (3d Cir.1985)). And it did not abuse its discretion in denying Schumann‘s reconsideration motion, which was not based on a change in law, newly available evidence, or manifest injustice. See Max‘s Seafood Café, 176 F.3d at 677.
F. Dismissal With Prejudice
Finally, we review the District Court‘s denial of leave to amend for abuse of discretion, and review de novo its determination that amendment would be futile. In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1434 (3d Cir.1997).
Under
Schumann was on notice of the deficiencies in the CFAC after BMS moved to dismiss the TAC with prejudice, and he has had many opportunities over the seven-plus years and five iterations of the complaint to plead facts indicating he was an original source; if he could plead such facts, he would have already done so. See Gasoline Sales, Inc. v. Aero Oil Co., 39 F.3d 70, 74 (3d Cir.1994) (noting, where plaintiff sought to add facts to a twice-amended complaint, “three attempts at a proper pleading is enough“); see also Atkinson, 473 F.3d at 517 (“Repleading is futile [after dismissal for lack of subject matter jurisdiction] because the legal inadequacy cannot be solved by providing a better factual account of the alleged claim.“). Accordingly, we affirm dismissal of Schumann‘s claims with prejudice because further amendment would be futile.9
III. CONCLUSION
For the foregoing reasons, we will affirm the judgment of the District Court.
ROTH
CIRCUIT JUDGE
