Mart v. Tactile Systems Technology, Inc.

CourtDistrict Court, D. Minnesota
DecidedMarch 31, 2022
Docket0:20-cv-02074
StatusUnknown

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

Bluebook
Mart v. Tactile Systems Technology, Inc., (mnd 2022).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

BRIAN MART, individually and on behalf Case No. 20-CV-2074 (NEB/BRT) of all others similarly situated, and ST. CLAIR COUNTY EMPLOYEES’ RETIREMENT SYSTEM,

Plaintiffs, ORDER ON DEFENDANTS’ MOTION TO DISMISS v.

TACTILE SYSTEMS TECHNOLOGY, INC., GERALD R. MATTYS, LYNN L. BLAKE, BRENT A. MOEN, WILLIAM W. BURKE, ROBERT J. FOLKES, RICHARD J. NIGON, BRYAN F. RISHE, and KEVIN H. ROCHE,

Defendants.

This putative class action alleges claims under Sections 10(b), 20(a), and 20A of the Securities Exchange Act of 1934 (“Exchange Act”) and SEC Rule 10b-5 against Tactile Systems Technology, Inc. (“Tactile”) and several of its officers and outside directors. Defendants now move to dismiss. For the reasons below, the Court grants in part and denies in part the motion. BACKGROUND I. The Complaint Allegations1

A. Tactile and the Flexitouch Device Tactile manufactures and sells pneumatic compression devices (“PCD”) for at- home treatment of lymphedema2 and chronic venous insufficiency (“CVI”). (ECF No. 49

(“Compl.”) ¶¶ 1–2, 25.) One of Tactile’s devices—the Flexitouch—generates 90% of Tactile’s revenues. (Id. ¶¶ 30–31.) Tactile’s business relies in part on so-called third-party payers, including the Centers for Medicare & Medicaid Services (“Medicare”) and the

Veterans Association (“VA”), which pay for the device for patients. (Id. ¶ 33.) The VA represented 18% of Tactile’s revenues in 2017; that percentage declined to 13% by 2020. (Id.) During the same period, Tactile’s revenues from Medicare grew from 8% to 16%. (Id.)

Based in part on strong sales to the VA and Medicare, Tactile announced several consecutive quarters of over 30% revenue growth in 2018 and 2019. (E.g., Compl. ¶¶ 79, 81 (1Q18—35% year-over-year); id. ¶ 85 (2Q18–30% year-over-year); id. ¶¶ 87–88 (3Q18–

claiming 27% and 31% year-over-year); id. ¶ 89 (4Q18/FY18–“in excess of 30%” driven by

1 The Court sets forth the facts and events alleged in the operative Complaint, which it takes as true in ruling on the motion to dismiss. Pub. Pension Fund Grp. v. KV Pharm. Co., 679 F.3d 972, 975 (8th Cir. 2012).

2 Lymphedema is a chronic disease characterized by swelling localized in a body part, such as the arms, legs, neck, or trunk, when the body’s lymphatic vessels cannot drain lymph fluid. (Compl. ¶ 26.) Flexitouch sales); id. ¶¶ 95–96 (press release and earnings call regarding 4Q18/FY18); id. ¶¶ 105–06 (1Q19–40% year-over-year); id. ¶ 109 (2Q19–32% year-over-year); id. ¶ 111

(3Q19–37% year-over-year).) Tactile publicly attributed its sales growth to the VA and Medicare, also noting that the market for Flexitouch was untapped, suggesting room for more growth. (See id. ¶¶ 133–208 (passim).)

As a general matter, the Complaint alleges that investors who traded Tactile stock between May 7, 2018, and June 8, 2020 (“Class Period”) suffered damages under the Exchange Act because Tactile: (1) hid that illegal kickback schemes were a source of its

revenue growth; (2) hid that false claims to federal healthcare programs also contributed to revenue growth; and (3) misrepresented the Flexitouch market size to investors. B. Alleged Kickback Schemes According to the Complaint, Tactile participated in two illegal kickback schemes

designed to induce prescriptions of Tactile’s Flexitouch. (Compl. ¶¶ 36–48.) In the first scheme, Tactile gave perks and benefits to doctors recruited to be “Key Opinion Leaders” (“KOLs”) in exchange for Flexitouch “referrals.” (Id. ¶ 37.) The KOLs

organized speaking events and identified “warm” leads before the event. (Id. ¶¶ 40–41.) Tactile hosted these events at luxury hotels and expensive restaurants. (Id.) At one event, the bill far exceeded the permitted gift allowance for the four VA employees attending.3

3 Tactile allegedly encouraged targeting sales to its VA channel by, for example, establishing the “VA Million Dollar Club” for its sales team in 2018 and distributing (Id. ¶ 40.) The Department of Health and Human Services Office of the Inspector General had flagged these kinds of “speaking arrangements” as high risk for fraud and abuse in

a “Special Fraud Alert,” and the U.S. Department of Justice and Office of Inspector General had investigated numerous cases in which compensation for “speaking events” was found to be illegal remuneration. (Id. ¶ 39.)

In the second scheme, Tactile implemented a “trainer” program to obtain referrals from non-physician healthcare providers, such as therapists. (Id. ¶¶ 43–44.) These healthcare providers trained patients on how to use the Flexitouch at home. (Id.) Tactile

allegedly dismissed trainers who failed to provide enough referrals. (Id. ¶¶ 44–45.) Tactile’s compliance officer allegedly “documented that Tactile’s arrangements with therapists [for its trainer program] posed a high ‘Business Risk’ for ‘kickbacks.’” (Id. ¶ 44.) These two schemes allegedly violated the federal Anti-Kickback Statute (“AKS”),

42 U.S.C. § 1320a, et al., which generally prohibits remuneration in return for recommending or arranging for the purchase, lease, or order of an item or service for which a federal health program may provide reimbursement. (Compl. ¶¶ 36–37, 164–65,

200–01.) The kickback schemes also allegedly violated the False Claims Act (“FCA”), 31 U.S.C. § 3729. (Id. ¶¶ 50–51.) Violations of the AKS or the FCA could result in exclusion from participating in federal healthcare programs. (Id. ¶¶ 48, 56, 200.) Thus, if Tactile was

bonuses to sales management specifically for meeting quarterly VA revenue targets. (Compl. ¶¶ 42, 256.) found to have violated the AKS or the FCA, it could lose nearly one-third of its business. (Id. ¶ 48, 56.) Defendants affirmed compliance with the AKS and the FCA in Tactile’s SEC

filings. (E.g., id. ¶¶ 164–65, 201.) C. Alleged False Claims of Medical Necessity The Complaint next alleges that Defendants made false claims to Medicare about

the medical necessity of its devices for patients, in violation of the FCA.4 (Compl. ¶¶ 52– 53.). Medicare’s Recovery Audit Contractor (“RAC”) conducted an audit of PCDs and the medical necessity requirement. (Id. ¶¶ 55, 129.) In its first round of audits, the RAC

auditor flagged 71% of Tactile’s claims for failure to establish medical necessity; in the second round, that number rose to 81%. (Id. ¶ 55.) The Complaint also alleges that Tactile sales representatives routinely provided pre-filled forms to doctors and drafted medical necessity narratives with instructions to doctors to copy to their letterhead and sign. (Id.

¶ 54.) D. Assertions about Flexitouch’s Market Size In the last category of false statements, the Complaint alleges that Tactile made

false and misleading statements about Flexitouch’s market size. First, Tactile allegedly overstated the number of U.S. lymphedema diagnoses, thus overstating the potential

4 The Complaint also alleges that Tactile made false claims about the efficacy of the Flexitouch to Medicare, leading it to cover the device. (Compl. ¶ 53.) In support, the Complaint relies on an anonymous former Tactile employee. (Id.) For the reasons discussed below, the Court will not consider allegations attributed to this source. market, also known as the “total addressable market” (“TAM”). Tactile reported a TAM of $4–$5 billion; the actual market size was at least three times smaller. (Id. ¶¶ 35, 59–61,

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