Staggers v. Medtronic, Inc.

District Court, District of Columbia·Decided October 15, 2024·No. Civil Action No. 2015-0392·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

)

UNITED STATES ex rel. MELLISSA ) STAGGERS and RHONDA ) KURDELMEYER, )

)

Plaintiffs-Relators, )

)

v. ) Case No. 15-cv-392 (TSC/GMH)

)

MEDTRONIC, INC., )

)

Defendant. )

____________________________________)

MEMORANDUM OPINION AND ORDER In this qui tam action against Defendant Medtronic, Inc. (“Defendant” or “Medtronic”)

under the False Claims Act, 31 U.S.C. § 3729 et seq., Plaintiffs-Relators Melissa Staggers and Rhonda Kurdelmeyer (“Relators”) have filed a motion seeking to modify an order—proposed by both parties and entered (with minor modifications) by the Court—bifurcating discovery in this case into phases: a geographically limited Phase 1 after which, if Relators could establish the merits of their claims by surviving a motion for summary judgment, the case would progress to nationwide discovery in Phase 2. Specifically, Relators seek to unravel that agreed-upon process, dodge formal summary judgment briefing, and skip to nationwide discovery. Because Relators fail to show good cause for the modification, the motion is denied. 1

1 The docket entries most relevant to this Memorandum Opinion and Order are: (1) the Order imposing a phased discovery plan (the “Phased Discovery Order”), ECF No. 94; (2) the Scheduling Order with Respect to Phase 1 (the “Phase 1 Scheduling Order”), ECF No. 128; (3) Plaintiff-Relators’ Motion to Proceed to Full Nationwide Discovery (the “Motion for Nationwide Discovery”), ECF Nos. 150 & 151 through 151-316; (4) Defendant’s Opposition to the Motion for Nationwide Discovery, ECF Nos. 174-2 through 174-39; and (5) Relators’ Reply, ECF Nos. 178-2 through 178-46. Page numbers cited herein are those assigned by the Court’s CM/ECF system.

I. BACKGROUND

Relators are two former sales representatives who marketed and sold Defendant’s product InterStim—a surgically implantable device that stimulates the sacral nerve for the treatment of incontinence. See ECF No. 18, ¶¶ 8–9, 23–24; ECF No. 174-2 at 10. In this action, they allege that Medtronic “engaged in fraudulent conduct, resulting in the submission of false Medicare claims by physicians in connection with . . . InterStim.” 2 United States ex rel. Staggers v. Medtronic, Inc., No. 15-cv-392, 2019 WL 13132849, at *1 (D.D.C. Mar. 25, 2019). As described by Judge Chutkan in her opinion granting in part and denying in part Medtronic’s motion to dismiss, the “theory of liability” remaining in this case

essentially alleges that Medtronic purposefully causes treating physicians to submit Medicare claims for InterStim implantation, which falsely certify that the implantation is documented as medically necessary in accordance with Medicare regulations. The pertinent regulation provides:

[b]efore a patient is eligible for permanent implantation, he/she must demonstrate a 50% or greater improvement through test stimulation.

Improvement is measured through voiding diaries. Patient must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.

As this regulation makes clear, medical necessity must be demonstrated on the basis of “voiding diaries.” Nonetheless, Relators’ First Amended Complaint alleges in comprehensive particularity how Medtronic has thoroughly insinuated itself into the doctor-patient relationship, so that doctors delegate to Medtronic representatives the responsibility for assessing symptom improvement during the testing period even though Medtronic’s assessments are not based on the examination of patients’ diaries, as the regulation requires.

Id. at *2 (internal citation omitted) (quoting The National Coverage Determination for Sacral Nerve Stimulation for Urinary Incontinence (Publication No. 100-3, Manual Section No. 230.18, Version 1, Effective Date Jan. 1, 2002 (“NCD 230.18”)). Soon after Judge Chutkan ruled on

2 The United States declined to intervene and “take over the action” pursuant to 31 U.S.C. § 3730(b)(4)(B). See ECF No. 6. Therefore, it is being conducted by Relators.

Defendant’s motion to dismiss, she referred the action to a magistrate judge for resolution of discovery disputes and Magistrate Judge Meriweather was assigned to the case. Minute Order (May 3, 2019); Docket Entry Referring Case (May 3, 2019).

Defendant filed a motion to limit discovery, which was opposed by Relators, see ECF Nos.

45, 49, 67, 68; then, in compliance with a request from Judge Meriweather, Relators filed a plan for phased discovery, which Defendant opposed, see ECF Nos. 81, 83, 90. Before those disputes were resolved, the parties filed a joint motion seeking entry of an agreed-upon Phased Discovery Order. See ECF No. 93. Judge Chutkan issued an order imposing that plan (with two minor modifications noted below). See ECF Nos. 93, 94, 94-1.

The Phased Discovery Order includes seven “Steps”: (Step 1) Patient Selection for Phase 1 Discovery, (Step 2) Phase 1 Discovery, (Step 3) Meet and Confer, (Step 4) Motion for Summary Judgment on Liability and Scope, (Step 5) Response to Summary Judgment Decision, (Step 6) Phase 2 Discovery, and (Step 7) Subsequent Proceedings. Phase 1 discovery focuses on “Medicare claims submitted by the physicians whose practice the Relators supported during their tenure as Medtronic sales representatives.” ECF No. 94-1 at 2. Step 1 was designed to randomly identify 100 patients of those physicians for whom a Medicare claim was submitted relating to a new InterStim implant. See id. at 2–3. Step 2 allowed discovery related to those 100 patients, “their physicians, the physicians’ medical staff, and current and former Medtronic employees and consultants concerning claims submitted to Medicare involving Medtronic’s InterStim device for the selected patients.” Id. at 3. In addition, Step 2 allowed discovery regarding Medtronic’s relevant “policies, procedures, sales training, marketing, physician education materials, and patient education materials”; materials distributed to Relators or offered at meetings to which Relators were invited “pertaining to submission of claims to Medicare”; relevant conduct of Medtronic

supervisory or management personnel; and “third-party discovery concerning the interpretation or enforcement of [NCD 230.18] and applicable statutes, regulations, and rulings (if any) related to medical necessity and documentation requirements.” Id. at 3–4. Step 3 outlined a process to raise specific discovery disputes with the Court. 3 See ECF No. 94 at 1–2; ECF No. 94-1 at 4.

Steps 4 and 5 are particularly relevant here and are therefore set out in their entirety:

Step 4: Motions for Summary Judgment on Liability and Scope

Upon completion of Phase 1 Discovery, the Parties may file motions or cross-motions, including for summary judgment with respect to the following:

a. Issues of law, including interpretation of the National Coverage Decision and applicable statutes, regulations, and rulings related to medical necessity and documentation requirements;

b. Whether a fact issue exists as to Medtronic’s liability in connection with the Medicare claims submitted by one or more of the physicians for the patients who were subject to Phase 1 Discovery. The motions may address any or all of the elements of liability, including the questions of whether the physicians submitted false claims within the meaning of the False Claims Act, whether Medtronic caused any such false claims to be submitted, intent, and materiality; and

c. The extent to which the Court determines the record developed in Phase 1 Discovery supports possible further discovery regarding patients who are not within the scope of Phase 1. 4

Step 5: Response to Summary Judgment Decision.

What further discovery, if any, will be permitted will depend on the Court’s disposition of the Parties’ motions or cross-motions as follows:

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