United States Ex Rel. Nathan v. Takeda Pharmaceuticals North America, Inc.

PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

UNITED STATES ex rel. NOAH 

NATHAN, On Behalf Of The United

States Government and the States,

Plaintiff-Appellant,

v.

 No. 11-2077

TAKEDA PHARMACEUTICALS NORTH

AMERICA, INCORPORATED; TAKEDA

PHARMACEUTICALS AMERICA,

INCORPORATED,

Defendants-Appellees.



Appeal from the United States District Court

for the Eastern District of Virginia, at Alexandria.

Anthony J. Trenga, District Judge.

(1:09-cv-01086-AJT-JFA)

Argued: October 25, 2012

Decided: January 11, 2013

Before MOTZ and KEENAN, Circuit Judges, and

James K. BREDAR, United States District Judge

for the District of Maryland,

sitting by designation.

Affirmed by published opinion. Judge Keenan wrote the opin-

ion, in which Judge Motz and Judge Bredar joined.

2 UNITED STATES v. TAKEDA PHARMACEUTICALS

COUNSEL

ARGUED: Jeffrey A. Lamken, MOLOLAMKEN, LLP,

Washington, D.C., for Appellant. William F. Cavanaugh, Jr.,

PATTERSON, BELKNAP, WEBB & TYLER, New York,

New York, for Appellees. ON BRIEF: Michael G. Pattillo,

Jr., Martin V. Totaro, MOLOLAMKEN, LLP, Washington,

D.C., for Appellant. Susan R. Podolsky, THE LAW OFFICES

OF SUSAN R. PODOLSKY, Alexandria, Virginia; Daniel S.

Ruzumna, Sean H. Murray, Aileen M. McGill, PATTERSON,

BELKNAP, WEBB & TYLER, New York, New York, for

Appellees.

OPINION

BARBARA MILANO KEENAN, Circuit Judge:

Noah Nathan (Relator), a sales manager for Takeda Phar-

maceuticals (Takeda), brought this qui tam action against his

employer under the False Claims Act (the Act), 31 U.S.C.

§§ 3729 through 3733. Relator alleges that Takeda violated

§ 3729(a)(1)(A) of the Act by causing false claims to be pre-

sented to the government for payment under Medicare and

other federal health insurance programs.1 After allowing Rela-

tor to file a third amended complaint (the amended com-

plaint), the district court dismissed Relator’s claims under

Federal Rule of Civil Procedure 12(b)(6). In this appeal, Rela-

tor argues that the district court erred in concluding that Rela-

tor did not plausibly allege in the amended complaint that

false claims had been presented to the government for pay-

ment, or that Takeda caused the presentment of any such false

claims. Relator also contends that the district court abused its

discretion in denying Relator’s request for leave to file a

fourth amended complaint.

1

Relator does not appeal the district court’s dismissal of Relator’s sepa-

rate claim brought under 31 U.S.C. § 3729(a)(1)(B).

UNITED STATES v. TAKEDA PHARMACEUTICALS 3

Upon our review, we hold that the district court did not err

in dismissing the amended complaint, because Relator failed

to plausibly allege that any false claims had been presented to

the government for payment. We further hold that the district

court did not abuse its discretion in denying Relator leave to

file a fourth amended complaint.

I.

Among other things, the Act prohibits any person from

knowingly "caus[ing] to be presented" to the government

false claims for payment or approval. 31 U.S.C.

§ 3729(a)(1)(A). A false statement is actionable under the Act

only if it constitutes a "false or fraudulent claim." Harrison v.

Westinghouse Savannah River Co., 176 F.3d 776, 785 (4th

Cir. 1999) (emphasis added). Importantly, to trigger liability

under the Act, a claim actually must have been submitted to

the federal government for reimbursement, resulting in "a call

upon the government fisc." Id.; see also Hopper v. Solvay

Pharm., Inc., 588 F.3d 1318, 1325-26 (11th Cir. 2009).

Relator alleges in the amended complaint that prescriptions

written for certain medical uses, which have not been

approved by the Food and Drug Administration (the FDA) or

included in statutorily specified compendia, are not reimburs-

able under federal health insurance programs. Such uses com-

monly are referred to as "off-label" uses. Relator further

alleges that because the cost of prescriptions for off-label uses

is not subject to reimbursement by the federal government,

the presentment of these types of claims for payment consti-

tutes a violation of the Act.2

2

Nevertheless, physicians are permitted to prescribe drugs for off-label

uses. See 21 U.S.C. § 396. However, under the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. § 301, et seq., pharmaceutical companies are not

permitted to promote their drugs for uses not approved by the FDA. See

Wash. Legal Found. v. Henney, 202 F.3d 331, 332-33 (D.C. Cir. 2000).

4 UNITED STATES v. TAKEDA PHARMACEUTICALS

In the amended complaint, Relator additionally alleges that

Takeda marketed its prescription drug Kapidex, a proton

pump inhibitor used to treat various gastric conditions, for

off-label uses.3 Relator alleges that two of Takeda’s marketing

practices caused presentation of false claims to the govern-

ment. The identified marketing practices were: (1) Takeda’s

promotion of Kapidex to rheumatologists, who typically do

not treat patients having conditions for which Kapidex has

been approved; and (2) Takeda’s practice of marketing high

doses of Kapidex for the treatment of conditions for which

only a lower dose has been approved by the FDA.

In particular, Relator alleges that 60 mg doses of Kapidex

have been approved by the FDA only for the treatment of the

active condition of erosive esophagitis (EE). However,

Kapidex has been approved by the FDA at a lower 30 mg

dose to treat the more common condition of gastroesophogeal

reflux disease (GERD), as well as for the maintenance of

already "healed" cases of EE. Relator alleges that Takeda has

provided doctors with samples of Kapidex exclusively in 60

mg doses, irrespective whether such physicians treat active

cases of EE. As Relator further alleges, by this sampling prac-

tice, Takeda improperly implies that a 60 mg dose of Kapidex

is the only available dosage of that drug, thereby causing doc-

tors to prescribe 60 mg doses for unapproved conditions.4

Relator also alleges that Takeda sales representatives regu-

larly misled physicians by deflecting or dismissing their ques-

tions about proper dosages, and by making misrepresentations

concerning the available dosages.

Additionally, Relator alleges that the motivation for Take-

3

Relator alleges that Kapidex has been renamed Dexilant. Because the

amended complaint refers to the drug at issue exclusively as Kapidex, we

do the same here.

4

Relator alleges that although Takeda sought government approval for

higher dosages of Kapidex, including a 60 mg dose to treat GERD, the

Food and Drug Administration rejected this request.

UNITED STATES v. TAKEDA PHARMACEUTICALS 5

da’s alleged fraudulent marketing stems from Takeda’s desire

to replicate the success of its previously approved drug, Pre-

vacid, the patent for which was set to expire in 2009. Prevacid

has been approved to treat 13 conditions, including GERD.

Prevacid also has been approved to provide gastric protection

and to treat gastric ulcers, indications relevant to rheuma-

tology patients who regularly take anti-inflammatory pain

medications. In contrast, Kapidex is not approved for these

two conditions. Relator alleges that because the patent expira-

tion date for Prevacid was approaching, Takeda promoted

Kapidex to "fill the Prevacid void."

The district court dismissed the amended complaint on two

independent grounds: (1) the amended complaint failed to

allege the "presentment" of a false or fraudulent claim to the

government for payment or approval under 31 U.S.C.

§ 3729(a)(1)(A); and (2) the amended complaint failed to

allege adequately that Takeda "caused" the issuance of off-

label prescriptions.5 The district court also denied Relator’s

request to amend his complaint for a fourth time. Because we

conclude that the district court properly dismissed the

amended complaint based on Relator’s failure to allege pre-

sentment of a false claim, we do not reach the additional ques-

tion whether Relator alleged sufficient facts to support the

required causation element for a claim asserted under the Act.

We further hold that the district court did not abuse its discre-

tion in denying Relator’s motion for leave to file a fourth

amended complaint.

II.

We review de novo the district court’s dismissal of a com-

plaint for failure to state a claim under Fed. R. Civ. P.

12(b)(6). Harrison, 176 F.3d at 783. To survive a Rule

5

Because Relator does not appeal the district court’s decision declining

to exercise supplemental jurisdiction over Relator’s state law claims, we

do not address those claims here.

6 UNITED STATES v. TAKEDA PHARMACEUTICALS

12(b)(6) motion to dismiss, a complaint must "state a claim to

relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S.

662, 678 (2009) (citation omitted). Facts that are "merely con-

sistent with" liability do not establish a plausible claim to

relief. Id. (citation omitted). In addition, although we must

view the facts alleged in the light most favorable to the plain-

tiff, we will not accept "legal conclusions couched as facts or

unwarranted inferences, unreasonable conclusions, or argu-

ments." Wag More Dogs, LLC v. Cozart, 680 F.3d 359, 365

(4th Cir. 2012) (citation and internal quotation marks omit-

ted).

Before addressing the substantive allegations in the

amended complaint, we first state the pleading requirements

for fraud-based claims brought under the Act. In addition to

meeting the plausibility standard of Iqbal, fraud claims under

the Act must be pleaded with particularity pursuant to Rule

9(b) of the Federal Rules of Civil Procedure. Harrison, 176

F.3d at 783-85. Rule 9(b) provides:

In alleging fraud or mistake, a party must state with

particularity the circumstances constituting fraud or

mistake. Malice, intent, knowledge, and other condi-

tions of a person’s mind may be alleged generally.

To satisfy Rule 9(b), a plaintiff asserting a claim under the

Act "must, at a minimum, describe the time, place, and con-

tents of the false representations, as well as the identity of the

person making the misrepresentation and what he obtained

thereby." United States ex rel. Wilson v. Kellogg Brown &

Root, Inc., 525 F.3d 370, 379 (4th Cir. 2008) (citation and

internal quotation marks omitted).

The parties dispute the proper application of Rule 9(b) in

this case. In Relator’s view, to meet the requirements for

pleading a fraud claim under the Act, a relator need only

allege the existence of a fraudulent scheme that supports the

inference that false claims were presented to the government

UNITED STATES v. TAKEDA PHARMACEUTICALS 7

for payment. In contrast, Takeda argues that Rule 9(b)

requires that a relator plead facts plausibly alleging that par-

ticular, identifiable false claims actually were presented to the

government for payment.

In view of the rationale underlying Rule 9(b), we decline

to adopt Relator’s argument for a more lenient application of

the Rule. We have adhered firmly to the strictures of Rule

9(b) in applying its terms to cases brought under the Act. See,

e.g., Wilson, 525 F.3d at 379-80 (explaining the requirements

of Rule 9(b) and affirming dismissal for failing to comply);

Harrison, 176 F.3d at 784, 789-90 (same). The multiple pur-

poses of Rule 9(b), namely, of providing notice to a defendant

of its alleged misconduct, of preventing frivolous suits, of

"eliminat[ing] fraud actions in which all the facts are learned

after discovery," and of "protect[ing] defendants from harm to

their goodwill and reputation," Harrison, 176 F.3d at 784

(citation omitted), are as applicable in cases brought under the

Act as they are in other fraud cases. Indeed, such purposes

may apply with particular force in the context of the Act,

given the potential consequences flowing from allegations of

fraud by companies who transact business with the govern-

ment. Moreover, we have emphasized that a claim brought

under the Act that "rest[s] primarily on facts learned through

the costly process of discovery . . . is precisely what Rule 9(b)

seeks to prevent." Wilson, 525 F.3d at 380; see also Harrison,

176 F.3d at 789. For these reasons, nothing in the Act or in

our customary application of Rule 9(b) suggests that a more

relaxed pleading standard is appropriate in this case.

Neither are we persuaded by Relator’s contention that alle-

gations of a fraudulent scheme, in the absence of an assertion

that a specific false claim was presented to the government for

payment, is a sufficient basis on which to plead a claim under

the Act in compliance with Rule 9(b). As the Supreme Court

has cautioned, the Act "was not designed to punish every type

of fraud committed upon the government." Harrison, 176

F.3d at 785 (citing United States v. McNinch, 356 U.S. 595,

8 UNITED STATES v. TAKEDA PHARMACEUTICALS

599 (1958)). Instead, the critical question is whether the

defendant caused a false claim to be presented to the govern-

ment, because liability under the Act attaches only to a claim

actually presented to the government for payment, not to the

underlying fraudulent scheme. Id. (citing United States v.

Rivera, 55 F.3d 703, 709 (1st Cir. 1995)). Therefore, when a

relator fails to plead plausible allegations of presentment, the

relator has not alleged all the elements of a claim under the

Act. See United States ex rel. Clausen v. Lab. Corp. of Am.,

290 F.3d 1301, 1313 (11th Cir. 2002) ("[W]e cannot be left

wondering whether a plaintiff has offered mere conjecture or

a specifically pleaded allegation on an essential element of the

lawsuit.").

We agree with the Eleventh Circuit’s observation that the

particularity requirement of Rule 9(b) "does not permit a

False Claims Act plaintiff merely to describe a private scheme

in detail but then to allege simply and without any stated rea-

son for his belief that claims requesting illegal payments must

have been submitted, were likely submitted or should have

been submitted to the Government." Id. at 1311. Rather, Rule

9(b) requires that "some indicia of reliability" must be pro-

vided in the complaint to support the allegation that an actual

false claim was presented to the government. Id. Indeed, with-

out such plausible allegations of presentment, a relator not

only fails to meet the particularity requirement of Rule 9(b),

but also does not satisfy the general plausibility standard of

Iqbal. See Clausen, 290 F.3d at 1313 ("If Rule 9(b) is to carry

any water, it must mean that an essential allegation and cir-

cumstance of fraudulent conduct cannot be alleged in such

conclusory fashion."); cf. United States ex rel. Joshi v. St.

Luke’s Hosp., Inc., 441 F.3d 552, 557 (8th Cir. 2006) (requir-

ing relator to "provide some representative examples of [the

defendants’] alleged fraudulent conduct").

Our conclusion is not altered by the cases cited by Relator,

in which courts have held that the requirements of Rule 9(b)

can be satisfied in the absence of particularized allegations of

UNITED STATES v. TAKEDA PHARMACEUTICALS 9

specific false claims. Based on the nature of the schemes

alleged in many of those cases, specific allegations of the

defendant’s fraudulent conduct necessarily led to the plausible

inference that false claims were presented to the government.

For example, in United States ex rel. Grubbs v. Kanne-

ganti, 565 F.3d 180 (5th Cir. 2009), the relator alleged a con-

spiracy by doctors to seek reimbursement from governmental

health programs for services that never were performed. The

court concluded that, because the complaint included the

dates of specific services that were recorded by the physicians

but never were provided, such allegations constituted "more

than probable, nigh likely, circumstantial evidence that the

doctors’ fraudulent records caused the hospital’s billing sys-

tem in due course to present fraudulent claims to the Govern-

ment." Id. at 192. Accordingly, the court further concluded

that it would "stretch the imagination" for the doctors to con-

tinually record services that were not provided, but "to deviate

from the regular billing track at the last moment so that the

recorded, but unprovided, services never get billed." Id.; see

also United States ex rel. Duxbury v. Ortho Biotech Prods.,

L.P., 579 F.3d 13, 30 (1st Cir. 2009) (holding that, in scheme

alleging kickbacks to health care providers, allegations

regarding "the dates and amounts of the false claims filed by

these providers with the Medicare program" met the standard

imposed by Rule 9(b)).6

Applying these principles, we hold that when a defendant’s

actions, as alleged and as reasonably inferred from the allega-

6

In another case cited by Relator, the Tenth Circuit held that "claims

under the [False Claims Act] need only show the specifics of a fraudulent

scheme and provide an adequate basis for a reasonable inference that false

claims were submitted as part of that scheme." United States ex rel. Lem-

mon v. Envirocare of Utah, Inc., 614 F.3d 1163, 1172 (10th Cir. 2010).

In Lemmon, however, it was clear that the relator had pleaded specific

details of false claims, including the dates of the alleged violations, the

dates payment requests were submitted, details of the purported violations,

and the allegedly false certification language.

10 UNITED STATES v. TAKEDA PHARMACEUTICALS

tions, could have led, but need not necessarily have led, to the

submission of false claims, a relator must allege with particu-

larity that specific false claims actually were presented to the

government for payment. To the extent that other cases apply

a more relaxed construction of Rule 9(b) in such circum-

stances, we disagree with that approach.

In reaching this conclusion, we acknowledge the practical

challenges that a relator may face in cases such as the present

one, in which a relator may not have independent access to

records such as prescription invoices, and where privacy laws

may pose a barrier to obtaining such information without

court involvement. Nevertheless, our pleading requirements

do not permit a relator to bring an action without pleading

facts that support all the elements of a claim. See Dickson v.

Microsoft Corp., 309 F.3d 193, 213 (4th Cir. 2002) (noting

"the basic pleading requirement that a plaintiff set forth facts

sufficient to allege each element of his claim"). We further

emphasize, however, that the standard we articulate today

does not foreclose claims under the Act when a relator plausi-

bly pleads that specific, identifiable claims actually were pre-

sented to the government for payment. Of course, whether

such factual allegations in a given case meet the required stan-

dard must be evaluated on a case-specific basis.

III.

Employing the above pleading standard, we turn to con-

sider the sufficiency of the amended complaint in this case.

Relator relies on four categories of allegations in the amended

complaint, which he contends state with particularity that

Takeda caused false claims to be presented to the government

for payment. We address each set of allegations in turn, and

conclude that, individually as well as collectively, Relator’s

allegations fail to allege an essential element of a claim under

the Act.

UNITED STATES v. TAKEDA PHARMACEUTICALS 11

First, Relator alleges in the amended complaint that Takeda

promoted Kapidex to rheumatologists, who do not treat the

conditions for which Kapidex has been approved.7 According

to Relator, when promoting Kapidex to rheumatologists,

Takeda sales representatives equated Kapidex with Prevacid,

even though Kapidex was not approved for 10 of the 13 indi-

cations for which Prevacid was approved, including the gas-

tric conditions commonly suffered by rheumatology patients.

Relator further alleges that Takeda sales representatives were

instructed to promote Kapidex to rheumatologists without dis-

closing that the drug is not approved for the gastric condition

often experienced by rheumatology patients.

These allegations concerning the promotion of Kapidex to

rheumatologists fall far short of the pleading standards set

forth in Rule 9(b) and in Iqbal. Fatal to the claim, Relator

does not allege in the amended complaint that the targeted

rheumatologists wrote any off-label prescriptions that were

submitted to the government for payment, a critical omission

in a case brought under the Act.8 See United States ex rel.

7

According to Relator, rheumatologists do not treat GERD or EE, the

two indications for which Kapidex is approved. Rheumatology patients

may use Prevacid for gastric protection, a need associated with long-term

ingestion of anti-inflammatory drugs such as Advil. However, as dis-

cussed above, Kapidex is not approved for gastric protection.

8

After filing the amended complaint, Relator submitted to the district

court a supplemental affidavit with attachments, which allegedly showed

that two rheumatologists in Relator’s sales territory wrote Kapidex pre-

scriptions during a particular month. However, Relator cannot cure plead-

ing deficiencies in the amended complaint with later-filed supporting

documentation. See E.I. du Pont de Nemours & Co. v. Kolon Indus., 637

F.3d 435, 448-49 (4th Cir. 2011) (explaining that "matters beyond the

pleadings . . . cannot be considered on a Rule 12(b)(6) motion"); Sec’y of

State for Defence v. Trimble Navigation Ltd., 484 F.3d 700, 705 (4th Cir.

2007) (stating the documents that may be considered in evaluating a Rule

12(b)(6) motion). Moreover, we agree with the district court’s observation

that, even if these allegations had been included in the amended com-

plaint, "there is nothing that prevents a rheumatologist from prescribing

Kapidex for an approved condition at an approved dosage," and there was

no indication in the record of the prescriptions’ dosage, the conditions for

which they were written, or that the prescriptions were submitted to the

government for reimbursement.

12 UNITED STATES v. TAKEDA PHARMACEUTICALS

Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 2007) (holding

that a complaint does not meet the requirements of Rule 9

when the complaint did not "give notice to [the defendant] of

false claims submitted by others for federal reimbursement of

off-label uses, only of illegal practices in promotion of the

drug"), overruled on other grounds by Allison Engine Co. v.

United ex rel. Sanders, 553 U.S. 662 (2008). Accordingly,

Relator has not plausibly alleged that Takeda caused rheuma-

tologists to write Kapidex prescriptions for off-label uses that

actually were presented to the government for payment.

Second, in the amended complaint, Relator identifies 16

primary care physicians (PCPs) who received 60 mg samples

of Kapidex from Takeda and collectively wrote 98 prescrip-

tions for the drug that were submitted to the government for

reimbursement. Although Relator alleges that these claims

were presented to the government for payment, Relator does

not plausibly allege that the prescriptions were written for off-

label uses.

Rather, Relator alleges in the amended complaint that

because PCPs generally do not treat active cases of EE, the

only condition for which a 60 mg dose is indicated, any 60

mg prescriptions written by PCPs necessarily were for off-

label uses. Notably, however, Relator does not allege facts

that specifically address the dosage level of any of the 98 pre-

scriptions. Instead, Relator relies on speculative contentions

regarding the 98 prescriptions he has identified. Relator

alleges that physicians tend to prescribe drugs in the same

dose as the sample the patient has received and that, therefore,

the identified PCPs must have prescribed 60 mg doses

because they received only 60 mg samples. The allegations in

the amended complaint contain the additional speculative

assertion that at least 90 percent of the 98 prescriptions must

have been written at the 60 mg level, because 93 percent of

the overall sales of Kapidex are for dosages of 60 mg.

As the district court observed, Relator fails to state any

plausible allegation connecting these general statistics to the

UNITED STATES v. TAKEDA PHARMACEUTICALS 13

98 prescriptions identified or to prescriptions written by PCPs

generally. To the contrary, drawing on the language in the

amended complaint, it is logical to assume that a much lower-

than-average percentage of the 98 prescriptions were written

for 60 mg doses, given that PCPs purportedly do not treat the

condition for which the higher 60 mg dose is indicated. Rela-

tor also fails to allege directly that any of the identified pre-

scriptions were for off-label uses, instead requiring that a

court draw an implausible inference linking general statistics

to the 98 prescriptions for Kapidex. Cf. United States ex rel.

Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899,

903 (5th Cir. 1997) (upholding dismissal of False Claims Act

claim for lack of particularity because statistical studies cited

by the relator did not "directly implicate defendants").

Moreover, even if Relator had pleaded adequately that the

98 prescriptions were written at the 60 mg dosage level, the

existence of a 60 mg prescription written by a PCP would not

itself constitute a plausible allegation that the prescription was

for an off-label use. PCPs can still prescribe a 60 mg dose for

an approved use, even though such physicians allegedly do

not typically treat the approved condition. This possibility

highlights the weakness in the amended complaint, namely,

Relator’s attempt to draw inferences from general facts, such

as that PCPs generally do not treat active cases of EE and that

Kapidex generally is prescribed in 60 mg doses, to reach the

conclusion that the 98 prescriptions identified in the amended

complaint were for off-label uses. We conclude that such

inferences are implausible and unsupported by the stated facts

and, thus, that the allegations relating to the PCPs do not state

with particularity that any false claims were submitted to the

government for payment.

Third, Relator alleges in the amended complaint that about

9,000 Kapidex prescriptions were submitted to the govern-

ment for reimbursement in two of Takeda’s sales districts dur-

ing certain one-year periods. Again, Relator does not allege

the dosages of these prescriptions, nor, as the district court

14 UNITED STATES v. TAKEDA PHARMACEUTICALS

observed, do these generalized statistics "identify the types of

doctors issuing the prescriptions, the types of illnesses for

which they issued the prescriptions at issue, or whether the

doctors were subjected to Takeda’s sample distribution prac-

tices." Thus, the references in the amended complaint to these

9,000 prescriptions do not constitute plausible allegations that

Takeda caused presentment of a false claim to the govern-

ment.

Fourth, in the amended complaint, Relator relies on allega-

tions that are based on the affidavits of two gastroenterolo-

gists and one PCP, who averred that they prescribed 60 mg

dosages of Kapidex to treat GERD in Medicare patients and

were unaware that the drug was available in a 30 mg dosage

due to Takeda’s sampling practices. However, the amended

complaint does not include any details about the particular

prescriptions these physicians wrote for Medicare patients,

such as approximate dates or patient information, nor does the

amended complaint contain allegations that the Medicare

patients ever "filled" these prescriptions or that corresponding

claims for reimbursement ever were submitted to the govern-

ment.9

As previously discussed, liability under the Act attaches

only to false claims actually submitted to the government for

reimbursement. General allegations such as those made here,

that unidentified Medicare patients received prescriptions for

off-label uses, do not identify with particularity any claims

that would trigger liability under the Act. In the absence of the

required specific allegations, a court is unable to infer that a

Medicare patient who has received a prescription for an off-

9

In a supplemental affidavit, Dr. Michael Yaffe, the PCP, averred that

he had personal knowledge that some of his Medicare patients filled the

off-label Kapidex prescriptions because the patients contacted his office to

seek prescription refills. Once again, it is improper for Relator to attempt

to buttress his faulty complaint with supplemental affidavits submitted

later in the litigation, in this case, in opposition to Takeda’s motion to dis-

miss.

UNITED STATES v. TAKEDA PHARMACEUTICALS 15

label use actually filled the prescription and sought reimburse-

ment from the government. Indeed, "[i]t may be that physi-

cians prescribed [the drug] for off-label uses only where the

patients paid for it themselves or when the patients’ private

insurers paid for it." Rost, 507 F.3d at 733. We therefore dis-

agree with Relator’s assertion that, if a patient is insured

under a government program, we reasonably may infer that

any prescription the patient received for an off-label use was

filled and that a claim was presented to the government. For

these reasons, we conclude that Relator’s allegations in the

amended complaint relating to the three physician affidavits

do not adequately state that any false claims were presented

to the government for payment.

Based on our consideration of the facts stated in the

amended complaint, we observe that Relator essentially has

alleged that some claims must have been presented to the gov-

ernment for payment, because prescriptions of this kind fre-

quently and routinely are obtained by persons who participate

in health care programs sponsored by the federal government,

or because federally insured patients received off-label pre-

scriptions. As we have explained, allegations of this type are

insufficient because they are inherently speculative in nature.

In contrast to cases such as Grubbs, 565 F.3d 180, Relator’s

claim does not involve an integrated scheme in which present-

ment of a claim for payment was a necessary result. We there-

fore hold that Relator has failed to plead with particularity a

plausible claim that any off-label prescriptions were presented

to the government for payment.

IV.

Finally, Relator challenges the district court’s denial of his

motion for leave to amend his complaint for a fourth time. We

review the district court’s denial of this motion for abuse of

discretion. Wilson, 525 F.3d at 376. Federal Rule of Civil Pro-

cedure 15(a)(2) provides that a court "should freely give

leave" to amend a complaint "when justice so requires."

16 UNITED STATES v. TAKEDA PHARMACEUTICALS

Despite this general rule liberally allowing amendments, we

have held that a district court may deny leave to amend if the

amendment "would be prejudicial to the opposing party, there

has been bad faith on the part of the moving party, or the

amendment would have been futile." Laber v. Harvey, 438

F.3d 404, 426 (4th Cir. 2006) (en banc) (quoting Johnson v.

Oroweat Foods Co., 785 F.2d 503, 509 (4th Cir. 1986)).

Relator has amended his complaint three times. A decision

granting him leave to amend yet again would have resulted in

a fifth complaint filed in this case. We also observe that two

years have elapsed between the filing of the original com-

plaint and the district court’s dismissal of the amended com-

plaint currently before us in this appeal. The granting of leave

to file another amended complaint, when Relator was on

notice of the deficiencies before filing the most recent

amended complaint,10 would undermine the substantial inter-

est of finality in litigation and unduly subject Takeda to the

continued time and expense occasioned by Relator’s pleading

failures. In view of the multiple opportunities Relator has

been afforded to correct his pleading deficiencies and the def-

erence due to the district court’s decision, we conclude that

the district court did not abuse its discretion in denying him

leave to file a fourth amended complaint.

V.

For these reasons, we hold that the district court properly

dismissed the amended complaint under Rule 12(b)(6) for

10

In May 2011, the district court dismissed Relator’s second amended

complaint for failure to state a claim, but granted leave to amend. In its

order, the district court noted the lack of specific allegations regarding

actual presentation of false claims to the government. Although the

amended complaint before us includes considerably more detail, this fun-

damental defect was not addressed adequately by the last amendment. The

district court also cautioned Relator that any evidence provided outside the

amended complaint could not be considered in an attempt to avoid dis-

missal under Rule 12(b)(6).

UNITED STATES v. TAKEDA PHARMACEUTICALS 17

failure to state a claim, and did not abuse its discretion in

denying Relator leave to file a fourth amended complaint.

AFFIRMED