State v. Medimmune, Inc.
State v. Medimmune, Inc.
Opinion of the Court
Plaintiff, the State of New York ("New York"), brings this action against Defendant MedImmune, Inc. ("MedImmune") alleging violations of the New York False Claims Act and a variety of other New York state laws stemming from MedImmune's participation in a kickback scheme designed to boost sales of MedImmune's neonatal respiratory drug, Synagis. (Doc. No. 49 (the "Complaint-in-Intervention" or "Compl.") at ¶ 1.) Now before the Court is MedImmune's motion to dismiss the Complaint-in-Intervention for failure to state a claim pursuant to Federal Rules of Civil Procedure 12(b)(6) and 9(b). (Doc. No. 123.) For the reasons discussed below, MedImmune's motion is DENIED.
I. BACKGROUND
This case begins not with the New York Attorney General, but with Dr. Susan Vierczhalek ("Relator"), a licensed pediatrician and attending physician at Bellevue Hospital Center.
Vierczhalek's case was stayed for a number of years as the States and the United States decided whether or not to intervene in the action. See
Thereafter, on March 31, 2017, New York elected to intervene and filed the Complaint-in-Intervention against MedImmune. (Doc. No. 49.) New York seeks to recover treble damages and civil penalties under the New York State False Claims Act, and to obtain a variety of other relief under related New York state law. (Id. ¶ 1.)
The theory of New York's Complaint-in-Intervention differs notably from the theory underpinning Vierczhalek's Original Complaint. Instead of focusing on off-label promotion, New York alleges that MedImmune engaged in a kickback scheme with Trinity, which resulted in Trinity presenting "false claims to Medicaid for Synagis from January 2007 through March 2011." (Compl. ¶ 3.) The gist of the scheme, as alleged, can be summarized as follows. Synagis is used to prevent the onset of lower respiratory tract disease caused by respiratory syncytial virus ("RSV"). (Compl. ¶ 69.) Synagis was approved by the FDA in 1998, and is prescribed to infants who are at risk of contracting RSV - ordinarily, babies who are born prematurely or who have heart or lung diseases. (Id. ) Trinity is a specialized pharmacy that "dispenses and delivers drugs to patient homes [and] provides or arranges for homecare services." (Id. ¶ 6.) It also "controlled the Medicaid business for Synagis in New York." (Id. ¶ 89.)
Thus, according to the Complaint-in-Intervention, MedImmune salespersons - dubbed the "Synagis people" by hospital staff (Compl. ¶ 132) - would curry favor with hospital administrators, including nurses and doctors, in order to gain access to the neo-natal intensive care unit ("NICU"). (Compl. ¶ 43.) That access allowed *550MedImmune to obtain "confidential personal information about specific babies from NICU logbooks and hospital records." (Id. ¶ 4.) This information, otherwise known as protected health information ("PHI") (id. ¶ 12), typically included an infant's name, gender, date of birth, medical record number, gestational birth weight, and hospital notes, as well as the mother's name, address, insurance information, and phone number. (Id. ¶ 8.) Of particular interest to MedImmune (and to Trinity) was the PHI of babies born prematurely, as these infants would be prime candidates for Synagis. (Id. ¶ 101.) Once in possession of the PHI, MedImmune would pass the information along to Trinity so that Trinity could use it as "leads" for its pharmaceutical representatives. (Id. ¶ 8.) In other words, Trinity used the PHI to pursue patients who would potentially need Synagis. (Id. ¶ 94.)
After receiving the PHI, Trinity would contact the infant's pediatrician or parents and attempt to secure a prescription for Synagis. (Id. ¶ 94.) The end goal was to turn these PHI-leads into "Trinity customers for outpatient Synagis prescriptions." (Id. ¶ 95.) Trinity would then present Synagis claims for reimbursement through New York's Medicaid program. (Id. ¶ 96.) New York alleges that this scheme, which ran from 2007 to 2011 (id. ¶ 187), resulted in "millions of dollars of Synagis Medicaid claims presented by Trinity" (id. ¶ 120). MedImmune benefited as sales of Synagis increased.
On January 22, 2018, MedImmune moved to dismiss the Complaint-in-Intervention. (Doc. No. 124.) Specifically, MedImmune argues that New York has not adequately pleaded a violation of the state or federal anti-kickback statutes. MedImmune also argues that New York has failed to sufficiently demonstrate a violation of the New York False Claims Act or its other state law claims. The motion was fully briefed on June 4, 2018. (Doc. No. 191.)
II. LEGAL STANDARD
To survive a motion to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, a complaint must "provide the grounds upon which [the] claim rests." ATSI Commc'ns, Inc. v. Shaar Fund. Ltd. ,
III. DISCUSSION
The Complaint-in-Intervention sets forth six causes of action. Counts 1 and 2 allege violations of the New York State False Claims Act ("NYFCA"),
A. New York False Claims Act
The NYFCA makes liable any person who: "(a) knowingly presents, or causes to be presented[,] a false or fraudulent claim for payment or approval [or] (b) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim."
"To prove a false claim under [ Section 189(1)(a) ], a relator must show that the defendant '(1) made a claim, (2) to the [ ] government, (3) that is false or fraudulent, (4) knowing of its falsity, and (5) seeking payment from the federal treasury.' " United States v. N. Adult Daily Health Care Ctr. ,
The crux of the Complaint-in-Intervention is that MedImmune violated the NYFCA by causing Trinity to submit false Medicaid billing certifications to New York. (Compl. ¶ 194.) These certifications were allegedly false because while they represented that Trinity furnished Synagis in "compliance with all applicable State and Federal laws and regulations," Trinity and MedImmune were actually in violation of state and federal anti-kickback prohibitions. (
Defendant argues that New York has failed to make out a claim for breach of the NYFCA on three grounds. First, MedImmune insists that New York has not pleaded a violation of New York State's anti-kickback statute,
*5521. Federal Anti-Kickback Statute
The federal anti-kickback statute proscribes "knowingly and willfully offer[ing] or pay[ing] any remuneration (including any kickback, bribe, or rebate) ... to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made ... under a Federal health care program." 42 U.S.C. § 1320a-7b(b)(2)(A), (B).
Under New York's theory of liability, MedImmune is the entity "offer[ing] or pay[ing] any remuneration," 42 U.S.C. § 1320a-7b(b)(2), and the "remuneration" is the PHI. The entity that "purchase[s], lease[s] or order[s] any good, facility, service or item for which payment is made,"
MedImmune argues that it did not violate the federal anti-kickback statute because the term "remuneration" does not encompass PHI. (Doc. No. 124 at 9, 10.) The statute, however, is not so narrow, and the Court sees no reason to read the word "remuneration," at least at this early stage in the litigation, to exclude PHI. Remuneration is defined under the federal statute as "transfers of items or services for free or for other than fair market value." 42 U.S.C § 1320a-7a(i)(6). The U.S. Department of Health and Human Services Office of the Inspector General ("HHS-OIG") has explained that remuneration may include "the offer or payment of anything of value for patient referrals." OIG Compliance Program Guidance for Pharmaceutical Manufacturers ,
Indeed, United States ex rel. Kester v. Novartis Pharm. Corp. ,
*553United States ex rel. Westmoreland v. Amgen, Inc. ,
Defendant's assertion that PHI cannot constitute "remuneration" because it "does not have an independent and objective 'fair market' value" (Doc. No. 124 at 9) is equally unpersuasive. Even if "fair market value" is the proper lodestar for assessing whether or not a given item amounts to "remuneration" - and the Court is doubtful of that premise - New York adequately pleads that PHI had such market value. Given that PHI revealed a host of proprietary data about infants in the NICU, it is obvious that PHI retained more than just "nominal value" since it was instrumental in developing leads targeting particular doctors and patients. United States ex rel. Wood v. Allergan, Inc. ,
MedImmune also argues that New York has not alleged the existence of a quid pro quo between MedImmune and Trinity, since "Trinity provided nothing to MedImmune in return that can fairly be characterized as a 'referral of services' or the 'purchase, lease or order' of anything." (Doc. No. 124 at 12.) But the federal anti-kickback statute also prohibits "recommend[ing]" the purchase of any good or item. 42 U.S.C. § 1320a-7b(b)(2)(B). And New York explicitly, and repeatedly, points out that MedImmune provided "remuneration to Trinity [in the form of PHI] to induce referrals of Synagis." (Compl. ¶ 92.) Indeed, the "more than 1250 baby leads and/or referrals" to Trinity "resulted in millions of dollars in Synagis Medicaid claims ... presented [to New York]." (Id. ) The Complaint-in-Intervention clearly alleges that MedImmune sought to induce Trinity to "recommend Synagis" to patients and doctors. (Id. ¶ 198.) The quo , according to the Complaint-in-Intervention, is obvious: Trinity would recommend Synagis to patients and doctors, thereby "increas[ing] sales of Synagis for MedImmune paid for with public funds." (Id. ¶ 120.) For all these reasons, the Court is persuaded that the Complaint-in-Intervention has adequately alleged a violation of the federal anti-kickback statute.
2. False Certification
Having failed with respect to its arguments regarding the federal anti-kickback statute, MedImmune next insists that the representations made in the Medicaid billing certifications were not false statements as required under the NYFCA. Once again, MedImmune reads the relevant statute too narrowly.
The NYFCA contemplates two types of falsity: factual falsity and legal falsity. Kester ,
Legal falsity comes in two forms. First, there is an "express false certification," which constitutes "a claim that falsely certifies compliance with a ... statute, regulation or contractual term, where compliance is a prerequisite to payment." Mikes v. Straus ,
MedImmune argues that because Trinity's Medicaid Certification Statements ("Certification Statements") only certify that "the signatory has 'furnished the care, services and supplies ... in accordance with applicable federal and state laws and regulations' " (Doc. No. 124 at 14 (quoting Compl. Ex. B; Compl. ¶¶ 59, 184) ), the Certification Statements are too generalized to satisfy the requirement that it reference a "particular" statute or regulation. The Court disagrees.
While MedImmune insists that the Certification Statements do not reference compliance with a "particular" statute or regulation, the Second Circuit has specifically rejected this argument. See Bishop v. Wells Fargo & Co. ,
Having misstated the legal standard, MedImmune relies on cases that reference the now-discredited "particularity" requirement of Mikes ; as such, they are of dubious value. For instance, MedImmune cites to United States ex rel. Colucci v. Beth Israel Med. Ctr. ,
Given Bishop 's rejection of the "particularity" requirement, the Court agrees with Chief Judge McMahon's conclusion in Kester - involving the very certification forms at issue here - that "a certification of compliance with 'all applicable Federal laws' is [an] express certification of compliance with a statute." United States v. TEVA Pharm. USA, Inc. , No. 13-cv-3702 (CM),
MedImmune briefly argues that it did not "cause" Trinity to submit the Certification Statements because they did not "play[ ] any role in Trinity's submission of the certifications themselves." (Doc. No. 188 at 6; Doc. No. 124 at 13.) But this argument "borders on the frivolous," since courts have long recognized that "the FCA reaches claims that are rendered false by one party, but submitted to the government by another." Feldman ,
Additionally, the Complaint-in-Intervention satisfies Rule 9(b) because "[w]here numerous false claims are involved, the plaintiff may satisfy Rule 9(b) by providing sufficient identifying information about those false claims, or by providing example false claims that enable the defendant to identify similar claims." United States ex rel. Forcier v. Computer Scis. Corp. , No. 12-cv-1750 (DAB),
Accordingly, New York has adequately alleged that MedImmune made false statements under the NYFCA.
3. Materiality
Finally, MedImmune argues that New York's NYFCA claims must be dismissed because the allegedly false statements in the Medicaid billing certifications were simply not material. As noted above, Section 189(1)(b) prohibits making "a false record or statement material to a false or fraudulent claim."
*556Relying on the Supreme Court's discussion in Universal Health Services , courts confronting the issue of materiality must ask whether the conduct at issue has "a natural tendency to influence, or [is] capable of influencing, the payment or receipt of money or property."
Even prior to 2010, "the overwhelming weight of authority" on this issue was that "compliance with the statute was such a precondition [to payment]."
Put simply, anti-kickback statutes are important pieces of the governmental healthcare apparatus, ensuring that claims presented for reimbursement are the product of untainted and independent medical judgment. Understandably, then, "courts, without exception, agree that compliance with the Anti-Kickback Statute is a precondition of Medicare payment." United States ex rel. Westmoreland v. Amgen, Inc. ,
B. Remaining Claims
In addition to its NYFCA claim, New York also brings claims alleging violations of New York Social Services Law § 145-b, New York Executive Laws §§ 63(12) and 63-c, and unjust enrichment. MedImmune moves to dismiss those claims as well. (Doc. No. 124 at 18-20.)
New York Social Services Law § 145-b makes it "unlawful for any person ... knowingly by means of a false statement or representation, or by deliberate concealment of any material fact[,] ... to attempt to obtain or to obtain payment from public funds for services or supplies furnished."
*557MedImmune argues that this claim should be dismissed because the "Social Services Law does not impose liability for causing another to make a misrepresentation." (Doc. No. 124 at 18-19.) But Section 145-b clearly provides that "[w]here public welfare benefits are obtained fraudulently by an entity ... the individual supervising, overseeing, performing or conspiring to effectuate the fraudulent acts can be held personally responsible, and is liable for treble damages." People v. Brooklyn Psychosocial Rehab. Inst. ,
New York's claims under New York Executive Laws §§ 63(12) and 63-c are also sufficiently pleaded. MedImmune recognizes that these provisions do not "create a new cause of action, but rather give[ ] an additional remedy upon which the State can recover." (Doc. No. 124 at 19). Therefore, MedImmune's arguments for dismissal are premised on the contention there is no valid NYFCA or Section 145-b claim to permit recovery under Sections 63(12) and 63-c. However, since the Court has denied MedImmune's motion to dismiss the NYFCA and Section 145-b claims, it necessarily follows that this derivative motion must also be denied.
Finally, the Court rejects MedImmune's motion to dismiss the state's unjust enrichment claim. Under New York law, unjust enrichment requires (1) that the defendant was enriched, (2) at the plaintiff's expense, and (3) it would be inequitable for the defendant to retain the benefit. Phillips Int'l Inv. LLC v. Pektor ,
IV. CONCLUSION
For the reasons set forth above, MedImmune's motion to dismiss the Complaint-in-Intervention is DENIED. The Clerk is respectfully directed to terminate the motion pending at docket number 124.
IT IS HEREBY ORDERED THAT, by October 11, 2018, the parties shall submit to the Court a proposed case management plan and scheduling order. A template for the order is available at: http://www.nysd.uscourts.gov/judge/Sullivan. IT IS FURTHER ORDERED THAT the parties shall appear for a status conference on October 19, 2018 at 3:00 p.m in Courtroom 905 of the Thurgood Marshall United States Courthouse, 40 Foley Square, New York, New York.
SO ORDERED.
The facts set forth in this opinion and order are taken from the Complaint-in-Intervention (Doc. No. 49), Vierczhalek's original complaint (Doc. No. 70) and amended complaint (Doc. No. 102), and documents incorporated therein by reference. See ATSI Commc'ns, Inc. v. Shaar Fund, Ltd. ,
The states are California, Delaware, Florida, Georgia, Illinois, Indiana, Michigan, Montana, Nevada, New Jersey, New Mexico, New York, Oklahoma, Rhode Island, Tennessee, Texas, and Wisconsin, and the Commonwealths of Virginia and Massachusetts. (Original Compl.).
While New York does not allege a substantive violation of subsection (1)(a), it does allege a conspiracy to violate that provision (Compl. ¶ 200), thereby requiring consideration of subsection (a). Moreover, it bears noting that "Courts generally treat these two provisions [subsections (a) and (b) ] together, as their elements overlap significantly." United States ex rel. Hussain v. CDM Smith, Inc. , 14-CV-9107,
However, because the Court finds that New York adequately pleads a violation of the federal anti-kickback statute, it does not address whether New York sufficiently pleads a violation of either the state anti-kickback statute or state Medicaid regulations.
The materiality standard applies to Section 189(1)(a) as well. See, e.g. , United States v. Visiting Nurse Serv. of New York , No. 14-cv-5739 (AJN),
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