Hopper v. Solvay Pharmaceuticals, Inc.

[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT FILED
________________________ U.S. COURT OF APPEALS
ELEVENTH CIRCUIT
DECEMBER 4, 2009
No. 08-15810 THOMAS K. KAHN
________________________ CLERK

D.C. Docket No. 04-02356-CV-T-23-TGW

JAMES HOPPER,
COLIN HUTTO,

Plaintiffs-Appellants,

versus

SOLVAY PHARMACEUTICALS, INC.,
UNIMED PHARMACEUTICALS, INC.
UNITED STATES OF AMERICA,

Defendants-Appellees.

________________________

Appeal from the United States District Court
for the Middle District of Florida
________________________
(December 4, 2009)

Before BLACK, WILSON and COX, Circuit Judges.

COX, Circuit Judge:

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 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

2
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

1
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.

3
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.

4
The Government was served with these complaints, investigated the allegations, and

in 2006 ultimately chose not to 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

2
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 pre-amendment sections of the False Claims Act that apply to this case and do not reflect
the 2009 amendments.

5
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

6
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 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

7
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. Hillsborough

County Pub. Transp. Comm’n, 558 F.3d 1301, 1305 (11th Cir. 2009).

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., 290 F.3d 1301, 1309-10 (11th Cir. 2002) (noting

“it was ‘well settled’ and ‘self-evident’ that the False Claims Act is ‘a fraud statute’

for the purposes of Rule 9(b)”) (citation omitted). A False Claims Act complaint

satisfies Rule 9(b) if it sets forth “‘facts as to time, place, and substance of the

defendant’s alleged fraud,’ specifically ‘the details of the defendants’ allegedly

fraudulent acts, when they occurred, and who engaged in them.’” Id. at 1310 (quoting

United States ex rel. Cooper v. Blue Cross & Blue Shield of Fla., 19 F.3d 562, 567-68

(11th Cir. 1994)).

8
 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., 428 F.3d 1008 (11th Cir. 2005), cert. denied, 549 U.S. 810,

127 S. Ct. 42 (2006); and United States ex. rel Atkins v. McInteer, 470 F.3d 1350 (11th

Cir. 2006), we did not differentiate between claims raised under subsection (a)(1) and

subsection (a)(2) of the False Claims Act. The relators acknowledge that under

subsection (a)(1), a plaintiff must prove that the defendant submitted or caused to be

submitted a false claim to the government. But, they contend that submission of an

actual false claim is not an element of a subsection (a)(2) claim. So, we will consider

the claims separately.

9
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 “[w]ithout 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.” 290 F.3d at 1311 (emphasis in original). We reasoned,

“if Rule 9(b) is to be adhered to, some indicia of reliability must be given in the

complaint to support the allegation of an actual false claim for payment being made

to the Government.” Id. (emphasis in original).

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

10
complaint included “the conclusory 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. 428

F.3d at 1011. Here, too, the relator failed to allege specific fraudulent submissions to

the government. Id. at 1014. The relator argued “that a pattern of improper practices

of the defendants leads to the inference that fraudulent claims were submitted to the

government . . . .” Id. at 1013. Nevertheless, we upheld the dismissal of the complaint

because it did not allege that “a specific fraudulent claim was in fact submitted to the

government.” Id. at 1014 (citing Clausen, 290 F.3d at 1311).

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. 470 F.3d at 1354. The complaint in Atkins

described “an elaborate scheme for defrauding the government by submitting false

11
claims.” Id. at 1359. It cited “particular patients, dates and corresponding medical

records for services” that were not eligible for reimbursement. Id. We upheld the

dismissal of the complaint, however, because the relator failed “to provide the next

link in the [False Claims Act] liability chain: showing that the defendants actually

submitted reimbursement claims for the services he describes.” Id. (emphasis in

original).

Like in Clausen, Corsello, and Atkins, the Complaint in this case offers detailed

allegations of an illegal scheme to 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

12
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., 507 F.3d 720, 732-33 (1st Cir.

2007) (suggesting that submitting off-label prescriptions for federal reimbursement

could lead to the filing of false claims). Nonetheless, the relators’ Complaint does not

identify a single physician who wrote a prescription with such knowledge, does not

identify a single pharmacist who filled such a prescription, and does not identify a

single state healthcare program that submitted a claim for reimbursement to the federal

government. The relators contend that their Complaint “contains factual allegations

which reliably indicate that false claims were submitted to the Government.”

(Appellants’ Br. at 16.) We disagree. The Complaint piles inference upon inference

to suggest that Solvay’s marketing campaign influenced some unknown third parties

to file false claims. We cannot conclude that the Complaint satisfies the particularity

requirements of Rule 9(b) by offering “some indicia of reliability . . . of an actual false

13
claim for payment being made to the Government.” Clausen, 290 F.3d at 1311

(emphasis in original).

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. 433 F.3d 1349, 1360 (11th Cir. 2005). The relator in

Walker pled a claim with particularity because the complaint included allegations

grounded in first-hand knowledge that explained why she believed a specific

defendant submitted false or fraudulent claims to the government. Id. Here, unlike

in Walker, the relators do not allege personal knowledge of the billing practices of any

person or entity. The complaint does little more than hazard a guess that unknown

third parties submitted false claims for Medicaid reimbursement.

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, 290 F.3d at 1311 (quotation and citation omitted). Therefore, Rule 9(b)

requires that actual presentment of a claim be pled with particularity. Because the

relators’ complaint fails to assert the “‘who,’ ‘what,’ ‘where,’ ‘when,’ and ‘how’ of

fraudulent submissions to the government,” Corsello, 428 F.3d at 1014, the district

14
court did not err by concluding the complaint failed to plead allegations of fraud with

particularity.

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, 290

F.3d at 1307 (quoting § 3729(a)(1)). In cases following Clausen, we have never

explicitly considered whether the pleading requirements of § 3729(a)(1) apply with

equal force to claims under § 3729(a)(2). See, e.g., Corsello, 428 F.3d at 1012 (noting

relator brought claims under both subsections (a)(1) and (a)(2), but not distinguishing

between claims in analysis). Subsection (a)(2) does not contain a presentment clause.

It imposes liability on any person who “knowingly makes, uses, or causes to be made

or used, a false record or statement to get a false or fraudulent claim paid or approved

by the Government.”3

3
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), 123 Stat. at 1625 (emphasis added). We interpret the word “claim” in section 4(f) to
mean “any request or demand . . . for money or property,” as defined by 31 U.S.C. § 3729(b)(2)(A)
(as amended May 2009). While this case was pending on and after June 7, 2008, the relators do not
allege that any claims, as defined by § 3729(b)(2)(A), were pending on or after June 7, 2008.
Therefore, we conclude the Fraud Enforcement and Recovery Act does not apply retroactively to this

15
 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.

case. See United States v. Sci. Applications Int’l Corp., No. 04-1543, 2009 WL 2929250, at *13-14
(D.D.C. Sept. 14, 2009) (concluding Fraud Enforcement and Recovery Act not retroactive because
no claims were pending on or after June 7, 2008).

16
2123 (2008), the Supreme Court discussed the presentment requirement of §

3729(a)(2):

[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.”

__ U.S. at __, 128 S. Ct. at 2129-30. The relators interpret this language to suggest

that § 3729(a)(2) is violated as soon as a defendant makes a false or fraudulent

statement for the purpose of causing the government to pay a false claim. In their

view, § 3729(a)(2) may be violated even if a false claim is never submitted to or paid

by the government. Essentially, the relators contend that Allison Engine teaches that

subsection (a)(2) is an attempt provision, imposing liability for statements made with

the intent to defraud the government, whether or not the government actually pays a

false claim. We disagree; the language of § 3729(a)(2) suggests it demands proof that

the government paid a false claim, and Allison Engine does not cast doubt on this

conclusion.

We have repeatedly held that the submission of a false claim is the “sine qua

non of a False Claims Act violation.” Clausen, 290 F.3d at 1311. Improper practices

17
standing alone are insufficient to state a claim under either § 3729(a)(1) or (a)(2)

absent allegations that a specific fraudulent claim was in fact submitted to the

government. Corsello, 428 F.3d at 1014. Subsection (a)(2) relieves plaintiffs of the

presentment requirement found in subsection (a)(1): the burden of proving that the

defendant presented or caused to be presented a false claim to the government. But,

the text of § 3729(a)(2)—proscribing false statements made “to get a false or

fraudulent claim paid or approved by the Government”—suggests Congress intended

this subsection to impose liability for false statements that actually cause the

government to pay amounts it does not owe. See United States ex rel. Schmidt v.

Zimmer, Inc., 386 F.3d 235, 242 (3d Cir. 2004) (citing 1 John T. Boese, Civil False

Claims and Qui Tam Actions § 2.01[B], at 2-20 (2d ed. 2003) (“[A] plaintiff must also

show that the defendant made or used . . . a false record in order to cause [a] false

claim to be actually paid or approved.”)). A defendant’s false statements themselves

need not be presented to the government, and the defendant need not personally

submit a false claim. Nevertheless, because the Act protects the government from loss

due to fraud, and it is not “an all-purpose antifraud statute,” Allison Engine, ___ U.S.

at ___, 128 S. Ct. at 2130, the relators must show that the government paid a false

claim to prove a violation of subsection § 3729(a)(2). Subsection (a)(2) is not, as the

relators contend, a separate “attempt” provision of the False Claims Act. Nothing

18
in Allison Engine conflicts with our conclusion. If Allison Engine speaks to this issue

at all, it implies that under 31 U.S.C. § 3729(a)(2), a relator must prove that the

government paid a false claim. The opinion states, “[o]ur reading of § 3729(a)(2) . .

. gives effect to Congress’ efforts to protect the Government from loss due to fraud but

also ensures that ‘a defendant is not answerable for anything beyond the natural,

ordinary and reasonable consequences of his conduct.’” Id. (citation omitted). If the

government has not paid funds it does not owe, it has suffered no loss. To impose

liability in such a case would do nothing to protect the government from loss due to

fraud, and it would extend liability beyond the “natural, ordinary and reasonable

consequences” of a defendant’s conduct.

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

4
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.
5
Our precedents interpreting 31 U.S.C. § 3729(a)(1) speak of the “submission” of false
claims. See, e.g., Clausen, 290 F.3d at 1311 (discussing the submission and presentment of claims,
not the payment of false claims). We have not explicitly considered whether a violation of §
3729(a)(1) occurs when a false claim is submitted, but the government does not pay the claim. The
Third Circuit has held that payment of a false claim is not an element of a subsection (a)(1) claim,
but actual payment is an element of a subsection (a)(2) claim. Schmidt, 386 F.3d at 242. Because
the relators do not allege that Solvay submitted or caused to be submitted false claims that went
unpaid, we do not address whether actual payment of a claim is an element of 31 U.S.C. §
3729(a)(1). We do consider whether actual payment of a claim is an element of 31 U.S.C. §
3729(a)(2), and we answer that it is an element.

19
particularity, pursuant to Rule 9(b), that Solvay’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,

428 F.3d at 1014. But, under subsection (a)(2), a plaintiff must prove that the

defendant made false statements to get a false claim paid or approved, not that the

defendant caused the submission of the claim itself. So, our analyses in Clausen,

Corsello, and Atkins do not necessarily foreclose the possibility that, for claims under

subsection (a)(2), general allegations of improper government payments to third

parties, supported by factual or statistical evidence to strengthen the inference of

fraud, like those in the relators’ Complaint, could satisfy the particularity requirements

of Rule 9(b). The identity of the person or entity who submitted or caused to be

submitted a claim for payment is not an element of a § 3729(a)(2) cause of action. So,

in the appropriate case, we may consider whether the particularity requirements of

20
Rule 9(b), as to the details of the alleged false claims at issue, are more relaxed for

claims under 31 U.S.C. § 3729(a)(2) than for claims under § 3729(a)(1). See United

States ex rel. Duxbury v. Ortho Biotech Prods., 579 F.3d 13, 29 (1st Cir. 2009)

(distinguishing between qui tam actions alleging that the defendant made a false claim

and actions in which the defendant induced third parties to file false claims; reasoning,

“[i]n the latter context . . . a relator could satisfy Rule 9(b) by providing factual or

statistical evidence to strengthen the inference of fraud beyond possibility without

necessarily providing details as to each false claim”) (quotation and citation omitted).

Nevertheless, because we conclude the relators’ Complaint in this case is deficient

whether or not it alleges with particularity that a false claim was paid by the

government, we do not reach this issue.

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, __ U.S.

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at __, 128 S. Ct. at 2128 (emphasis added). “Instead, a plaintiff asserting a §

3729(a)(2) claim must prove that the defendant intended that the false record or

statement be material to the Government’s decision to pay or approve the false claim.”

Id. at __, 128 S. Ct. at 2126.

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

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 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, __ U.S. at __, 128 S. Ct. at 2130.

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.” 579 F.3d at 30 (emphasis

in original). For example, the complaint in Duxbury alleged, in part, that the defendant

pharmaceutical marketer gave a healthcare provider “more than $5,000 of [prescription

drugs] so that [the provider] could submit the free product for reimbursement to

Medicare under the false and fraudulent certification that the provider had paid for the

product and that [the provider] was reimbursed by Medicare for the free [prescription

drugs].” Id. at 31 (quotations omitted) (emphasis in original). The First Circuit found

these and similar allegations supported the claim that the defendant intended its false

statements to be material to the government’s decision to pay a claim. Id. at 30 (citing

Allison Engine, __ U.S. at __, 128 S. Ct. at 2126). In contrast, the relators’ Complaint

in this case alleges that Solvay intended its statements to be material to physicians’

decisions to write off-label prescriptions. It does not allege that Solvay intended its

false statements to play any role in the government’s decision to reimburse state health

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programs for the cost of those prescriptions. Because the relators failed to allege any

connection between Solvay’s alleged false statements and the government’s decision

to pay amounts it does not owe, the Complaint does not meet the particularity

requirements of Rule 9(b).

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.

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