United States Court of Appeals
For the First Circuit
No. 06-2627
UNITED STATES OF AMERICA EX REL. PETER ROST,
Plaintiff, Appellant,
v.
PFIZER, INC.; PHARMACIA CORPORATION,
Defendants, Appellees.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Joseph L. Tauro, U.S. District Judge]
Before
Torruella, Circuit Judge,
Cyr, Senior Circuit Judge,
and Lynch, Circuit Judge.
Mark I. Labaton with whom Megan Benett, Hilary B. Taylor, and
Kreindler & Kreindler LLP were on brief for appellant.
Jamie Ann Yavelberg, Attorney, with whom Peter D. Keisler,
Acting Attorney General, Michael J. Sullivan, United States
Attorney, Douglas N. Letter, Attorney, and Michael D. Granston,
Attorney, Civil Division, Department of Justice, were on brief for
United States, amicus curiae.
Ethan M. Posner with whom Carolyn F. Corwin, Tara M. Steeley,
Mark W. Mosier, and Covington & Burling LLP were on brief for
appellees.
Mary Ita Snyder, Timothy J. Hatch, James C. Dougherty, Karen
L. Manos, Minodora D. Vancea, and Gibson, Dunn & Crutcher LLP on
brief for National Defense Industrial Association, amicus curiae.
Jonathan L. Diesenhaus, Catherine E. Stetson, Jessica L.
Ellsworth, Jake M. Shields, Hogan & Hartson LLP, Diane E. Bieri,
Melinda Reid Hatton, and Maureen D. Mudron were on brief for
Pharmaceutical Research and Manufacturers of America and American
Hospital Association, amici curiae.
November 15, 2007
LYNCH, Circuit Judge. Dr. Peter Rost filed this
whistleblower action against Pfizer, Inc. and its subsidiary
Pharmacia Corporation under the federal False Claims Act ("FCA"),
31 U.S.C. § 3729 et seq., and analogous state statutes. The suit
alleges that Pharmacia's misconduct in marketing a human growth
hormone, Genotropin, for uses unapproved by the Food and Drug
Administration led to claims for reimbursement to the United States
for unreimbursable, off-label drug prescriptions.
The district court rejected defendants' argument that the
suit be dismissed for lack of jurisdiction under 31 U.S.C.
§ 3730(e)(4), but granted the motion to dismiss on the ground that
Rost's complaint failed to meet the pleading requirements for
allegations of fraud under Federal Rule of Civil Procedure 9(b).
United States ex rel. Rost v. Pfizer Inc., 446 F. Supp. 2d 6, 28
(D. Mass. 2006).
Rost's appeal urges reversal of that holding. Pfizer,
supported by two sets of amici, agrees that Rost's complaint fails
the pleading standard of Rule 9(b) -- but claims error by the
district court in deciding the threshold issue of whether one of
the FCA's jurisdictional bars, see 31 U.S.C. § 3730(e)(4), applies
to Rost's suit. The United States, appearing as amicus, argues for
affirmance on the jurisdictional ground and notes that the Rule
9(b) ruling is consistent with the law of this circuit. The
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jurisdictional bar issue raises questions of statutory
interpretation unresolved in this circuit.
We affirm the decision of the district court that
§ 3730(e)(4) does not bar Rost's suit. We also agree that the
complaint fails to meet the heightened pleading standard for FCA
claims, but remand so that the district court may consider Rost's
request for leave to amend, which it did not address.
I.
Genotropin is a brand of synthetic human growth hormone
originally marketed by Pharmacia. The FDA has approved Genotropin
only for the treatment of three specific pediatric disorders and of
adult growth hormone deficiency. Physicians may prescribe
Genotropin for non-FDA-approved indications, but the Food, Drug &
Cosmetic Act ("FDCA"), 21 U.S.C. § 321 et seq., prohibits
pharmaceutical companies from marketing drugs for such "off-label"
uses. In addition, Medicaid generally does not reimburse patients
for off-label prescriptions. See 42 U.S.C. §§ 1396b(i)(10), 1396r-
8(k)(3), (k)(6).1 There is a wide and lucrative market for off-
label uses of human growth hormone. One such use is to slow the
effects of aging in adults. Also, some parents request the drug to
boost the growth of short children, even absent a hormonal
1
Medicaid reimbursement is available for certain off-label
uses that are medically "essential" or recognized within one of
several medical compendia. See 42 U.S.C. § 1396r-8(a)(3),
(g)(1)(B)(i), (k)(6). Such uses are not at issue in this case.
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deficiency. Sales to the domestic market for off-label uses
significantly enhance the profitability of synthetic human growth
hormone.
Rost joined Pharmacia in 2001 as Vice President of
Marketing in the company's Endocrine Care unit. Among his
responsibilities was oversight of global marketing for Genotropin.
Rost soon became concerned that subordinates in charge of marketing
Genotropin within the United States were utilizing problematic
tactics. Pharmacia sales representatives received incentive
payments for each new patient prescribed Genotropin, whether for
on- or off-label uses.
Rost also suspected Pharmacia of using a Genotropin
"study program" to funnel improper payments to doctors for
prescribing the drug. Every doctor that prescribed Genotropin
became eligible to participate in the program, which collected data
about patients with growth disorders who took Genotropin.
Participating doctors would receive a cash payment for every
patient to whom they prescribed Genotropin and enrolled in the
study. Doctors participating in the study program also received
all-expenses-paid trips to conferences at luxury resorts where,
among other Genotropin-related topics, doctors would discuss off-
label uses of the drug.
In addition, Rost discovered that Pharmacia granted
financial incentives to distributors targeting the off-label market
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for human growth hormone. These discount pricing contracts and
rebates benefitted "anti-aging" clinics, internet-based vendors,
and others unlikely to dispense Genotropin for its FDA-approved
uses. Rost feared these incentives subsidized the off-label market
for Genotropin.
The company hired physicians and others as "independent
consultants" to promote Genotropin for off-label uses. For
instance, Pharmacia retained a company in Canada to create
marketing materials touting Genotropin's anti-aging uses.
Pharmacia also made substantial payments to the director of several
anti-aging clinics in Florida.
Rost believed these practices ran afoul of the FDCA.
See, e.g., 21 U.S.C. §§ 331, 355 (prohibiting interstate
distribution of drugs that have not undergone FDA approval
process); id. § 333 (providing criminal penalties for such
distribution). Rost also believed these practices were suspect
under the anti-kickback statute, 42 U.S.C. § 1320a-7b(b), which
criminalizes the payment of kickbacks, bribes, or other inducements
to doctors in an effort to influence decisions about prescriptions
that are reimbursed by a federal health care program.
Rost reported his concerns up the chain of management at
Pharmacia. The company initiated an internal investigation and cut
back on the problematic marketing activity. Rost, however,
remained skeptical of some continuing practices.
-6-
In July 2002, Pfizer announced it would acquire
Pharmacia. In meetings with Pfizer personnel during October and
November of 2002, Rost and other Pharmacia employees aired their
concerns about Genotropin marketing. Rost also wrote to a Pfizer
marketing executive in early 2003 regarding Pharmacia's off-label
sale and marketing of Genotropin.
Pfizer completed its acquisition of Pharmacia on April
16, 2003. Pfizer immediately initiated an internal investigation
into the legacy marketing practices of its new subsidiary. It also
moved quickly to inform the relevant federal authorities about
potential problems.
On May 16, 2003, Pfizer contacted two separate offices
within the Department of Health and Human Services ("HHS")
regarding Pharmacia's problematic marketing practices. One was the
FDA's Division of Drug Marketing, Advertising, and Communications
("DDMAC"), to which Pfizer wished to disclose information regarding
the off-label marketing and distribution of Genotropin. Pfizer
followed up on May 19, 2003, with a confidential letter to the
DDMAC and the FDA's Office of Chief Counsel. The letter summarized
Pharmacia's past off-label sales to anti-aging doctors and clinics,
referring to the improper discount contracts and to sales
representatives who focused their marketing efforts on the off-
label market. The letter also described remedial measures taken by
Pharmacia and Pfizer.
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Pfizer also contacted on May 16, 2003, the HHS Office of
Inspector General ("OIG"), which is charged with investigating and
preventing fraud in federal health care programs such as Medicare
and Medicaid. The OIG administers a voluntary disclosure program
to encourage health care providers to inform the office of
fraudulent conduct, and Pfizer sought to enter the program. Pfizer
representatives met with OIG officials on May 21, 2003, to discuss
the off-label marketing of Genotropin and various forms of improper
payments to prescribing physicians. The OIG officials informed
Pfizer that an investigative agent had been assigned to the matter
and invited Pfizer to submit a letter requesting admission into the
voluntary disclosure program. In another confidential letter sent
to the OIG on June 3, 2003, Pfizer identified three areas of
potential misconduct related to Pharmacia's promotion of
Genotropin: first, payments made to physicians in the form of
consulting contracts and "professional or educational" junkets;
second, payments for participating in the Genotropin study program,
which the letter acknowledged may have been motivated by "sales and
marketing concerns"; and third, Pharmacia's engagement of "outside
entities to provide product support services" for Genotropin to
physicians. Pfizer sent a copy of the letter to the Civil Fraud
Section of the Department of Justice.
Pfizer continued its internal investigation into
Pharmarcia's former marketing practices after its correspondence to
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the HHS but did not make any public announcement regarding
Genotropin at that time. Pfizer first disclosed problems with
Genotropin marketing in a publicly available document on March 10,
2004, in materials appended to a Form 10-K filed with the
Securities and Exchange Commission. That document states that
Pfizer "recently was notified that the U.S. Department of Justice
is conducting investigations relating to the marketing and sale of
Genotropin . . . . [Pfizer is] cooperating in these
investigations."
In April 2007, the U.S. Attorney's Office for
Massachusetts announced that Pfizer would plead guilty and pay a
fine in response to a criminal charge for violating the anti-
kickback statute through Genotropin-related payments to doctors.
Pfizer simultaneously entered into a Deferred Prosecution Agreement
with the government as to a criminal information charging the
company with one count of violating the FDCA for off-label
promotion and distribution of Genotropin. Pfizer paid the
government a total of $34.7 million to resolve Genotropin-related
investigations conducted over four years by the HHS, DOJ, and FBI.
Rost had begun considering a False Claims Act lawsuit in
late 2002. Rost filed his qui tam complaint on June 5, 2003, in
camera and under seal pursuant to 31 U.S.C. § 3730(b)(2). The FCA
requires a private plaintiff bringing a claim under the Act to file
a complaint under seal and serve the government with "the complaint
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and written disclosure of substantially all material evidence and
information" underlying the complaint, a procedure designed to
allow the government to decide whether to intervene in the action.
31 U.S.C. § 3730(b)(2); see also United States ex rel. Karvelas v.
Melrose-Wakefield Hosp., 360 F.3d 220, 225 (1st Cir. 2004).
The United States spent more than two years investigating
the allegations in Rost's complaint and considering whether to
intervene in the action. On November 8, 2005, the United States
notified the district court that it would not intervene. Two days
later, the court ordered Rost's complaint unsealed and served on
the defendants.
The complaint pleads claims for damages under the FCA and
the statutes of ten states and the District of Columbia.2 Rost
bases those claims on marketing practices that he previously
brought to the attention of Pharmacia and Pfizer management:
encouraging sales representatives to promote Genotropin for off-
2
Rost pleads state-law claims under the California False
Claims Act, Cal. Gov't Code § 12651(a)(1)-(2), the Delaware False
Claims and Reporting Act, 6 Del. Code Ann. tit. 6, § 1201(a)(1)-
(2), the Florida False Claims Act, Fla. Stat. Ann. § 68.082(2), the
Hawaii False Claims Act, Haw. Rev. Stat. § 661-21(a), the Illinois
Whistleblower Reward and Protection Act, 740 Ill. Comp. Stat.
§ 175/3(a)(1)-(2), the Massachusetts False Claims Law, Mass. Gen.
Laws ch. 12, § 5B(1)-(2), the Nevada False Claims Act, Nev. Rev.
Stat. Ann. § 357.040(1)(a)-(b), the Tennessee Medicaid False Claims
Act, Tenn. Code Ann. § 71-5-182(a)(1), the Texas Medicaid Fraud
Prevention Law, Tex. Hum. Res. Code Ann. § 36.002, the Virginia
Fraud Against Taxpayers Act, Va. Code Ann. § 8.01-216.3(A)(1)-(2),
and the District of Columbia Procurement Reform Amendment Act, D.C.
Code Ann. § 2-308.14(a)(1)-(2).
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label uses, making payments and other inducements to doctors
through the Genotropin research program, granting discounts and
rebates to distributors known to target the off-label market, and
hiring physicians as "independent consultants" to promote and
prescribe Genotropin for off-label uses. The complaint alleges
that Pharmacia knew a significant portion of its sales were for
off-label uses because it maintains a database containing
information on 30,000 patients prescribed Genotropin. That
information includes the identity of the prescribing doctor, the
primary and secondary diagnosis, and the dosage prescribed. The
complaint alleges that the database reveals that approximately
sixty percent of all adult and twenty-five percent of all pediatric
sales of Genotropin were for off-label uses.
The complaint does not allege Pharmacia itself ever
submitted false claims. It alleges that Pharmacia knowingly caused
the submission of fraudulent claims by others to the government in
the form of claims for reimbursement for off-label prescriptions of
Genotropin. The complaint does not identify any false claim
presented by others to any government health program or any
particular entity or person who actually submitted such a claim.
Instead, the complaint pleads that "[t]he false claims were
presented by thousands of separate entities, across the United
States, and over many years. [Rost] has no control over or
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dealings with such entities and [has] no access to the records in
their possession."
Pfizer moved to dismiss the complaint for lack of subject
matter jurisdiction and for failure to meet the Rule 9(b) pleading
requirements for allegations of fraud. On the first point, Pfizer
argued that its communications with government officials
constituted "public disclosures" triggering the jurisdictional bar
of 31 U.S.C. § 3730(e)(4)(A), and that Rost did not qualify as an
"original source" for the information in his complaint so as to
exempt him from the bar, see id. § 3730(e)(4)(B).
The district court held that Pfizer's confidential
disclosures to the HHS and DOJ were not "public disclosures" that
would trigger the FCA's jurisdictional bar but granted dismissal on
the Rule 9(b) grounds. Rost, 446 F. Supp. 2d at 18, 28.
II.
The False Claims Act prohibits the knowing submission of
false or fraudulent claims for payment, or causing the submission
of such claims, to the federal government and prescribes fines and
treble damages to penalize offenders. 31 U.S.C. § 3729(a).3
3
The Act states, in relevant part,
Any person who --
(1) knowingly presents, or causes to be
presented, to an officer or employee of the
United States Government . . . a false or
fraudulent claim for payment or approval; [or]
(2) knowingly makes, uses, or causes to
be made or used, a false record or statement
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Violations of the Act may be enforced by civil actions initiated by
either the Attorney General, id. § 3730(a), or a private person,
id. § 3730(b). In the latter category of qui tam4 actions, the Act
affords the government an opportunity to evaluate the relator's
complaint and decide whether to assume primary responsibility for
prosecuting the action. Id. § 3730(b)(2), (b)(4), (c)(1). A
private relator is entitled to a portion of any proceeds from the
suit, whether the United States intervenes as an active participant
in the action or not. If the government intervenes, the Act grants
between 15 and 25% of the government's damages (or settlement
amount) to the relator. Id. § 3730(d)(1). If the government does
not intervene, as here, the relator is entitled to between 25 and
30% of the recovery. Id. § 3730(d)(2). In either case, the Act
requires defendants to pay attorneys' fees for a successful qui tam
plaintiff. Id. § 3730(d)(1)-(2).
to get a false or fraudulent claim paid or
approved by the Government;
. . .
is liable to the United States Government for
a civil penalty of not less than $5,000 and
not more than $10,000, plus 3 times the amount
of damages which the Government sustains
because of the act of that person . . . .
31 U.S.C. § 3729(a).
4
"Qui tam" comes from the phrase "qui tam pro domino rege
quam pro se ipso in hac parte sequitur," which translates as "who
pursues this action on our Lord the King's behalf as well as his
own." Rockwell Int'l Corp. v. United States, 127 S. Ct. 1397, 1403
n.2 (2007).
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The qui tam provisions of the FCA supplement federal law
enforcement resources by encouraging private citizens to uncover
fraud on the government. Karvelas, 360 F.3d at 224 & n.5. The qui
tam mechanism has historically been susceptible to abuse, however,
by "parasitic" relators who bring FCA damages claims based on
information within the public domain or that the relator did not
otherwise discover. See United States ex rel. S. Prawer & Co. v.
Fleet Bank of Me., 24 F.3d 320, 324-26 (1st Cir. 1994) (summarizing
history of FCA litigation and legislative amendments). Congress
has tailored the FCA to "walk a fine line between encouraging
whistle-blowing and discouraging opportunistic behavior." Id. at
326 (quoting United States ex rel. Springfield Terminal Ry. Co. v.
Quinn, 14 F.3d 645, 651 (D.C. Cir. 1994)). The current Act
contains a series of jurisdictional bars designed in part to
mediate that fine line. See 31 U.S.C. § 3730(e).
The Act does not create a cause of action against all
fraudulent conduct affecting the government. Karvelas, 360 F.3d at
225. Rather, FCA liability attaches to a "false or fraudulent
claim for payment" or to a "false record or statement [made] to get
a false or fraudulent claim paid" by the government. 31 U.S.C.
§ 3729(a)(1)-(2); see also Karvelas, 360 F.3d at 225 ("Evidence of
an actual false claim is 'the sine qua non of a False Claims Act
violation.'") (quoting United States ex rel. Clausen v. Lab. Corp.
of Am., Inc., 290 F.3d 1301, 1311 (11th Cir. 2002)). FCA liability
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does not attach to violations of federal law or regulations, such
as marketing of drugs in violation of the FDCA, that are
independent of any false claim.
A. Jurisdictional Bar
The threshold question in a False Claims Act case is
whether the statute bars jurisdiction. Rockwell Int'l Corp. v.
United States, 127 S. Ct. 1397, 1405-07 (2007). The relevant bar,
contained in 31 U.S.C. § 3730(e)(4)(A) and (B), provides:
(4)(A) No court shall have jurisdiction over
an action under this section based upon the
public disclosure of allegations or
transactions in a criminal, civil, or
administrative hearing, in a congressional,
administrative, or Government Accounting
Office report, hearing, audit, or
investigation, or from the news media, unless
the action is brought by the Attorney General
or the person bringing the action is an
original source of the information.
(B) For purposes of this paragraph, "original
source" means an individual who has direct and
independent knowledge of the information on
which the allegations are based and has
voluntarily provided the information to the
Government before filing an action under this
section which is based on the information.
Our case turns on the "public disclosure" language of
§ 3730(e)(4)(A). Pfizer asserts that its self-disclosure to HHS
and DOJ, the appropriate investigative bodies, constitutes "public
disclosure of allegations" in an appropriate government
investigation setting under § 3730(e)(4)(A) and thus bars the
action.
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Analysis of § 3730(e)(4)(A) requires several inquiries:
(1) whether there has been public disclosure of the allegations or
transactions in the relator's complaint; (2) if so, whether the
public disclosure occurred in the manner specified in the statute;
(3) if so, whether the relator's suit is "based upon" those
publicly disclosed allegations or transactions; and (4) if the
answers to these questions are in the affirmative, whether the
relator falls within the "original source" exception as defined in
§ 3730(e)(4)(B). We reach only the first question. Our case law
has not previously defined the term "public disclosure."
The question here is whether self-disclosure made by a
private party only to government agencies, without further
disclosure, is "public disclosure."5 In our view, a "public
disclosure" requires that there be some act of disclosure to the
public outside of the government. The mere fact that the
disclosures are contained in government files someplace, or even
that the government is conducting an investigation behind the
5
It could be that disclosure in the form of a filing to a
government body such as a court (not under seal) where all records
are public could be public disclosure. See Springfield Terminal,
14 F.3d at 652; United States ex rel. Stinson, Lyons, Gerlin &
Bustamante, P.A. v. Prudential Ins. Co., 944 F.2d 1149, 1155-56 (3d
Cir. 1991). It could also be that when the government itself makes
available to the public information which has been disclosed to it,
say in response to a FOIA request, the later disclosure by the
government constitutes a public disclosure. See United States ex
rel. Schumer v. Hughes Aircraft Co., 63 F.3d 1512, 1519-20 (9th
Cir. 1995), vacated on other grounds, 520 U.S. 939 (1997). These
are not our case.
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scenes, does not itself constitute public disclosure. Our
construction of the term "public disclosure" does not turn on the
fact that Pfizer requested or assumed that its disclosures to the
investigating agencies would be held confidential. The United
States has taken the litigation position in this action that
"public disclosure" does not include the disclosure from Pfizer to
the government that occurred here.6
Pfizer's reading is inconsistent with our understanding
of the language, structure, and history of the Act. The plain
language of the statute cuts against Pfizer's interpretation of the
public disclosure bar for several reasons. This court has already
held that "the logical reading is that the [public disclosure]
subsection serves to prohibit courts from hearing qui tam actions
based on information made available to the public during the course
of a government hearing, investigation or audit or from the news
media." United States ex rel. LeBlanc v. Raytheon Co., 913 F.2d
17, 20 (1st Cir. 1990). What Pfizer did was to make confidential
disclosures to the government, which triggered an investigation.
But the statute does not bar jurisdiction over qui tam actions
based on disclosures of allegations or transactions to the
government; it does so only for actions based on qualifying
6
The United States also argues that the district court
went too far in defining "public disclosure" as requiring that
disclosure be to "all members of the community or, in other words,
the general public." Rost, 446 F. Supp. 2d at 17. We agree.
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disclosures made to the public. If providing information to the
government were enough to trigger the bar, the phrase "public
disclosure" would be superfluous.
Pfizer's reading also equates the government with the
public; this is inconsistent with the rest of the statute.
Government may be of the people, by the people, and for the people,
but that does not mean the government and the public are the same.
As the United States, in opposing Pfizer's reading, notes, the
ordinary understanding of the term "public" means "something apart
from the government itself." Br. for United States as Amicus
Curiae Supp. Appellant 12; see also Black's Law Dictionary 1264
(8th ed. 2004) (defining "public" as "1. Relating or belonging to
an entire community, state, or nation. . . . 2. Open or available
for all to use, share, or enjoy."). The statute itself uses the
term "Government" numerous times and does not once equate the
government with the public. See, e.g., 31 U.S.C. § 3730(e)(4)(B)
("'[O]riginal source' means an individual who . . . has voluntarily
provided the information to the Government . . . ." (emphasis
added)). See generally id. § 3730 (delineating rights and
responsibilities of "the Government" under the FCA). If Congress
had wished to equate self-disclosure to the government with
disclosure to the public, it easily could have done so.
To the extent there is any material ambiguity in the term
"public disclosure" on these facts, we find that Pfizer's reading
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is contrary to the structure of the statute as a whole, the
legislative history, and the policy objectives Congress articulated
at the time it enacted the language. Cf. Prawer, 24 F.3d at 327
(interpreting ambiguous provision of the FCA with reference to
legislative history and congressional intent). The legislative
history of the statute, particularly the 1986 amendments, see False
Claims Amendments Act of 1986, Pub. L. No. 99-562, 100 Stat. 3153,
shows that Pfizer's reading is contrary to the legislative intent
in several respects.
The 1986 amendments sought to achieve the two goals of
discouraging "parasitic" or "free-loading" qui tam suits while also
encouraging productive private enforcement suits. Springfield
Terminal, 14 F.3d at 651. Pfizer's reading furthers neither
purpose.
With the 1986 amendments, Congress deliberately removed
a previous provision that barred jurisdiction whenever the
government had knowledge of the allegations or transactions in the
relator's complaint. The pre-1986 version of 31 U.S.C. § 3730(d)
provided that courts had no jurisdiction over qui tam actions
"based on evidence or information the Government had when the
action was brought." See LeBlanc, 913 F.2d at 19 n.1. In
practice, the "government knowledge" bar proved too restrictive of
qui tam actions, resulting in under-enforcement of the FCA. See
Prawer, 24 F.3d at 325-26. Thus, in 1986, Congress shifted the
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examination away from the information in the government's
possession and instead looked to whether there was public
disclosure of information given to the government. "Congress thus
changed the focus of the jurisdictional bar from evidence of fraud
inside the government's overcrowded file cabinets to fraud already
exposed in the public domain." United States ex rel. Findley v.
FPC-Boron Employees' Club, 105 F.3d 675, 684 (D.C. Cir. 1997).
The effect of Pfizer's argument would be to reinstate
exactly what Congress eliminated -- the "government knowledge" bar.
It is an insufficient response to argue, as Pfizer does, that the
government knowledge bar created by its reading is a very limited
one and applies only where the government official receiving the
disclosure is the appropriate investigatory official. Only one
court has adopted such a reading. See United States ex rel.
Mathews v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. 1999).
We find no support in either the language or the history of the
statute for such a reading. Indeed, Pfizer's argument runs
directly contrary to our reasoning in Prawer, where we held that
"Congress has explicitly deemed a 'notice' regime insufficient to
protect the government against false claims (indeed it was
precisely such a regime that Congress sought to abandon in enacting
the 1986 amendments) . . . ." 24 F.3d at 329.
The 1986 amendments "broadened the universe of potential
[qui tam] plaintiffs, with only four exclusions" enumerated in
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§ 3730(e). LeBlanc, 913 F.2d at 19. Congress amended the statute
to "encourage more private enforcement suits." Id. (quoting S.
Rep. No. 93-345, at 23-24 (1986), reprinted in 1986 U.S.C.C.A.N.
5266, 5288-89) (internal quotation marks omitted). Yet Pfizer's
reading would create a new exclusion not articulated in the text.
That is inconsistent with the second goal of encouraging productive
private enforcement.
Pfizer's interpretation is also contrary to another
legislative purpose reflected in the 1986 amendments: it was the
Congressional intent, through the requirement of public disclosure,
to help keep the government honest in its investigations and
settlements with industry. Once allegations are made public, the
government can be forced to act by public pressure. See Findley,
105 F.3d at 684 n.4.
Not only would Pfizer's argument recreate problems
Congress sought to eliminate in 1986, but it fails to further
Congress's purpose of discouraging "parasitic" qui tam actions.
Prawer, 24 F.3d at 327. If information that could form the basis
of a qui tam action is kept confidential and confined to a limited
circle of government officials, there is no real danger that a
private citizen who does not have "direct and independent
knowledge" of that information, see 31 U.S.C. § 3730(e)(4)(B), will
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bring an opportunistic qui tam suit based upon the information in
the government's possession.7
Our conclusion is also consistent with the majority view
among the circuits. The Tenth Circuit has held the public
disclosure requirement "clearly contemplates that the information
be in the public domain in some capacity and the Government is not
the equivalent of the public domain." Kennard v. Comstock Res.,
Inc., 363 F.3d 1039, 1043 (10th Cir. 2004); accord United States ex
rel. Schumer v. Hughes Aircraft Co., 63 F.3d 1512, 1518 (9th Cir.
1995) ("[I]nformation that was 'disclosed in private' [between
government and defendant company] has not been publicly
disclosed."); United States ex rel. Williams v. NEC Corp., 931
F.2d 1493, 1496 n.7 (11th Cir. 1991) ("Even if a government
investigation was pending at the time [the relator] filed his qui
tam complaint, such fact would not jurisdictionally bar [the FCA
claim]."); see also Springfield Terminal, 14 F.3d at 653 (requiring
information to be "in the public eye" for bar to apply).
Only one circuit has held that mere disclosure to the
government is a public disclosure, though cabining its holding to
disclosures made to appropriate investigative officials. See
Mathews, 166 F.3d at 861. We simply disagree with Mathews for the
7
Except as noted in footnote 6, we do not reach the issue
of how many members of the public must receive or have access to
the disclosure. Cf. Kennard v. Comstock Res., Inc., 363 F.3d 1039,
1043 (10th Cir. 2004) ("There is no requirement that a certain
number of people read or receive the information.").
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reasons already stated and as lucidly set forth in the district
court's opinion. See Rost, 446 F. Supp. 2d at 16-18.
Two amici, industry groups for the pharmaceutical and
hospital industries, argue that unless Pfizer's participation in
HHS's self-disclosure program and cooperation with the government
are fully protected from qui tam suits by adopting Pfizer's reading
of "public disclosure," the FCA's objective -- to reduce fraud on
the government -- will be undercut. The argument is misplaced and
should be addressed to Congress. HHS's administrative efforts at
encouraging corporate disclosure and cooperation are a more recent
development, see Publication of the OIG's Provider Self-Disclosure
Protocol, 63 Fed. Reg. 58399 (Oct. 30, 1998), and were not the
object of Congress's concerns in adopting the 1986 amendments.
B. Rule 9(b) Requirement
The district court ultimately held that Rost failed to
plead his fraud claims with sufficient specificity under Federal
Rule of Civil Procedure 9(b). We affirm.
Rule 9(b) requires that "[i]n all averments of fraud or
mistake, the circumstances constituting fraud or mistake shall be
stated with particularity." The particularity requirement means
that a complaint must specify "the time, place, and content of an
alleged false representation." Doyle v. Hasbro, Inc., 103 F.3d
186, 194 (1st Cir. 1996) (quoting McGinty v. Beranger Volkswagen,
Inc., 633 F.2d 226, 228 (1st Cir. 1980), superseded by statute on
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other grounds, Private Securities Litigation Reform Act of 1995,
Pub. L. No. 104-67, 109 Stat. 737). Conclusory allegations and
references to "plans and schemes" are not sufficient. Id. (quoting
Hayduk v. Lanna, 775 F.2d 441, 444 (1st Cir. 1985)). Rule 9(b)
applies to FCA claims. Karvelas, 360 F.3d at 228. In the FCA
context, this court has previously held that the rule requires
relators to "provide details that identify particular false claims
for payment that were submitted to the government." Id. at 232.
Rost argues that the district court overall applied too
stringent a standard. He also argues that he asserted two
different claims -- one under 31 U.S.C. § 3729(a)(1) for false
claims, the other under § 3729(a)(2) for false statements -- and
that the court erred in not analyzing the particularity
requirements separately for the two subsections.8
In defense of the district court's ruling, Pfizer first
argues this result is required by this court's decision in
Karvelas. Pfizer, we think, over-reads Karvelas, which has more
flexibility than Pfizer posits.
Karvelas, like this case, involved allegations of
submission of false claims for medical insurance payments to
8
Rost also argues that the court should have separately
analyzed his state law claims. The heightened pleading standard of
Rule 9(b) generally applies to state law fraud claims brought in
federal court. See Universal Commc'n Sys., Inc. v. Lycos, Inc.,
478 F.3d 413, 427 (1st Cir. 2007); see also 5A Wright & Miller,
Federal Practice and Procedure § 1297 (3d ed. 2004). The district
court did not err in applying the rule to Rost's entire action.
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federal health insurance programs such as Medicare and Medicaid.
The FCA, Karvelas held, attaches liability not to the underlying
fraudulent activity or to the government's wrongful payment, but to
the claim for payment. 360 F.3d at 225. Karvelas held that "a qui
tam relator may not present general allegations in lieu of the
details of actual false claims in the hope that such details will
emerge through subsequent discovery." Id. at 231. That principle
is not at stake here.
In Karvelas, the relator worked at a hospital that
allegedly submitted false claims to government health care programs
for services that were "provided improperly or not at all." 360
F.3d at 223. In the context of a defendant that submits claims
directly to government programs, Karvelas held that relators must
provide details that identify particular false claims for payment
that were actually submitted to the government. Id. at 232.
Karvelas's claim failed because it provided no specifics, such as
the dates of claims, identification numbers, or amounts charged to
the government, that identified particular false claims. Id. at
233-35.
Nonetheless, Karvelas recognized that Rule 9(b) may be
satisfied where, although some questions remain unanswered, the
complaint as a whole is sufficiently particular to pass muster
under the FCA. Id. at 233 n.17. Giving Rost the benefit of such
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flexibility, we analyze the case with this test in mind; the claim
still fails.
The fraud alleged here is in a different category than in
Karvelas. Those differences both help and hurt Rost. The
submission of the alleged false claims here was not by defendants
Pharmacia and Pfizer; false claims were allegedly submitted by
doctors who were allegedly induced and seduced by defendants into
prescribing Genetropin for off-label uses to their patients,
including federally insured patients. According to Rost's
complaint, more than half of all adult and a quarter of all
pediatric sales of Genotropin are for off-label uses. Given that,
it is a possible but not a necessary or even strong inference that
doctors, persuaded by Pharmacia's financial and other incentives to
prescribe Genotropin for off-label uses, have written such
prescriptions even if the patient was federally insured. And it is
not irrational to infer that, given the large percentage of
children and the elderly who are insured under federal health
programs, some false claims for Genotropin reimbursement were
submitted to the government.
We also note, though, that while the April 2007 criminal
information against Pfizer covering off-label uses of Genotropin
acknowledges that "Pharmacia earned millions of dollars for [off-
label uses]," it also states that "[i]n most, if not all,
instances, patients taking Genotropin [for off-label uses] paid .
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. . out-of-pocket without reimbursement from any public or private
third-party payors." This tends to undercut the strength of the
inference that fraud on the government in fact occurred.
Rost's complaint amply describes illegal practices in
which Pfizer allegedly engaged. But those practices, while
illegal, are not a sufficient basis for an FCA action because they
do not involve claims for government reimbursement.9 Id. at 234.
As presently pled, the complaint does not sufficiently establish
that false claims were submitted for government payment in a way
that satisfies the particularity requirement. Cf. id. at 233.
Rost argues that the primary purpose of pleading fraud
with particularity is to give notice to Pfizer of the false claims,
and that his complaint accomplishes this. The argument fails on
two grounds: First, the complaint does not give notice to Pfizer
of false claims submitted by others for federal reimbursement of
off-label uses, only of illegal practices in promotion of the drug.
9
Rule 9(b)'s heightened pleading standards apply to the
allegations that false claims were submitted to the government.
There is a separate element to the cause of action. Under the FCA,
Rost must show that Pfizer "cause[d] to be presented" a false claim
for payment. 31 U.S.C. § 3729(a)(1). That there were allegedly
intervening persons who actually submitted the claims does not
itself necessarily break the causal connection when the claims are
foreseeable. See United States ex rel. Cantekin v. Univ. of
Pittsburgh, 192 F.3d 402, 416-17 (3d Cir. 1999).
In other cases, relators have pled a connecting causal
link, which strengthens the inference that false claims were
submitted. Cf. United States ex rel. Franklin v. Parke-Davis, 147
F. Supp. 2d 39, 46 (D. Mass. 2001) (describing pharmaceutical
company's efforts "to coach doctors on how to conceal the off-label
nature of the prescription"). No such allegations are made here.
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Second, notice is not the only reason for the requirement of Rule
9(b). It is a serious matter to accuse a person or company of
committing fraud, and the mere accusation often causes harm. See
Doyle, 103 F.3d at 194; 5A Wright & Miller, Federal Practice and
Procedure § 1296 (3d ed. 2004). Further, the rule discourages
plaintiffs from filing allegations of fraud merely in the hopes of
conducting embarrassing discovery and forcing settlement. See New
Eng. Data Servs., Inc. v. Becher, 829 F.2d 286, 288 (1st Cir.
1987).
At most, Rost raises facts that suggest fraud was
possible; but the complaint contained no factual or statistical
evidence to strengthen the inference of fraud beyond possibility.
It may well be that doctors who prescribed Genotropin for off-label
uses as a result of Pharmacia's illegal marketing of the drug
withstood the temptation and did not seek federal reimbursement,
and neither did their patients. It may be that physicians
prescribed Genotropin for off-label uses only where the patients
paid for it themselves or when the patients' private insurers paid
for it. Rost did not plead enough to satisfy the concerns behind
Rule 9(b).
As for Rost's § 3729(a)(2) argument, Pfizer asserts that
Rost waived the argument by not presenting it below. See Tobin v.
Liberty Mut. Ins. Co., 433 F.3d 100, 105 n.3 (1st Cir. 2005)
("Theories not raised in the district court cannot be raised for
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the first time on appeal.") We do not address the waiver issue.
Our analysis -- which recognizes the role played by third parties
other than Pfizer in submitting claims and making statements to the
government -- undermines Rost's § 3729(a)(2) argument as well. In
addition, the plain language of § 3729(a)(2) requires proof of a
"false record or statement" for liability to attach under the
section. Rost's complaint alleges that Pharmacia made statements
in violation of federal law, but does not allege that those
statements were false. Cf. Franklin, 147 F. Supp. 2d at 48-49
(describing allegations that defendant trained salespeople to
"actively deceive physicians" about off-label uses of drugs). We
affirm the Rule 9(b) ruling.
That does not end the matter. In dismissing the action,
the district court never ruled on Rost's request that he be allowed
to amend his complaint to allege fraud with particularity. If it
were obvious that leave to amend should be denied, we would affirm.
That level of certainty does not exist. This distinguishes our
decision here from the disposition of Epstein v. C.R. Bard, Inc.,
460 F.3d 183 (1st Cir. 2006).
Federal Rule of Civil Procedure 15(a) provides that leave
to amend a pleading "shall be freely given when justice so
requires," and reflects a liberal amendment policy. O'Connell v.
Hyatt Hotels of P.R., 357 F.3d 152, 154 (1st Cir. 2004). Grounds
for denial generally involve undue delay, bad faith, dilatory
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motive of the requesting party, repeated failure to cure
deficiencies, and futility of amendment. Foman v. Davis, 371 U.S.
178, 182 (1962). At this stage we cannot say amendment would be
futile, and the district court should make the initial
determination.
Pfizer says Rost has waived his opportunity to amend by
making only a "passing reference" to a request for leave to amend
in his briefs to the district court. That is not our law. This
court has treated many similar requests to be sufficient
invocations for leave to amend under Rule 15(a). See, e.g.,
Epstein, 460 F.3d at 190-91 (request for leave to amend made in
opposition to motion to dismiss treated as motion to amend pursuant
to Rule 15(a)); Rodi v. S. New Eng. Sch. of Law, 389 F.3d 5, 20
(1st Cir. 2004) (request to amend contained in motion for
reconsideration treated as Rule 15(a) motion); Invest Almaz v.
Temple-Inland Forest Prods. Corp., 243 F.3d 57, 71 (1st Cir. 2001)
(request at oral argument on motion to dismiss for leave to amend
complaint "if necessary" constituted motion to amend pursuant to
Rule 15(a)). We express no views on the outcome of this issue
before the district court.
The dismissal of the action is vacated. The case is
remanded to the district court for further proceedings consistent
with this opinion. No costs are awarded.
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