Staggers v. Medtronic, Inc.

CourtDistrict Court, District of Columbia
DecidedOctober 15, 2024
DocketCivil Action No. 2015-0392
StatusPublished

This text of Staggers v. Medtronic, Inc. (Staggers v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Staggers v. Medtronic, Inc., (D.D.C. 2024).

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.

2 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

3 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.

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