UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
UNITED STATES OF AMERICA, and THE
STATES OF CALIFORNIA, COLORADO,
CONNECTICUT, DELAWARE, THE DISTRICT
OF COLUMBIA, FLORIDA, GEORGIA,
HAWAII, ILLINOIS, INDIANA, LOUISIANA,
MARYLAND, MASSACHUSETTS, MICHIGAN,
MINNESOTA, MONTANA, NEVADA, NEW
JERSEY, NEW MEXICO, NEW YORK, NORTH
CAROLINA, OKLAHOMA, RHODE ISLAND,
TENNESSEE, TEXAS, VIRGINIA, and
WISCONSIN, ex rel. DAVID KESTER,
Plaintiffs and Relator,
-against-
NOVARTIS PHARMACEUTICALS
CORPORATION
Defendant.
11 CIV. 8196 (CM) (JCF)
NOVARTIS PHARMACEUTICALS CORPORATION’S
MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION TO COMPEL FURTHER
DISCOVERY RESPONSES FROM THE UNITED STATES AND FROM THE STATES
OF CALIFORNIA, GEORGIA, ILLINOIS, INDIANA, MARYLAND, MICHIGAN,
NEW JERSEY, NEW YORK, OKLAHOMA, WASHINGTON AND WISCONSIN
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TABLE OF CONTENTS
Page
PRELIMINARY STATEMENT .....................................................................................................1
RELEVANT LEGAL AND FACTUAL BACKGROUND ............................................................4
ARGUMENT ...................................................................................................................................9
I. THE GOVERNMENT SHOULD BE ORDERED TO PRODUCE DOCUMENTS
RELATING TO ITS MEDICATION ADHERENCE PROGRAMS AND
INITIATIVES ......................................................................................................................9
A. The Requested Adherence-Related Discovery Is Relevant To The Claims
And Defenses In This Case ......................................................................................9
B. The Government Has Not Asserted Any Valid Objections To NPC’s
Requests .................................................................................................................12
1. The Deliberative Process Does Not Apply ................................................12
2. The Requested Documents Are Within The States’ Control And
Must Be Produced ......................................................................................13
II. THE GOVERNMENT SHOULD BE ORDERED TO PRODUCE DOCUMENTS
RELATING TO ITS IMMUNOSUPPRESSIVE THERAPIES FOR KIDNEY
TRANSPLANT PATIENTS AND ITS IRON CHELATION THERAPIES ....................16
III. THE GOVERNMENT SHOULD BE COMPELLED TO PRODUCE ITS
COMMUNICATIONS WITH BIOSCRIP REGARDING BIOSCRIP’S
STIPULATIONS OF FACT ..............................................................................................21
CONCLUSION ..............................................................................................................................25
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TABLE OF AUTHORITIES
Page
Cases
Almenares v. Wyman,
334 F. Supp. 512 (S.D.N.Y. 1971) ..........................................................................................13
Compagnie Francaise d’Assurance Pour le Commerce Exteriur v.
Phillips Petroleum Co.,
105 F.R.D. 16 (S.D.N.Y. 1984) ...............................................................................................14
Conopco, Inc. v. Wein,
No. 05-civ-9899, 2007 WL 1040676 (S.D.N.Y. Apr. 4 2007) ................................................23
Davidson v. Goord,
215 F.R.D. 73 (W.D.N.Y. 2003) ..............................................................................................12
Emily Q. v. Bonta,
208 F. Supp. 2d 1078 (C.D. Cal. 2001) ...................................................................................15
In re Flag Telecom Holdings, Ltd. Sec. Litig.,
236 F.R.D. 177 (S.D.N.Y. 2006) .............................................................................................14
Grand Central P’ship v. Cuomo,
166 F.3d 473 (2d Cir. 1999).....................................................................................................12
In re Initial Pub. Offering Sec. Litig.,
No. 21 MC 92, 2004 WL 60290 (S.D.N.Y. Jan. 12, 2004) .....................................................23
Keaton v. Hannum,
No. 1:12-cv-00641, 2013 WL 1818993 (S.D. Ind. Apr. 29, 2013)..........................................22
MacNamara v. City of New York,
No. 04 Civ. 9216, 2007 WL 1169204 (S.D.N.Y Apr. 20, 2007) .......................................12, 13
S.E.C. v. Collins & Aikman Corp.,
256 F.R.D. 403 (S.D.N.Y. 2009) .............................................................................................13
Schanfield v. Sojitz Corp. of Am.,
258 F.R.D. 211 (S.D.N.Y. 2009) .............................................................................................24
Shcherbakovskiy v. Da Capo Al Fine, Ltd.,
490 F.3d 130 (2d Cir. 2007).....................................................................................................14
Tigue v. U.S. Dep’t of Justice,
312 F.3d 70 (2d Cir.2002)........................................................................................................12
Travelers Indemn. v. Northrop Grumman Corp.,
No. 12 Civ. 3040, 2012 WL 6200680 (S.D.N.Y. Dec. 10, 2012) ............................................12
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U.S. ex rel. Finney v. Nextwave Telecom, Inc.,
337 B.R. 479 (S.D.N.Y. 2006) .................................................................................................11
Visiting Nurse Ass’n of Brooklyn v. Thompson,
378 F. Supp. 2d 75 (E.D.N.Y. 2004) .......................................................................................11
Statutes
42 C.F.R. § 430.0 ...........................................................................................................................15
42 C.F.R. § 431.10 .........................................................................................................................15
42 C.F.R. § 431.16 .........................................................................................................................15
42 C.F.R. § 431.17 .........................................................................................................................15
42 C.F.R. § 447.202 .......................................................................................................................15
42 C.F.R. § 1001.952(h)(4) ..............................................................................................................5
31 U.S.C. § 3729 ....................................................................................................................1, 7, 11
42 U.S.C. § 602(a)(3) .....................................................................................................................13
42 U.S.C. § 1320a-7b .........................................................................................1, 2, 4, 5, 7, 8, 9, 11
42 U.S.C. § 1320a-7b(g) ..................................................................................................................4
42 U.S.C. § 1382(a)(3) ...................................................................................................................13
42 U.S.C. § 1396a(a)(5) .................................................................................................................15
S.D.N.Y. Rule 26.2 ........................................................................................................................13
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Pursuant to Rule 37 of the Federal Rules of Civil Procedure and Rules 7 and 37 of the
Local Rules for the Southern District of New York, Defendant Novartis Pharmaceuticals
Corporation (“NPC”) respectfully submits this memorandum of law in support of its motion to
compel the United States (the “U.S.”) and the States of California, Georgia, Illinois, Indiana,
Maryland, Michigan, New Jersey, New York, Oklahoma, Washington, and Wisconsin
(collectively, the “States” and, with the U.S., the “Government”) to produce discovery relating
to: (i) medication adherence programs and initiatives by the Government;
(ii) immunosuppressive therapies for kidney transplant patients and iron chelation therapy at
Government hospitals and healthcare facilities; and (iii) settlement communications between the
Government and BioScrip relating to BioScrip’s stipulation of facts.
PRELIMINARY STATEMENT
This case is an attempt by the Government to impose significant civil liability on NPC
pursuant to the federal False Claims Act, 31 U.S.C. § 3729 (“FCA”) and its state law
counterparts. The alleged false claims are predicated upon purported violations of the Anti-
Kickback Statute, 42 U.S.C. § 1320a-7b (“AKS”). Specifically, the Government seeks to label
certain discounts, rebates, and medication adherence-related incentives NPC provided to
specialty pharmacies as “kickbacks” that resulted in the submission of “tens of thousands” of
false claims to Medicare and Medicaid. The Government contends that NPC engaged in two
different kickback “schemes”:
The first alleged scheme concerns Exjade®, a once-a-day oral medication that removes
excess iron from the blood that can build up in patients who require frequent blood transfusions
or have a non-transfusion-dependent blood disorder. NPC distributed Exjade primarily through a
network of three specialty pharmacies. One of those pharmacies was then co-defendant
BioScrip. The Government contends that NPC’s discounts, rebates, and allocations of Exjade
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prescriptions to BioScrip became illegal kickbacks when, in February 2007, BioScrip increased
its patient outreach and refill reminder services to improve medication adherence among its
Exjade patients.
The second alleged scheme concerns Myfortic®, an immunosuppressant prescribed to
prevent organ rejection in kidney transplant recipients. The U.S. (the States did not intervene as
to Myfortic) alleges that market share rebates NPC paid to certain specialty pharmacies violate
the AKS. Although the U.S. appears to acknowledge that NPC’s market share rebate contracts
are legal, the U.S. contends that the rebates somehow became illegal kickbacks when the
specialty pharmacies agreed to influence doctors to “switch” patients to Myfortic from a
competing immunosuppressant, CellCept, and/or generic forms of CellCept, or maintain patients
on Myfortic instead of the alternative immunosuppressant treatment on the basis of “pretext[ual]”
clinical information. Ex. B1 at 8:21-9:3; see also Second Amended Complaint-in-Intervention of
the U.S., Dkt. No. 231 (“Second Am. Compl.”) ¶ 6 (“[H]undreds, possibly thousands, of
transplant patients have undergone switches in their medication as a result of recommendations
from pharmacies that were based on undisclosed financial, rather than independent clinical,
considerations.”).
NPC contends that its rebates, discounts, and medication adherence-related incentives do
not violate the AKS or FCA and that, contrary to the Government’s allegations, these incentives
have not resulted in improper Exjade adherence initiatives or pretextual conversions to Myfortic.
Indeed, the Government itself promotes medication adherence programs and Government
hospitals will likely have information regarding the clinical attributes of both drugs that pertain
1 All references to “Ex.” are to Exhibits to the Declaration of Manisha M. Sheth, filed
concurrently herewith (“Sheth Decl.”). The verbatim text of the discovery requests and
responses at issue in this motion are set forth in full in Exhibit A to the Sheth Declaration.
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to the validity of Exjade adherence efforts and clinical reasons for “switching” patients to
Myfortic that the Government describes as “pretext.” Although the information NPC seeks from
the Government is relevant to the Government’s claims and allegations, the Government has
refused to produce such evidence, necessitating this motion.
This motion seeks an order compelling the Government to produce three categories of
documents: First, this motion seeks documents relating to the Government’s own adherence
programs and initiatives. Given the Government’s allegations that the Exjade adherence
initiatives at issue in this case were improper, NPC is entitled to discovery regarding the contours
of what the Government deems a proper adherence initiative (as it presumably regards its own).
Second, this motion seeks documents related to immunosuppressive therapies for kidney
transplant patients and iron chelation therapies at Government medical facilities. Here too, NPC
should be permitted to test the Government’s allegations that NPC’s rebates and discounts led to
the conversion of patients to Myfortic for pretextual clinical reasons or caused patients to
continue taking Exjade contrary to the clinical advice of their prescribing physicians on the
recommendation of allegedly underqualified and undertrained BioScrip employees. If
Government-authored medication protocols or other documents reflect the same clinical
considerations flagged by specialty pharmacies, confirm that Exjade should be taken consistently
and not on an as-needed basis as the Government has argued, or endorse BioScrip as a qualified
or even preferred Exjade provider, these documents are relevant to assessing the validity of the
Government’s contentions.
Third, this motion seeks communications between the Government and BioScrip relating
to a series of facts to which BioScrip stipulated as part of its settlement with the Government.
The Government has repeatedly invoked these “facts” in setting forth its case against NPC at
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court conferences and in press releases. There can be no serious dispute that communications
between the Government and BioScrip about these facts are relevant. Nor can there be any
argument that these communications are shielded from discovery by any privilege. The
settlement privilege—to the extent it might apply—affects at most their admissibility at trial and
any attorney-client or work product protections were waived when the communications were
shared between the Government and BioScrip.
The Government’s refusal to provide these three categories of discovery that are relevant
(and potentially highly relevant) to the Government’s claims and allegations is improper, and
prejudices NPC’s ability to prepare its case in response to such allegations. The Government
should be compelled to provide complete discovery responses and produce all non-privileged
documents responsive to the discovery requests identified herein without further delay.
RELEVANT LEGAL AND FACTUAL BACKGROUND
The AKS. The AKS makes it illegal to “knowingly and willfully offer[] or pay[] any
remuneration (including any kickback, bribe, or rebate)” to any person to induce that person to
“purchase . . . order . . . or recommend purchasing . . . or ordering any good . . . or item for which
payment may be made in whole or in part under a Federal health care program.” 42 U.S.C.
§ 1320a-7b(b)(2). Relevant to the allegations in this lawsuit, “a claim that includes items or
services resulting from a violation of [the AKS] constitutes a false or fraudulent claim for
purposes of [the False Claims Act].” 42 U.S.C. § 1320a-7b(g).
The Department of Justice (“DOJ”) has stated that the AKS is “intended to ensure that a
physician’s medical judgment is not compromised by improper financial incentives and is
instead based on the best interests of the patient.” See Ex. C. Notably, not all payments or
incentives from a pharmaceutical manufacturer to a healthcare provider (“HCP”) are prohibited
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by the AKS. Indeed, the first exception Congress made to the broad sweep of the AKS was for
discounts and price reductions to HCPs. Pursuant to the statutory exception, the AKS:
[s]hall not apply to a discount or other reduction in price obtained
by a provider of services or other entity under a Federal health care
program if the reduction of price is properly disclosed and
appropriately reflected in the costs claimed or charges made by the
provider or entity under a Federal health care program.
42 U.S.C. § 1320a-7b(b)(3)(A). The corresponding discount safe harbor regulation at 42 C.F.R.
§ 1001.952(h)(4) makes clear that permissible discounts may take the form of rebates.
The NPC Medications at Issue. NPC researches, develops, manufactures and markets
innovative prescription medicines. One of those medicines is Exjade (deferasirox), an oral
medication that is indicated for the treatment of chronic iron overload resulting from blood
transfusions. See, e.g., Second Am. Compl. ¶ 231. Chronic iron overload is a dangerous
condition that, if left untreated, can ultimately be fatal. See id. Although chelation therapy,
including Exjade, is critical to the patient’s health, compliance with such therapy is challenging
because, among other things, it may take some time for a patient to feel the benefit of treatment.
See Ex. D, John Porter et al., “The challenges of adherence and persistence with iron chelation
therapy,” 94 Int’l J. of Hematology 453, 454-455 (2011).
The other medication at issue, Myfortic (mycophenolic acid), is prescribed to kidney
transplant patients to help prevent organ rejection by suppressing the body’s immune response.
Second Am. Compl. ¶ 119. The alternative immunosuppressant in Myfortic’s class of
medications is CellCept, sold in branded form by F. Hoffman-LaRoche Ltd., and in generic
forms (mycophenolate mofetil or “MMF”) since 2009. Id. ¶ 122.
Specialty Pharmacies. The pharmacies involved in this case are primarily “specialty
pharmacies.” Specialty pharmacies are full service pharmacies that specialize in dispensing
specialty medications that treat complex conditions including multiple sclerosis, certain cancers,
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solid organ transplant, and hemophilia, and “typically require special handling and other
specialty expertise.” See, e.g., Ex. E. The distribution of Exjade is largely coordinated through a
single point of contact called Exjade Patient Assistance & Support Services (“EPASS”) that
receives prescriptions for new Exjade patients and conducts an initial benefits investigation to
evaluate patients’ insurance coverage for the product. For much of the time period relevant to
the litigation, EPASS sent the Exjade prescription to one of three specialty pharmacies in the
EPASS distribution network, one of which was BioScrip, the settling co-defendant named in the
Government’s complaints. See, e.g., Second Am. Compl. ¶ 241. The specialty pharmacies
dispense Exjade to patients, contact them about refills, and provide patient education and
counseling. Id. ¶¶ 241, 243-44.
NPC distributes Myfortic through many pharmacies across the United States, including
various specialty pharmacies that have market share rebate agreements with NPC. See
id. ¶¶ 140-41, 145.
This Lawsuit and the Government’s Extensive Pre-Intervention Investigation. In
November 2011, Relator David Kester, then a Sales Manager for NPC’s cystic fibrosis medicine
TOBI, initiated this case by filing a qui tam suit under seal. Following the filing of the qui tam
suit, the Government conducted an extensive investigation of NPC’s relationships with specialty
pharmacies regarding the dispensing of Exjade, Myfortic, and three other medications. In the
course of its lengthy investigation, the Government issued over fifty civil investigative demands,
obtained more than 15 million pages of documents from NPC, pharmacies, and hospitals, and
deposed and interviewed numerous NPC and pharmacy employees. In addition, the Government
had access to its own data on claims reimbursed by government healthcare programs including
Medicare and Medicaid. The U.S. intervened as to the Relator’s allegations concerning Myfortic
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and filed its original complaint in intervention on April 23, 2013. On January 8, 2014, the U.S.
amended its complaint, adding allegations related to Exjade and naming BioScrip as a co-
defendant. On the same day, the States, except for Washington, also filed complaints against
NPC and BioScrip relating to Exjade only. Dkt. Nos. 60, 61. Washington filed its complaint on
January 27, 2014. Dkt. No. 82. On August 28, 2014, the U.S. filed a Second Amended
Complaint-in-Intervention. Dkt. No. 231.
The Exjade Allegations. The Government alleges that from February 2007 to May 2012
NPC paid kickbacks to BioScrip in exchange for which BioScrip engaged in “intensive”
adherence-related efforts—namely, encouraging patients to order their doctor-prescribed Exjade
refills and/or resume doctor-prescribed Exjade therapy that they had discontinued. Second Am.
Compl. ¶ 302. These alleged kickbacks took the form of contractual discounts and rebates, as
well as the allocation of additional patients to BioScrip when BioScrip showed improvement in
patient adherence. Id. ¶¶ 303-04.
NPC first contracted with BioScrip to dispense Exjade in 2005, at which time it provided
discounts to BioScrip under an agreement that also provided that BioScrip would contact patients
about refills, provide patient education and ship Exjade to patients, among other activities. Id.
¶¶ 242-44. The Government does not allege that the discounts paid beginning in 2005 violated
the AKS or the FCA. Rather, the Government contends that a “threat” by NPC in February 2007
to reconsider whether BioScrip should be part of EPASS because its refill levels were below
those of the other two EPASS pharmacies transformed BioScrip’s patient outreach calls and
refill reminders into improper activity and NPC’s discounts into purported “kickbacks.” Id.
¶¶ 253-58. The Government contends that after 2007 BioScrip used insufficiently trained and
unqualified personnel to call patients, id. ¶ 284, and prompted patients to order refills of Exjade
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that were not “needed or clinically appropriate,” id. ¶ 274. This conduct, according to the
Government, resulted in the submission of “tens of thousands of false claims to Medicare and
Medicaid.” Id. ¶ 311.
The Myfortic Allegations. The U.S. also alleges that discounts and market share rebates
NPC paid to “twenty-some” pharmacies based on their purchases of Myfortic constitute
kickbacks in violation of the AKS because of alleged extra-contractual side agreements between
NPC and the pharmacies. Id. ¶¶ 141, 146, 207. The U.S. contends that “agreements” outside the
four corners of the written contracts, through which the pharmacies supposedly “committed” to
NPC that they would encourage doctors to “switch” patients to Myfortic from CellCept and
“prevent” those doctors from using generic CellCept, transformed otherwise-legal contractual
discounts and rebates into illegal kickbacks. Id. ¶¶ 5, 141-47. Despite its broad allegation that
NPC paid Myfortic-related kickbacks to “twenty-some” specialty pharmacies, the U.S. has
alleged the particulars of supposed side agreements with only five. See id. ¶¶ 151-201. As with
Exjade, the U.S. alleges that these “agreements” collectively resulted in “tens of thousands” of
false claims. Id. ¶ 221.2
2 There are no allegations in this case that NPC engaged in off-label promotion or made
improper payments to doctors with respect to either drug. Nor are there any allegations that any
discounts or rebates that NPC paid to any specialty pharmacy were not disclosed or passed on to
the Government.
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ARGUMENT
I. THE GOVERNMENT SHOULD BE ORDERED TO PRODUCE DOCUMENTS
RELATING TO ITS MEDICATION ADHERENCE PROGRAMS AND
INITIATIVES
A. The Requested Adherence-Related Discovery Is Relevant To The Claims
And Defenses In This Case
To prove its claims as alleged under the federal and state FCAs, the Government must
show that NPC’s rebates and adherence programs crossed the line between legal conduct that
legislators and regulators encourage, on the one hand, and illegal conduct actionable under the
AKS on the other. However, NPC believes the Government promotes conduct that is
substantially the same as the conduct it seeks to penalize here. For example, the federal
government actively encourages medication adherence—by, among other things, promoting
refill reminder programs and offering financial incentives to Medicare Part D plan sponsors for
achieving certain adherence goals—recognizing that when patients adhere to their prescribed
medication therapies it benefits both patient health and the public fisc by reducing medical
services expenditures.3 The States have similar programs.4
3 See, e.g., Ex. F, Daniella Perlroth, et al., Medication Therapy Management in
Chronically Ill Populations: Final Report Prepared for Centers for Medicare & Medicaid
Services (CMS) (Aug. 2013), at 3, available at
http://innovation.cms.gov/Files/reports/MTM_Final_Report.pdf (“Poor medication adherence
has been associated with adverse health outcomes and increased risk of mortality across multiple
disease conditions, particularly among patients with chronic conditions. Medication non-
adherence accounted for 33%-69% of all medication-related hospital admissions in the U.S. in
2000. The cost of medication non-adherence was estimated to exceed $177 billion, with
medication-related hospitalizations accounting for almost 70% ($121.5 billion) of that estimate
(2000 U.S. dollars).”) (citations omitted).
4 See, e.g., Ex. G, James J. Figge, M.D., State of N.Y. Dep’t of Health, NYS Medicaid E-
Prescribing Incentive Program: Interface with HITECH and Meaningful Use (May 2010), at 13
(New York conditions e-prescription incentives on patient collection of medication to
“[i]ncentivize[] . . . promotion of patient medication adherence”), available at
http://www.health.ny.gov/regulations/arra/docs/ nys_medicaid_e-prescribing_incentive.pdf;
Ex. H, Md. Dep’t of Health and Mental Hygiene, Maryland P3 (Patients, Pharmacists,
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In order to defend itself against the Government’s claims that NPC sponsored illegal
rebate and adherence programs, NPC seeks documents and information concerning the
Government’s own rebate and adherence programs—programs the Government presumably
regards as proper and legal. In particular, NPC’s Requests for Production (“RFP”) Nos. 71-73,
75-82, and 89-92 to the U.S. seek documents relating to the U.S.’s own initiatives to promote
medication adherence, including documents regarding:
• Adherence-related components or requirements of certain federal health-related
programs and grants, and other federal adherence-related policies, activities,
programs, plans, or initiatives (RFP Nos. 71-73, 80, 82, 89, 90, 92);
• The U.S.’s exclusion of communications encompassing adherence-related
communications from the definition of “marketing” in certain laws and
regulations and its publication regarding refill reminders (RFP Nos. 75-78); and
• The U.S.’s report regarding the budgetary impact of medication adherence and
other documents regarding the savings, costs, and/or patient outcomes associated
with medication adherence (RFP Nos. 79, 81, 91).
Ex. I at Nos. 71-73, 75-82; Ex. J at Nos. 89-92. NPC directed similar requests to the States. See
Exs. K-U at Nos. 36, 38-39; Ex. V at No. 50. The Government refuses to produce documents
responsive to these Requests and incorrectly asserts that the discovery sought is not relevant. See
Ex. W at Nos. 71-73, 75-82; Ex. X at Nos. 89-92 ; Ex. Y at 3-5; Ex. Z at 3; Ex. BB & CC at
Nos. 36, 38-39 ; Ex. DD at No. 50; Ex. EE at 4; Ex. FF at 2; Ex. GG.5
Partnerships) Program (Oct. 18, 2013) (describing state-sponsored program pairing patients
with pharmacists who meet several times a year to improve medication adherence), available at
http://dhmh.maryland.gov/ innovations/SitePages/maryland-p3-program.aspx.
5 Following extensive meet and confer efforts, the States agreed to produce non-
privileged documents in the possession, custody, and control of the States’ Single State Agencies
(“SSAs”) that relate to Exjade adherence only. Ex. GG. The U.S. still refuses to produce any
materials related to its adherence programs, arguing that such materials are not relevant because
they are not public and therefore NPC had no “notice” of these programs. Sheth Decl. ¶ 37.
This argument misses the point. NPC’s defense is not that it modeled its adherence programs on
the U.S. programs. Its defense is that its adherence programs were proper and consistent with
industry standard, as made clear by the fact that the U.S. engages in substantially similar conduct.
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Documents related to the Government’s own adherence programs and initiatives are
relevant to the appropriateness of the adherence programs at issue here. The Government does
not merely enforce the law in this arena; it is also an active participant in it, formulating its own
adherence initiatives to encourage medication compliance. What the Government deems
appropriate and desirable in conducting its own affairs as a market participant is unquestionably
relevant to whether it can deem similar conduct illegal when it dons its enforcement hat. If the
Government’s own programs encourage patients to adhere diligently to their iron chelation
therapies rather than take their medication only on an “as needed” basis, that is relevant to the
Government’s and Relator’s argument that BioScrip’s patient outreach was improper for doing
the same thing.
Moreover, documents evidencing the contours of the Government’s own adherence
programs are also relevant to establishing the reasonableness of NPC’s conduct regarding the
incentives at issue in this case. If NPC’s allegedly illegal adherence programs resemble those the
Government sponsors or otherwise sanctions, it would be compelling evidence that NPC’s
conduct was reasonable and cannot be a knowing and willful violation of the AKS and the FCA.
See, e.g., U.S. ex rel. Finney v. Nextwave Telecom, Inc., 337 B.R. 479, 488 (S.D.N.Y. 2006)
(McMahon, J.) (“‘[U]nresolved disputes about the proper interpretation of a statute or regulation
should not lead to suits under the FCA, at least where a claimant’s interpretation of the
governing law is reasonable.’”) (quoting Visiting Nurse Ass’n of Brooklyn v. Thompson, 378 F.
Supp. 2d 75, 96 (E.D.N.Y. 2004)). Given that the Government will have to establish that NPC
“knowingly and willfully” offered illegal remuneration to BioScrip, see 42 U.S.C. § 1320a-
7b(b)(2), the reasonableness of NPC’s conduct will be a critical issue in this case.
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Thus, the requested documents are relevant and should be produced absent some
compelling objection. The Government offers none.
B. The Government Has Not Asserted Any Valid Objections To NPC’s Requests
Aside from the Government’s relevance objections, which are without merit for the
reasons set forth above, the U.S. also argues that these documents are protected by the
deliberative process privilege. See Ex. W at Nos. 71-73, 75-82; Ex. X at Nos. 89-92.6 The
States assert the additional objection that they are obligated to produce only documents within
the custody, possession, or control of the Single State Agencies (“SSAs”) charged with the
administration of Medicaid in each State. Exs. BB & CC at Nos. 36, 38-39; Ex. DD at No. 50.
Neither of these objections has merit.
1. The Deliberative Process Does Not Apply
“The deliberative process privilege ‘covers documents reflecting advisory opinions,
recommendations and deliberations comprising part of a process by which governmental
decisions and policies are formulated.’” MacNamara v. City of New York, No. 04 Civ. 9216,
2007 WL 1169204, at *1 (S.D.N.Y Apr. 20, 2007) (Francis, J.) (quoting Tigue v. U.S. Dep’t of
Justice, 312 F.3d 70, 76 (2d Cir.2002). “‘Purely factual’ material is not protected by the
privilege.” Id. (quoting Grand Central P’ship v. Cuomo, 166 F.3d 473, 482 (2d Cir. 1999)
Moreover, the deliberative process privilege is “qualified and as such must be balanced against a
litigant’s substantial need for the information in issue.” Id. at 92.
6 The U.S. has also pressed the objection that the requested documents are publicly
available and/or in NPC’s possession. See, e.g., Ex. W at Nos. 71-73, 75-82. That requested
documents are publicly-available and/or in the possession of the requesting party is not a valid
basis for refusing to produce them. See Travelers Indemn. v. Northrop Grumman Corp., No. 12
Civ. 3040, 2012 WL 6200680 at *2 (S.D.N.Y. Dec. 10, 2012) (ordering production of documents
obtained from publicly-available sources); Davidson v. Goord, 215 F.R.D. 73, 77 (W.D.N.Y.
2003).
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The non-public documents that NPC seeks through these requests concern factual
information about the Government’s adherence programs—including how they work and are
administered—not its deliberations concerning those programs. Such documents are not
protected by the deliberative process privilege and, consequently, must be produced. See id. at
93 (rejecting claim of deliberative process privilege over memoranda that contained factual
material and were not “policy-oriented”).7
2. The Requested Documents Are Within The States’ Control And Must
Be Produced
The States have also refused to produce the requested documents on the basis that they
are purportedly not in the possession, custody, or control of the Single State Agencies (“SSAs”)
that administer each State’s Medicaid program.8 Specifically, the States contend that the SSAs,
not the States themselves, are the “real parties” to this action and that the SSAs have no
obligation to produce documents in the possession of other state agencies. See, e.g., Ex. HH at
1-2.
As a threshold matter, the States cannot now claim that the SSAs—not the States—are
the plaintiffs in this case simply to reduce their discovery obligations when they have pled to the
contrary.9 The Government, like any other civil litigant, must abide by the rules of discovery,
particularly where, as here, it is the party bringing suit. See, e.g., Collins & Aikman, 256 F.R.D.
7 To the extent any responsive documents also contain information that is protected by
the deliberative process privilege, the Government should furnish a privilege log that sets forth in
detail the bases on which it claims the withheld information is “predecisional, deliberative,
purely subjective, and neither adopted nor incorporated in the agency’s final decision.” S.E.C. v.
Collins & Aikman Corp., 256 F.R.D. 403, 416 (S.D.N.Y. 2009); accord S.D.N.Y. Rule 26.2.
8 Pursuant to the Social Security Act, each State is required to establish a “single state
agency” to administer Medicaid within the State. See Almenares v. Wyman, 334 F. Supp. 512,
517 (S.D.N.Y. 1971) (citing 42 U.S.C. §§ 602(a)(3), 1382(a)(3) (1970)).
9 See, e.g., Dkt. No. 61 at ¶¶ 12-20; Dkt. No. 162 at ¶ 12; Dkt. No. 82 at ¶ 12.
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at 414 (“Like any ordinary litigant, the Government must abide by the Federal Rules of Civil
Procedure. It is not entitled to special consideration concerning the scope of discovery,
especially when it voluntarily initiates an action.”). As parties to this case, the States are
obligated to produce responsive documents in their possession, custody, or control. This
obligation extends to documents that parties have the “legal right or the practical ability to
obtain,” such that the party “is deemed to have ‘control,’ even if the documents are actually in
the possession of a non-party.” In re Flag Telecom Holdings, Ltd. Sec. Litig., 236 F.R.D. 177,
180 (S.D.N.Y. 2006); accord Shcherbakovskiy v. Da Capo Al Fine, Ltd., 490 F.3d 130, 138 (2d
Cir. 2007) (“[I]f a party has access and the practical ability to possess documents not available to
the party seeking them, production may be required.”).
In addition, even if the States were correct (and they are not) that the “real parties” in this
case are the SSAs, see Ex. HH at 1, their objection would still fail. “[W]hen an agency of
government institutes suit, any obligation to disclose relevant information extends to the
government qua government requiring disclosure of all documents in its possession, custody or
control, not just those materials in the immediate possession of the particular agency-plaintiff.”
See, e.g., Compagnie Francaise d’Assurance Pour le Commerce Exteriur v. Phillips Petroleum
Co., 105 F.R.D. 16, 35 (S.D.N.Y. 1984). Even if the States had to produce only those documents
in the possession, custody, or control of the SSAs, the States’ production would still be
unquestionably insufficient because the States have failed to produce responsive documents over
which the SSAs unquestionably have control, including from other state agencies and state-run
hospitals. See Ex. II.
The SSAs have possession, custody, or control for discovery purposes over documents
held by other state entities involved in the administration of Medicaid. The SSAs are tasked with
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15
the far-reaching mission to “[a]dminister or supervise the administration of the plan” as well as
“[m]ake rules and regulations that it follows in administering the plan or that are binding upon
local agencies that administer the plan.” 42 C.F.R. § 431.10(b); 42 U.S.C.
§ 1396a(a)(5). Federal regulations grant nearly plenary authority to the SSAs to control the
administration of Medicaid. See, e.g., 42 C.F.R. § 430.0 (authorizing the SSAs to administer all
aspects of the Medicaid program, including determining eligibility, the types and range of
services, payment levels for services, and administrative and operating procedures); see also 42
C.F.R. § 431.10(e) (noting that the SSAs “may not delegate . . . the authority to supervise the
plan or to develop or issue policies, rules, and regulations on program matters”). This expansive
grant of authority alone negates any claim that the SSAs are unable to obtain documents from
state entities that provide Medicaid services. See Emily Q. v. Bonta, 208 F. Supp. 2d 1078, 1093
(C.D. Cal. 2001) (noting that state entities participating in Medicaid in California “must comply
with any decision of DHS [California’s SSA],” and finding that those agencies “are subject to the
‘control’ of DHS in the administration of Medicaid”). Moreover, since “[p]ayments for services
are made directly by the State to the individuals or entities that furnish the services,” the SSAs
necessarily have possession, custody, or control over Medicaid documents concerning the
services rendered by such entities. See 42 C.F.R. § 430.0; see also 42 C.F.R. § 447.202 (“The
Medicaid agency must assure appropriate audit of records if payment is based on costs of
services or on a fee plus cost of materials.”). In addition, federal regulations require the SSAs to
maintain or supervise the maintenance of extensive records and periodically submit that
information to the federal government, and the SSAs necessarily obtain that information from the
state entities involved in the administration of Medicaid as part of this task. See, e.g., 42 C.F.R.
§§ 431.16-431.17; Ex. JJ, Centers for Medicare & Medicaid Servs., Medicaid Data Sources–
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General Information, available at http://www.cms.gov/Research-Statistics-Data-and-
Systems/Computer-Data-and-Systems/MedicaidDataSourcesGenInfo/index.html (explaining that
Medicaid data is based on periodic reports and the collection of program and financial data from
the States). Thus, in light of their broad administrative authority and reporting requirements, the
SSAs cannot legitimately claim that they lack possession, custody, or control over documents
held by other state entities that participate in Medicaid, such as State Hospitals.
* * *
Because the documents sought by RFP Nos. 71-73, 75-82, and 89-92 to the U.S., RFP
Nos. 36 and 38-39 to the States, and RFP No. 50 to California are relevant and reasonably
calculated to lead to the discovery of admissible evidence, and because the Government offers no
valid objection to their production, the U.S. and the States should be compelled to produce all
non-privileged documents responsive to these discovery requests.
II. THE GOVERNMENT SHOULD BE ORDERED TO PRODUCE DOCUMENTS
RELATING TO ITS IMMUNOSUPPRESSIVE THERAPIES FOR KIDNEY
TRANSPLANT PATIENTS AND ITS IRON CHELATION THERAPIES
NPC has also sought, and the Government has refused to provide, documents relating to
immunosuppressive therapy for kidney transplant patients and iron chelation therapy for patients
in hospitals and medical facilities operated by the U.S., and the identities of HCPs at Veterans
Affairs (“VA”) hospitals who make prescribing decisions for patients after kidney transplant
surgery. RFP Nos. 19, 94-97, and 99 and Interrogatory No. 9 to the U.S. seek:
• Documents reflecting or relating to any treatment protocols for kidney transplants
and iron chelation therapy performed at federally operated healthcare facilities
(RFP Nos. 19, 99);
• Documents relating to the administration of Exjade or the promotion of Exjade
treatment adherence developed by certain federal agencies or provided by HCPs
at VA facilities (RFP Nos. 94- 97); and
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• The identities of “any [provider of healthcare services] at a VA Hospital who
makes prescribing decisions of appropriate medications for patients after kidney
transplant surgery” (Interrogatory No. 9).
See Ex. KK at No. 19; Ex. J at Nos. 94-97, 99; Ex. LL at No. 9. NPC issued similar requests to
the States for Exjade and iron chelation therapy treatment protocols developed by the States. See
Exs. K-U at Nos. 37, 44, 46; Ex. V at No. 51.
Other than the States’ objection that the States are obligated to produce only documents
within the custody, possession or control of the SSAs, and the Government’s objections on
deliberative process grounds, both of which fail for the reasons set forth in Section I.B, supra,
the Government appears to be withholding responsive documents and a substantive interrogatory
response based only on its objection that the discovery sought is not relevant. See Ex. MM at
No. 19; Ex. X at Nos. 94-97, 99; Ex. Z at 3-4; Ex. AA; Ex. NN at 4; Ex. OO at 5; Exs. BB & CC
at Nos. 37, 44, 46; Ex. DD at No. 51. Here too, the Government’s own claims and arguments
have made this information relevant and discoverable.
The documents and information sought through these discovery requests are plainly
relevant to the Government’s claims that specialty pharmacies were improperly suggesting that
transplant physicians “switch” patients to Myfortic, or improperly convincing patients to resume
Exjade therapies for financial, non-clinical reasons. For example, with respect to Myfortic, when
the Court questioned whether transplant surgeons were “complete pushovers” that “would do
anything that the pharmacists said,” the Government argued that the pharmacy recommendations
“were made under the pretext of certain clinical justifications, and the result was in many cases
that patients were switched from a competing drug to Myfortic.” Ex. B at 8:21-9:3; accord
Second Am. Compl. ¶ 148 (alleging that specialty pharmacy’s faxed recommendations to
physicians to switch patients to Myfortic were “presented . . . as an exercise in clinical
judgment” but were in fact made “entirely as a matter of economic calculation”). Asked whether
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18
these switches were made to the patients’ detriment, the Government indicated that they were
because “there is generally some risk whenever patients, as we understand it, switch from one
drug to another.” Id. at 9:4-8.
The clinical considerations the Government argues were “pretext[ual]” relate to findings
that Myfortic has important advantages for certain patient populations. Myfortic’s branded
competitor, CellCept, and its generic forms are metabolized in the stomach, which may cause
gastrointestinal problems. In contrast, Myfortic is enteric-coated, permitting it to pass through
the stomach to metabolize in the small intestine, and therefore, may cause fewer gastrointestinal
complications than CellCept and generic MMF. In addition, proton pump inhibitors (“PPIs”),
such as Prilosec®, Prevacid®, and Nexium®, which are now available over-the-counter, and are
often taken by patients suffering from gastrointestinal disorders, can interfere with the absorption
of CellCept’s active ingredient.10 However, Myfortic is not rendered less effective by PPIs.11
The requested documents bear directly on the plausibility of the Government’s
allegations that the clinical justifications for switching patients to Myfortic were pretextual. For
example, if a kidney transplant treatment document from a VA hospital indicates that patients
reporting gastrointestinal complications while taking CellCept or generic MMF should be
switched to Myfortic, or that patients taking PPIs should be switched to Myfortic, these facts
would substantially undermine the U.S.’s contention that the alleged “switches” to Myfortic were
the result of the efforts of financially incentivized pharmacists rather than the independent
10 See, e.g., Ex. PP, U.S. Dep’t of Health & Human Servs., U.S. Food and Drug Admin.,
“CellCept (mycophenolate mofetil) Capsules, Tablets, Oral Suspension and CellCept
(mycophenolate mofetil hydrochloride) for injection” (last updated Nov. 1, 2013) at 2 (“PPIs
should be used with caution when coadministered to transplant patients being treated with
CellCept.”), available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/
ucm310868.htm.
11 See, e.g., Ex. QQ, CellCept Label approved September 27, 2013, at 21.
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medical judgment—based on valid clinical considerations—of prescribing HCPs. See, e.g.,
Second Am. Compl. ¶¶ 6, 148, 188. Additionally, documents in the possession of the U.S.
indicating that HCPs at Government hospitals switched patients to Myfortic for independent
clinical reasons and without a recommendation from any specialty pharmacy would undermine
the U.S.’s allegations of improper “switching” as part of the purported NPC kickback scheme.
Similarly, the identities of the HCPs at VA hospitals who prescribe immunosuppressants
following kidney transplant surgery will permit NPC to identify HCPs it may wish to interview
or depose regarding the factors that influence their immunosuppressant prescribing decisions.
Facts indicating that the U.S.’s own HCPs made prescribing decisions similar to the ones it
contends in the Amended Complaint were influenced by purported kickbacks are relevant to the
U.S.’s theory that the specialty pharmacies were using “pretext[ual]” clinical reasons to convince
physicians to switch patients to Myfortic.
With respect to Exjade, the Government and the Relator have argued to the Court that
incentivizing BioScrip to promote Exjade adherence was somehow improper because Exjade is a
medication that iron overload patients should only take after transfusions and “for a short period
of time,” on an as-needed basis. See, e.g., Ex. B at 26:6-13, 29:19-30:4. Documents showing
that the Government’s patient guides and protocols for treating iron overload include prescribing
Exjade and encouraging adherence to an Exjade treatment therapy are relevant to disproving the
allegation that BioScrip’s adherence efforts were improper. See, e.g., Second Am. Compl.
¶¶ 259-60. Similarly, protocols indicating that Exjade treatment and/or iron chelation therapies
should be undertaken consistently, rather than only on an “as-needed” basis as deemed by the
patient, is relevant to disproving the Government’s claim that doctors want their patients to take
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Exjade only when they were undergoing transfusions or actually feeling the effects of iron
overload. See Ex. B at 26:6-13.
Finally, the Government has alleged that “Novartis and BioScrip were aware that nearly
all the BioScrip employees assigned to ‘counsel’ Exjade patients lacked the clinical knowledge
or patient information to provide appropriate counseling to patients regarding Exjade.” See
Second Am. Compl. ¶ 228. Because of this and other Government contentions that NPC’s use of
BioScrip to distribute Exjade was inappropriate, NPC requested documents regarding the
Government’s use of BioScrip, specifically the VA’s use of BioScrip to dispense Exjade to its
patients, which NPC believes to have been the case based on BioScrip’s representations to NPC
personnel. Ex. J at No. 94. The Government refuses to produce that information. Ex. X at No.
94. The documents NPC seeks regarding the Government’s selection or designation, whether
official or unofficial, of BioScrip as a pharmacy to dispense Exjade or other medications related
to iron chelation therapy are relevant to the validity of the Government’s allegation that BioScrip
was unqualified to provide appropriate counseling to patients regarding Exjade and the ability of
outside entities, such as NPC or the Government, to make that assessment.
NPC’s ability to effectively defend against the Government’s “switching” and kickback
allegations will be prejudiced if it is unable to obtain discovery of the extent to which the
Government itself—through federal and State hospitals and agencies—endorses Exjade
adherence and Myfortic based on clinical reasons, or approved of BioScrip as a qualified Exjade
provider. The relevance objections to RFP Nos. 19, 94-97, and 99, and Interrogatory No. 9 to
the U.S., RFP Nos. 37, 44, and 46 to the States, and RFP No. 51 to California, are baseless, and
the Government should be compelled to produce all non-privileged documents responsive to
these RFPs and respond completely to the interrogatory.
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21
III. THE GOVERNMENT SHOULD BE COMPELLED TO PRODUCE ITS
COMMUNICATIONS WITH BIOSCRIP REGARDING BIOSCRIP’S
STIPULATIONS OF FACT
On January 6, 2014, the U.S. and BioScrip entered into a Settlement Agreement and
Stipulation pursuant to which BioScrip stipulated to certain alleged facts relating to the
Government’s Exajde-related allegations. See Ex. RR, Dkt. No. 41, at 3-7. The States entered
into similar settlement agreements with BioScrip. See, e.g., Ex. SS, Dkt. No. 127-1; Ex. TT, Dkt.
No. 129-1.
NPC served document requests on the Government seeking documents relating to its
settlement agreements with BioScrip, including the agreements themselves, any documents
reflecting any communications relating to such agreements, and any related admissions or
acknowledgements of facts. See Ex. J at No. 85; Exs. K-U at No. 42. Although the U.S. agreed
to produce responsive documents “to the extent that such documents are relevant to the claims or
defenses asserted in this action and are not otherwise [privileged],” see Ex. X at No. 85, it
ultimately has not produced any documents responsive to this request, contending that all of the
requested documents are privileged and/or not relevant. The States initially refused to produce
any responsive documents, objecting primarily on the grounds of privilege and relevance. See
Exs. BB & CC at No. 42. The States subsequently agreed to produce the settlement agreements
as well as the same types of documents that the U.S. agreed to produce to NPC. See Ex. HH at 4;
Ex. FF at 3.
In an attempt to resolve this dispute without motion practice, Sheth Decl. ¶ 51, NPC
agreed to the Government’s proposal that it would produce its communications with BioScrip
about the admissions of fact if NPC would not seek to depose the Government’s attorneys
regarding the settlement. See Ex. UU at 2. After NPC acquiesced to the Government’s demand,
however, BioScrip sought to condition the Government’s compliance with NPC’s discovery
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22
requests on a similar concession for BioScrip’s attorneys. See id. Given the possible need for
such discovery from these very differently situated percipient witnesses, NPC did not accede to
BioScrip’s demand. See id. at 1-2. Unfortunately, notwithstanding its prior agreement to
produce, the Government has followed BioScrip’s instruction that it withhold these responsive,
non-privileged documents while BioScrip attempts to extract this additional concession from
NPC. See id.; Ex. VV. There can be no question that the Government cannot withhold relevant,
non-privileged documents simply because BioScrip asks it to do so. See, e.g., Keaton v. Hannum,
No. 1:12-cv-00641, 2013 WL 1818993, at *4 (S.D. Ind. Apr. 29, 2013) (“The Court is unaware
of any basis for [a party] to refuse to produce documents in her possession because a non-party
to this case may have an objection to their production, but that party has not intervened or sought
a protective order to prevent their disclosure.”).12
In any event, there can be no question that the requested documents are relevant to the
claims and defenses in this case. BioScrip’s stipulation encompasses numerous stipulated facts,
including that NPC “provided input on aspect of . . . how to discuss potential side effects with
Exjade patients”; “approved” BioScrip’s call scripts; and “increased rebates that BioScrip earned
for each Exjade shipment . . . in order to encourage BioScrip to continue the efforts of its Exjade
Team.” See Ex. RR, Dkt. No. 41 at (l), (p) & 3-7. The Government has repeatedly invoked
these stipulated facts to support their claims against NPC. See, e.g., Ex. B at 28:5-10 (counsel
for U.S. citing BioScrip’s stipulation to explain NPC’s alleged scheme to induce BioScrip to
12 This recent turn of events is particularly concerning given that BioScrip initially agreed to
produce the same documents in response to a third party subpoena but for the Government’s
objection to their production. See Ex. AAA at 2; see also Exs. WW–ZZ. BioScrip later reversed
course, claiming that NPC should obtain the documents from the Government directly through
party discovery for alleged burden reasons, and NPC decided to pursue its requests with the
Government instead. Now that the Government has otherwise agreed to produce the documents
in response to party discovery, BioScrip is obstructing the documents’ production.
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23
directly contact patients to “push” Exjade refills); Second Am. Compl. ¶¶ 245, 299 (complaint
allegations tracking BioScrip’s stipulated facts); California Second Amended Complaint-In-
Intervention, Dkt. No. 162 ¶¶ 56, 110 (same); Ex. BBB (DOJ press release touting BioScrip
stipulations). Communications regarding these stipulated “facts,” which relate to the
Government’s key allegations regarding Exjade, could provide substantial insight into what
BioScrip was—and, even more importantly, was not—willing to stipulate to in connection with
the purported kickback scheme as well as what revisions the Government wanted incorporated
into those “facts.”
No privilege applies to preclude discovery of these materials. Federal Rule of Evidence
408—the “settlement privilege”—does not shield these communications from production
because it “pertains only to evidentiary issues at trial, and does not govern pretrial disclosure of
settlement agreements. Rather, Federal Rule of Civil Procedure 26(b)(1) sets the standard for
pretrial disclosure, and requires only that the information sought be relevant and calculated to
lead to the discovery of admissible evidence.” Conopco, Inc. v. Wein, No. 05-civ-9899, 2007
WL 1040676, at * 5 (S.D.N.Y. Apr. 4 2007); see also In re Initial Pub. Offering Sec. Litig., No.
21 MC 92, 2004 WL 60290, at *2 (S.D.N.Y. Jan. 12, 2004) (“[T]he discovery of settlement
materials is not governed by a different standard than other documents under the Federal Rules
of Civil Procedure. Because plaintiffs have made the minimal showing of relevance required
under the Rules, they are entitled to discovery”); id. at *4 (“Rule [26] specifically permits
discovery of inadmissible information, so long as that information may lead to the discovery of
admissible evidence. Thus, admissibility is not a prerequisite to discoverability, and the scope of
relevance under Rule 26 is broader than under the Rules of Evidence.”).
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Nor are the documents subject to any attorney-client or work product privilege because
they consist of communications between the Government, on the one hand, and a third party,
BioScrip, on the other. Having waived any potential privilege claim by including BioScrip in
these communications,13 the Government cannot refuse production on privilege grounds. See,
e.g., Schanfield v. Sojitz Corp. of Am., 258 F.R.D. 211, 214 (S.D.N.Y. 2009) (Francis, J.) (“It is
well-established that voluntary disclosure of confidential material to a third party waives any
applicable attorney-client privilege.”).
Because the requested documents are unquestionably relevant and not privileged, the
Government should be compelled to produce its settlement communications without further
delay.
13 To the extent the Government possesses purely internal, privileged communications
reflecting these settlement communications, those communications should be redacted, logged
and produced to the extent they also contain non-privileged material (such as the settlement
communications themselves).
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CONCLUSION
For all of the foregoing reasons, NPC respectfully requests that the Court grant NPC’s
motion to compel in its entirety.
Dated: September 10, 2014
Respectfully submitted,
/s/ Manisha M. Sheth
Faith E. Gay
Manisha M. Sheth
QUINN EMANUEL URQUHART & SULLIVAN LLP
51 Madison Avenue, 22nd Floor
New York, New York 10010
Tel. No.: 212-849-7000
Evan R. Chesler
Rachel G. Skaistis
CRAVATH, SWAINE & MOORE LLP
Worldwide Plaza
825 Eighth Avenue
New York, New York 10019
Tel. No.: 212-474-1000
Michael A. Rogoff
Manvin Mayell
KAYE SCHOLER LLP
425 Park Avenue
New York, New York 10022
Tel. No.: 212-836-8000
Counsel for Defendant
Novartis Pharmaceuticals Corporation
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