Solvay Pharmaceuticals, Inc. and its wholly owned subsidiary, Unimed Pharmaceuticals, Inc., manufacture and market Marinol, a synthetic form of THC, a hallucinogenic compound found naturally in marijuana. Qui tam relators James Hopper and Colin Hutto allege that Solvay engaged in an off-label marketing campaign to increase sales of Marinol for purposes not approved by the United States Food and Drug Administration. The relators sought recovery on behalf of the United States pursuant to the False Claims Act, 31 U.S.C. § 3729 et seq., for claims paid by government health programs as a result of the marketing campaign. The district court dismissed their action because the relators’ Second Amended Complaint failed to plead the submission of specific false claims with particularity as required by Federal Rule of Civil Procedure 9(b). The relators appeal. We affirm.
I. BACKGROUND & PROCEDURAL HISTORY
Relevant sections of the False Claims Act, 31 U.S.C. § 3729 et seq., prohibit the presentment of false claims to the government and the use of false records or statements to get a false claim paid or approved. The Act may be enforced *1322 through civil actions initiated by the government or suits by private individuals on behalf of the United States, called qui tam actions. The private plaintiffs in qui tam actions are known as “relators,” and the Act entitles them to a percentage of any recovery made on behalf of the government from a False Claims Act defendant.
We summarize the allegations of the relators in this case, Hopper and Hutto, from their Second Amended Complaint. Solvay employed the relators as sales representatives in its Mental Health Division. One of their duties was to implement what they allege to be an illegal marketing scheme for Marinol, a prescription drug manufactured and sold by Solvay.
In 1999, Solvay acquired Unimed, which owned the rights to manufacture and distribute Marinol, a synthetic form of THC, the active compound in marijuana. 1 Marinol is approved by the FDA for use as an appetite stimulant for AIDS patients and for the treatment of nausea and vomiting associated with cancer chemotherapy. According to the relators, Marinol is not particularly effective for these on-label uses, so sales of the drug did not generate substantial profits for Solvay. To increase Marinol sales, the relators allege, Solvay implemented an off-label marketing campaign for the drug beginning in 2001. The relators assert that Solvay instructed its sales representatives to encourage physicians to prescribe Marinol for appetite loss in cancer patients and for treatment of nausea in HIV patients, purposes for which Marinol was not approved. Because the FDA prohibits the marketing of drugs for off-label uses, the relators allege that Solvay’s marketing scheme was illegal.
The relators assert that sales generated from the marketing scheme caused the government to pay false claims through Medicaid and other programs that provide prescription drug benefits. The government does not knowingly pay for drugs through these programs if they are prescribed for off-label uses. The relators allege that the marketing campaign convinced doctors to prescribe Marinol for off-label uses, and claims were ultimately submitted by state health programs and other third parties to the federal government to pay for some of those prescriptions. The relators do not allege that Solvay itself submitted any false claims. Rather, they allege that every time federal funds were used to pay for an off-label prescription, the third party who requested payment from the government made a false claim. (R.2-84 at 52-53.) Those false claims were attributable to Solvay, according to the relators, because the off-label marketing campaign caused the claims to be submitted against federal funds and because Solvay intended that its campaign cause the filing of false claims. (Id. at 60.) To support their allegations that the government paid false claims, the relators point to a marked increase in prescriptions for Marinol and an increase in Medicaid payments for Marinol between 2001 and 2005, years in which Solvay is alleged to have engaged in the marketing campaign.
In 2004, the relators filed a complaint based on these allegations, under seal, pursuant to the qui tam provisions of the False Claims Act. See 31 U.S.C. § 3730(b)(2) (requiring complaints be filed under seal and submitted to the government so it can conduct an investigation). They filed a First Amended Complaint in 2005. The Government was served with these complaints, investigated the allegations, and in 2006 ultimately chose not to *1323 intervene in the case. Shortly thereafter, the court ordered the lawsuit unsealed; and the relators sought leave to file a Second Amended Complaint (“Complaint”), which the court granted.
The Complaint alleges that Solvay violated two subsections of the False' Claims Act, 31 U.S.C. § 3729(a)(1) and (a)(2) 2 , and parallel Illinois, California, and Massachusetts statutes. In a nutshell, it alleges that Solvay executed a sophisticated marketing plan for the purpose of inducing physicians to prescribe Marinol for uses not approved by the FDA, and this conduct “caused submission for reimbursement by Government Healthcare Programs of millions of dollars worth of prescriptions which were ineligible for such reimbursement.” (R.2-84 at 2.) It also alleges that Solvay gave kickbacks to physicians and other healthcare providers to induce them to prescribe Marinol for off-label purposes. (Id. at 3.) The complaint does not identify any specific false claims presented to a government healthcare program or any person or entity who submitted a claim. Nor does it allege that Solvay intended that the government rely on the alleged false statements or records in deciding whether to pay claims. Instead, it alleges that Solvay’s marketing campaign caused healthcare providers to submit claims to state healthcare programs, and the state programs submitted false claims to the federal government. (Id. at 62.)
Solvay filed a motion to dismiss pursuant to Federal Rules of Civil Procedure 12(b)(1), and 12(b)(6). The Rule 12(b)(6) motion was grounded in an assertion that the relators failed to plead their allegations of fraud with particularity as required by Rule 9(b). Solvay also asserted that the court lacked subject matter jurisdiction over the case because some of the allegations were based on publicly disclosed information, and the relators were not the original source. See 31 U.S.C. § 3730(e)(4)(A) (creating jurisdictional bar to claims where plaintiffs are not the original source for information in the complaint). The district court referred the matter to a magistrate judge who recommended that the motion to dismiss be denied as to subject matter jurisdiction. He recommended, however, that the federal claims be dismissed for failing to satisfy Rule 9(b) because the relators failed to plead with particularity their allegations that Solvay’s marketing scheme caused the submission of actual false or fraudulent claims to the government. (R.2-101 at 26-27.) The magistrate judge also recommended that the court decline to retain supplemental jurisdiction over the state law claims. The relators filed objections to the magistrate judge’s report, but the district court adopted it in full, dismissed the relators’ federal claims with prejudice, and declined to exercise supplemental jurisdiction over the state law claims. The relators appeal.
II. ISSUE ON APPEAL & CONTENTIONS OF THE PARTIES
The sole issue on appeal is whether the Complaint, which does not include allegations of specific false claims or allege that Solvay intended for its statements to influence the government’s decisions to pay any claims, satisfies the particularity requirements of Rule 9(b). The relators brought *1324 claims under 31 U.S.C. § 3729(a)(1) and (a)(2). Subsection (a)(1) makes liable any person who presents, or causes to be presented, a false or fraudulent claim. Subsection (a)(2) makes liable any person who knowingly makes, uses, or causes to be made or used, a false record or statement to get a false claim paid or approved. Solvay contends that to satisfy the particularity requirements under either 31 U.S.C. § 3729(a)(1) or (a)(2), a complaint must identify actual false claims. The relators counter that the requirements of Rule 9(b) may be satisfied as to subsection (a)(1) without identifying specific false claims as long as the complaint contains factual allegations which reliably indicate that false claims were submitted to the government. As to subsection (a)(2), the relators argue that the presentment of a false claim to the government is not an element of the cause of action. So, they claim the particularity requirements of Rule 9(b) are satisfied by alleging that the defendants made false statements for the purpose of causing the payment of false claims. For claims under subsection (a)(2), the relators argue they need not allege that false or fraudulent claims were actually submitted to or paid by the government.
III. STANDARD OF REVIEW
We review de novo the grant of a motion to dismiss pursuant to Rule 12(b)(6) for failure to state a claim upon which relief can be granted.
Leib v. Hills-borough County Pub. Transp. Comm’n,
IV. DISCUSSION
A complaint under the False Claims Act must meet the heightened pleading standard of Rule 9(b), which states “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”
See United States ex rel. Clausen v. Lab. Corp. of Am.,
The district court held that the relators’ Complaint did not satisfy the particularity requirements of Rule 9(b) because it failed to include specific allegations of “the actual presentment of false claims.” (R.2-101 at 25.) The court did not distinguish between the relators’ allegations under 31 U.S.C. § 3729(a)(1) and their allegations under § 3729(a)(2). It reasoned that our precedents require all False Claims Act complaints to identify specific false claims, and the court appears to have concluded that these precedents apply equally to subsections (a)(1) and (a)(2) of the Act. Because the Complaint did not identify a specific false claim, the court found it did not satisfy Rule 9(b) and was subject to dismissal, pursuant to Rule 12(b)(6), for failing to state a claim upon which relief can be granted. (R.2-101 at 20.)
Indeed, in cases on which the district court relied,
Clausen; United States ex rel. Corsello v. Lincare, Inc.,
A. 31 U.S.C. § 3729(a)(1)
31 U.S.C. § 3729(a)(1) contains a “presentment clause.” It imposes liability on a person who “knowingly
presents, or causes to be presented,
to an officer or employee of the United States Government or a member of the Armed Forces of the United States a false or fraudulent claim for payment or approval.”
Id.
(emphasis added). In
Clausen,
we explained that “[wjithout the
presentment
of such a claim, while the practices of an entity that provides services to the Government may be unwise or improper, there is simply no actionable damage to the public fisc as required under the False Claims Act.”
In Clausen, the relator alleged that a medical testing corporation billed the government for unnecessary laboratory tests. Id. at 1303. The complaint included detailed allegations of a scheme to overcharge; it identified the patients who received tests, specified which tests were improper, and set forth the dates on which the procedures were performed. Id. at 1304-05. We upheld the dismissal of the complaint pursuant to Rule 9(b), however, because it failed to provide any information linking the testing schemes to the submission of actual false claims. Id. at 1313. The complaint included “the eonclusory allegation that [the defendant] submitted bills to the Government ‘on the date of service or within a few days thereafter.’ ” Id. We explained that if “Rule 9(b) is to carry any water, it must mean that an essential allegation and circumstance of fraudulent conduct cannot be alleged in such conclusory fashion.” Id.
We considered similar circumstances in
Corsello,
in which a relator alleged that medical equipment companies engaged in kickback and referral schemes to falsify certificates of medical necessity to submit false claims for Medicare payments.
Similar issues were again presented in
Atkins,
where a relator alleged that psychiatrists improperly sought payments from Medicare and Medicaid for psychiatric services that were not actually rendered, were provided with substandard levels of care, and were medically unnecessary.
Like in Clausen, Corsello, and Atkins, the Complaint in this case offers detailed allegations of an illegal scheme to *1326 cause the government to pay amounts it did not owe. The Complaint also includes what the relators describe as “a highly-compelling statistical analysis [that] renders inescapable the conclusion that a huge number of claims for ineffective off-label uses of Marinol resulted from [Solvay’s illegal marketing] campaign.” (Appellants’ Br. at 19.) But, the Complaint does not allege the existence of a single actual false claim. In fact, we are unable to discern from the complaint a specific person or entity that is alleged to have presented a claim of any kind, let alone a false or fraudulent claim.
The relators contend that the illegal marketing campaign first induced physicians to write off-label prescriptions for Marinol. Then, pharmacies and other healthcare providers submitted claims to various state healthcare programs for reimbursement. Finally, these state agencies submitted claims to the federal government for payment. (R.2-84 at 52-53.) The Complaint does not identify specific persons or entities that participated in any step of this process. Nor does it allege dates, times, or amounts of individual false claims.
We will assume
arguendo
that when a physician writes an off-label prescription with knowledge or intent that the cost of filling that prescription will be borne by the federal government, and when a claim is ultimately submitted to the federal government to pay for that prescription, 31 U.S.C. § 3729(a)(1) may have been violated.
See United States ex rel. Rost v. Pfizer, Inc.,
This is not a case like
United States ex rel. Walker v. R&F Properties of Lake County, Inc.,
in which a relator alleged personal knowledge of the defendants’ billing practices that gave rise to a well-founded belief that the defendant submitted actual false or fraudulent claims.
The relators’ allegations pursuant to 31 U.S.C. § 3729(a)(1) are deficient under Rule 9(b). The “central question” in such a claim “is whether the defendant ever presented [or caused to be presented] a ‘false or fraudulent claim’ to the government.”
Clausen,
B. 31 U.S.C. § 3729(a)(2)
In
Clausen,
we relied on the “presentment clause” of 31 U.S.C. § 3729(a)(1) to require that a complaint allege with particularity that the defendant submitted or caused to be submitted an actual false claim to the government. See
Clausen,
The relators contend that because subsection (a)(2) does not contain a presentment clause, proof that a false claim was submitted to the government is not an element of the cause of action. Plaintiffs are not required to allege what they are not required to prove. Therefore, the relators argue, their Complaint need not allege that a false claim was submitted to the government. We agree that 31 U.S.C. § 3729(a)(2) does not demand proof that the defendant presented or caused to be presented a false claim to the government or that the defendant’s false record or statement itself was ever submitted to the government. We conclude, however, that a plaintiff must show that (1) the defendant made a false record or statement for the purpose of getting a false claim paid or approved by the government; and (2) the defendant’s false record or statement caused the government to actually pay a false claim, either to the defendant itself, or to a third party. The Complaint fails to satisfy the first requirement; it does not allege that Solvay intended its false statements to influence the government’s decision to pay a false claim. Therefore, even if we were to assume that it alleges with particularity that the government paid a false claim, the Complaint remains deficient.
In
Allison Engine Co. v. United States ex rel. Sanders,
— U.S. -, 128 S.Ct.
*1328
2123,
[T]he concept of presentment is not mentioned in § 3729(a)(2). The inclusion of an express presentment requirement in subsection (a)(1), combined with the absence of anything similar in subsection (a)(2), suggests that Congress did not intend to include a presentment requirement in subsection (a)(2).... What § 3729(a)(2) demands is not proof that the defendant caused a false record or statement to be presented or submitted to the Government but that the defendant made a false record or statement for the purpose of getting “a false or fraudulent claim paid or approved by the Government.”
We have repeatedly held that the submission of a false claim is the
“sine qua non
of a False Claims Act violation.”
Clausen,
We hold that under § 3729(a)(2),
4
a plaintiff must prove that the government in fact paid a false claim.
5
Therefore, the relators’ Complaint must allege with particularity, pursuant to Rule 9(b), that Solva/s false statements ultimately led the government to pay amounts it did not owe. The relators contend that they have done so. Their Complaint alleges that state health programs presented false claims of uncertain amounts on uncertain dates to the government, and this resulted in a marked increase in Medicaid payments. As discussed above, these allegations would be insufficient to state a claim under subsection (a)(1) of the Act. Because liability under subsection (a)(1) is predicated upon the defendant itself submitting or directly causing the submission of a false claim, we require a plaintiff prove the “ ‘who,’ ‘what,’ ‘where,’ ‘when,’ and ‘how’ of fraudulent submissions to the government.”
Corsello,
Whether the relators’ Complaint alleges with particularity the payment of a false claim is a question we need not answer. Even if it did, the Complaint remains deficient because it fails to allege that the defendants intended for the government to rely on their false statements in deciding whether to pay a false claim.
To be liable under 31 U.S.C. § 3729(a)(2), a defendant must make a false record or statement “to get a false or fraudulent claim paid or approved by the Government.” It is insufficient for a plaintiff to show merely that “a false statement
resulted in
the use of Government funds to pay a false or fraudulent claim.”
Allison Engine,
The relators in this case claim that their Complaint “allege[s] copiously that [the] defendants intended their off-label campaign to cause the submission of false claims.” (Appellants’ Br. at 26.) But, their complaint does not link the alleged false statements to the government’s decision to pay false claims. It fails to allege that the defendants intended for the government to rely on the substance of their off-label marketing campaign to decide to pay a claim. The Complaint alleges that Solvay intended for physicians to rely on their false statements to write off-label prescriptions. (R.2-84 at 2.) It does not allege that, aside from the unnamed physicians, any person or entity had knowledge of the off-label marketing campaign — not any pharmacists, state health programs, or significantly, the federal government. We cannot infer that because Solvay allegedly intended its marketing campaign to convince physicians to write off-label prescriptions, Solvay intended for that campaign to influence the government’s decision to pay for those prescriptions.
If a ... defendant makes a false statement to a private entity and does not intend the. Government to rely on that false statement as a condition of payment, the statement is not made with the purpose of inducing payment of a false claim “by the Government.” In such a situation, the direct link between the false statement and the Government’s decision to pay or approve a false claim is too attenuated to establish liability.
Allison Engine,
To illustrate why the relators’ Complaint is deficient, compare this case with
Duxbury,
a recent First Circuit case involving the off-label promotion of a prescription drug. In
Duxbury,
the relator “alleged facts ... that support his claim that [the defendant]
intended
to cause the submission of false claims.”
V. CONCLUSION
Therefore, we affirm the district court’s dismissal of the relators’ federal claims for failure to comply with Federal Rule of Civil Procedure 9(b). And, we find no error in the court’s declining to retain supplemental jurisdiction over the state law claims.
AFFIRMED.
Notes
. Unimed, a wholly owned subsidiary of Solvay, is a named defendant in this case, but most of the allegations in the Second Amended Complaint refer to Solvay. It is unclear which of these allegations are alleged to be attributable to Unimed. References to Solvay hereafter include Unimed.
. The Fraud Enforcement and Recovery Act of 2009 amended and renumbered sections of the False Claims Act relevant to this appeal. Pub.L. No. 111-21, 123 Stat. 1617. These amendments, however, do not apply retroactively to this case. See infra note 3. Citations to the U.S. Code herein refer to the preamendment sections of the False Claims Act that apply to this case and do not reflect the 2009 amendments.
. In May 2009, Congress enacted the Fraud Enforcement and Recovery Act, which amended 31 U.S.C. § 3729(a)(2) (2003), replacing the words "to get a false or fraudulent claim paid or approved by the government” with the words “material to a false or fraudulent claim.” Pub.L. No. 111-21, § 4, 123 Stat. 1617, 1621. Section 4(f)(1) of the Act provides that this change "shall take effect as if enacted on June 7, 2008, and apply to all
claims ...
that are pending on or after that date.”
Id.
§ 4(f)(1),
. Because the May 2009 amendments to 31 U.S.C. § 3729(a)(2) do not apply retroactively to this case, see supra note 3, we do not consider whether actual payment of a false claim is an element of this subsection as amended by the Fraud Enforcement Recovery-Act of 2009.
. Our precedents interpreting 31 U.S.C. § 3729(a)(1) speak of the "submission” of false claims.
See, e.g., Clausen,