23-1334-cv United States of America v. U.S. Oncology, Inc.

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

SUMMARY ORDER

RULINGS BY SUMMARY ORDER DO NOT HAVE PRECEDENTIAL EFFECT. CITATION TO A SUMMARY ORDER FILED ON OR AFTER JANUARY 1, 2007, IS PERMITTED AND IS GOVERNED BY FEDERAL RULE OF APPELLATE PROCEDURE 32.1 AND THIS COURT’S LOCAL RULE 32.1.1. WHEN CITING A SUMMARY ORDER IN A DOCUMENT FILED WITH THIS COURT, A PARTY MUST CITE EITHER THE FEDERAL APPENDIX OR AN ELECTRONIC DATABASE (WITH THE NOTATION “SUMMARY ORDER”). A PARTY CITING A SUMMARY ORDER MUST SERVE A COPY OF IT ON ANY PARTY NOT REPRESENTED BY COUNSEL.

At a stated term of the United States Court of Appeals for the Second Circuit, held at the Thurgood Marshall United States Courthouse, 40 Foley Square, in the City of New York, on the 12th day of November, two thousand twenty-four.

Present:

EUNICE C. LEE, MARIA ARAÚJO KAHN, Circuit Judges, MARGARET M. GARNETT, District Judge. * _____________________________________

OMNI HEALTHCARE INC.,

Plaintiff-Relator-Appellant,

UNITED STATES OF AMERICA, ex rel. Omni Healthcare, STATE OF CALIFORNIA, ex rel. Omni Healthcare, STATE OF COLORADO, ex rel. Omni Healthcare, STATE OF CONNECTICUT, ex rel. Omni Healthcare, STATE OF DELAWARE, ex rel. Omni Healthcare, STATE OF DISTRICT OF COLUMBIA, ex rel. Omni Healthcare, STATE OF FLORIDA, ex rel. Omni Healthcare, STATE OF GEORGIA, ex rel. Omni Healthcare, STATE OF HAWAII, ex rel. Omni Healthcare, STATE OF ILLINOIS, ex rel. Omni Healthcare, STATE OF INDIANA, ex rel. Omni Healthcare, STATE OF IOWA, ex rel. Omni Healthcare, STATE OF LOUISIANA, ex rel. Omni Healthcare, STATE OF MARYLAND, ex rel. Omni Healthcare, STATE OF MASSACHUSETTS, ex rel. Omni Healthcare, STATE OF MICHIGAN, ex rel. Omni Healthcare, STATE OF MINNESOTA, ex rel. Omni Healthcare, STATE OF MONTANA, ex rel. Omni Healthcare, STATE OF NEVADA, ex rel. Omni Healthcare, STATE OF NEW HAMPSHIRE, ex rel. Omni Healthcare, STATE OF NEW JERSEY, ex rel. Omni Healthcare, STATE OF NEW MEXICO, ex rel. Omni

* Judge Margaret M. Garnett, of the United States District Court for the Southern District of New York, sitting by designation. Healthcare, STATE OF NEW YORK, ex rel. Omni Healthcare, STATE OF NORTH CAROLINA, ex rel. Omni Healthcare, STATE OF OKLAHOMA, ex rel. Omni Healthcare, STATE OF RHODE ISLAND, ex rel. Omni Healthcare, STATE OF TENNESSEE, ex rel. Omni Healthcare, STATE OF TEXAS, ex rel. Omni Healthcare, STATE OF VERMONT, ex rel. Omni Healthcare, STATE OF VIRGINIA, ex rel. Omni Healthcare, STATE OF WASHINGTON, ex rel. Omni Healthcare, STATE OF WISCONSIN, ex rel. Omni Healthcare, THE CITY OF CHICAGO, ex rel. Omni Healthcare, THE CITY OF NEW YORK, ex rel. Omni Healthcare,

Plaintiffs,

v. No. 23-1334-cv

U.S. ONCOLOGY, INC.,

Defendant-Appellee.

_____________________________________

For Plaintiff-Relator-Appellant: GEORGE F. CARPINELLO, Boies Schiller Flexner LLP, Albany, NY.

For Defendant-Appellee: MARK W. MOSIER (Jason C. Raofield, Michael M. Maya, Mary H. Schnoor, Grace Pyo, on the brief), Covington & Burling LLP, Washington, DC.

Appeal from a September 11, 2023 judgment of the United States District Court for the

Eastern District of New York (Gershon, J.).

UPON DUE CONSIDERATION, IT IS HEREBY ORDERED, ADJUDGED, AND

DECREED that the judgment of the district court is AFFIRMED.

Plaintiff-Relator-Appellant Omni Healthcare Inc. (“Omni”), a Florida medical company

specializing in oncology and hematology treatment, appeals from the district court’s dismissal of

its amended qui tam complaint filed on August 19, 2022, against Defendant-Appellee U.S.

2 Oncology Inc. (“U.S. Oncology”), a Delaware corporation providing specialty pharmacy services

to physicians who treat cancer patients, claiming violations of the False Claims Act (“FCA”),

et seq., violations of various state and municipal FCA analogs, and unjust

enrichment. Specifically, Omni alleges U.S. Oncology harvested the “overfill” of injectable

oncology drugs to fill and sell unapproved syringes to other medical providers, and profited from

providers’ administration of these overfill drugs to patients by submitting fraudulent

reimbursement claims to the Center for Medicare and Medicaid Services, in violation of the Anti-

Kickback Statute, 42 U.S.C. § 1320a-7b(b). 1

Omni first brought FCA claims against U.S. Oncology in 2012 as part of a qui tam action

filed against multiple defendants (the “Omni I” action). In February 2019, the district court

dismissed the claims pertaining to U.S. Oncology without prejudice, finding that the claims were

precluded by the FCA’s “first-to-file bar,”

(b)(5). Omni then initiated the

current lawsuit against U.S. Oncology when it filed a new complaint in September 2019 (“Omni

II Complaint”). In July 2022, the district court dismissed the Omni II Complaint, this time

holding that the FCA’s “public disclosure bar” applied, see

(e)(4), and that

Omni’s allegations did not satisfy the bar’s “original source exception,” see

(e)(4)(B). Upon the district court’s grant of leave to amend, Omni subsequently filed the

operative amended complaint (“Omni II Amended Complaint”) in hopes of satisfying that

exception. In September 2023, the district court found that Omni’s amended allegations failed

1 “Overfill” is the excess volume of a drug contained in a vial to guard against loss during extraction and ensure proper dosage. Under the applicable commercial good manufacturing practices and FDA regulations, this excess volume cannot be recycled, reused, or adulterated in any way.

3 to meet the original source exception’s requirements and granted U.S. Oncology’s renewed motion

to dismiss for lack of subject-matter jurisdiction and failure to state a claim. Omni appeals both

the 2022 and 2023 dismissals.

We assume the parties’ familiarity with the remaining underlying facts, the procedural

history, and the issues on appeal, to which we refer only as necessary to explain our decision to

affirm.

DISCUSSION

“We review dismissal of a cause of action under Fed. R. Civ. P. 12(b)(1) or 12(b)(6) de

novo.” Jaghory v. N.Y. State Dep’t of Educ.,

, 329 (2d Cir. 1997). “Under these

rules, the court must accept all factual allegations in the complaint as true and draw inferences

from those allegations in the light most favorable to the plaintiff.” Id. “To survive a motion to

dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to

relief that is plausible on its face.” Ashcroft v. Iqbal,

(2009) (internal quotation

marks omitted).

I. The Public Disclosure Bar

The district court dismissed the Omni II Complaint as precluded by the public disclosure

bar, which prohibits qui tam actions that allege misconduct already disclosed to the public where

no statutory exception applies. On appeal, Omni argues that the district court erred because the

allegations against U.S. Oncology were not public when Omni began pursuing its claims in 2012.

However, by the time Omni II was filed in September 2019, two federal actions had publicized

U.S. Oncology’s alleged role in harvesting overfill: Omni I, initially filed in 2012 with a second

amended complaint publicly filed in April 2018, and United States ex rel. Underwood v. Amgen,

4 Inc. (“Underwood”), No. 10-CV-2441 (E.D.N.Y.), initially filed in 2010 and unsealed in 2016.

Because Omni never contested that the public allegations from Omni I and Underwood are

“substantially the same” as Omni II’s allegations, the district court held that both actions qualified

as prior public disclosures. United States ex rel. Omni Healthcare Inc. v. U.S. Oncology, Inc.,

No. 19-CV-5125 (NG) (LB),

, at *7–8 (E.D.N.Y. July 21, 2022). We agree.

Since Omni’s allegations relate to U.S. Oncology’s conduct from 2003 to 2014, we are

obliged to consider the FCA’s public disclosure provisions before and after the 2010 amendment.

Both the pre-2010 and post-2010 public disclosure bars apply to this action if substantially the

same allegations in the Omni II Complaint and Amended Complaint were publicly disclosed by

the time of filing. 2 See

(e)(4)(A);

(e)(4)(A) (2000). As

relevant here, public disclosures include the publicly accessible dockets of federal civil cases.

See

(e)(4)(A)(i);

(e)(4)(A) (2000).

Omni’s primary contention is that applying the bar to the Omni II action would be unfair

and inconsistent with the FCA’s purposes. The public disclosure bar is intended to “stifl[e]

parasitic lawsuits” that are predicated on already-known information. Graham Cnty. Soil &

Water Conservation Dist. v. United States ex rel. Wilson,

(2010). Omni insists

that is not the case here. In its view, Omni has pursued its claims in good faith since 2012, and

2 The post-2010 bar applies to actions involving “substantially the same” allegations as those publicly disclosed, while the pre-2010 version applies to actions “based upon public disclosures.”

(e)(4)(A);

(e)(4)(A) (2000). Because this Circuit has interpreted “based upon” to mean “the same [allegations] as those” publicly disclosed, the 2010 amendment did not alter the bar’s applicability. United States ex rel. Doe v. John Doe Corp.,

(2d Cir. 1992); see United States ex rel. Patriarca v. Siemens Healthcare Diagnostics, Inc.,

(E.D.N.Y. 2018).

5 its previous Omni I action was dismissed only because the first-to-file bar required it. See United

States ex rel. Wood v. Allergan, Inc.,

(2d Cir. 2018). Since Omni is not a

“parasitic relator,” but instead reviving its own earlier claims, it contends Omni II should be treated

as the “continuation of [Omni I], re-filed under a new caption.” Appellant’s Br. at 21, 24.

Following this logic, Omni II should be viewed as if initially filed in October 2012, when Omni I

was amended under seal to include allegations against U.S. Oncology prior to any public

disclosures.

This relation-back argument is both unpersuasive and contrary to the FCA’s plain text.

While it is true that Omni I was dismissed pursuant to the first-to-file bar, and so Omni had to file

Omni II in order to continue pursuing its claims, Omni’s contention that the public disclosure bar

does not or should not apply in such instances seeks to carve out a new exception. The FCA does

not treat two separate actions, filed under different captions, as a continuation. The pre-2010 and

post-2010 text of the public disclosure bar both reference “an action or claim,” which cannot

proceed if substantially similar allegations have already been publicly disclosed.

(e)(4)(A) (2000);

(e)(4)(A). The referent “action or claim” is the present

litigation before a court. Because a court cannot exercise jurisdiction over, nor dismiss, an action

or claim not before it, the Omni II action filed in 2019 is the relevant “action or claim” for the

purposes of this appeal, not Omni I. Since Omni I publicly disclosed allegations against U.S.

Oncology when Omni filed a publicly accessible second amended complaint in April 2018, and it

is uncontested that the later-filed Omni II Complaint and Amended Complaint include allegations

substantially similar to Omni I, the public disclosure bar applies. Moreover, even if, as Omni

insists, applying the public disclosure bar to actions dismissed under the first-to-file bar creates

6 perverse incentives or stymies the FCA’s legislative purpose, this Court is not entitled to rewrite

the FCA’s text to decide the policy stakes for Congress. Cf. Bartenwerfer v. Buckley,

(2023) (“No statute pursues a single policy at all costs, and we are not free to rewrite this

statute (or any other) as if it did.”).

Omni also suggests that the Underwood complaint does not serve as a separate public

disclosure because Omni I was filed prior to Underwood’s unsealing. This argument is meritless.

The Underwood complaint was filed on May 28, 2010 (before the Omni I action) and unsealed on

May 11, 2016, well before the Omni II Complaint was filed and, as Omni concedes, Underwood

alleged substantially similar conduct as Omni II. As a result, Underwood also triggers the public

disclosure bar.

II. Original Source Exception

Because the public disclosure bar applies, Omni must satisfy the original source exception

to proceed. The district court dismissed the Omni II Amended Complaint because Omni failed

to plead sufficient allegations to qualify as an original source. In particular, the district court

found that Omni did not sufficiently allege direct and independent knowledge of U.S. Oncology’s

involvement in the overfill-harvesting fraud, a voluntary disclosure to the government, nor a

material addition to prior public disclosures. We agree.

The pre- and post-amendment definitions of an “original source” are distinct. Pre-

amendment, a relator must have “direct and independent knowledge of the information on which

the allegations are based” and “voluntarily provided the information to the Government before

filing an action” to qualify.

(e)(4)(B) (2000). Post-amendment, a relator can

qualify as an original source if it either (1) “voluntarily disclosed” the information underlying its

7 claim to the government, prior to a public disclosure; or (2) has “knowledge that is independent of

and materially adds to the publicly disclosed allegations or transactions” and has “voluntarily

provided the information to the Government before filing an action.”

(e)(4)(B)(i), (2).

For the pre-amendment definition, Omni argues that it has plausibly alleged direct and

independent knowledge, because the Omni II Amended Complaint avers that its allegations “are

based upon the personal knowledge Relator’s principal [Dr. Deligdish]” gained through his work

as an oncologist. J. App’x at 285–86. However, Omni claims that Dr. Deligdish found out

about the overfilling scheme through “conversations” with oncologists affiliated with U.S.

Oncology.

at 306–07. This Court has held that “if a third party is the source of the core

information upon which the qui tam complaint is based,” the relator does not satisfy the pre-

amendment bar’s direct and independent knowledge requirement. United States v. N.Y. Med.

Coll.,

, 121 (2d Cir. 2001) (per curiam) (internal quotations omitted). Because Dr.

Deligdish’s knowledge is predicated on conversations with third parties, Omni has failed to plead

direct knowledge of U.S. Oncology’s fraudulent conduct. Therefore, Omni is not an original

source under the pre-amendment definition.

For the first prong of the post-amendment definition, Omni alleges it “voluntarily”

disclosed information regarding U.S. Oncology’s fraudulent activity, satisfying

(e)(4)(B)(i), by submitting a disclosure statement to the government, “as required by

(b)(2),” weeks prior to filing Omni I and before any public disclosures. J. App’x

at 284. The district court concluded that Omni did not allege voluntary disclosure because

Omni’s pleading explicitly references the FCA’s mandatory disclosure provision, which obligates

8 a relator to serve on the government a “[a] copy of the complaint and written disclosure of

substantially all material evidence,”

(b)(2). The district court rejected Omni’s

argument, repeated before us, that this mandatory disclosure may simultaneously be voluntary if a

relator discloses information to the government prior to public disclosures. We agree with the

district court that Omni’s argument “reads the voluntary requirement out of [

(e)(4)(A)(i)],” which requires both “voluntarily” disclosing information and doing so “prior

to a public disclosure.” United States ex rel. Omni Healthcare Inc. v. U.S. Oncology, Inc., No.

19-CV-5125 (NG) (LB),

, at *5 (E.D.N.Y. Sept. 8, 2023). The timing of

disclosures, alone, is insufficient to conclude that a disclosure is voluntary; to hold otherwise

would erase the provision’s voluntariness requirement. See United States. ex rel. Beauchamp v.

Academi Training Ctr., Inc.,

(E.D. Va. 2013) (“Courts that have

addressed whether these mandatory disclosures under § 3730(b)(2) also qualify as voluntary

disclosures under § 3730(e)(4) have held that they do not, as these are mandatory disclosures rather

than voluntary disclosures.”), vacated and remanded on other grounds sub nom.

(4th

Cir. 2016). In addition, Omni’s inclusion of the word “voluntarily” in its complaint to describe

its disclosure is a legal conclusion that we do not accept as true without plausible substantiating

factual assertions. 3 See Iqbal, 556 U.S. at 678–81. Consequently, Omni is not an original

3 Omni attached the declaration of J. Marc Vezina, its former counsel, with its brief opposing U.S. Oncology’s motion to dismiss the Omni II Amended Complaint, as evidence that Omni made a voluntary disclosure to the government months before filing Omni I. Appellant’s Br. at 4 n.3, 35; see also J. App’x at 370-76. Assuming arguendo the declaration may be considered, the declaration does not help Omni show voluntariness. Mr. Vezina’s declaration details a “prefiling disclosure statement” and meetings with the U.S. Attorney’s Office in anticipation of filing a lawsuit. See J. App’x at 373-76. Such efforts are consistent with Omni’s mandatory disclosure obligation under

(b)(2).

9 source under

(b)(4)(B)(i).

Finally, for the second prong of the post-amendment definition, Omni contends that its

averments regarding Dr. Kolodziej, a physician at U.S. Oncology who can “attest to the company’s

scienter,” materially add to publicly disclosed allegations, thus satisfying one requirement of

(e)(4)(B)(2). Appellant’s Br. at 45. But here, Omni I already publicly disclosed

that “[U.S. Oncology] knew that [its] conduct was illegal.” J. App’x at 139. The identification

of specific individuals “aware of, or complicit in,” U.S. Oncology’s overfilling fraud does not

“materially add to the already robust universe of publicly-available information.” Ping Chen ex

rel. United States v. EMSL Analytical, Inc.,

(S.D.N.Y. 2013) (emphasis

omitted). Therefore, Omni does not satisfy

(e)(4)(B)(2).

III. Statute of Limitations

Because we conclude that the public disclosure bar applies and Omni is not an original

source under any definition, we do not reach whether Omni’s action is nonetheless precluded by

the FCA’s statute of limitations,

(b).

* * *

We have considered Omni’s remaining arguments and conclude they are without merit.

Accordingly, for the reasons set forth above, we AFFIRM the judgment of the district court.

FOR THE COURT: Catherine O’Hagan Wolfe, Clerk of Court

10