United States Ex Rel. Drakeford v. Tuomey

PUBLISHED

UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

No. 13-2219

UNITED STATES ex rel. MICHAEL K. DRAKEFORD, M.D.,

Plaintiff – Appellee,

v.

TUOMEY, d/b/a Tuomey Healthcare System, Inc.,

Defendant – Appellant.

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AMERICAN HOSPITAL ASSOCIATION; SOUTH CAROLINA HOSPITAL
ASSOCIATION,

Amici Supporting Appellant.

Appeal from the United States District Court for the District of
South Carolina, at Columbia. Matthew J. Perry, Jr., Senior
District Judge; Margaret B. Seymour, Senior District Judge.
(3:05-cv-02858-MBS)

Argued: October 31, 2014 Decided: July 2, 2015

Before DUNCAN, WYNN, and DIAZ, Circuit Judges.

Affirmed by published opinion. Judge Diaz wrote the majority
opinion, in which Judge Duncan joined. Judge Wynn wrote a
separate opinion concurring in the judgment.

ARGUED: Helgi C. Walker, GIBSON, DUNN & CRUTCHER, LLP,
Washington, D.C., for Appellant. Tracy Lyle Hilmer, UNITED
STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellee.
ON BRIEF: James M. Griffin, Margaret N. Fox, A. Camden Lewis,
LEWIS, BABCOCK & GRIFFIN, LLP, Columbia, South Carolina; Daniel
M. Mulholland III, HORTY SPRINGER & MATTERN, Pittsburgh,
Pennsylvania; E. Bart Daniel, Charleston, South Carolina, for
Appellant. Stuart F. Delery, Assistant Attorney General,
Michael D. Granston, Michael S. Raab, Civil Division, UNITED
STATES DEPARTMENT OF JUSTICE, Washington, D.C.; G. Norman Acker,
III, Assistant United States Attorney, OFFICE OF THE UNITED
STATES ATTORNEY, Raleigh, North Carolina, for Appellee. Melinda
R. Hatton, Maureen D. Mudron, AMERICAN HOSPITAL ASSOCIATION,
Washington, D.C.; Jessica L. Ellsworth, Amanda K. Rice, HOGAN
LOVELLS US LLP, Washington, D.C., for Amici Curiae.

2
DIAZ, Circuit Judge:

In a qui tam action in which the government intervened, a

jury determined that Tuomey Healthcare System, Inc., did not

violate the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-33

(2012). 1 The district court, however, vacated the jury’s verdict

and granted the government a new trial after concluding that it

had erroneously excluded excerpts of a Tuomey executive’s

deposition testimony. The jury in the second trial found that

Tuomey knowingly submitted 21,730 false claims to Medicare for

reimbursement. The district court then entered final judgment

for the government and awarded damages and civil penalties

totaling $237,454,195.

Tuomey contends that the district court erred in granting

the government’s motion for a new trial. Tuomey also lodges

numerous other challenges to the judgment entered against it

following the second trial. It argues that it is entitled to

judgment as a matter of law (or, in the alternative, yet another

new trial) because it did not violate the FCA. In the

alternative, Tuomey asks for a new trial because the district

court failed to properly instruct the jury. Finally, Tuomey

1Under the qui tam provisions of the FCA, a whistleblower
(known as the relator) can file an action on behalf of the
federal government for alleged fraud committed against the
government. If the action is successful, the relator shares in
the recovery.

3
asks us to strike the damages and civil penalties award as

either improperly calculated or unconstitutional.

We conclude that the district court correctly granted the

government’s motion for a new trial, albeit for a reason

different than that relied upon by the district court. We also

reject Tuomey’s claims of error following the second trial.

Accordingly, we affirm the district court’s judgment.

I.

A.

Tuomey is a nonprofit hospital located in Sumter, South

Carolina, a small, largely rural community that is a federally-

designated medically underserved area. At the time of the

events leading up to this lawsuit, most of the physicians that

practiced at Tuomey were not directly employed by the hospital,

but instead were members of independent specialty practices.

Beginning around 2000, doctors who previously performed

outpatient surgery at Tuomey began doing so in their own offices

or at off-site surgery centers. The loss of this revenue stream

was a source of grave concern for Tuomey because it collected

substantial facility fees from patients who underwent surgery at

the hospital’s outpatient center. Tuomey estimated that it

stood to lose $8 to $12 million over a thirteen-year period from

the loss of fees associated with gastrointestinal procedures

4
alone. To stem this loss, Tuomey sought to negotiate part-time

employment contracts with a number of local physicians.

In drafting the contracts, Tuomey was well aware of the

constraints imposed by the Stark Law. While we discuss the

provisions of that law in greater detail below, in broad terms,

the statute, 42 U.S.C. § 1395nn, prohibits physicians from

making referrals to entities where “[t]he referring

physician . . . receives aggregate compensation . . . that

varies with, or takes into account, the volume or value of

referrals or other business generated by the referring physician

for the entity furnishing” the designated health services. 42

C.F.R. § 411.354(c)(2)(ii) (2014). Pursuant to the Stark Law,

“[a] hospital may not submit for payment a Medicare claim for

services rendered pursuant to a prohibited referral.” United

States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., 675

F.3d 394, 397–98 (4th Cir. 2012).

Beginning in 2003, Tuomey sought the advice of its longtime

counsel, Nexsen Pruet, on the Stark Law implications arising

from the proposed employment contracts. Nexsen Pruet in turn

engaged Cejka Consulting, a national consulting firm that

specialized in physician compensation, to provide an opinion

concerning the commercial reasonableness and fair market value

of the contracts. Tuomey also conferred with Richard Kusserow,

a former Inspector General for the United States Department of

5
Health and Human Services, and later, with Steve Pratt, an

attorney at Hall Render, a prominent healthcare law firm.

The part-time employment contracts had substantially

similar terms. Each physician was paid an annual guaranteed

base salary. That salary was adjusted from year to year based

on the amount the physician collected from all services rendered

the previous year. The bulk of the physicians’ compensation was

earned in the form of a productivity bonus, which paid the

physicians eighty percent of the amount of their collections for

that year. The physicians were also eligible for an incentive

bonus of up to seven percent of their earned productivity bonus.

In addition, Tuomey agreed to pay for the physicians’ medical

malpractice liability insurance as well as their practice

group’s share of employment taxes. The physicians were also

allowed to participate in Tuomey’s health insurance plan.

Finally, Tuomey agreed to absorb each practice group’s billing

and collections costs.

The contracts had ten-year terms, during which physicians

could maintain their private practices, but were required to

perform outpatient surgical procedures exclusively at the

hospital. Physicians could not own any interest in a facility

located in Sumter that provided ambulatory surgery services,

save for a less-than-two-percent interest in a publicly traded

company that provided such services. The physicians also agreed

6
not to perform outpatient surgical procedures within a thirty-

mile radius of the hospital for two years after the expiration

or termination of the contracts.

Tuomey ultimately entered into part-time employment

contracts with nineteen physicians. Tuomey, however, was unable

to reach an agreement with Dr. Michael Drakeford, an orthopedic

surgeon. Drakeford believed that the proposed contracts

violated the Stark Law because the physicians were being paid in

excess of their collections. He contended that the compensation

package did not reflect fair market value, and thus the

government would view it as an unlawful payment for the doctor’s

facility-fee-generating referrals.

To address Drakeford’s concerns, Tuomey suggested a joint

venture as an alternative business arrangement, whereby “doctors

would become investors . . . in . . . a management company that

would provide day-to-day management of the outpatient surgery

center,” J.A. 3268, and both Tuomey and its co-investors would

“receive payments based on that management [structure].” J.A.

2036. Drakeford, however, declined that option.

Unable to break the stalemate in their negotiations, in May

2005, Tuomey and Drakeford sought the advice of Kevin McAnaney,

an attorney in private practice with expertise in the Stark Law.

McAnaney had formerly served as the Chief of the Industry

Guidance Branch of the United States Department of Health and

7
Human Services Office of Counsel to the Inspector General. In

that position, McAnaney wrote a “substantial portion” of the

regulations implementing the Stark Law. J.A. 2026.

McAnaney advised the parties that the proposed employment

contracts raised significant “red flags” under the Stark Law. 2

J.A. 2054. In particular, Tuomey would have serious difficulty

persuading the government that the contracts did not compensate

the physicians in excess of fair market value. Such a

contention, said McAnaney, would not pass the “red face test.”

J.A. 2055. McAnaney also warned Tuomey that the contracts

presented “an easy case to prosecute” for the government. J.A.

2078.

Drakeford ultimately declined to enter into a contract with

Tuomey. He later sued the hospital under the qui tam provisions

of the FCA, alleging that because the part-time employment

contracts violated the Stark Law, Tuomey had knowingly submitted

false claims for payment to Medicare. As was its right, the

government intervened in the action and filed additional claims

2According to McAnaney, the joint venture alternative
raised separate concerns under the Anti-Kickback Statute, 42
U.S.C. § 1320a-7b(b), which bars “the payment of remuneration
for the purpose of inducing the purchase of health care covered
by any federal health care insurance program.” Michael K.
Loucks & Carol C. Lam, Prosecuting and Defending Health Care
Fraud Cases 233 (2d ed. 2010).

8
seeking equitable relief for payments made under mistake of fact

and unjust enrichment theories.

B.

At the first trial, Tuomey argued that McAnaney’s testimony

and related opinions regarding the contracts should be excluded

as an offer to compromise or settle under Federal Rule of

Evidence 408 because McAnaney was mediating a dispute between

Tuomey and Drakeford. Alternatively, Tuomey contended that

because McAnaney was hired jointly by Tuomey and Drakeford, he

owed a duty of loyalty to both clients that precluded him from

testifying. The district court sustained Tuomey’s objection,

although it did not articulate the ground for its ruling.

Tuomey also objected to the government’s attempt to admit

excerpts from the deposition testimony of Gregg Martin, Tuomey’s

Senior Vice President and Chief Operating Officer. Tuomey

argued that the deposition testimony should be excluded because

it contained Martin’s recollections of a discussion he had with

Tuomey’s counsel concerning McAnaney’s opinions regarding the

employment contracts. According to Tuomey, the testimony was

merely a “back doorway to get in Mr. McAnaney’s opinions.” J.A.

808. The government countered that the deposition testimony was

admissible to show Tuomey’s state of mind and intent to violate

the Stark Law. The district court again sustained Tuomey’s

objection.

9
 The jury returned a verdict finding that, while Tuomey had

violated the Stark Law, it had not violated the FCA. The

government filed a post-verdict motion for judgment on its

equitable claims. It also moved for judgment as a matter of law

under Federal Rule of Civil Procedure 50 on the FCA claim, or

alternatively for a new trial under Rule 59 because of the

district court’s decision to exclude McAnaney’s testimony and

opinions, as well as the Martin deposition excerpts.

The district court denied the government’s motion for

judgment as a matter of law. But the court agreed that it had

committed “a substantial error” by excluding the Martin

deposition excerpts. J.A. 1296. It therefore granted the

government’s motion for a new trial. Notably, the district

court’s decision was based solely on its error in excluding the

Martin deposition excerpts.

While the government asked for a new trial only on the

knowledge element of the FCA claim, the district court granted a

new trial as to the entirety of the claim. Notwithstanding the

court’s decision to grant a new trial on the FCA claim, the

district court entered judgment for the government on its

equitable claims based on the jury’s finding of a Stark Law

violation, and ordered Tuomey to pay damages in the amount of

$44,888,651 plus pre- and post-judgment interest.

10
 On appeal, we vacated the judgment, concluding that the

jury’s finding of a Stark Law violation was a common factual

issue necessary to the resolution of both the equitable claims

and the FCA claim. 3 Yet, because the district court rendered the

jury’s verdict finding a Stark Law violation a “legal nullity”

when it granted the government’s motion for a new trial, we held

that the court deprived Tuomey of its Seventh Amendment right to

a jury trial by entering judgment on the equitable claims.

Drakeford, 675 F.3d at 405. We remanded the case for a new

trial as to all claims.

While the case was on appeal, the presiding judge passed

away. At the second trial, the new presiding judge allowed the

government to introduce the previously excluded Martin

deposition testimony, and also allowed McAnaney to testify. The

jury found that Tuomey violated both the Stark Law and the FCA.

It further found that Tuomey had submitted 21,730 false claims

to Medicare with a total value of $39,313,065. The district

court trebled the actual damages and assessed an additional

civil penalty, both actions required by the FCA. 31 U.S.C.

§ 3729(a)(1). From the resulting judgment of $237,454,195,

Tuomey appeals.

3
Tuomey also sought leave to pursue an interlocutory appeal
of the district court’s order granting a new trial on the FCA
claim. We denied that motion.

11
 II.

A.

Tuomey’s appeal presents these issues: First, did the

district court err in granting the government’s motion for a new

trial on the FCA claim? If not, did the district court err in

(1) denying Tuomey’s motion for judgment as a matter of law (or,

in the alternative, for yet another new trial) following the

second trial; and (2) awarding damages and penalties against

Tuomey based on the jury’s finding of an FCA violation? We

address each issue in turn, but first provide a general overview

of the Stark Law.

B.

The Stark Law is intended to prevent “overutilization of

services by physicians who [stand] to profit from referring

patients to facilities or entities in which they [have] a

financial interest.” Drakeford, 675 F.3d at 397. The statute

prohibits a physician from making a referral to an entity, such

as a hospital, with which he or she has a financial

relationship, for the furnishing of designated health services.

42 U.S.C. § 1395nn(a)(1). If the physician makes such a

referral, the hospital may not submit a bill for reimbursement

to Medicare. Id. § 1395nn(a)(1)(B). Similarly, the government

may not make any payment for a designated health service

provided in violation of the Stark Law. Id. § 1395nn(g)(1). If

12
a person collects any payment for a service billed in violation

of the Stark Law, “the person shall be liable to the individual

for, and shall refund on a timely basis to the individual, any

amounts so collected.” Id. § 1395nn(g)(2). 4

Inpatient and outpatient hospital services are considered

designated health services under the law. Id. § 1395nn(h)(6).

A referral includes “the request by a physician for the item or

service.” Id. § 1395nn(h)(5)(A). A referral does not include

“any designated health service personally performed or provided

by the referring physician.” 42 C.F.R. § 411.351. However,

there is a referral when the hospital bills a “facility fee”

(also known as a “facility component” or “technical component”)

“in connection with the personally performed service.” Medicare

and Medicaid Programs; Physicians’ Referrals to Health Care

Entities With Which They Have Financial Relationships, 66 Fed.

Reg. 856, 941 (Jan. 4, 2001); see also Medicare Program;

Physicians’ Referrals to Health Care Entities With Which They

Have Financial Relationships (Phase II), 69 Fed. Reg. 16054,

16063 (Mar. 26, 2004).

4
Because the Stark Law does not create its own right of
action, the government in this case sought relief under the FCA,
which provides a right of action with respect to false claims
submitted for Medicare reimbursement. See Drakeford, 675 F.3d
at 396 & n.2.

13
 A financial relationship constitutes a prohibited “indirect

compensation arrangement,” if (1) “there exists an unbroken

chain of any number . . . of persons or entities that have

financial relationships . . . between them,” (2) “[t]he

referring physician . . . receives aggregate compensation . . .

that varies with, or takes into account, the volume or value of

referrals or other business generated by the referring physician

for the entity furnishing” the designated health services, and

(3) the entity has knowledge that the compensation so varies.

42 C.F.R. § 411.354(c)(2); see also Drakeford, 675 F.3d at 408

(“[C]ompensation arrangements that take into account anticipated

referrals . . . implicate the volume or value standard.”). The

statute, however, does not bar indirect compensation

arrangements where: (1) the referring physician is compensated

at fair market value for “services and items actually provided”;

(2) the compensation arrangement is “not determined in any

manner that takes into account the volume or value of

referrals”; (3) the compensation arrangement is “commercially

reasonable”; and (4) the compensation arrangement does not run

afoul of any other federal or state law. 42 C.F.R.

§ 411.357(p); Drakeford, 675 F.3d at 398.

Once a relator or the government has established the

elements of a Stark Law violation, it becomes the defendant’s

burden to show that the indirect compensation arrangement

14
exception shields it from liability. See United States ex rel.

Kosenske v. Carlisle HMA, Inc., 554 F.3d 88, 95 (3d Cir. 2009).

C.

We first address the district court’s decision to grant the

government a new trial on the FCA claim. The government pressed

two grounds in support of its motion. First, it argued that the

district court erred by excluding McAnaney’s testimony, along

with all evidence containing the views he expressed to the

parties on the potential Stark Law liability surrounding the

contracts. Second, the government argued that the district

court erroneously excluded the Martin deposition excerpts.

While the district court granted a new trial on the latter

ground, we instead affirm the district court on the basis of its

more glaring error, the exclusion of McAnaney’s testimony and

related evidence.

1.

We review a district court’s decision to grant a new trial

for abuse of discretion. Cline v. Wal-Mart Stores, Inc., 144

F.3d 294, 301 (4th Cir. 1998). We apply the same standard to

the district court’s decision to exclude evidence. Buckley v.

Mukasey, 538 F.3d 306, 317 (4th Cir. 2008). “By definition, a

district court abuses its discretion when it makes an error of

law.” RZS Holdings AVV v. PDVSA Petroleo S.A., 506 F.3d 350,

356 (4th Cir. 2007). Even so, we may reverse a district court

15
only if its evidentiary error affects a party’s substantial

rights. Buckley, 538 F.3d at 317. And, of course, we may

affirm a district court’s ruling on any ground apparent in the

record. Republican Party of N.C. v. Martin, 980 F.2d 943, 952

(4th Cir. 1992).

2.

We believe that the district court abused its discretion in

granting a new trial on the ground that it had improperly

excluded the Martin deposition excerpts. Even if the district

court should not have excluded this evidence in the first

instance, an evidentiary error is harmless when it does not

affect a party’s substantial rights--in this case, whether it

can be said with a high probability that the error did not

affect the judgment. Taylor v. Va. Union Univ., 193 F.3d 219,

235 (4th Cir. 1999) (en banc), abrogated on other grounds by

Desert Palace, Inc. v. Costa, 539 U.S. 90 (2003); Daskarolis v.

Firestone Tire & Rubber Co., 651 F.2d 937, 942 (4th Cir. 1981)

(noting that even if the district court believed that it had

excluded admissible evidence, the erroneous exclusion could not

be grounds for a new trial because it did not affect the

substantial rights of the parties). The district court made no

effort to assess the alleged error under this stringent harmless

error standard. Furthermore, because the exclusion of the

Martin deposition testimony was, in fact, a harmless error, the

16
district court abused its discretion in granting a new trial on

this ground.

In its motion for a new trial, the government argued that

Martin’s testimony was necessary evidence supporting the

scienter element of its FCA claim. Specifically, the government

contended that Martin, Tuomey’s agent, received and ignored

McAnaney’s warnings that the part-time employment contracts

raised significant Stark Law compliance issues. Thus, says the

government, the evidence would have demonstrated Tuomey’s

reckless disregard of the legal minefield that it was

traversing. We think, however, that the probative value of this

particular evidence is weak at best, and excluding it did not

negatively affect the government’s substantial rights.

The deposition excerpts predominantly focus on Martin’s

recollection of a discussion he had with Tuomey’s lawyer, Tim

Hewson. Hewson recounted to Martin the details of a conference

call between Hewson, McAnaney, and Drakeford’s lawyer, Greg

Smith. 5 Specifically, Hewson told Martin that McAnaney had Stark

Law compliance concerns with both the proposed part-time

5
Hewson was likely recounting the details of two separate
conference calls. The first call was between McAnaney, Smith,
and Hewson and covered the part-time employment contracts. The
following day, Steve Pratt joined those three for a second call
focusing on the joint venture arrangement. When asked if he was
aware that there were two separate conference calls, Martin
responded that he did not “remember for sure.” J.A. 105.

17
employment contracts as well as the joint venture arrangement

(which Martin referred to as the “under arrangement”). However,

Martin was unable to remember specifics about the conversation,

and often confused McAnaney’s concerns with issues raised by

Steve Pratt.

Martin did vaguely recall that Hewson had told him that

McAnaney said the proposed arrangements would raise “red flags”

with the government. J.A. 104-05. Yet, Martin could not

remember whether McAnaney’s warnings were particular to the

part-time employment contracts, the joint venture arrangement,

or both. Indeed, in Martin’s recollection it was hard to

“separate the two.” J.A. 107. To the extent that Martin could

distinguish the two proposed arrangements, he recalled being

warned of greater problems with the joint venture arrangement.

With respect to McAnaney’s concerns about the employment

contracts, Martin had a vague recollection of some issues

related to fair market value, but was unable to offer more

detail. Ultimately, Martin acknowledged that there was a

“difference of opinion” between McAnaney and Hewson, but decided

to trust Hewson’s opinion that the contracts posed no Stark Law

concerns. J.A. 111.

That Martin’s deposition testimony was hazy is not at all

surprising, given that he was being asked to recall--nearly four

years after the fact--the substance of a conversation with

18
Tuomey’s lawyer, who himself was recalling an earlier conference

call with McAnaney. Standing alone, we fail to see how the

government was substantially prejudiced by the district court’s

decision to exclude this evidence. Thus, we hold that the

district court abused its discretion in relying on this ground

to grant the government’s motion for a new trial.

3.

Nonetheless, we affirm the district court’s order granting

a new trial on the alternative ground urged by the government--

that it was prejudiced by the exclusion of McAnaney’s testimony

and other related evidence of his warnings to Tuomey regarding

the legal peril that the employment contracts posed. 6 To make

its case that Tuomey “knowingly” submitted false claims under

the FCA, the government needed to show that Tuomey knew that

there was a substantial risk that the contracts violated the

Stark Law, and was nonetheless deliberately ignorant of, or

recklessly disregarded that risk. In our view, McAnaney’s

6 Tuomey says that we may not affirm on this alternative
ground because the government’s brief never asked us to do so.
But this assertion splits the thinnest of hairs. While perhaps
the government could have been more direct in its brief, it
clearly alerted us (and Tuomey) that there was an alternate
ground for affirming the district court. See Appellee’s Br. at
82 (“[The] new trial ruling was correct not only because of the
exclusion of Martin’s testimony, but also because the exclusion
of McAnaney’s testimony and related evidence was clearly
erroneous and affected the substantial rights of the
government.”).

19
testimony was a relevant, and indeed essential, component of the

government’s evidence on that element, and Tuomey offered no

good reason why the jury should not hear it.

The district court has now presided over two trials in this

case, with strikingly disparate results. In the first trial,

the jury did not hear from McAnaney and found for Tuomey on the

FCA claim. When the case was retried, McAnaney was allowed to

testify and the jury found for the government. Coincidence? We

think not. Rather, we believe that these results bespeak the

importance of what the jury in the first trial was not allowed

to consider.

And this is so even while acknowledging that McAnaney was a

looming presence throughout the first trial. For example, the

jury heard audio of a Tuomey board meeting, where a board member

mentioned that McAnaney had voiced concerns with the part-time

employment contracts. Left unsaid, however, was the precise

nature of those concerns or the weight and seriousness that

McAnaney attached to them. The jury also knew that Hewson

(Tuomey’s counsel at Nexson Pruet) was generally aware of

McAnaney’s views on the employment contracts, but that he

dismissed them as not credible because, in his view, Drakeford

was deliberately seeking to cherry pick a legal opinion that

would undermine the entire deal.

20
 The jury was also aware that Drakeford 7 wrote to Tuomey’s

board summarizing McAnaney’s opinions. The district court,

however, excluded Drakeford’s letter, although it did allow the

jury to consider the board’s response wherein it summarily

rejected Drakeford’s unspecified objections. Finally, the jury

heard that Tuomey refused to allow McAnaney to prepare a written

opinion discussing his concerns regarding the contracts, and

subsequently terminated McAnaney’s engagement altogether on

September 2, 2005.

While certainly not insubstantial, the sum of the evidence

at the first trial regarding McAnaney was that Tuomey (1) was

aware that McAnaney had unspecified concerns about the

employment contracts; (2) refused to allow McAnaney to relay his

concerns in writing; and (3) later terminated McAnaney’s joint

representation. Yet, under the FCA, the government had to prove

that Tuomey knew of, was deliberately ignorant of, or recklessly

disregarded the falsity of its claims (i.e. that its claims

violated the Stark Law). We think that McAnaney’s specific

warnings to Tuomey regarding the dangers posed by the contracts

were critical to making this showing.

McAnaney warned Tuomey that procuring fair market

valuations, by itself, was not conclusive of the accuracy of the

7 Drakeford was not called as a witness at either trial.

21
valuation. He emphasized that it would be very hard to convince

the government that a contract that paid physicians

“substantially above even their collections, much less their

collections minus expenses,” would constitute fair market value.

J.A. 2053. According to McAnaney, compensation arrangements

under which the contracting physicians are paid in excess of

their collections were “basically a red flag to the government.”

Id. He noted that similar cases had previously been prosecuted

before, although all of them ultimately settled.

McAnaney also pointed out that the ten-year term of the

contracts, combined with the thirty-mile, two-year noncompete

provision would reinforce the government’s view that Tuomey was

“paying [the physicians] above fair market value for referrals.”

J.A. 2055. He concluded that the contracts did not pass the

“red face test,” and warned that the government would find this

“an easy case to prosecute.” J.A. 2055, 2078.

We think the importance of McAnaney’s testimony to the

government’s case is self-evident. Indeed, it is difficult to

imagine any more probative and compelling evidence regarding

Tuomey’s intent than the testimony of a lawyer hired by Tuomey,

who was an undisputed subject matter expert on the intricacies

of the Stark Law, and who warned Tuomey in graphic detail of the

22
thin legal ice on which it was treading with respect to the

employment contracts. 8

4.

Tuomey urges, however, that McAnaney’s testimony and other

evidence containing his views were properly excluded under

Federal Rule of Evidence 408. That rule, however, mandates the

exclusion of evidence relating to offers to compromise or settle

disputed claims if the evidence is being offered to prove

liability on the claim. Bituminous Constr., Inc. v. Rucker

Enters., Inc., 816 F.2d 965, 968 (4th Cir. 1987). We are not

persuaded that McAnaney was retained to help Drakeford and

Tuomey compromise or settle a disputed claim. Rather, the

record unambiguously shows that Drakeford and Tuomey hired

McAnaney to advise them of the Stark Law risks posed by the

employment contracts. As a result, Rule 408 does not support

the district court’s decision to exclude McAnaney’s testimony. 9

8 We note that Tuomey waived the attorney-client privilege
with respect to its communications with McAnaney when it
asserted the advice-of-counsel defense. See Rhone-Poulenc Rorer
Inc. v. Home Indem. Co., 32 F.3d 851, 863 (3d Cir. 1994) (“A
defendant may . . . waive [attorney-client] privilege by
asserting reliance on the advice of counsel as an affirmative
defense.”).
9 In any event, as our concurring colleague ably explains,
even assuming that McAnaney’s testimony would ordinarily be
excludable under Rule 408, Tuomey nonetheless opened the door to
its admission by raising the advice-of-counsel defense.

23
See ICAP, Inc. v. Global Digital Satellite Sys., Inc., 225 F.3d

654, 2000 WL 1049854, at *3 (4th Cir. 2000) (unpublished table

opinion) (finding Rule 408 inapplicable where the parties’

communications involved contract negotiations rather than

settlement negotiations).

Nor do we find merit in Tuomey’s objection based on

McAnaney’s supposed duty of loyalty to his clients. At trial,

Tuomey never suggested which evidentiary rule supported

exclusion on this ground, although it now characterizes this

argument as a claim for exclusion under Rule 403. That rule of

course allows a district court to exclude relevant evidence, but

only “if its probative value is substantially outweighed by a

danger of one or more of the following: unfair prejudice,

confusing the issues, misleading the jury, undue delay, wasting

time, or needlessly presenting cumulative evidence.” Fed. R.

Evid. 403. Left unsaid by Tuomey is precisely how the probative

value of McAnaney’s compelling testimony was substantially

outweighed by the countervailing factors set out in Rule 403.

In sum, Tuomey has offered no good reason why the jury in

the first trial was not allowed to hear from McAnaney. And we

agree with the government that this evidence was critical to its

ability to satisfy its burden to prove that Tuomey acted with

the requisite intent under the FCA. We therefore affirm the

district court’s order granting a new trial on the FCA claim.

24
 III.

We turn now to Tuomey’s challenges to the judgment entered

following the second trial. Tuomey asks for judgment as a

matter of law because a reasonable jury could not have found

that (1) the part-time employment contracts violated the Stark

Law, or (2) Tuomey knowingly submitted false claims.

Alternatively, Tuomey asks for a new trial because of the

district court’s refusal to tender certain jury instructions.

A.

We review the district court’s denial of Tuomey’s motion

for judgment as a matter of law de novo. Austin v. Paramount

Parks, Inc., 195 F.3d 715, 727 (4th Cir. 1999). We “view all

the evidence in the light most favorable to the prevailing party

and draw all reasonable inferences in [its] favor.” Konkel v.

Bob Evans Farms Inc., 165 F.3d 275, 279 (4th Cir. 1999). We

will reverse the district court if a reasonable jury could rule

only in favor of the moving party. Dennis v. Columbia Colleton

Med. Ctr., Inc., 290 F.3d 639, 645 (4th Cir. 2002) (“[I]f

reasonable minds could differ, we must affirm.”).

1.

Tuomey argues that it is entitled to judgment as a matter

of law because the contracts between it and the physicians did

not run afoul of the Stark Law. As we explain, however, a

reasonable jury could find that Tuomey violated the Stark Law

25
when it paid aggregate compensation to physicians that varied

with or took into account the volume or value of actual or

anticipated referrals to Tuomey.

To begin with, we note that the Stark Law’s “volume or

value” standard can be implicated when aggregate compensation

varies with the volume or value of referrals, or otherwise takes

into account the volume or value of referrals. 42 C.F.R.

§ 411.354(c)(2)(ii). That is precisely what the district court

directed the jury in the second trial to assess. Tuomey

insists, however, that our earlier opinion in this case

foreclosed the jury’s consideration of whether the contracts

varied with the volume or value of referrals. Instead, says

Tuomey, the only question that should have been put to the jury

was “whether the contracts, on their face, took into account the

value or volume of anticipated referrals.” Drakeford, 675 F.3d

at 409.

We disagree. The district court properly understood that

the jury was entitled to pass on the contracts as they were

actually implemented by the parties. We said as much in our

earlier opinion, where

we emphasize[d] that our holding . . . [was] limited
to the issues we specifically address[ed]. On remand,
a jury must determine, in light of our holding,
whether the aggregate compensation received by the
physicians under the contracts varied with, or took
into account, the volume or value of the facility
component referrals.

26
Id. at 409 n.26 (emphasis added).

A reasonable jury could have found that Tuomey’s contracts

in fact compensated the physicians in a manner that varied with

the volume or value of referrals. There are two different

components of the physicians’ compensation that we believe so

varied. First, each year, the physicians were paid a base

salary that was adjusted upward or downward depending on their

collections from the prior year. In addition, the physicians

received the bulk of their compensation in the form of a

productivity bonus, pegged at eighty percent of the amount of

their collections.

As Tuomey concedes, “the aggregate compensation received by

the physicians under the Contracts was based solely on

collections for personally performed professional services.”

Appellant’s Br. at 42. And as we noted in our earlier opinion,

there are referrals here, “consisting of the facility component

of the physicians’ personally performed services, and the

resulting facility fee billed by Tuomey based upon that

component.” Drakeford, 675 F.3d at 407. In sum, the more

procedures the physicians performed at the hospital, the more

facility fees Tuomey collected, and the more compensation the

physicians received in the form of increased base salaries and

productivity bonuses.

27
 The nature of this arrangement was confirmed by Tuomey’s

former Chief Financial Officer, William Paul Johnson, who

admitted “that every time one of the 19 physicians . . . did a

legitimate procedure on a Medicare patient at the hospital

pursuant to the part-time agreement[,] the doctor [got] more

money,” and “the hospital also got more money.” J.A. 2012. We

thus think it plain that a reasonable jury could find that the

physicians’ compensation varied with the volume or value of

actual referrals. The district court did not err in denying

Tuomey’s motion for judgment as a matter of law on this ground. 10

10 We are not persuaded by Tuomey’s reliance on commentary
promulgated by the Centers for Medicare & Medicaid Services as
it developed implementing regulations for the Stark Law. Tuomey
points to a portion of the commentary wherein the agency states
that the “fact that corresponding hospital services are billed
would not invalidate an employed physician’s personally
performed work, for which the physician may be paid a
productivity bonus (subject to the fair market value
requirement).” 69 Fed. Reg. at 16089. But this statement deals
only with a productivity bonus based on the fair market value of
the work personally performed by a physician--it says nothing
about the propriety of varying a physician’s base salary based
on the volume or value of referrals.

In any case, the commentary regarding productivity bonuses
appears under a section of the regulations that specifically
addresses comments related to the exception for bona fide
employment relationships. This exception covers circumstances
where there is a meaningful administrative relationship between
the physician and the hospital. The jury was instructed on this
exception at trial, and rejected it. Tuomey does not quarrel
with that aspect of the jury’s verdict; rather it contends that
the commentary applies irrespective of whether a bona fide
employment relationship actually exists. Nothing in the statute
or the regulations, however, supports this notion.

28
 2.

Tuomey next argues that the district court erred in not

granting its motion for judgment as a matter of law because it

did not knowingly violate the FCA. Specifically, Tuomey claims

that because it reasonably relied on the advice of counsel, no

reasonable jury could find that Tuomey possessed the requisite

intent to violate the FCA. Because the record here is replete

with evidence indicating that Tuomey shopped for legal opinions

approving of the employment contracts, while ignoring negative

assessments, we disagree.

The FCA imposes civil liability on any person who

“knowingly presents, or causes to be presented, a false or

fraudulent claim for payment or approval” to an officer or

employee of the United States Government. 31 U.S.C.

§ 3729(a)(1)(A), (b)(2)(A)(i). Under the Act, the term

“knowingly” means that a person, with respect to information

contained in a claim, (1) “has actual knowledge of the

information;” (2) “acts in deliberate ignorance of the truth or

falsity of the information;” or (3) “acts in reckless disregard

of the truth or falsity of the information.” Id. § 3729(b)(1).

The purpose of the FCA’s scienter requirement is to avoid

punishing “honest mistakes or incorrect claims submitted through

mere negligence.” United States ex rel. Owens v. First Kuwaiti

29
Gen. Trading & Contracting Co., 612 F.3d 724, 728 (4th Cir.

2010) (internal quotation marks omitted).

The record evidence provides ample support for the jury’s

verdict as to Tuomey’s intent. Indeed, McAnaney’s testimony,

summarized above, is alone sufficient to sweep aside Tuomey’s

claim of error. 11 We agree with the district court’s conclusion

that “a reasonable jury could have found that Tuomey possessed

the requisite scienter once it determined to disregard

McAnaney’s remarks.” J.A. 4055-56. A reasonable jury could

indeed be troubled by Tuomey’s seeming inaction in the face of

McAnaney’s warnings, particularly given Tuomey’s aggressive

efforts to avoid hearing precisely what McAnaney had to say

regarding the contracts.

Nonetheless, a defendant may avoid liability under the FCA

if it can show that it acted in good faith on the advice of

counsel. Cf. United States v. Painter, 314 F.2d 939, 943 (4th

Cir. 1963) (holding, in a case involving fraud, that “[i]f in

good faith reliance upon legal advice given him by a lawyer to

whom he has made full disclosure of the facts, one engages in a

11
We note also that the jury at the second trial considered
the deposition testimony of Tuomey executive Gregg Martin.
While this evidence is (for reasons we have explained) not
overly compelling in isolation, it is not without some value in
showing that Tuomey was aware that its proposed contracts raised
Stark Law concerns.

30
course of conduct later found to be illegal, the trier of fact

may in appropriate circumstances conclude the conduct was

innocent because ‘the guilty mind’ was absent”). However,

“consultation with a lawyer confers no automatic immunity from

the legal consequences of conscious fraud.” Id. at 943.

Rather, to establish the advice-of-counsel defense, the

defendant must show the “(a) full disclosure of all pertinent

facts to [counsel], and (b) good faith reliance on [counsel’s]

advice.” United States v. Butler, 211 F.3d 826, 833 (4th Cir.

2000) (internal quotation marks omitted).

Tuomey contends that it provided full and accurate

information regarding the proposed employment contracts to

Hewson, who in turn advised Tuomey that the contracts did not

run afoul of the Stark Law. But as the government aptly notes,

“[i]n determining whether Tuomey reasonably relied on the advice

of its counsel, the jury was entitled to consider all the advice

given to it by any source.” Appellee’s Br. at 53.

In denying Tuomey’s post-trial motions, the district court

noted--and we agree--that a reasonable jury could have concluded

that Tuomey was, after September 2005, no longer acting in good

faith reliance on the advice of its counsel when it refused to

give full consideration to McAnaney’s negative assessment of the

part-time employment contracts and terminated his

31
representation. 12 Tuomey defends its dismissal of McAnaney’s

warnings by claiming that his opinion was tainted by undue

influence exerted by Drakeford and his counsel. But there was

evidence before the jury suggesting that Tuomey also tried to

procure a favorable opinion from McAnaney. Indeed, Tuomey’s

counsel admitted that he was trying “to steer McAnaney towards

[Tuomey’s] desired outcome” and that Tuomey needed to “continue

playing along and influence the outcome of the game as best we

can.” J.A. 4482. Thus, a reasonable jury could conclude that

Tuomey ignored McAnaney because it simply did not like what he

had to say.

Tuomey points to the fact that it retained Steve Pratt, a

prominent healthcare lawyer, and Richard Kusserow, former

Inspector General at the United States Department of Health and

Human Services, as further evidence that it acted in good faith

and did not ignore McAnaney’s warnings. Pratt rendered two

12
The government contended that Tuomey submitted 25,973
total claims for payment to Medicare between fiscal years 2005
and 2009. The government’s evidence on this point consisted of
a summary chart detailing the number of claims filed by Tuomey
in each fiscal year. It appears, however, that the jury
subtracted the 4,243 claims that Tuomey submitted in fiscal year
2005 (running from October 1, 2004 to September 30, 2005) from
the government’s number. From this, the district court surmised
that the jury resolved to hold Tuomey responsible for those
claims filed beginning in fiscal year 2006 (that is, on or after
October 1, 2005) given that they were filed after Tuomey
terminated McAnaney’s joint representation on September 2, 2005.
We think this is an entirely reasonable view of the evidence.

32
opinions that generally approved of the employment contracts.

But he did so without being told of McAnaney’s unfavorable

assessment, even though Tuomey had that information available to

it at the time. In addition, Pratt reviewed and relied on the

view of Tuomey’s fair-market-value consultant that the

employment contracts would compensate the physicians at fair

market value, but he did not consider how the consultant arrived

at its opinion. Nor did he know how much the doctors earned

prior to entering into the contracts, or that the hospital stood

to lose $1.5-2 million a year, not taking into account facility

fees, by compensating the physicians above their collections.

We thus think it entirely reasonable for a jury to look

skeptically on Pratt’s favorable advice regarding the contracts.

The same can be said of the Kusserow’s advice. Kusserow--

who was called by the government to rebut Tuomey’s advice-of-

counsel defense--advised Tuomey regarding the employment

contracts about eighteen months before the parties retained

McAnaney. As was the case with Pratt, he received no

information regarding the fair market value of the employment

contracts, information that Kusserow considered vital “to be

able to do a full Stark analysis of [the proposed contracts].”

J.A. 1676. And although Kusserow did say in a letter to

Tuomey’s counsel that he did not believe the contracts presented

“significant Stark issues,” J.A. 1675, he hedged considerably on

33
that view because of “potentially troubling issues related to

the productivity and [incentive bonus provisions in the

contracts] that have not been fully addressed.” J.A. 1677.

As the district court observed, “the jury evidently

rejected Tuomey’s advice of counsel defense” as of the date that

Tuomey received McAnaney’s warnings, “grounded on the fact that

the jury excluded damages from [before the termination of

McAnaney’s engagement] in making its determination” of the civil

penalty and damages. J.A. 4055. Thus, while Kusserow’s advice

was certainly relevant to Tuomey’s advice-of-counsel defense, a

reasonable jury could have determined that McAnaney’s warnings

(and Tuomey’s subsequent inaction) were far more probative on

the issue.

In sum, viewing the evidence in the light most favorable to

the government, we have no cause to upset the jury’s reasoned

verdict that Tuomey violated the FCA.

B.

Next, Tuomey raises several challenges to the district

court’s jury instructions. We review a district court’s

“decision to give (or not give) a jury instruction and the

content of an instruction . . . for abuse of discretion.”

United States v. Russell, 971 F.2d 1098, 1107 (4th Cir. 1992).

Our task is to determine “whether the instructions[,] construed

as a whole, and in light of the whole record, adequately

34
informed the jury of the controlling legal principles without

misleading or confusing the jury to the prejudice of the

objecting party.” Spell v. McDaniel, 824 F.2d 1380, 1395 (4th

Cir. 1987). We will reverse the district court’s decision not

to give a party’s proposed instruction “only when the requested

instruction (1) was correct; (2) was not substantially covered

by the court’s charge to the jury; and (3) dealt with some point

in the trial so important, that failure to give the requested

instruction seriously impaired that party’s ability to make its

case.” Noel v. Artson, 641 F.3d 580, 586 (4th Cir. 2011)

(internal quotation marks omitted). 13

1.

First, Tuomey urges us to grant it a new trial because the

district court failed to give jury instructions consistent with

our analysis in the first appeal. Specifically, Tuomey claims

that the district court ignored our admonition that “the

question, which should properly be put to a jury, is whether the

contracts, on their face, took into account the value or volume

of anticipated referrals.” Drakeford, 675 F.3d at 409.

According to Tuomey, the district court’s failure to so instruct

the jury erroneously permitted the jury to consider extrinsic

13
Because two of Tuomey’s challenges to the instructions
address the proper calculation of damages, we address them
separately infra at Sections IV.A.1, and IV.B.

35
evidence of intent in determining whether the physicians’

compensation took into account the volume or value of referrals.

As the district court correctly determined, however, we did

not mean to limit the government’s ability to present evidence

as to Tuomey’s intent to violate the FCA. Rather, we sought to

emphasize that the government could not rely on such evidence

alone to show a violation. See id. at 409 n.25 (“We agree with

[United States ex rel. Villafane v. Solinger, 543 F. Supp. 2d

678, 693 (W.D. Ky. 2008)] that intent alone does not create a

violation. However, that does not aid Tuomey if the jury

determines that the contracts took into account the volume or

value of anticipated referrals.”). Thus, the district court did

not err in declining to give this instruction.

2.

Tuomey next argues that the district court erred in not

separately instructing the jury on the knowledge element in the

Stark Law regulations’ definition of an indirect compensation

arrangement. As Tuomey correctly notes, the Stark Law requires

that “[t]he entity furnishing [designated health services must]

ha[ve] actual knowledge of, or act[] in reckless disregard or

deliberate ignorance of, the fact that the referring

physician . . . receives aggregate compensation that varies

with, or takes into account, the volume or value of referrals.”

42 C.F.R. § 411.354(c)(2)(iii).

36
 Here, however, the district court instructed the jury that

Tuomey would have acted knowingly under the FCA if it “realized

what it was doing and was aware of the nature of its conduct and

did not act through ignorance, mistake or accident.” J.A. 3942–

43. Given that a jury found Tuomey possessed the requisite

scienter under the FCA, it necessarily also found Tuomey knew

that its contracts varied with or took into account referrals.

Therefore, the district court’s error (if any) in not separately

instructing the jury as to the knowledge component of the Stark

Law was harmless.

3.

Third, Tuomey argues that the district court erred by

refusing to charge the jury that claims based upon differences

of interpretation of disputed legal questions are not false

under the FCA. For this proposition, it cites to our decision

in United States ex rel. Wilson v. Kellogg Brown & Root, Inc.,

525 F.3d 370, 377 (4th Cir. 2008), in which we said as much.

However, we also held there that for a claim to be “false” under

the FCA, “the statement or conduct alleged must represent an

objective falsehood.” Id. at 376.

When submitting its claims to the government, Tuomey was

required to certify its compliance with the Stark Law. See

United States ex rel. Thompson v. Columbia/HCA Healthcare Corp.,

125 F.3d 899, 902 (5th Cir. 1997) (“[W]here the government has

37
conditioned payment of a claim upon a claimant’s certification

of compliance with . . . a statute or regulation, a claimant

submits a false or fraudulent claim when he or she falsely

certifies compliance with that statute or regulation.”); United

States ex rel. Pogue v. Diabetes Treatment Ctrs. of Am., 565 F.

Supp. 2d 153, 158–59 (D.D.C. 2008). Here, Tuomey either

complied with the Stark Law or it didn’t. This is an objective

inquiry. And the jury found that Tuomey, in fact, violated the

Stark Law. As a result, Tuomey’s certification that it complied

with the Stark Law was false. The subjective inquiry--whether

Tuomey knew that its claims were in violation of the Stark Law--

is covered under the knowledge element. 14 Therefore, the

district court did not err in refusing to give this instruction.

4.

For their last jury instruction challenge, Tuomey contends

that the district court erred by failing to instruct the jury

that Tuomey was entitled to rely on legal advice even if it

turned out to be wrong. However, the district court instructed

14In Wilson, there was no either/or proposition of the kind
present here. Rather, in that case, the relators contended that
the disputed statement was false because the defendant “agreed
to [certain conditions] in the contract even though it knew it
would not, and later did not, abide by those terms.” Wilson,
525 F.3d at 377. As we explained, the relators’ assertion did
not rest on an objective falsehood, “but rather on Relators’
subjective interpretation of [the defendant’s] contractual
duties.” Id.

38
the jury that knowledge does not include actions taken “through

ignorance, mistake or accident.” J.A. 3943. It later

emphasized that the jury could not conclude that Tuomey had

knowledge “from proof of mistake, negligence, carelessness or a

belief in an inaccurate proposition.” Id. (emphasis added).

Because the import of Tuomey’s proposed charge was covered by

the district court’s instructions, we reject Tuomey’s claim of

error.

IV.

Finally, Tuomey makes several challenges to the

$237,454,195 judgment entered against it. First, it argues that

the district court improperly calculated the civil penalty.

Next, it claims that the district court used the incorrect

measure of actual damages. Finally, it brings constitutional

challenges to the award under the Fifth and Eighth Amendments.

A defendant found liable under the FCA must pay the

government “a civil penalty of” not less than $5,500 and not

more than $11,000 “plus 3 times the amount of damages which the

Government sustains because of that person.” 31 U.S.C.

§ 3729(a)(1); 28 C.F.R. § 85.3(a)(9). 15 In this case, the jury

15
The FCA sets the civil penalty range at $5,000 to
$10,000, but includes a provision that adjusts the range for
inflation.

39
found that Tuomey had submitted 21,730 false claims, for which

it awarded actual damages of $39,313,065, which the district

court trebled. The district court then added a civil penalty of

$119,515,000 to that sum, which it calculated by multiplying the

number of false claims by the $5,500 statutory minimum penalty.

Ordinary, we review a court’s calculation of damages for

clear error. Universal Furniture Int’l, Inc. v. Collezione

Europa USA, Inc., 618 F.3d 417, 427 (4th Cir. 2010). However,

to the extent the claim is that the calculations are influenced

by legal error, our review is de novo. Id. Likewise, the

constitutionality of a damages award is a legal question that we

review de novo. See Cooper Indus., Inc. v. Leatherman Tool

Grp., Inc., 532 U.S. 424, 436 (2001).

A.

1.

According to Tuomey, the civil penalty assessed was

improperly inflated because the jury was permitted to take into

account both inpatient and outpatient procedures performed by

the contracting physicians. Instead, relying on our earlier

opinion in this case, Tuomey claims that the only relevant

claims “were those Tuomey ‘presented, or caused to be presented,

to Medicare and Medicaid for payment of facility fees generated

as a result of outpatient procedures performed pursuant to the

40
contracts.’” Appellant’s Br. at 54 (alterations omitted)

(quoting Drakeford, 675 F.3d at 399). Tuomey is incorrect.

It is true that the contracts solely addressed compensation

for outpatient procedures. That is, the physicians’ collections

(which form the basis for both their base salaries and their

productivity bonuses) do not account for the volume or value of

inpatient procedures performed. Tuomey, however, takes out of

context language from our earlier opinion recognizing this fact

to suggest that we commanded that the relevant claims be limited

to those seeking payment for outpatient procedures. We said

nothing of the sort.

If a physician has a financial relationship with a

hospital, then the Stark Law prohibits the physician from making

any referral to that hospital for the furnishing of designated

health services. E.g., United States ex rel. Bartlett v.

Ashcroft, 39 F. Supp. 3d 656, 669 (W.D. Pa. 2014) (“Because a

‘compensation arrangement’ existed between Physician Defendants

and [the] Hospital, the Stark [Law] prohibited Physician

Defendants from making any patient referrals to [the] Hospital

for designated health services.” (emphasis added)). Inpatient

hospital services are designated health services. 42 U.S.C. §

1395nn(h)(6). And a referral includes “the request or

establishment of a plan of care by a physician which includes

the provision of the designated health service.” Id.

41
§ 1395nn(h)(5). Plainly, then, inpatient services constitute a

prohibited referral for the furnishing of designated health

services, and the district court properly instructed the jury to

factor them into the damages calculation.

2.

Tuomey also asserts that the jury’s damage award is flawed

because the government failed to present sufficient evidence of

referrals. Specifically, Tuomey contends that the government

did not identify the “referring physician,” and thus failed to

prove that the alleged false claims came about through a

prohibited referral.

The government’s proof on this point came in the form of

summary evidence and testimony detailing the claims submitted by

Tuomey. We agree with the district court that the government’s

evidence was sufficient to support the jury’s verdict. We note

also, as did the district court, that “Tuomey was entitled to

offer its own expert and its own alternate damages calculations,

but elected not to do so.” J.A. 4061.

In any case, Tuomey offers no authority to support its

argument that the claims must explicitly identify the referring

provider. Conversely, several courts have accepted that the

“‘attending/operating’ physician identified in Form UB-92

42
qualifies as a referring physician.” 16 United States v. Rogan,

459 F. Supp. 2d 692, 713 (N.D. Ill. 2006); see also United

States v. Halifax Hosp. Med. Ctr., No. 6:09-cv-1002-Orl-31TBS,

2013 WL 6017329, at *10-11 (M.D. Fla. Nov. 13, 2013) (finding

that the fact that one of the physicians with whom the hospital

has a financial relationship is identified as an “operating” or

“attending” physician is sufficient evidence that the physician

was also the “referring physician” absent evidence to the

contrary). Given the lack of support for Tuomey’s position, we

conclude that the jury had sufficient evidence to identify the

prohibited referrals.

3.

Tuomey next argues that the district court erroneously

assessed the penalty based on the 21,730 UB-92/04 forms Tuomey

submitted to Medicare for reimbursement. Instead, Tuomey

asserts that the number of false claims should be limited to

four Medicare cost reports that it submitted. 17

16Form UB-92 (later replaced by Form UB-04) is used by
hospitals to submit a claim for reimbursement to Medicare.
17Cost reports (CMS-2552) “are the final claim that a
provider submits to the fiscal intermediary for items and
services rendered to Medicare beneficiaries. . . . Medicare
relies upon the hospital cost report to determine whether the
provider is entitled to more reimbursement than already received
through interim payments, or whether the provider has been
overpaid and must reimburse Medicare.” J.A. 68-69 (citing 42
C.F.R. §§ 405.1803, 413.60, 413.64(f)(1)).

43
 Tuomey provides no Stark Law case to support its argument.

Rather, it cites to FCA cases where the UB-92/04 forms

themselves were not fraudulent, but were submitted as part of an

ongoing fraudulent scheme. In those cases, the fraud was

consummated only when the cost report was submitted. See United

States ex rel. Hockett v. Columbia/HCA Healthcare Corp., 498 F.

Supp. 2d 25, 70-71 (D.D.C. 2007); Visiting Nurse Ass’n of

Brooklyn v. Thompson, 378 F. Supp. 2d 75, 99 (E.D.N.Y. 2004).

But even those cases suggest that a UB-92/04 form can

constitute a discrete fraudulent claim under the FCA when the

government proves that the forms were, in fact, false or

fraudulent. See Hockett, 498 F. Supp. 2d at 70-71; Visiting

Nurse Ass’n, 378 F. Supp. 2d at 99. This occurs when “the

provider knowingly asks the Government to pay amounts it does

not owe.” United States ex rel. Clausen v. Lab. Corp. of Am.,

Inc., 290 F.3d 1301, 1311 (11th Cir. 2002).

Here, each time Tuomey submitted to Medicare a UB-92/04

form asking for reimbursement for a prohibited referral, it was

knowingly asking the government to pay an amount that, by law,

it could not pay. Consequently, we find the district court did

not err in finding that each UB-92/04 form constituted a

separate claim.

44
 B.

Tuomey also challenges the district court’s measure of

actual damages. It argues that the true measure is not the sum

total of all claims the government paid (as the court instructed

the jury), but rather the difference (if any) between the true

value of the services provided by Tuomey and what the government

actually paid. According to Tuomey, since “there was no

evidence that the Government did not get what it paid

for[,] . . . there were no actual damages under the FCA.”

Appellant’s Br. at 87. Here again, Tuomey’s view of the law is

incorrect.

The Stark Law prohibits the government from paying any

amount of money for claims submitted in violation of the law.

42 U.S.C. § 1395nn(g)(1). Compliance with the Stark Law is a

condition precedent to reimbursement of claims submitted to

Medicare. When Tuomey failed to satisfy that condition, the

government owed it nothing. United States v. Rogan, 517 F.3d

449, 453 (7th Cir. 2008).

The Stark Law expresses Congress’s judgment that all

services provided in violation of that law are medically

unnecessary. By reimbursing Tuomey for services that it was

legally prohibited from paying, the government has suffered

injury equivalent to the full amount of the payments. Cf.

United States v. Mackby (Mackby II), 339 F.3d 1013, 1018-19 (9th

45
Cir. 2003) (finding that the fact that the defendant actually

rendered the service billed did not negate the government’s

injury, as “[d]amages under the FCA flow from the false

statement”). In this case, the damage from the false statement

came from the payment to an entity that was not entitled to any

payment at all. Accordingly, we reject Tuomey’s claim of

error. 18

C.

Finally, Tuomey argues that the district court’s award of

$237,454,195, consisting of damages and a civil penalty, is

unconstitutional under the Excessive Fines Clause of the Eighth

Amendment and the Due Process Clause of the Fifth Amendment.

While the award is substantial, we cannot say that it is

unconstitutional.

“The Excessive Fines Clause of the Eighth Amendment

prohibits the government from imposing excessive fines as

punishment.” Korangy v. FDA, 498 F.3d 272, 277 (4th Cir. 2007).

“Civil fines serving remedial purposes do not fall within the

reach of the Eighth Amendment.” Id. But where “a civil

sanction ‘can only be explained as serving in part to punish,"

18For the same reason, we also reject Tuomey’s contention
that the district court erred in failing to instruct the jury
that the government had to prove that the services received were
worth less than what the government paid.

46
then the fine is subject to the Eighth Amendment.” Id. (quoting

Austin v. United States, 509 U.S. 602, 610 (1993)). In such a

case, the fine “will be found constitutionally excessive only if

it is ‘grossly disproportional to the gravity of [the]

offense.’” Id. (alteration in original) (quoting United States

v. Bajakajian, 524 U.S. 321, 334, (1998)). We have said,

however, that instances in which the penalty prescribed under

the FCA is unconstitutionally excessive will be “infrequent.”

United States ex rel. Bunk v. Gosselin World Wide Moving, N.V.,

741 F.3d 390, 408 (4th Cir. 2013).

By contrast, the Due Process Clause “imposes substantive

limits beyond which penalties may not go.” TXO Prod. Corp. v.

Alliance Res. Corp., 509 U.S. 443, 453-54 (1993) (internal

quotation marks omitted) (Fourteenth Amendment case); Morgan v.

Woessner, 997 F.2d 1244, 1255 (9th Cir. 1993) (finding that the

Supreme Court’s analysis under the Due Process Clause of the

Fourteenth Amendment applies equally under the Fifth Amendment),

cited with approval in EEOC v. Fed. Express Corp., 513 F.3d 360,

376 (4th Cir. 2008). Like the Eighth Amendment, the Due Process

Clause does not apply to compensatory damage awards. This is

because compensatory damages “redress the concrete loss the

plaintiff has suffered by reason of the defendant’s wrongful

conduct,” and the assessment of the plaintiff’s injury is

“essentially a factual determination.” Cooper Indus., 532 U.S.

47
at 432. On the other hand, punitive damages are “essentially

‘private fines’ intended to punish the defendant and to deter

future wrongdoing.” Id. Consequently, there must be

“procedural and substantive constitutional limitations on these

awards.” See State Farm Mut. Auto Ins. Co. v. Campbell, 538

U.S. 408, 416 (2003). Thus, the Due Process Clause imposes

limits on “grossly excessive” monetary penalties that go beyond

what is necessary to vindicate the government’s “legitimate

interests in punishment and deterrence.” BMW of N. Am., Inc. v.

Gore, 517 U.S. 559, 562 (1996).

The “FCA imposes damages that are essentially punitive in

nature.” Vt. Agency of Natural Res. v. United States ex rel.

Stevens, 529 U.S. 765, 784 (2000). But the Supreme Court has

also noted that the treble damages provision of the statute has

a compensatory aspect, in that they account for the fact that

some amount of money beyond actual damages is “necessary to

compensate the Government completely for the costs, delays, and

inconveniences occasioned by fraudulent claims.” Cook Cnty.,

Ill. v. United States ex rel. Chandler, 538 U.S. 119, 130

(2003). Additionally, the provision allows the government to

recover some measure of the amount it must pay to compensate

relators in qui tam actions. Id.; see also 31 U.S.C. § 3730(d)

(“If the Government proceeds with an action brought by [a

relator, the relator] shall . . . receive at least 15 percent

48
but not more than 25 percent of the proceeds of the action or

settlement of the claim . . . .”). On the other hand, the civil

penalty is completely punitive. United States v. Mackby (Mackby

I), 261 F.3d 821, 830 (9th Cir. 2001).

The Supreme Court has instructed courts to consider three

guideposts when reviewing punitive damages awards under the Due

Process Clause: “(1) the degree of reprehensibility of the

defendant’s misconduct; (2) the disparity between the actual or

potential harm suffered by the plaintiff and the punitive

damages award; and (3) the difference between the punitive

damages awarded by the jury and the civil penalties authorized

or imposed in comparable cases.” 19 State Farm, 538 U.S. at 418.

There is no reason to believe that the Court’s “approach to

punitive damages under the Fifth Amendment would differ

dramatically from analysis under the Excessive Fines Clause.”

Rogan, 517 F.3d at 454.

The degree of reprehensibility of the defendant’s conduct

is “[p]erhaps the most important indicium of the reasonableness

of a punitive damages award.” Gore, 517 U.S. at 575. Of

19
Because the FCA’s civil penalty and treble damages
provisions are Congressional mandates, we believe this final
factor is not instructive here. Indeed, to the extent that the
district court exercised any discretion at all, it did so by
imposing the statutory minimum civil penalty for each fraudulent
claim.

49
course, in this case the damages and penalties assessed against

Tuomey are congressionally prescribed. 31 U.S.C. § 3729(a)(1).

As we have previously stated, the Stark Law expresses Congress’s

judgment of the reprehensibility of the conduct at issue by

deeming services provided in violation of the law worthless.

And “[t]he fact . . . that Congress provided for treble damages

and an automatic civil monetary penalty per false claim shows

that Congress believed that making a false claim to the

government is a serious offense.” Mackby II, 339 F.3d at 1018;

cf. Rogan, 517 F.3d 454 (“[O]ne would think that a fine

expressly authorized by statute could be higher than a penalty

selected ad hoc by a jury.”).

In addition, the Supreme Court has directed courts to

evaluate the degree of reprehensibility of the defendant’s

conduct by considering whether:

the harm caused was physical as opposed to economic;
the tortious conduct evinced an indifference or a
reckless disregard of the health or safety of others;
the target of the conduct had financial vulnerability;
the conduct involved repeated actions or was an
isolated incident; and the harm was the result of
intentional malice, trickery, or deceit, or mere
accident.

State Farm, 538 U.S. at 419. While Tuomey’s conduct in this

case does not implicate the first three factors, we think the

last two are relevant here. See Saunders v. Branch Banking &

Trust Co. of Va., 526 F.3d 142, 153 (4th Cir. 2008) (finding

50
that even the presence of a single State Farm factor “can

provide justification for a substantial award of punitive

damages”).

Clearly, Tuomey’s conduct “involved repeated actions,”

State Farm, 538 U.S. at 419, as it submitted 21,730 false

claims. Thus, while the penalty is certainly severe, it is

meant to reflect the sheer breadth of the fraud Tuomey

perpetrated upon the federal government. Bunk, 741 F.3d at 407-

08 (explaining that the court was comfortable assessing high

civil penalties in FCA actions involving a large number of

claims). As we have said, “[w]hen an enormous public

undertaking spawns a fraud of comparable breadth [high

penalties] help[] to ensure what we reiterate is the primary

purpose of the FCA: making the government completely whole.”

Id. Substantial penalties also serve as a powerful mechanism to

dissuade such a massive course of fraudulent conduct. See id.

at 408. And the government has “a strong interest in preventing

fraud” because “[f]raudulent claims make the administration of

Medicare more difficult, and widespread fraud would undermine

public confidence in the system.” Mackby II, 339 F.3d at 1019.

Nor were Tuomey’s actions in this case the result of a

“mere accident.” State Farm, 538 U.S. at 419. Rather, the jury

determined that Tuomey submitted false claims for Medicare

reimbursement “knowingly,” that is, with actual knowledge, in

51
deliberate ignorance, or with reckless disregard that the claims

violated the Stark Law. Under the circumstances, we agree with

the government that “strong medicine is required to cure the

defendant’s disrespect for the law.” Gore, 517 U.S. at 577.

Next, we consider the disparity between actual harm and the

punitive damages award. Specifically, we compare the actual

damages assessed against Tuomey to the civil penalty and the

portion of treble damages that can be considered punitive.

Here, we can properly regard the entire civil penalty,

$119,515,000, as punitive. On the other hand, the actual

damages of $39,313,065 are entirely compensatory. As discussed

above, the additional sum of $78,626,130 resulting from the

trebling of actual damages is a hybrid of compensatory and

punitive damages.

Although the Supreme Court has not told us where to draw

the line, see Chandler, 538 U.S. at 131, we may safely assume

that the portion of the trebled award allocated to the relator

is compensatory. See id. Assuming further that Drakeford

receives the minimum amount allotted by the statute--that is

fifteen percent of the total recovery--the relator would be

entitled to $11,793,920 of the trebled award, leaving

$66,832,210 to be allocated to punitive damages. By this

calculation, the portion of damages that is compensatory is

$51,106,985 and the $186,347,210 balance is punitive.

52
 While the Court has been reluctant to fix a bright-line

ratio that punitive damages cannot exceed for purposes of the

Due Process Clause, it has suggested that “an award of more than

four times the amount of compensatory damages might be close to

the line of constitutional impropriety.” State Farm, 538 U.S.

at 425. Here, the ratio of punitive damages to compensatory

damages is approximately 3.6-to-1, which falls just under the

ratio the Court deems constitutionally suspect. 20 We therefore

conclude that the damages award is constitutional under the

Fifth and Eighth Amendments.

V.

Finally, we do not discount the concerns raised by our

concurring colleague regarding the result in this case. But

having no found no cause to upset the jury’s verdict in this

case and no constitutional error, it is for Congress to consider

whether changes to the Stark Law’s reach are in order.

AFFIRMED

20 The government contends that the ratio between the
penalty awarded and the actual damages (after accounting for the
relator’s recovery) may be as low as 2-to-1 or even 1-to-1.
This calculation, however, ignores the treble damages award, a
portion of which we consider to be punitive.

53
WYNN, Circuit Judge, concurring:

Because Tuomey opened the door to the admission of Kevin

McAnaney’s testimony by asserting an advice of counsel defense,

and because I cannot say, based on the record before me, that no

rational jury could have determined that Tuomey violated both

the Stark Law and the False Claims Act, I concur in the outcome

today.

But I write separately to emphasize the troubling picture

this case paints: An impenetrably complex set of laws and

regulations that will result in a likely death sentence for a

community hospital in an already medically underserved area.

I.

Regarding the issue of whether the district court correctly

granted a new trial, we review such a decision for abuse of

discretion. Cline v. Wal-Mart Stores, Inc., 144 F.3d 294, 301

(4th Cir. 1998). Similarly, we “review a trial court’s rulings

on the admissibility of evidence for abuse of discretion,” and

we will overturn such a ruling only if it is “arbitrary and

irrational.” United States v. Cole, 631 F.3d 146, 153 (4th Cir.

2011) (quotation marks and citation omitted).

A.

Judge Perry, who presided over the first trial, excluded

McAnaney’s testimony pursuant to Evidence Rule 408, which can be
used to exclude evidence of settlement negotiations. Under Rule

408, “conduct or a statement made during compromise negotiations

about [a disputed] claim” is generally inadmissible when used to

“prove or disprove the validity or amount of a disputed claim.”

Fed. R. Evid. 408(a).

It is unclear to me that the district court abused its

discretion in determining that McAnaney’s testimony could be

excluded under Rule 408. In his deposition testimony, McAnaney

described himself as “a tie breaker” who was jointly hired by

Drakeford and Tuomey when they could not agree about whether the

contracts violated the Stark Law—arguably a disputed claim.

J.A. 139-41. Tuomey’s and Drakeford’s dispute about the

legality of the contracts reached impasse and ended in Drakeford

acting as a relator of this qui tam action only three months

later. Had Drakeford and Tuomey been able to reach an

agreement, Drakeford presumably would not have filed this suit,

in which the government, having intervened, now stands in

Drakeford’s shoes.

Rule 408’s exclusionary provision applies where a “dispute

or a difference of opinion exists,” not just “when discussions

crystallize to the point of threatened litigation.” Affiliated

Mfrs., Inc. v. Aluminum Co. of Am., 56 F.3d 521, 527 (3d Cir.

1995). When viewed thusly, it is hard to say that Judge Perry

55
acted either arbitrarily or irrationally in deeming McAnaney’s

testimony excludable.

Crucially, however, evidence subject to exclusion under

Rule 408 is so excludable “only if the evidence is offered to

prove either liability for or invalidity of a claim or its

amount;” otherwise, it may come in. Bituminous Const., Inc. v.

Rucker Enterprises, Inc., 816 F.2d 965, 968 (4th Cir. 1987)

(emphasis added); Fed. R. Evid. 408(b) (“The court may admit

this evidence for another purpose.”). Stated differently,

“[s]ince the rule excludes only when the purpose is proving the

validity or invalidity of the claim or its amount, an offer for

another purpose is not within the rule.” 2-408 Weinstein’s Fed.

Evid. § 408.08 (quotation marks and citation omitted).

Therefore, if the McAnaney evidence was admissible for a purpose

beyond the validity or amount of a disputed claim, Rule 408

would provide no basis for barring it wholesale from the first

trial.

B.

The government argues, among other things, that the

McAnaney evidence went to the heart of an issue wholly beyond

the scope of Rule 408’s limited exclusionary ambit—namely,

Tuomey’s advice of counsel defense. With this, I must agree.

As explained by a district court in this Circuit in the

context of a False Claims Act fraud claim, “good faith reliance

56
on the advice of counsel may contradict any suggestion that a

[defendant] ‘knowingly’ submitted a false claim.” United States

v. Newport News Shipbuilding, Inc., 276 F. Supp. 2d 539, 565

(E.D. Va. 2003). “[I]f a [defendant] seeks the advice of

counsel in good faith, provides full and accurate information,

receives advice which can be reasonably relied upon, and, in

turn, faithfully follows that advice, it cannot be said that the

defendant ‘knowingly’ submitted false information or acted with

deliberate ignorance or reckless disregard of its falsity, even

if that advice turns out in fact to be false.” Id. See also,

e.g., United States v. Butler, 211 F.3d 826, 833 (4th Cir. 2000)

(identifying the elements of the advice of counsel defense as

“(a) full disclosure of all pertinent facts to [a lawyer], and

(b) good faith reliance on the [lawyer]’s advice”).

When a party raises an advice of counsel defense, however,

all advice on the pertinent topic becomes fair game. “It has .

. . become established that if a party interjects the ‘advice of

counsel’ as an essential element of a claim or defense,” then

“all advice received concerning the same subject matter” is

discoverable, not subject to protection by the attorney-client

privilege, and, by logical extension, admissible at trial. 1

McCormick On Evid. § 93 (7th ed. 2013). See also, e.g., In re

EchoStar Commc’ns Corp., 448 F.3d 1294, 1299 (Fed. Cir. 2006)

(“Once a party announces that it will rely on advice of counsel

57
. . . the attorney-client privilege is waived. The widely

applied standard for determining the scope . . . is that the

waiver applies to all other communications relating to the same

subject matter. . . . Thus, when EchoStar chose to rely on the

advice of in-house counsel, it waived the attorney-client

privilege with regard to any attorney-client communications

relating to the same subject matter, including communications

with counsel other than in-house counsel, which would include”

the advice of outside counsel.) (quotation marks and citation

omitted).

Here, there can be no doubt that Tuomey pressed an advice

of counsel defense. Tuomey argued to the first jury, for

example, that “[t]he lawyers were the ones running the show . .

. . All Tuomey did was accept their recommendations and vote on

them if they thought that it was something that would be good

for the hospital. Advice of counsel is a very, very good

defense. It is one that the law recognizes, and it is one that

. . . fits perfectly in this situation.” Trial I, Transcript

for Mar. 25, 2010, at 1986.

Further, the district court instructed the jury on the

advice of counsel defense, making clear that it provided a

vehicle for absolving Tuomey of False Claims Act liability. The

court instructed, among other things, that “the defendant has

asserted an affirmative defense of advice of counsel to the

58
United States’ allegation that it acted in violation of the

False Claims Act. An affirmative defense is an argument that,

if true, will defeat the government’s claim.” Trial I,

Transcript for Mar. 26, 2010, at 2098-99. Regarding what Tuomey

needed to show to succeed with that defense, Judge Perry

instructed that “in order for the defendant to prevail on its

affirmative defense of advice of counsel, Tuomey must prove the

following: One, that the advice was sought in good faith; two,

that Tuomey provided full and accurate information to the

attorney; three, the advice could be reasonably relied upon;

and, four, Tuomey faithfully followed the attorney’s advice.”

Id.

Having put the advice it got from its lawyers squarely at

issue, Tuomey should not have been permitted to cherry-pick

which advice of counsel the jury was permitted to hear.

Instead, the jury should have been allowed to consider all the

advice of all Tuomey’s counsel—including McAnaney.

The record makes clear that, whatever else McAnaney’s

assessment was, it was also advice of counsel. McAnaney’s

engagement letter to Tuomey and Drakeford, who had hired him

jointly, stated that McAnaney, a lawyer, had been “retained” to

“review and advise” the parties “with respect to a proposed

business relationship.” J.A. 145. McAnaney committed to being

guided by the parties’ “instructions in carrying out the

59
representation” and reporting to the parties his “conclusions”

and “any potential compliance issues.” Id. In other words,

McAnaney was Tuomey’s counsel, and he advised Tuomey about the

contracts at the heart of this case.

The record makes similarly clear that Tuomey did not follow

McAnaney’s advice. McAnaney advised Tuomey that the proposed

contracts raised significant “red flags” under the Stark Law.

J.A. 2054. McAnaney advised that Tuomey would have difficulty

persuading the government that the contracts did not compensate

the physicians in excess of fair market value. And McAnaney

warned Tuomey that the contracts presented “an easy case to

prosecute” for the government. J.A. 2078. Rather than heed

this advice and back away from the contracts, however, Tuomey

told McAnaney not to put his conclusions in writing and ended

his engagement.

Allowing McAnaney’s testimony into evidence to show the

advice he gave in light of Tuomey’s advice of counsel defense

would have been outside of Rule 408’s limited exclusionary

ambit. In other words, by pressing an advice of counsel

defense, Tuomey itself opened the door for McAnaney’s testimony

to come in, even if it otherwise might have been excludable

under Rule 408. See Fed. R. Evid. 408(b). Despite this, the

district court barred McAnaney’s testimony wholesale.

60
 In keeping McAnaney out of the first trial, the district

court prevented the jury from getting the full picture of what

advice Tuomey had gotten from counsel. Tuomey told the jury

that “[t]he lawyers were the ones running the show . . . All

Tuomey did was accept their recommendations.” Trial I,

Transcript for Mar. 25, 2010, at 1986. But the government was

effectively prevented from showing that Tuomey had gotten

conflicting recommendations from its different counsel, picked

its preferred advice, and discarded the rest. It is hard to

imagine that this constituted anything other than a prejudicial

abuse of discretion. Cf. Rodriguez-Garcia v. Municipality of

Caguas, 495 F.3d 1 (1st Cir. 2007) (reversing because erroneous

Rule 408 ruling hamstrung plaintiff’s ability to show elements

of claim).

In sum, in allowing Tuomey to press its advice of counsel

defense and giving the jury an advice of counsel instruction yet

preventing the jury from hearing all the advice that Tuomey got,

the district court abused its discretion and prejudiced the

government. This error alone was grave enough to warrant a new

trial. Accordingly, I, too, conclude that Judge Perry’s

decision to grant a new trial must be upheld.

61
 II.

Moving beyond the district court’s decision to grant a new

trial, I agree with the majority that the jury’s determination

that Tuomey violated both the Stark Law and the False Claims Act

must stand. Our standard of review at this juncture is a highly

deferential one, “accord[ing] the utmost respect to jury

verdicts” and “constraining” us to affirm so long as the record

contains “sufficient evidence for a reasonable jury” to have

returned the verdict it did. Lack v. Wal-Mart Stores, Inc., 240

F.3d 255, 259 (4th Cir. 2001). After careful review of the

record, I cannot conclude that no reasonable jury could have

reached the verdict before us.

Nevertheless, I am troubled by the picture this case

paints: An impenetrably complex set of laws and regulations

that will result in a likely death sentence for a community

hospital in an already medically underserved area.

A.

The Stark Law is, at its core, a prohibition on self-

referrals, barring doctors from referring patients for certain

services to entities in which the doctors (or their immediate

family members) have a financial interest, unless an exception

applies. Patrick A. Sutton, The Stark Law in Retrospect, 20

Annals Health L. 15, 25-26 (2011). Further, entities providing

62
the pertinent services are prohibited from billing Medicare or

Medicaid pursuant to such a prohibited referral. Id.

“The Stark Law is a strict liability statute so it is

immaterial whether one intended to violate the law; an

inadvertent violation can trigger liability.” Paula Tironi, The

“Stark” Reality: Is the Federal Physician Self-Referral Law Bad

for the Health Care Industry?, 19 Annals Health L. 235, 237-38

(2010). Individuals and entities that violate the Stark Law can

be subject to severe monetary penalties and exclusion from

federal health care programs. Id. These “steep civil sanctions

and program exclusions may be ruinous. Health care providers

are open to extensive liability, their financial security

resting uneasily upon a combination of their attorneys’ wits

[and] prosecutorial discretion.” Jo-Ellyn Sakowitz Klein, The

Stark Laws: Conquering Physician Conflicts of Interest?, 87 Geo.

L.J. 499, 503-04 (1998).

Despite attempts to establish “bright line” rules so that

physicians and healthcare entities could “ensure compliance and

minimize . . . costs,” 66 Fed. Reg. 856, 860 (Jan. 4, 2001), the

Stark Law has proved challenging to understand and comply with.

Indeed, “[t]he Stark law is infamous among health care lawyers

and their clients for being complicated, confusing and counter-

intuitive; for producing results that defy common sense, and

sometimes elevating form over substance. Ironically, the Stark

63
law was actually intended to simplify life by creating ‘bright

lines’ between what would be permitted and what would be

disallowed, and creating certainty by removing intent from the

equation.” Charles B. Oppenheim, The Stark Law: Comprehensive

Analysis + Practical Guide 1 (AHLA 5th ed. 2014). Some of the

invective used to describe the Stark law even borders on

lyrical: “ambiguous[,] arcane[,] and very vague;” and “heaps of

words in barely decipherable bureaucratese.” Steven D. Wales,

The Stark Law: Boon or Boondoggle? An Analysis of the

Prohibition on Physician Self-Referrals, 27 Law & Psychol. Rev.

1, 22-23 (2003) (quotation marks and citations omitted).

Given this complexity and the strict liability nature of

the statute, a Stark Law “compliance program can help a

physician or [] entity prove good faith and obtain leniency in

the event of a violation; however, the Stark Law’s complexity

and frequent revisions make it difficult for physicians and

entities to develop and implement such programs.” Tironi, supra

at 238. Against this problematic backdrop, the availability of

an advice of counsel defense should perhaps be especially robust

in Stark Law cases prosecuted under the False Claims Act.

B.

The False Claims Act discourages fraud against the federal

government by imposing liability on “any person who . . .

knowingly presents, or causes to be presented, a false or

64
fraudulent claim for payment or approval.” 31 U.S.C. §

3729(a)(1)(A) (emphasis added). The False Claims Act is meant

“to indemnify the government . . . against losses caused by a

defendant’s fraud,” Mikes v. Straus, 274 F.3d 687, 696 (2d Cir.

2001) (citing United States. ex rel. Marcus v. Hess, 317 U.S.

537, 549, 551–52 (1943)), as opposed to a defendant’s mistake.

Accordingly, a defendant may skirt False Claims Act

liability by showing good faith reliance on the advice of

counsel. As the majority opinion recognizes, in fraud cases,

“‘[i]f in good faith reliance upon legal advice given him by a

lawyer to whom he has made full disclosure of the facts, one

engages in a course of conduct later found to be illegal,” the

trier of fact may conclude that the conduct was innocent because

“‘the guilty mind’ was absent.” Ante at 30-31 (quoting United

States v. Painter, 314 F.2d 939, 943 (4th Cir. 1963)).

In the context of the Stark Law, it is easy to see how even

diligent counsel could wind up giving clients incorrect advice.

Between the law’s being amended to have a broader scope but then

narrowed with various exceptions, along with the promulgation

and amendment of copious associated rules and regulations, “the

Stark Law bec[ame] a classic example of a moving target. For

lawyers, who must depend on the predictability of the law when

they give counsel to their clients, such unpredictability [i]s

an unusually heavy burden.” Wales, supra at 21.

65
 In this case, there can be no doubt that Tuomey sought and

followed the advice of its long-time counsel, Nexsen Pruet.

Nexsen Pruet drafted and approved the contracts at the heart of

this litigation. Tuomey and Nexsen Pruet consulted with others,

including the nation’s largest healthcare law firm and a

national consulting firm with expertise in physician

compensation. Those experts, too, signed off on the

arrangements (though the parties dispute whether Tuomey had

shared all pertinent information for purposes of these

additional assessments).

Nevertheless, as the majority opinion notes, “a reasonable

jury could have concluded that Tuomey was . . . no longer acting

in good faith reliance on the advice of its counsel when it

refused to give full consideration to McAnaney’s negative

assessment of the” contracts. Id. at 32. As already explained,

McAnaney, the former Chief of the Industry Guidance Branch at

the Department of Health and Human Services’ Office of Counsel

to the Inspector General, also served as Tuomey’s counsel. And

he advised Tuomey that the proposed arrangements raised

significant red flags and may well be unlawful. Had Tuomey

followed McAnaney’s advice, it likely would have faced no

lawsuit in which to raise an advice of counsel, or any other,

defense.

66
 III.

This case is troubling. It seems as if, even for well-

intentioned health care providers, the Stark Law has become a

booby trap rigged with strict liability and potentially ruinous

exposure—especially when coupled with the False Claims Act.

Yet, the district court did not abuse its discretion when it

granted a new trial and the jury did not act irrationally when

it determined that Tuomey violated both the Stark Law and the

False Claims Act. Accordingly, I must concur in the outcome

reached by the majority.

67