Arthur v. THD America, Inc.

CourtDistrict Court, D. Maryland
DecidedMay 28, 2025
Docket1:16-cv-02571
StatusUnknown

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

Bluebook
Arthur v. THD America, Inc., (D. Md. 2025).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

UNITED STATES ex rel. AMBER ARTHUR, Relator,

v. Civil No. ELH-16-2571

THD AMERICA, INC., Defendant.

MEMORANDUM OPINION In this qui tam action,1 filed on July 14, 2016, the Relator, Amber Arthur, sued her former employer, THD America, Inc. (“THD”), pursuant to the False Claims Act (“FCA”), 31 U.S.C. §§ 3728 et seq. See ECF 1 (“Complaint”). Relator also sued THD S.p.A., the parent company of THD America, Inc., and five doctors. ECF 1, ¶¶ 10–15.2 At the relevant time, THD sold “medical devices and services to distributors that have contracts with federal agencies.” Id. ¶ 8. Arthur, who previously worked as a sales representative for THD, was terminated from employment on July 1, 2015. Id. ¶ 152. She alleges that defendants knowingly submitted false or fraudulent claims to the Medicare Program, 42 U.S.C. § 1395 et seq. (“Medicare”), a federally funded health insurance program for people ages 65 and older and for certain people with disabilities. In addition, she alleges that defendants committed “acts in direct retaliation for Relator’s efforts to reveal and properly disclose” defendant’s illegal conduct. ECF

1 “Qui tam is short for ‘qui tam pro domino rege quam pro se ipso in hac parte sequitur,’ which means ‘who pursues this action on our Lord the King’s behalf as well as his own.’” Rockwell Int’l Corp. v. United States, 549 U.S. 457, 463 n.2 (2007). 2 The Relator sometimes refers to the parent as “SpA.” See, e.g., caption; ECF 1 at 5. 1 at 54.3 As discussed, infra, the case was unsealed on September 1, 2024. ECF 64. Then, with the exception of THD, the Relator dismissed the suit as to all defendants on December 10, 2024. ECF 74. Thereafter, on March 7, 2025, the Relator filed a Third Amended Complaint. ECF 81 (“Third Amended Complaint” or “TAC”).

THD has moved to dismiss the Third Amended Complaint, pursuant to Fed. R. Civ. P. 12(b)(5), alleging untimely service. ECF 101. It is supported by a memorandum (ECF 101-4) (collectively, the “Motion”) and two declarations (ECF 101-2, ECF 101-3). The Relator opposes the Motion. ECF 105. Her submission is supported by a memorandum (ECF 105-1) (collectively, the “Opposition”) and one declaration (ECF 105-2). Defendant replied. ECF 106 (the “Reply”). No hearing is necessary to resolve the motions. See Local Rule 105.6. For the reasons that follow, I shall deny the Motion. I. Factual and Procedural Background On July 14, 2016, Relator filed suit against her former employer, THD, along with its

parent company and five doctors, alleging that defendants knowingly submitted false and fraudulent claims to Medicare, in violation of 31 U.S.C. § 3729. ECF 1. Relator also alleged that defendants engaged in acts of retaliation against her, in violation of 31 U.S.C. § 3730. The Complaint contains four counts, all under the False Claims Act: (1) violation of 31 U.S.C. § 3729(a)(1)(A); (2) violation of 31 U.S.C. § 3729(a)(1)(B); (3) violation of 31 U.S.C. § 3730(h); and (4) violation of 31 U.S.C. § 3729(a)(1)(C). As noted, Arthur dismissed the suit as to all

3 Throughout the Memorandum Opinion, the Court cites to the electronic pagination. However, the electronic pagination does not necessarily correspond to the page number imprinted on a particular submission. defendants, except THD, in December 2024. ECF 74. Thus, THD is the only remaining defendant. Id. According to the Relator, THD violated the FCA by committing violations of the Anti- Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b)(2)(A) and (B). Id. at 20–46. The AKS “imposes criminal penalties on anyone who knowingly and willfully offers to pay or pays any

remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind for a variety of reasons.” Id. ¶ 16. Relator also alleges violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., through off-label marketing. Id. at 46–50. The FDCA “states that companies may not market medical devices in the United States without prior approval from the Food and Drug Administration (‘FDA’) for the device’s intended use.” Id. ¶ 36. The allegations pertain to Transanal Hemorrhoidal Dearterialization, a multi-step surgical procedure for the repair of internal hemorrhoids. Id. ¶ 41. It is offered as a minimally invasive alternative to a hemorrhoidectomy and procedure for prolapse and hemorrhoids. Id. ¶ 39. THD

received clearance from the FDA for the THD Slide One Kit in 2009. Id. ¶ 40. Relator alleges that between 2008 and 2015, THD sold 29,849 kits to public and private hospitals. Id. at 20 n.3. Up to 80 percent or more of these kits were billed to Medicare or another government insurance carrier. Id. ¶ 42. The THD Slide One Kit requires use of a THD generator as a power source and a light source. Id. ¶ 44. Relator alleges that THD offered facilities either to purchase the generators or receive them from THD on loan. Id. ¶ 45. Through the loan program, the generator was offered to facilities indefinitely and for free. Id. ¶ 47. But, Relator alleges that, to receive the loaner generator, the Loan Generator Program required facilities to purchase a minimum of ten THD Kits, at a cost of $5,230 each, and to purchase subsequent kits in batches of at least ten. Id. ¶ 48. In contrast, the Purchase Generator Program required an initial order of five THD Kits, with reorders permitted on an individual basis. Id. According to Arthur, if facilities could not commit to the minimum initial order, the sales representatives would not offer the loaner generator. Id. ¶ 49. And, if facilities did not continually

repurchase more kits, THD would inform them that, “should they fail to purchase additional THD kits in the near future,” they would need to return the loan generator. Id. ¶ 50. Relator also claims that once facilities purchased a minimum quantity of THD Kits and received the loaner generator, the sales representatives would “begin engaging in aggressive sales tactics, off-label promotion, and the offer of additional forms of kickbacks in order to persuade the facilities to convert all of their hemorrhoid procedures to THD.” Id. ¶ 49. In early 2014, THD launched the Centers of Excellence Program. Id. ¶ 54. According to Relator, the program’s purposes were: “(1) to reward physicians who perform high volumes of THD procedures, (2) to train physicians to use the THD procedure, and (3) to recruit more

physicians to participate in the Centers of Excellence Program.” Id. The facilities that took part in the program “received paid consulting agreements and free internet marketing to solicit patient referrals.” Id. ¶ 55.

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Arthur v. THD America, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/arthur-v-thd-america-inc-mdd-2025.