United States v. Medtronic, Inc.

327 F. Supp. 3d 831
CourtDistrict Court, E.D. Pennsylvania
DecidedJune 4, 2018
DocketCIVIL ACTION NO. 15-6264
StatusPublished
Cited by6 cases

This text of 327 F. Supp. 3d 831 (United States v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Medtronic, Inc., 327 F. Supp. 3d 831 (E.D. Pa. 2018).

Opinion

Smith, District Judge.

*835In this case, the relator contends that the defendant, a medical device company, paid kickbacks to health care providers in violation of the False Claims Act. The False Claims Act, however, includes a public disclosure bar that prohibits lawsuits brought by relators where the relator's allegations of fraud have already been disclosed to the government. The company contends that the claims of fraud raised in the relator's complaint were publicly disclosed prior to the time the relator filed the complaint. Consequently, the company asks the court to enter summary judgment in its favor and dismiss the action under the public disclosure bar.

The company's motion, however, presents numerous technical legal issues, several of which have yet to be resolved in this circuit. A number of these issues arise from the fact that in 2010, as part of the Patient Protection and Affordable Care Act, Congress amended the public disclosure bar to restrict the material that counts as a public disclosure and broadened the exception to the public disclosure bar. The exception now provides, in broad terms, that a relator may avoid dismissal under the bar if she is an original source. While the Third Circuit has had occasion to address the post amendment disclosure bar, the parties, through the outstanding work of counsel, have raised a number of creative arguments that the Third Circuit has yet to address.

In addition to those unresolved legal questions, the motion also presents difficult factual issues. The public disclosure bar analysis involves an intricate comparison of the fraud allegations in this case to the fraud allegations in the prior public disclosures. After performing this comparison, the court must also address the original source exception. In an effort to solidify her status as an original source, the relator has submitted over two thousand pages of documents to the court.

After reviewing the amended public disclosure bar and the applicable case law, the court concludes that the vast majority of the relator's allegations of fraud were contained in valid prior public disclosures. The court also finds, however-after a rigorous examination of the documents the relator provided to the government-that under the Third Circuit's interpretation of the original source exception, the relator qualifies as an original source. Thus, despite the presence of prior public disclosures that advanced substantially the same allegations of fraud as the relator does here, the court denies the motion for summary judgment.

I. PROCEDURAL HISTORY

On November 20, 2015, the relator, Cathleen Forney ("Relator Forney"), filed a sealed complaint alleging that the defendant, Medtronic, Inc. ("Medtronic"), violated the federal False Claims Act ("FCA"). Doc. No. 1. Relator Forney named the United States and 29 state governments as plaintiffs in the action. See Compl. at 1, Doc. No. 1. The United States then filed two motions seeking to extend the seal while it determined whether to intervene in the case. Doc. Nos. 2, 6. The court *836granted both motions and extended the seal. Doc. Nos. 3, 7. Then, on December 12, 2016, the United States and the 29 plaintiff states filed notices that they declined intervene. Doc. Nos. 8, 9. Accordingly, on December 14, 2016, the court lifted the seal and ordered Relator Forney to serve the complaint on Medtronic. See Dec. 14, 2016 Order, Doc. No. 11.

Four months later, Relator Forney filed an amended complaint. Doc. No. 17. The court ordered Medtronic to respond to the amended complaint by April 24, 2017. See April 13, 2017 Order, Doc. No. 29. On April 24, 2017, Medtronic filed a motion to dismiss the amended complaint in which it asserted, inter alia , that Relator Forney had failed to plead fraud with sufficient particularity. See Def. Medtronic, Inc.'s Mem. of Law in Supp. of Its Mot. to Dismiss, Doc. No. 30-1; see Fed. R. Civ. P. Rule 9(b) (requiring fraud to be pled with particularity). The court found serious problems with the allegations in the amended complaint and, accordingly, granted the motion and dismissed the amended complaint without prejudice. See June 19, 2017 Mem. Op., Doc. No. 37; June 19, 2017 Order, Doc. No. 38.

Relator Forney then filed a second amended complaint on July 6, 2017. Doc. No. 42. On July 27, 2017, Medtronic moved to dismiss the second amended complaint. Doc. No. 48. On August 14, 2017, notwithstanding the court's lingering concern that the "relator's theory of support services amounting to illegal remuneration will not ultimately prove to be viable," the court denied the second motion to dismiss "without prejudice to the defendant raising its arguments in a motion for summary judgment." Aug. 14, 2017 Order, Doc. No. 52. Accordingly, the court set scheduling deadlines and ordered the parties to complete fact discovery by December 22, 2017. Aug. 14, 2017 Scheduling Order, Doc. No. 51.

Prior to the conclusion of fact discovery, Medtronic filed an early motion for summary judgment. See Def. Medtronic Inc.'s Mot. for Summ. J. Due to Public Disclosure Bar ("Def.'s Mot."), Doc. No. 64. In the motion, Medtronic contends that it is entitled to summary judgment in its favor because of the FCA's public disclosure bar. See id. Accordingly, the court placed all scheduling deadlines in suspense pending resolution of the motion for summary judgment. See Nov. 29, 2017 Order, Doc. No. 67. Relator Forney filed a response to the motion on December 8, 2017, and Medtronic filed a reply in further support of the motion on December 20, 2017. Doc. Nos. 69, 70. On December 20, 2017, the court heard oral argument on the motion for summary judgment.

The court ordered supplemental briefing on April 3, 2018. See Apr. 3, 2018 Order, Doc. No. 74. Relator Forney filed a supplemental memorandum on April 17, 2018. Doc. No. 75. Medtronic filed a response to the supplemental memorandum on May 1, 2018. Doc. No. 76. The motion for summary judgment is now ripe for adjudication.

II. FACTUAL BACKGROUND

The second amended complaint sets forth the following allegations: Medtronic is a massive international medical device manufacturer that, in the United States alone, "generate[s] between 8.8 and 9.2 billion dollars per year." Second Am. Compl. at 4, Doc. No. 42. Relator Forney worked at Medtronic for 16 years-from 1996 until 2012 when Medtronic terminated her employment. See id. at 2. At the time of her termination, Relator Forney was working as a District Service Manager for the Cardio and Vascular Group, where she reported to the District Manager for the Eastern Pennsylvania District. See id. at 2, 4.

*837Relator Forney contends that during her time at Medtronic she observed Medtronic engage in an extensive illegal fraud scheme. See id. at 1-2, 4. In broad terms, she contends that Medtronic provided free services to people "who made purchasing decisions about Medtronic devices" and that these free services were "intended to persuade health care providers to purchase Medtronic devices." Id. at 4. Relator Forney contends that these services constitute illegal remuneration under the FCA. See id. at 15.

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Cite This Page — Counsel Stack

Bluebook (online)
327 F. Supp. 3d 831, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-medtronic-inc-paed-2018.