throbber
Case: 23-2086 Document: 00118147549 Page: 1 Date Filed: 05/22/2024 Entry ID: 6643957
`
`No. 23-2086
`UNITED STATES COURT OF APPEALS
`FOR THE FIRST CIRCUIT
`________________
`UNITED STATES OF AMERICA,
`Plaintiff-Appellant,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Defendant-Appellee.
`________________
`Appeal from the United States District Court for the District of
`Massachusetts, No. 1:20-cv-11217, Hon. F. Dennis Saylor IV
`________________
`BRIEF OF THE CHAMBER OF COMMERCE OF THE
`UNITED STATES OF AMERICA AS AMICUS CURIAE IN
`SUPPORT OF DEFENDANT-APPELLEE AND AFFIRMANCE
`________________
`Jeffrey S. Bucholtz
`KING & SPALDING LLP
`1700 Pennsylvania Avenue NW
`Washington, DC 20006
`(202) 737-0500
`jbucholtz@kslaw.com
`Matthew V.H. Noller
`KING & SPALDING LLP
`50 California Street, Suite 3300
`San Francisco, CA 94111
`(415) 318-1200
`Counsel for Amicus Curiae
`
`Tara S. Morrissey
`Andrew R. Varcoe
`U.S. CHAMBER
`LITIGATION CENTER
`1615 H Street NW
`Washington, DC 20062
`(202) 463-5337
`
`May 22, 2024
`
`
`
`

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`Case: 23-2086 Document: 00118147549 Page: 2 Date Filed: 05/22/2024 Entry ID: 6643957
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`CORPORATE DISCLOSURE STATEMENT
`The Chamber of Commerce of the United States of America
`
`(“Chamber”) is a non-profit, tax-exempt organization incorporated in the
`
`District of Columbia. The Chamber has no parent corporation, and no
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`publicly held company has 10% or greater ownership in the Chamber.
`
`
`
`
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`

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`
`TABLE OF CONTENTS
`Corporate Disclosure Statement ................................................................. i
`Interest of Amicus Curiae .......................................................................... 1
`Introduction ................................................................................................ 2
`Argument .................................................................................................... 4
`I. Section 1320a-7b(g) requires at least but-for causation .................... 4
`II. The government’s interpretation would lead to an explosion
`of meritless and costly qui tam actions ............................................ 16
`Conclusion ................................................................................................. 21
`
`
`ii
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`

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`
`TABLE OF AUTHORITIES
`
`Cases
`AT&T Mobility LLC v. Concepcion,
`563 U.S. 333 (2011) .............................................................................. 18
`Baker v. Smith & Wesson, Inc.,
`40 F.4th 43 (1st Cir. 2022) ................................................................... 12
`Buckley v. Valeo,
`424 U.S. 1 (1976) .................................................................................. 20
`Burrage v. United States,
`571 U.S. 204 (2014) ...................................................................... passim
`Guilfoile v. Shields,
`913 F.3d 178 (1st Cir. 2019) ........................................................ 4, 5, 19
`Jam v. Int’l Fin. Corp.,
`586 U.S. 199 (2019) .............................................................................. 12
`Kellogg Brown & Root Servs. v. U.S. ex rel. Carter,
`575 U.S. 650 (2015) ................................................................................ 6
`Laaman v. Warden, N.H. State Prison,
`238 F.3d 14 (1st Cir. 2001) .................................................................. 12
`NLRB v. SW Gen., Inc.,
`580 U.S. 288 (2017) .............................................................................. 14
`Paroline v. United States,
`572 U.S. 434 (2014) .............................................................................. 10
`Reves v. Ernst & Young,
`507 U.S. 170 (1993) .............................................................................. 12
`Schindler Elevator Corp. v. U.S. ex rel. Kirk,
`563 U.S. 401 (2011) ............................................................................ 6, 7
`Seila Law LLC v. CFPB,
`591 U.S. 197 (2020) .............................................................................. 20
`
`iii
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`

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`
`Smith v. Duffey,
`576 F.3d 336 (7th Cir. 2009) ................................................................ 18
`U.S. ex rel. Atkins v. McInteer,
`470 F.3d 1350 (11th Cir. 2006) ............................................................ 17
`U.S. ex rel. Cairns v. D.S. Med. LLC,
`42 F.4th 828 (8th Cir. 2022) .............................................................. 3, 6
`U.S. ex rel. Martin v. Hathaway,
`63 F.4th 1043 (6th Cir. 2023) ............................................................ 3, 6
`U.S. ex rel. Polansky v. Exec. Health Res., Inc.,
`599 U.S. 419 (2023) ........................................................................ 13, 20
`U.S. ex rel. Schutte v. SuperValu Inc.,
`598 U.S. 739 (2023) ............................................................................ 4, 7
`United States ex rel. Hutcheson v. Blackstone Medical, Inc.,
`647 F.3d 377 (1st Cir. 2011) .......................................................... 15, 16
`Universal Health Servs., Inc. v. U.S. ex rel. Escobar,
`579 U.S. 176 (2016) .......................................................................... 3, 13
`Vt. Agency of Nat. Res. v. U.S. ex rel. Stevens,
`529 U.S. 765 (2000) ........................................................................ 11, 17
`Zucker v. Rodriguez,
`919 F.3d 649 (1st Cir. 2019) ................................................................ 14
`Statutes
`21 U.S.C. § 841............................................................................................ 5
`31 U.S.C. § 3729.................................................................................... 4, 14
`31 U.S.C. § 3730............................................................................ 11, 12, 17
`42 U.S.C. § 1320a-7b ........................................................................ passim
`
`iv
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`

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`
`Other Authorities
`155 Cong. Rec. S10,853
`(daily ed. Oct. 28, 2009) (statement of Sen. Kaufman) ................ 13, 14
`Bentivoglio, John T., et al.,
`False Claims Act Investigations: Time for a New Approach?,
`3 Fin. Fraud L. Rep. 801 (2011) .......................................................... 19
`Brief for United States as Amicus Curiae,
`U.S. ex rel. Flanagan v. Fresenius Med. Care Holdings, Inc.,
`No. 23-1305 (1st Cir. Aug. 21, 2023) ..................................................... 8
`Memo.,
`United States v. Teva Pharms. USA, Inc.,
`No. 1:20-cv-11548 (D. Mass.), ECF No. 161 .......................................... 8
`Reply,
`United States v. Teva Pharms. USA, Inc.,
`No. 1:20-cv-11548 (D. Mass.), ECF No. 189 .......................................... 8
`U.S. Dep’t of Justice, Fraud Statistics – Overview
`(Oct. 1, 1986–Sept. 30, 2023) (“DOJ Fraud Statistics”),
`https://www.justice.gov/opa/media/1339306/dl?inline ............ 17, 18, 19
`
`
`v
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`

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`INTEREST OF AMICUS CURIAE
`The Chamber of Commerce of the United States of America is the
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`world’s largest business federation. It represents approximately 300,000
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`direct members and indirectly represents the interests of more than 3
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`million companies and professional organizations of every size, in every
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`industry sector, and from every region of the country. An important
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`function of the Chamber is to represent the interests of its members in
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`matters before Congress, the Executive Branch, and the courts. To that
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`end, the Chamber regularly files amicus curiae briefs in cases, like this
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`one, that raise issues of concern to the nation’s business community.
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`False Claims Act cases touch on nearly every sector of the economy,
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`including banking, defense, education, healthcare, and technology, and
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`exact a substantial toll on the economy. Given the combination of the
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`FCA’s draconian liability provisions—treble damages plus per-claim
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`penalties—and enormous litigation costs, even meritless cases can be
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`used to extract substantial settlements. As a result, cases involving the
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`

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`proper application of the FCA are of particular concern to amicus and its
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`members.1
`
`INTRODUCTION
`The question presented in this appeal is straightforward. The Court
`
`accepted the appeal to decide whether 42 U.S.C. § 1320a-7b(g), which
`
`provides that “a claim that includes items or services resulting from a
`
`violation of” the Anti-Kickback Statute is a false claim under the FCA,
`
`requires but-for causation. The Supreme Court effectively resolved that
`
`question years ago when it held that “a phrase such as ‘results from’
`
`imposes a requirement of but-for causation.” Burrage v. United States,
`
`571 U.S. 204, 214 (2014). Section 1320a-7b(g)’s indistinguishable phrase
`
`“resulting from” must carry the same meaning: for an AKS violation to
`
`render a claim “false or fraudulent” under the FCA, the violation must be
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`at least a but-for cause of the “items or services” for which the claim
`
`sought payment. U.S. ex rel. Martin v. Hathaway, 63 F.4th 1043, 1052-
`
`
`1 All parties to this appeal have consented to the filing of this brief. No
`counsel for any party authored this brief in whole or in part, and no entity
`or person, aside from amicus, its members, or its counsel, made any
`monetary contribution intended to fund the preparation or submission of
`this brief.
`
`2
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`

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`
`53 (6th Cir.), cert. denied, 144 S. Ct. 224 (2023) (Mem.); U.S. ex rel. Cairns
`
`v. D.S. Med. LLC, 42 F.4th 828, 834-35 (8th Cir. 2022).
`
`The government’s contrary
`
`interpretation of § 1320a-7b(g)
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`impermissibly “give[s] the [statutory] text a meaning that is different
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`from its ordinary, accepted meaning.” Burrage, 571 U.S. at 216. If this
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`Court were to adopt that interpretation, it would open the floodgates to
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`a torrent of meritless FCA actions based on allegations of AKS violations.
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`Without a requirement of but-for causation, relators will seek exorbitant
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`qui tam settlements by alleging AKS violations—which are easy to allege,
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`given the breadth of the AKS—with only an unclear or attenuated
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`relationship to the “items or services” in claims for payment. 42 U.S.C.
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`§ 1320a-7b(g). That would impose deadweight costs on businesses and
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`the public, and it would distort the FCA—a statute focused on claims that
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`are false—into “a vehicle for punishing . . . regulatory violations” that do
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`not cause any false claims. Universal Health Servs., Inc. v. U.S. ex rel.
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`Escobar, 579 U.S. 176, 194 (2016). This Court should reject the
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`government’s arguments and affirm the district court’s interpretation of
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`§ 1320a-7b(g).
`
`3
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`

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`
`I.
`
`ARGUMENT
`Section 1320a-7b(g) requires at least but-for causation.
`When interpreting the FCA, the Court must “start . . . with [its]
`
`text.” U.S. ex rel. Schutte v. SuperValu Inc., 598 U.S. 739, 749 (2023). As
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`relevant here, the FCA imposes liability on “any person who . . .
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`knowingly presents, or causes to be presented, a false or fraudulent claim
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`for payment or approval.” 31 U.S.C. § 3729(a)(1)(A). The AKS, in turn,
`
`provides that “a claim that includes items or services resulting from a
`
`violation of [the AKS] constitutes a false or fraudulent claim for purposes
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`of [the FCA].” 42 U.S.C. § 1320a-7b(g). Under these provisions, therefore,
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`an underlying AKS “violation” renders a claim for payment “false or
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`fraudulent” under the FCA if the claim “includes items or services
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`resulting from” the AKS violation—but not if the “items or services”
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`covered by the claim did not “result[] from” the AKS violation. Id.
`
`(emphasis added).
`
`There can be no dispute that the phrase “resulting from” requires a
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`“causal connection between an AKS violation and a claim submitted to
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`the federal government.” Guilfoile v. Shields, 913 F.3d 178, 190 (1st Cir.
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`2019). This Court has so held, as shown by the preceding quote from
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`4
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`

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`Guilfoile.2 The government itself concedes that § 1320a-7b(g)’s “resulting
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`from” language imposes some requirement of “factual causation.” Gov’t
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`Br. 24. And the Supreme Court has held that the connection required by
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`that phrase is “but-for causation.” Burrage, 571 U.S. at 214.
`
`Burrage involved a criminal statute imposing a mandatory
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`minimum sentence for the sale of illegal substances when “death or
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`serious bodily injury results from the use of such substance.” 21 U.S.C.
`
`§ 841(a)(1), (b)(1)(A)-(C) (emphasis added). The Supreme Court held that
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`the “ordinary meaning” of “results from” requires proof “that the harm
`
`would not have occurred in the absence of—that is, but for—the
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`defendant’s conduct.” 571 U.S. at 210-11 (cleaned up).
`
`That holding resolves this appeal. As with the statute in Burrage,
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`the Supreme Court has held that the FCA must be interpreted according
`
`
`2 Contrary to the government’s argument, Guilfoile did not even
`implicitly reject a requirement of but-for causation. This Court simply
`held that § 1320a-7b(g) requires “a sufficient causal connection,” without
`deciding what sort of “causal connection” would be “sufficient.” 913 F.3d
`at 190. In fact, the Court went on to hold that the plaintiff had “plausibly
`alleged a sufficient causal connection” by alleging that the defendant
`could not have sought government benefits for its services “if not for” the
`alleged AKS violation—in other words, by alleging but-for causation. Id.
`at 191 (emphasis added). The government’s brief does not mention this
`aspect of the Court’s analysis.
`
`5
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`

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`to its “ordinary meaning.” Kellogg Brown & Root Servs. v. U.S. ex rel.
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`Carter, 575 U.S. 650, 662 (2015); Schindler Elevator Corp. v. U.S. ex rel.
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`Kirk, 563 U.S. 401, 407 (2011). And there is no meaningful difference
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`between “results from” and § 1320a-7b(g)’s causal phrase “resulting from.”
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`So there is no difference between the phrases’ ordinary meanings: they
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`both unambiguously require at least but-for causation. Burrage, 571 U.S.
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`at 210-11; see Martin, 63 F.4th at 1052 (“The ordinary meaning of
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`‘resulting from’ is but-for causation.”); Cairns, 42 F.4th at 835
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`(“‘Resulting,’ which is the present-participle form of the verb, has the
`
`same meaning as its present-tense cousin, ‘results.’ So we have little
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`trouble concluding that, in common and ordinary usage, the participle
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`phrase ‘resulting from’ also expresses ‘a but-for causal relationship.’”
`
`(citations omitted)).
`
`It is thus misleading at best for the government to say that
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`“§ 1320a-7b(g)’s ‘resulting from’ language is silent as to the appropriate
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`standard of factual causation.” Gov’t Br. 24-25. “Resulting from” is the
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`statutory standard, and it requires at least “but-for causation.” Burrage,
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`571 U.S. at 214. Nor can the government identify any plausible reason to
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`give the FCA’s “text a meaning that is different from its ordinary,
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`6
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`

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`accepted meaning.” Id. at 216; see Schindler Elevator, 563 U.S. at 410
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`(explaining that the Court has “cautioned . . . against” giving the FCA’s
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`text “a different, somewhat special meaning” instead of its “primary
`
`meaning” (quotation marks omitted)). The government suggests that
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`Burrage does not apply to different “statutory scheme[s],” Gov’t Br. 20,
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`but Burrage did not depend on anything specific to the statute at issue.3
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`Because that statute did “not define the phrase ‘results from,’” the
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`Supreme Court “g[a]ve it its ordinary meaning.” 571 U.S. at 210. And the
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`phrase’s “common understanding”—not some specialized, statute-
`
`specific meaning—reflects a “but-for requirement.” Id. at 211. It could not
`
`be clearer that the Court understood its interpretation of “results from”
`
`to apply generally as a matter of plain English: “[I]t is one of the
`
`traditional background principles against which Congress legislates that
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`a phrase such as ‘results from’ imposes a requirement of but-for
`
`
`3 The government’s citation to Schutte is misplaced. Gov’t Br. 21.
`There, the Supreme Court found that the meaning of “willfully” in one
`statute should not be applied to different terms in the FCA. 598 U.S. at
`754. The Court also held that its earlier decision had not interpreted
`“willfully” in the way the defendants claimed. Id. at 754-55. Burrage, in
`contrast, undeniably interpreted language indistinguishable from
`§ 1320a-7b(g)’s phrase “resulting from” to require but-for causation.
`
`7
`
`

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`causation.” Id. at 214 (emphasis added) (cleaned up). That background
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`principle applies with full force to the FCA and the AKS.
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`Indeed, as noted above, the government concedes that § 1320a-7b(g)
`
`requires some “appropriate standard of factual causation” between an
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`AKS violation and the items or services in a claim for payment. Gov’t
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`Br. 24; accord Gov’t Br. 20 (“some requirement of causation in fact”). But
`
`the government has long struggled to explain what it thinks that causal
`
`connection is. The government typically has relied on unhelpful labels:
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`there must be a “sufficient causal connection”; the claim must be
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`“tainted” by a kickback; a patient must be “exposed to” an AKS violation;
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`and so on. Memo. at 5-8, United States v. Teva Pharms. USA, Inc.,
`
`No. 1:20-cv-11548 (D. Mass.), ECF No. 161 (emphasis omitted); Reply at
`
`5-8, Teva Pharms., No. 1:20-cv-11548, ECF No. 189; Brief for United
`
`States as Amicus Curiae at 9-15, U.S. ex rel. Flanagan v. Fresenius Med.
`
`Care Holdings, Inc., No. 23-1305 (1st Cir. Aug. 21, 2023). But what does
`
`any of that mean? What kind of “causal connection” is “sufficient” or
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`“appropriate”? What constitutes an actionable “taint”? How, and how far,
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`does the “taint” spread? See Gov’t Br. 23 (suggesting services are “tainted
`
`by a kickback” “regardless of whether the kickback actually altered
`
`8
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`

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`medical
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`decisionmaking”
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`(quotation marks
`
`omitted)). More
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`fundamentally, what do any of those inquiries have to do with the
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`statutory phrase “resulting from”? The government has never been able
`
`to answer these questions coherently.
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`It still can’t. In this case, the government at least purports to offer
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`a test, but—belying its acknowledgment of a “factual causation”
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`requirement, Gov’t Br. 24—its proposal
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`imposes no causation
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`requirement at all. According to the government, a “claim ‘includes items
`
`or services resulting from’ the kickback within the meaning of § 1320a-
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`7b(g)” whenever “the claimed items or services are those that the
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`kickback was given to induce,” even if the kickback did not in fact induce
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`those items or services because they would have been provided in the
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`absence of the kickback. Gov’t Br. 22, 27-28.
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`With respect, the government’s proposal does not make sense.
`
`Whatever “nexus” the government thinks exists between an AKS
`
`violation and items or services that would have been provided even in the
`
`absence of the violation, id. at 22, it is not a causal nexus. If a
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`manufacturer tries to “induce the purchase of particular items or
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`services” with a kickback but the actual purchase is not at all influenced
`
`9
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`

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`by the kickback, then the manufacturer’s “intended result[]” may have
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`“materialize[d],” id. at 30—but the manufacturer plainly did not cause
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`that result. An act cannot cause an event “when the event would have
`
`occurred without it.” Burrage, 571 U.S. at 215-16 (cleaned up).4
`
`The upshot is that, far from offering a “natural interpretation of
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`‘resulting from,’” Gov’t Br. 24, the government reads that language out of
`
`the statute. If Congress had meant § 1320a-7b(g) to make a claim for
`
`payment a “false” claim under FCA anytime remuneration was “given to
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`induce the provision of the items or services” in the claim, Congress
`
`would have just said that, using the same language it used in the AKS.
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`Gov’t Br. 21-22. Likewise, if Congress had intended to make any claim
`
`occurring after an AKS violation a “false” claim, it would have said so.
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`Instead, it chose the phrase “resulting from,” along with its “ordinary,
`
`
`4 The only potential caveat is that an act sometimes may be deemed a
`sufficient “cause” of an event “when multiple sufficient causes
`independently, but concurrently, produce a result.” Burrage, 571 U.S. at
`214-15 (describing hypothetical where A stabs B at the same time as X
`shoots B, where both the stab wound and the gunshot wound would be
`independently fatal); Paroline v. United States, 572 U.S. 434, 451 (2014).
`While requiring “strict but-for causality” may be unworkable in such
`unusual situations, Burrage, 571 U.S. at 214-15, that is irrelevant here.
`Not even the government suggests that it is unworkable to assess
`whether items or services contained in a claim for payment would have
`been provided even in the absence of an alleged AKS violation.
`
`10
`
`

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`accepted meaning” that “imports but-for causality.” Burrage, 571 U.S.
`
`at 216. Courts must honor that choice.
`
`The government’s contextual arguments fare no better. The
`
`government relies on other AKS provisions, e.g., Gov’t Br. 21-22, but this
`
`case is about the scope of the FCA, not the AKS. There is nothing
`
`“inconsistent” about interpreting § 1320a-7b(g) to require a but-for
`
`causal connection between an AKS violation and a claim for payment
`
`even if no such causal relationship is required under the AKS itself. Gov’t
`
`Br. 18. The AKS and the FCA are distinct statutes that prohibit different
`
`conduct; the False Claims Act is focused on claims for payment and is not
`
`implicated if an AKS violation does not result in a claim for payment. In
`
`addition, the AKS is a criminal statute enforceable only by the United
`
`States, while the FCA, by virtue of its qui tam provisions, may be
`
`enforced by anyone. 31 U.S.C. § 3730(b). Because third-party “informer”
`
`actions are “highly subject to abuse,” Vt. Agency of Nat. Res. v. U.S. ex
`
`rel. Stevens, 529 U.S. 765, 775 (2000), Congress subjected them to
`
`multiple restrictions that do not apply to suits brought by the
`
`government. E.g., 31 U.S.C. § 3730(b)(5) (first-to-file bar); id. § 3730(e)(3)
`
`(government action bar); id. § 3730(e)(4)(A) (public disclosure bar); see
`
`11
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`

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`
`also id. § 3730(c)(2)(A)-(B) (authorizing government to dismiss or settle
`
`FCA action over relator’s objections). Section 1320a-7b(g), by limiting a
`
`private relator’s ability under the FCA to rely on AKS provisions that the
`
`government can always enforce directly in appropriate cases, serves the
`
`same purpose.
`
`Without statutory text or context on its side, the government
`
`resorts to speculation about congressional purpose. E.g., Gov’t Br. 18-19,
`
`23-24. As an initial matter, of course, a statute’s “purpose is expressed by
`
`the ordinary meaning of the words used.” Jam v. Int’l Fin. Corp., 586 U.S.
`
`199, 209 (2019) (cleaned up); see Laaman v. Warden, N.H. State Prison,
`
`238 F.3d 14, 16 (1st Cir. 2001). Because the Supreme Court has already
`
`decided the ordinary meaning of “resulting from,” the government’s
`
`suppositions about congressional intent have no legitimate role to play.
`
`E.g., Reves v. Ernst & Young, 507 U.S. 170, 177 (1993); Baker v. Smith &
`
`Wesson, Inc., 40 F.4th 43, 48 (1st Cir. 2022).
`
`That aside, the government’s arguments
`
`lack merit. The
`
`government focuses on the purpose of the AKS, arguing (for example) that
`
`“[t]he point of the AKS is that financial conflicts are so inherently
`
`corrupting that they are punishable as felonies regardless of whether
`
`12
`
`

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`Case: 23-2086 Document: 00118147549 Page: 19 Date Filed: 05/22/2024 Entry ID: 6643957
`
`
`they can be shown to have produced a concrete change in medical
`
`decisionmaking.” Gov’t Br. 14. But, again, this is not an AKS case—it’s
`
`an FCA case. Although the AKS may forbid “financial conflicts” even if
`
`they do not affect “medical decisionmaking,” id., the FCA prohibits only
`
`“false or fraudulent claims for payment” that are “meant to appropriate
`
`government assets,” U.S. ex rel. Polansky v. Exec. Health Res., Inc., 599
`
`U.S. 419, 423-24 (2023). The FCA is not “a vehicle for punishing garden-
`
`variety breaches of contract or regulatory violations.” Escobar, 579 U.S.
`
`at 194. So while an unsuccessful kickback scheme might violate the AKS,
`
`Gov’t Br. 11, 21, it does not violate the FCA. The FCA is not implicated
`
`unless the kickback scheme results in the provision of items or services
`
`for which a person seeks payment from the government.
`
`When the government addresses § 1320a-7b(g)’s legislative history,
`
`it cites two lone floor statements by individual legislators that § 1320a-
`
`7b(g) would “strengthen[] whistleblower actions based on medical care
`
`kickbacks.” Gov’t Br. 3 (quoting 155 Cong. Rec. S10,853 (daily ed. Oct.
`
`28, 2009) (statement of Sen. Kaufman)). To the extent individual floor
`
`13
`
`

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`Case: 23-2086 Document: 00118147549 Page: 20 Date Filed: 05/22/2024 Entry ID: 6643957
`
`
`statements could be considered,5 they are irrelevant to the causation
`
`question here. According to the statements, and as the government itself
`
`emphasizes, § 1320a-7b(g) was meant to permit liability for claims that
`
`“result[] from illegal kickbacks” but are “not submitted directly by the
`
`wrongdoers themselves.” 155 Cong. Rec. at S10,853 (Sen. Kaufman);
`
`Gov’t Br. 3, 19. All that means is that a claim can be false even if the
`
`submitter did not violate the AKS, as long as some other actor in the
`
`causal chain leading to the submission of the claim did violate the AKS.
`
`See also 31 U.S.C. § 3729(a)(1)(A) (creating FCA liability for anyone who
`
`“knowingly presents, or causes to be presented, a false or fraudulent
`
`claim” (emphasis added)). The items or services included in the claim still
`
`must “result[] from” an AKS violation, 155 Cong. Rec. at S10,853, and
`
`nothing in the legislative history suggests that Congress intended
`
`§ 1320a-7b(g)’s “resulting from” requirement to demand anything less
`
`than but-for causation.
`
`
`5 Because “‘[f]loor statements by individual legislators rank among the
`least illuminating forms of legislative history,’” courts should “not
`attribute to Congress as a whole the views expressed in individual
`legislators’ floor statements.” Zucker v. Rodriguez, 919 F.3d 649, 660 (1st
`Cir. 2019) (quoting NLRB v. SW Gen., Inc., 580 U.S. 288, 307 (2017)).
`
`14
`
`

`

`Case: 23-2086 Document: 00118147549 Page: 21 Date Filed: 05/22/2024 Entry ID: 6643957
`
`
`The government’s discussion of United States ex rel. Hutcheson v.
`
`Blackstone Medical, Inc., 647 F.3d 377 (1st Cir. 2011), reflects the same
`
`confusion. Gov’t Br. 13. For one thing, Hutcheson explicitly declined to
`
`“address” whether “AKS compliance is, without more, a precondition of
`
`Medicare payment.” 647 F.3d at 392. The court held only that the
`
`defendants could be held liable for violating an express “contract term”
`
`that conditioned payment on “the underlying transaction complying with
`
`. . . the Federal anti-kickback statute.” Id. at 381-82, 392-94 (quotation
`
`marks omitted).
`
` That aside, Hutcheson held that a device manufacturer that
`
`violated the AKS could be liable under the FCA for “causing” hospitals to
`
`submit false claims, even if the hospitals themselves were not aware of
`
`the manufacturer’s AKS violation. Id. at 388-91. The hospitals’ innocence
`
`had nothing to do with whether the AKS violation was the but-for cause
`
`of the hospitals’ services. The Hutcheson plaintiff alleged that the
`
`defendant “paid kickbacks to doctors” and that “as a result of the
`
`kickbacks, doctors across the country had performed spinal surgeries on
`
`Medicare and Medicaid patients using [its] devices.” Id. at 380-81
`
`(emphasis added). If kickbacks caused the doctors to perform surgeries
`
`15
`
`

`

`Case: 23-2086 Document: 00118147549 Page: 22 Date Filed: 05/22/2024 Entry ID: 6643957
`
`
`and the doctors’ hospitals billed the government for those surgeries, then
`
`the kickbacks were the but-for cause of the items and services in the
`
`hospitals’ claims even if the hospitals did not know about them. See also
`
`id. at 393 (holding that because the “‘underlying transaction’ violated the
`
`AKS,” “resulting claims were ineligible for payment” (emphasis added)).
`
`The bottom line is that the “ordinary meaning” of § 1320a-7b(g)’s
`
`phrase “resulting from” requires but-for causation, and the government
`
`identifies no genuine “textual or contextual indication” that Congress
`
`intended a different meaning. Burrage, 571 U.S. at 212. Congress could
`
`have written § 1320a-7b(g) to impose some other standard, but “[i]t chose
`
`instead to use language that imports but-for causality.” 571 U.S. at 216.
`
`This Court should honor that choice and hold that a claim is “false or
`
`fraudulent” under § 1320a-7b(g) only if an AKS violation was, at a
`
`minimum, the but-for cause of the “items or services” in the claim.
`
`II. The government’s interpretation would lead to an explosion
`of meritless and costly qui tam actions.
`Although the United States filed this case, the vast majority of FCA
`
`actions—70 percent of them since 1986—are initiated by private
`
`16
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`Case: 23-2086 Document: 00118147549 Page: 23 Date Filed: 05/22/2024 Entry ID: 6643957
`
`
`relators.6 And § 1320a-7b(g) applies equally to both government-initiated
`
`and qui tam actions. By relieving FCA plaintiffs from any obligation to
`
`plead and prove but-for causation, the government’s interpretation of
`
`§ 1320a-7b(g) would expose government contractors to a flood of qui tam
`
`actions based on allegations of AKS violations.
`
`The FCA’s qui tam provisions create strong incentives for relators
`
`to bring even extraordinarily weak claims. Those provisions authorize
`
`private citizens who have suffered no injury to bring actions for treble
`
`damages and per-claim penalties of $13,508–$27,018—remedies that
`
`“are essentially punitive in nature.” Stevens, 529 U.S. at 784. If the
`
`United States intervenes, a relator keeps 15 to 25 percent of any recovery,
`
`as well as attorneys’ fees and costs; if the United States declines to
`
`intervene, a relator keeps up to 30 percent of any recovery, as well as fees
`
`and costs. 31 U.S.C. § 3730(d)(1)-(2). Even if a qui tam suit is doomed to
`
`fail, defendants face tremendous pressure to settle because the costs of
`
`litigating are so high and the potential downside so great. U.S. ex rel.
`
`Atkins v. McInteer, 470 F.3d 1350, 1359-60 (11th Cir. 2006). These
`
`
`6 U.S. Dep’t of Justice, Fraud Statistics – Overview (Oct. 1, 1986–Sept.
`30, 2023) (“DOJ Fraud Statistics”) at 3, https://www.justice.gov/opa/
`media/1339306/dl?inline.
`
`17
`
`

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`Case: 23-2086 Document: 00118147549 Page: 24 Date Filed: 05/22/2024 Entry ID: 6643957
`
`
`potential remedies, along with the ability to extract in terrorem
`
`settlements from innocent defendants, have led to an explosion in qui
`
`tam litigation, with 712 new cases filed in fiscal year 2023 alone. DOJ
`
`Fraud Statistics at 2.
`
`If § 1320a-7b(g) is interpreted to require only some amorphous non-
`
`causal connection between an alleged AKS violation and claims for
`
`

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