Humana Inc. v. Medtronic Sofamor Danek USA, Inc.

133 F. Supp. 3d 1068, 2015 U.S. Dist. LEXIS 134692, 2015 WL 5695888
CourtDistrict Court, W.D. Tennessee
DecidedSeptember 25, 2015
DocketCase No. 2:14-cv-02405-JTF-cgc
StatusPublished
Cited by6 cases

This text of 133 F. Supp. 3d 1068 (Humana Inc. v. Medtronic Sofamor Danek USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Humana Inc. v. Medtronic Sofamor Danek USA, Inc., 133 F. Supp. 3d 1068, 2015 U.S. Dist. LEXIS 134692, 2015 WL 5695888 (W.D. Tenn. 2015).

Opinion

ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTION TO DISMISS

JOHN T. FOWLKES, JR., District Judge.

Before the Court comes Defendants’ Motion to Dismiss Plaintiff’s First Amended Complaint filed December 5, 2015. (ECF No. 33). On January 16, 2015, Plaintiff filed a Response in Opposition, (ECF No. 34), to which Defendants filed a Reply in Support on February 13, 2015, (ECF No. 36). On March 19, 2015, Plaintiff provided this Court with a Notice of Supplemental Authority, (ECF No. 38), to which Defendants responded on March 24, 2015, (ECF'No. 39). On May 22, 2015, oral arguments were held before this Court on Defendants’ Motion to Dismiss. (ECF No. 45). Defendants filed a Notice of Supplemental Authority on August 17, 2015, (ECF No. 47), to which Plaintiff responded on August 20, 2015, (ECF No. 48). Plaintiff filed another Notice of Supplemental Authority on September 3, 2015, (ECF No. 49) to which Defendant responded on September 14, 2015, (ECF No. 50). After reviewing the Motion, Response, Reply, supplemental authorities, and oral arguments by the parties, the Court GRANTS in PART and DENIES in PART Defendants’ Motion to Dismiss.

I. FACTUAL BACKGROUND

The Infuse Bone Graft (“Infuse”) is FDA approved for spinal fusion procedures when used in combination with the LT-Cage. (ECF No. 31 at ¶ 12, 29) (approving Premarket Approval status for Anterior Lumbar Interbody Fusion on July 2, 2002). Such is used as an alternative to bone grafting. Id. at ¶ 14. As further described in' the Important Medical Information (“IMI”) for the Infuse,

[t]he InFUSETM Bone Graft component is inserted into the LT-CAGETM Lumbar Tapered Fusion Device component to form the complete InFUSETM Bone Graft/LT-CAGETM Lumbar Tapered Fusion Device. These components must be used as a system. The InFUSEO Bone Graft component must not be used without the LT-CAGE0 Lumbar Tapered Fusion Device Component.

(ECF No. 33-2 at p. 2). The IMI further details ‘Warnings” and “Potential Adverse Effects” for the Infuse. Specifically, the “Warnings” in the IMI state that,

[t]he safety and effectiveness of the InFUSE Bone Graft component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than open anterior or anterior laparoscopic approaches have not been established. When degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances.

Id. at p. 5. Lastly, the IMI outlines the various “Potential Adverse Events” that can occur because of the Infuse, such as bone fracture, cessation of any potential growth of the operated portion of the spine or loss of spinal function, ectopic and/or exuberant bone formation, infection,, neurological system compromise, tissue or nerve damage, scar formation, or retrograde ejaculation, and noting that “Additional surgery may be necessary to correct some of these potential adverse events”. Id. at 10-11.

[1071]*1071Beginning in 2002, Plaintiff agreed to reimburse their insureds for off-label use1 of Infuse, in reliance on medical literature that touted the benefits of and.underre-ported the adverse events of Infuse. (ECF No. 31 at ¶ 145). Defendants edited and controlled such medical literature. Id. passim. Specifically, the Defendants have spent “millions of dollars” in fees to ghostwriters and Key Opinion Leaders (“KOLs”) related to Infuse. Id. at ¶¶ 33, 40, 187. In late 2008, Plaintiff became aware of new medical literature that questioned the safety and efficacy of Infuse in off-label procedures. Id. at ¶ 162. In February of 2009, Plaintiff adopted a policy prohibiting the reimbursement of off-label Infuse procedures. Id. However, Plaintiff continued to reimburse for such off-label procedures based on representations of Defendants at meetings held on May 25 and October 27, 2010. Id. at ¶¶ 165-73. Within such meeting, Defendants cited to what Plaintiff now calls fraudulent medical literature.2 Id. Apparently, Plaintiff mistakenly paid for many disguised off-label procedures. Id. at ¶¶ 176-81. Specifically, Plaintiff claims that Defendants provided medical practitioners with medical codes that would mask the use of off-label Infuse procedures. Consequently, reimbursements were made against Plaintiffs policy. Id. at ¶¶ 178, 181. Plaintiff identifies twelve claims, paid from May 2008 to April 2012. Id. at ¶¶ 188, 266.

Plaintiff states that many of Plaintiffs insureds were implanted with a debased version of the Infuse device by, inter alia, substitution of the cage component, implantation at unapproved locations of the spine, or utilization of a posterior approach. Id. Humana settled product liability claims related to Infuse. Id. at ¶ 350. As such, Plaintiff claims that it is entitled to reimbursement for certain Medicare benefits. Id. at ¶¶ 348, 352-55.

Due to Defendants’ alleged fraudulent actions, Plaintiff pursues fourteen causes of action: (1) fraudulent misrepresentation; concealment; omission and fraud in the inducement; (2) violation of 18 U.S.C. § 1962(c) (RICO statute); (3) violation of 18 U.S.C. § 1962(d) by conspiring to violate 18 U.S.C. § 1962(c); (4) negligent misrepresentation; (5) subrogation; (6) violation of the consumer protection statutes of the fifty states, the District of Columbia, and the Commonwealth of Puerto Rico; (7) breach of express warranty; (8) breach of implied warranty; (9) unjust enrich-' ment; (10) conversion; (11) Medicare Secondary Payer claim for declaratory judgment; (12) a private cause of action under the Medicare Secondary Payer claim; (13) right-to-charge action under the Medicare Secondary Payer claim; and (14) accounting. See generally id.

In Defendants’ Motion to Dismiss, (ECF No. 34), Defendants argue four major contentions for why Plaintiffs First Amended Complaint should be dismissed: (1) Plaintiff fails to allege any injury in fact or causal connection for Count 1-10; (2) Plaintiff fails to state a claim for relief on all counts; (3) Plaintiff fails to allege fraud with particularity for Counts i — 4, 6, 9-10; and (4) Plaintiff is time-barred as to Counts 1-5, 7-10. (ECF No. 33 at p. 1). To the contrary, Plaintiff contends that all claims are timely and sufficiently pled for all purposes. (ECF No. 34).

II. LEGAL STANDARD

Fed.R.Civ.P. 12(b)(6) provides for dismissal of a complaint that “fail[s] to state a [1072]*1072claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). This allows the “defendant to test whether, as a matter of law, the plaintiff is entitled to legal relief even if everything alleged in the complaint is true.” Mayer v. Mylod, 988 F.2d 635, 638 (6th Cir.1993) (emphasis added) (citing Nishiyama v.

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133 F. Supp. 3d 1068, 2015 U.S. Dist. LEXIS 134692, 2015 WL 5695888, Counsel Stack Legal Research, https://law.counselstack.com/opinion/humana-inc-v-medtronic-sofamor-danek-usa-inc-tnwd-2015.