                                   In the

       United States Court of Appeals
                     For the Seventh Circuit
                         ____________________
No. 17-2562
UNITED STATES EX REL. JEFFREY BERKOWITZ,
                                                      Plaintiff-Appellant,


                                      v.

AUTOMATION AIDS, INC., et al.,
                                                   Defendants-Appellees.
                         ____________________

            Appeal from the United States District Court for the
              Northern District of Illinois, Eastern Division.
              No. 13-cv-08185 — Edmond E. Chang, Judge.
                         ____________________

       ARGUED FEBRUARY 14, 2018 — DECIDED JULY 25, 2018
                         ____________________

   Before EASTERBROOK and ROVNER, Circuit Judges, and
GRIESBACH, District Judge. *
   GRIESBACH, District Judge. Relator Jeffrey Berkowitz filed
a qui tam complaint against nine separate defendants, alleg-
ing violations of the False Claims Act (FCA), 31 U.S.C.


   *   Of the Eastern District of Wisconsin, sitting by designation.
2                                                No. 17-2562

§ 3730. The defendants moved to dismiss Berkowitz’ third
amended complaint for failure to state a claim. The district
court granted the defendants’ motions and dismissed the
case. We affirm.
                       I. Background
    Berkowitz is the president of Complete Packaging and
Shipping Supplies, Inc., a company that holds a General Ser-
vice Administration (GSA) multiple award schedule con-
tract. Under the GSA schedule contract, Complete Packaging
sells office supplies, packaging and shipping supplies, in-
formation technology products, and janitorial maintenance
supplies to various government agencies and departments.
The defendants—Automation Aids, Inc.; A&E Office and In-
dustrial Supply; Support of Microcomputers Associated;
Aprisa Technology LLC; Supply Saver Corporation; United
Office Solutions, Inc.; Vee Model Management Consulting;
Caprice Electronics, Inc.; and Computech Data Systems—
also hold separate GSA schedule contracts and compete with
Berkowitz’ company. Vendors with GSA schedule contracts
are responsible for complying with the requirements of the
Trade Agreements Act (TAA), 19 U.S.C. § 501 et seq. As rele-
vant to this case, GSA requires that a vendor only offer and
sell U.S.-made or other designated country end products to
governmental agencies in accordance with the TAA. The
Federal Acquisition Regulations (FAR) catalogues the desig-
nated countries for the purposes of the TAA and defines
“designated country end product” as a product made in a
designated country. FAR 52.225-5. It also requires that a ven-
dor’s GSA agreement contain a “Trade Agreements Certifi-
cate,” certifying that each end product sold through the GSA
services contract is a U.S.-made or designated country end
No. 17-2562                                                 3

product and explicitly listing the other end products that are
not U.S.-made or designated country end products. FAR
52.225-6.
   Once a vendor enters into a GSA schedule contract with
the government, the vendor uploads its price list to the GSA
Advantage online portal, GSA’s online shopping and order-
ing system. From there, government employees may pur-
chase millions of commercial products and services from the
vendors.
    According to Berkowitz, as early as 2005, he became
aware that other vendors offered and sold products from
non-designated countries, such as China or Thailand, to the
government. He claims he came to this realization by com-
paring the sales other vendors made on the GSA Advantage
online portal with certain product lists he obtained through
the normal course of his business that identify the country of
origin for various products. Berkowitz contends that while
he carefully screens out the non-compliant products he plac-
es on the online portal, he realized many other vendors were
not doing the same. As a result, he began compiling reports
that compared non-TAA compliant products with sales
made on GSA Advantage. He determined that the defend-
ants sold end products that were from non-designated coun-
tries.
    Berkowitz claims the defendants violated the FCA by
making material false statements and presenting false claims
to the United States. He alleges the defendants knowingly
sold products from non-designated countries to the govern-
ment even though they filed Trade Agreements Certificates,
in accordance with FAR 52.225-6, affirming they would only
sell products from designated countries. It therefore follows,
4                                                 No. 17-2562

Berkowitz contends, that any invoices the defendants sub-
mitted to the government for payment for products that did
not comply with the TAA constitute material false state-
ments as defined by the FCA. Berkowitz recognizes there are
limited exceptions to GSA’s restriction on buying non-
compliant products from vendors but asserts none of these
exceptions apply to the defendants.
   Berkowitz filed his complaint on November 14, 2013. On
January 13, 2016, the government elected not to intervene in
Berkowitz’ case. Berkowitz subsequently amended his com-
plaint multiple times and filed a third amended complaint,
the subject of the instant appeal, on April 4, 2016. He at-
tached as exhibits to the complaint lists describing the num-
ber of alleged non-compliant products the defendants sold
as well as GSA notices advising certain defendants to re-
move non-compliant products from their product catalogs
maintained on the GSA Advantage online portal.
    All defendants, excluding Aprisa, moved to dismiss the
complaint for failure to state a claim under Rules 12(b)(6)
and 9(b) of the Federal Rules of Civil Procedure. Aprisa filed
a motion to dismiss under Rule 12(b)(1) asserting the district
court lacked subject matter jurisdiction over Berkowitz’
claims against it. On March 16, 2017, the district court denied
Aprisa’s 12(b)(1) motion but granted the other defendants’
Rule 12(b)(6) motions to dismiss and dismissed Berkowitz’
claims against them with prejudice. Aprisa then filed a mo-
tion to dismiss under Rule 12(b)(6). The district court grant-
ed the motion on July 12, 2017 and dismissed Berkowitz’
complaint with prejudice.
No. 17-2562                                                    5

                          II. Analysis
    We review the district court’s grant of a motion to dismiss
pursuant to Rule 12(b)(6) of the Federal Rules of Civil Proce-
dure de novo. Volling v. Kurtz Paramedic Servs., Inc., 840 F.3d
378, 382 (7th Cir. 2016). In construing the complaint, we ac-
cept all of the well-pleaded facts as true and “draw all rea-
sonable inferences in favor of the plaintiff.” Kubiak v. City of
Chicago, 810 F.3d 476, 480–81 (7th Cir. 2016). To survive a mo-
tion to dismiss, the complaint must contain sufficient factual
information to “state a claim to relief that is plausible on its
face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007).
“Threadbare recitals of the elements of a cause of action,
supported by mere conclusory statements, do not suffice.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In other words, a
claim has facial plausibility when “the plaintiff pleads factu-
al content that allows the court to draw the reasonable infer-
ence that the defendant is liable for the misconduct alleged.”
Id.
    Because Berkowitz’ claims arise under the FCA, an anti-
fraud statute, they are subject to the heightened pleading re-
quirements of Rule 9(b). United States ex rel. Gross v. AIDS
Research Alliance—Chicago, 415 F.3d 601, 604 (7th Cir. 2005).
Under Rule 9(b), a plaintiff “alleging fraud or mistake …
must state with particularity the circumstances constituting
fraud or mistake.” Fed. R. Civ. P. 9(b). The plaintiff must de-
scribe the “who, what, when, where, and how” of the
fraud—“the first paragraph of any newspaper story.” United
States ex rel. Lusby v. Rolls–Royce Corp., 570 F.3d 849, 853 (7th
Cir. 2009) (internal quotation marks omitted). What consti-
tutes “particularity,” however, may depend on the facts of a
given case. See Pirelli Armstrong Tire Corp. Retiree Med. Bene-
6                                                     No. 17-2562

fits Trust v. Walgreens Co., 631 F.3d 436, 442 (7th Cir. 2011) (ci-
tations omitted). Plaintiffs must “use some … means of in-
jecting precision and some measure of substantiation into
their allegations of fraud.” United States ex rel. Presser v. Aca-
cia Mental Health Clinic, LLC, 836 F.3d 770, 776 (7th Cir. 2016)
(quoting 2 James Wm. Moore et al., MOORE’S FEDERAL
PRACTICE § 9.03[1][b], at 9–22 (3d ed. 2015)). The heightened
pleading requirement in fraud cases “forces the plaintiff to
conduct a careful pretrial investigation” to minimize the risk
of damage associated with a baseless claim. Fidelity Nat’l Ti-
tle Ins. Co. of N.Y. v. Intercounty Nat’l Title Ins. Co., 412 F.3d
745, 748–49 (7th Cir. 2005).
    The FCA allows private persons, or relators, to prosecute
qui tam actions “against alleged fraudsters on behalf of the
United States government.” United States ex rel. Watson v.
King–Vassel, 728 F.3d 707, 711 (7th Cir. 2013); 31 U.S.C. § 3730.
If the government does not intervene in the action, as is the
case here, the relator may proceed with the case on his own,
though still on behalf of the government. 31 U.S.C.
§ 3730(c)(3). If the action is successful, the relator is eligible
to receive a percentage of the recovery. Id. § 3730(d)(1)–(2).
    The fraudulent conduct alleged in Berkowitz’ complaint
appears to be governed by both the current FCA statute,
which was amended in 2009 by the Fraud Enforcement Re-
covery Act, and the pre-amendment statute. Prior to the
amendment, the FCA limited liability to an individual who
“knowingly presents, or causes to be presented, to an officer
or employee of the United States Government or a member
of the Armed Forces of the United States a false or fraudu-
lent claim for payment or approval” or “knowingly makes,
uses, or causes to be made or used, a false record or state-
No. 17-2562                                                    7

ment to get a false or fraudulent claim paid or approved by
the government.” 31 U.S.C. § 3729(a)(1)–(3) (2006). Under the
current version of the statute, which applies only to claims
pending on or after June 7, 2008, a person is liable under the
FCA if he “knowingly presents, or causes to be presented, a
false or fraudulent claim for payment or approval” or
“knowingly makes, uses, or causes to be made or used, a
false record or statement material to a false or fraudulent
claim.” 31 U.S.C. § 3729(a)(1)(A)–(B). Both versions of the
FCA define “knowledge” or “knowingly” to encompass the
conduct of an individual who either has “actual knowledge
of the information,” “acts in deliberate ignorance of the truth
or falsity of the information,” or “acts in reckless disregard
of the truth or falsity of the information.” Id. § 3729(b)(1)(A).
    Berkowitz asserts four counts under both versions of the
statute based on when the defendants’ alleged fraudulent
activity occurred. To state an FCA claim under either version
of the statute, Berkowitz must allege the following essential
elements with particularity: “(1) the defendant made a
statement in order to receive money from the government;
(2) the statement was false; and (3) the defendant knew the
statement was false.” Gross, 415 F.3d at 604 (citing 31 U.S.C.
§ 3729(a)(2); United States ex rel. Lamers v. City of Green Bay,
168 F.3d 1013, 1018 (7th Cir. 1999)).
    Berkowitz concedes he cannot allege that the defendants
made any express misrepresentations to the government. In-
stead, his claims are premised on an implied false certifica-
tion theory. The Supreme Court recently recognized that this
theory may be a basis for FCA liability when a defendant not
only requests payment on a claim “but also makes specific
representations about the goods or services provided” and
8                                                     No. 17-2562

“the defendant’s failure to disclose noncompliance with ma-
terial statutory, regulatory, or contractual requirements
makes those representations misleading half-truths.” Univer-
sal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct.
1989, 2001 (2016). Though Universal Health clarified the cir-
cumstances under which a plaintiff may proceed on an im-
plied false certification claim, its analysis does not change
the fact that a plaintiff must sufficiently plead the essential
elements of an FCA claim.
    We must therefore consider whether the third amended
complaint states, with sufficient particularity, the facts neces-
sary to demonstrate that the defendants knowingly made
false statements to receive payment from the government.
Berkowitz alleges that the defendants knowingly or with
gross disregard sold products from non-designated coun-
tries to the government and presented false claims for the
payment for the sale of these items. Because the defendants
did not properly or truthfully complete the Trade Agree-
ments Certificate and offered and sold products from non-
designated countries in the face of misrepresentations and
omissions in their Trade Agreements Certificates, he contin-
ues, the defendants knowingly violated the FCA when they
submitted a claim to the government for payment and im-
pliedly certified that the products were compliant with TAA
regulations. The government then paid for the non-
compliant products and sustained damages because of the
defendants’ actions. If the defendants had properly identi-
fied the non-compliant products prior to their sale, the entire
offer would have been rejected or subject to a non-
availability analysis.
No. 17-2562                                                      9

     Though Berkowitz alleges the defendants defrauded the
government by knowingly submitting false statements for
payment, the third amended complaint does not contain the
underlying details of the fraud scheme. What the complaint
fails to allege are any specific facts demonstrating what oc-
curred at the individualized transactional level for each de-
fendant. Berkowitz contends that the Rule 9(b) standard
should be relaxed in this context because, as one of the de-
fendants’ competitors, he does not have access to the de-
tailed information that would substantiate his claims. In-
deed, this court has recognized that a party may make alle-
gations on information and belief in the fraud context when
“(1) the facts constituting the fraud are not accessible to the
plaintiff and (2) the plaintiff provides the grounds for his
suspicions.” Pirelli, 631 F.3d at 442 (citing Uni*Quality, Inc. v.
Infotronx, Inc., 974 F.2d 918, 924 (7th Cir. 1992)). Even under
this standard, however, the relator must still describe the
predicate acts with some specificity to inject “precision and
some measure of substantiation” into his allegations of
fraud. Presser, 836 F.3d at 776 (citation omitted); see also Pirel-
li, 631 F.3d at 443 (“The grounds for the plaintiff’s suspicions
must make the allegations plausible, even as courts remain
sensitive to information asymmetries that may prevent a
plaintiff from offering more detail.”). Berkowitz has not
done so here.
    Berkowitz alleges that he compiled reports showing the
defendants sold thousands of non-compliant products over a
three-year period. He does not, however, describe the nature
of the product lists he used to assist in the compilation of the
reports, indicate how these lists relate to the defendants’ ac-
tual sales, or say what particular information any sales or-
ders submitted by the defendants contained. The fact that
10                                                    No. 17-2562

the defendants may have sold non-compliant products dur-
ing a certain time period in violation of the TAA does not
equate to the defendants making a knowingly false state-
ment in order to receive money from the government.
    In Universal Health, the Court suggested that “concerns
about fair notice and open-ended liability [in FCA cases
based on an implied false certification theory should] be ’ef-
fectively addressed through strict enforcement of the Act’s
materiality and scienter requirements.’” 136 S. Ct. at 2002
(quoting United States v. Science Applications Int’l Corp., 626
F.3d 1257, 1270 (D.C. Cir. 2010)). That is what the district
court did here. At most, Berkowitz’ allegations amount to
claims that the defendants made mistakes or were negligent.
This alone is insufficient to infer fraud under the FCA. Unit-
ed States ex rel. Fowler v. Caremark RX, L.L.C., 496 F.3d 730, 742
(7th Cir. 2007), overruled on other grounds by Glaser v. Wound
Care Consultants, Inc., 570 F.3d 907 (7th Cir. 2009) (noting that
“‘innocent’ mistakes or negligence are not actionable” under
FCA (citations omitted)). The FCA is not “‘an all-purpose an-
tifraud statute’ … or a vehicle for punishing garden-variety
breaches of contract or regulatory violations.” Universal
Health, 136 S. Ct. at 2003; see also United States ex rel. Yannaco-
poulos v. Gen. Dynamics, 652 F.3d 818, 832 (7th Cir. 2011) (The
FCA “does not penalize all factually inaccurate statements,
but only those statements made with knowledge of their fal-
sity.”). This court has recognized that a violation of a regula-
tion “is not synonymous with filing a false claim.” United
States ex rel. Grenadyor v. Ukrainian Vill. Pharmacy, Inc., 772
F.3d 1102, 1107 (7th Cir. 2014). If this were the standard, eve-
ry allegedly inaccurate claim would transform “into a false
claim and consequently replace the Act’s knowledge re-
quirement with a strict liability standard.” Fowler, 496 F.3d at
No. 17-2562                                                  11

743; see also United States ex rel. Main v. Oakland City Univ.,
426 F.3d 914, 917 (7th Cir. 2005) (“[F]raud requires more than
breach of promise: fraud entails making a false representa-
tion, such as a statement that the speaker will do something
it plans not to do. Tripping up on a regulatory complexity
does not entail a knowingly false representation.”). Without
any specific allegations regarding the particularities of the
fraud scheme, Berkowitz cannot satisfy the requirements of
Rule 9(b) for these claims.
    Even if he did not sufficiently plead that the defendants
had actual knowledge of the false information, Berkowitz
maintains that he has alleged that the defendants acted with
reckless disregard of the truth or falsity of the information.
This court has recognized that “a person acts with reckless
disregard ‘when the actor knows or has reason to know of
facts that would lead a reasonable person to realize’ that
harm is the likely result of the relevant act.” Watson, 728 F.3d
at 713 (quoting BLACK’S LAW DICTIONARY 540–41 (9th ed.
2009)). In other words, Berkowitz is only required to allege
that the defendants “had reason to know of facts that would
lead a reasonable person to realize that [the defendants
were] causing the submission of a false claim … or that [the
defendants] failed to make a reasonable and prudent inquiry
into that possibility.” Id.
    To establish that the defendants acted with reckless dis-
regard, Berkowitz relies on GSA notices directing certain de-
fendants to remove non-compliant products from their GSA
Advantage online portal product inventories. But these no-
tices were sent to some, not all, of the defendants. In addi-
tion, Berkowitz does not allege that, after being instructed to
remove non-compliant products from their lists, the defend-
12                                                 No. 17-2562

ants who received the notices subsequently submitted claims
for payment for these products anyway or that any of the
defendants received non-compliant warnings regarding ac-
tual product sales. It also seems worth noting that the fact
that the government has allegedly paid millions of dollars
for the non-compliant products suggests that Berkowitz
cannot satisfy the materiality prong of the implied certifica-
tion theory. See Universal Health, 136 S. Ct. at 2002–03 (It is
not enough to demonstrate that “the Government would
have the option to decline to pay if it knew of the defend-
ant’s noncompliance. … [M]ateriality looks to the effect on
the likely or actual behavior of the recipient of the alleged
misrepresentation.”). Setting materiality aside, however,
Berkowitz has not alleged that the defendants acted with
reckless disregard of the truth or falsity of the information
they provided to the government. Simply put, Berkowitz has
failed to plead the elements of an FCA claim with particular-
ity.
    We acknowledge that it is difficult for a relator to allege
with accuracy what occurs inside a competitor’s operations.
But this difficulty does not relieve Berkowitz of his obliga-
tion to adequately plead all of the elements of an FCA claim
or to fully investigate his claim before filing a complaint. See
Ackerman v. Nw. Mut. Life Ins. Co., 172 F.3d 467, 469 (7th Cir.
1999) (“The purpose … of the heightened pleading require-
ment in fraud cases is to force the plaintiff to do more than
the usual investigation before filing his complaint.”).
   One final point warrants comment. Berkowitz hints in his
reply brief that he offered to cure any perceived pleading
deficiencies through the filing of an amended complaint, but
the district court denied his request for leave to amend and
No. 17-2562                                                    13

dismissed the complaint with prejudice. Arguments raised
for the first time in an appellate reply brief are waived. Hess
v. Reg–Ellen Mach. Tool Corp., 423 F.3d 653, 665 (7th Cir. 2005).
Even reaching the merits, Berkowitz has not established that
the district court erred in denying him leave to file a fourth
amended complaint. “We review a district court’s denial of
leave to amend for abuse of discretion and reverse only if no
reasonable person could agree with that decision.” Huon v.
Denton, 841 F.3d 733, 745 (7th Cir. 2016) (quoting Schor v. City
of Chicago, 576 F.3d 775, 780 (7th Cir. 2009)). The district court
explained in denying his request to amend that Berkowitz
did not actually specify what the additional allegations
might be and that he had ample opportunity to cure the de-
ficiencies in his complaint through his previous amend-
ments. In short, the district court did not err in denying
leave to amend.
   For the above reasons, the decision of the district court is
AFFIRMED.
