United States v. SpineFrontier, Inc.

CourtCourt of Appeals for the First Circuit
DecidedNovember 26, 2025
Docket25-1251
StatusPublished

This text of United States v. SpineFrontier, Inc. (United States v. SpineFrontier, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. SpineFrontier, Inc., (1st Cir. 2025).

Opinion

United States Court of Appeals For the First Circuit No. 25-1251

UNITED STATES OF AMERICA,

Appellee,

v.

SPINEFRONTIER, INC.,

Interested Party, Appellant,

ADITYA HUMAD,

Defendant.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Indira Talwani, U.S. District Judge]

Before

Rikelman, Lipez, and Aframe, Circuit Judges.

Robert L. Peabody, with whom Husch Blackwell LLP was on brief, for appellant.

Karen L. Eisenstadt, Assistant United States Attorney, with whom Leah B. Foley, United States Attorney, was on brief, for appellee.

November 26, 2025 RIKELMAN, Circuit Judge. We must decide if an executive

impliedly waived a corporation's attorney-client privilege by

indicating his intent to invoke an "involvement-of-counsel"

defense at his criminal trial. Aditya Humad, the Chief Financial

Officer (CFO) of SpineFrontier, Inc., a medical device company,

faces criminal charges for allegedly violating the Anti-Kickback

Statute (AKS), 42 U.S.C. § 1320a-7b. The district court determined

that it would treat Humad's planned defense as effecting an implied

waiver of SpineFrontier's attorney-client privilege as to his

communications with its corporate counsel. In turn,

SpineFrontier -- which is no longer a party to the criminal

case -- filed this interlocutory appeal to preserve its privilege.

In the days leading up to and after the district court's waiver

order, the facts and procedural posture of the case shifted

substantially. As a result, we vacate the waiver order and remand

so that the district court can evaluate the parties' current claims

in light of these changed facts and the principles we describe in

this opinion.

I. BACKGROUND

SpineFrontier designs, manufactures, markets, and sells

spinal medical devices. The company was founded by Dr. Kingsley

Chin, who is also its principal shareholder, President, Chief

Executive Officer (CEO), and sole Director. Humad serves as the

- 2 - company's CFO, Vice President of Business Development, Secretary,

and Treasurer, but he is not a shareholder. Chin and Humad are

SpineFrontier's only two officers.

On August 30, 2021, a grand jury charged SpineFrontier,

Chin, and Humad with violating numerous criminal statutes,

including the AKS. A violation of the AKS involves the "'knowing[]

and willful[]' offer or payment of 'any remuneration (including

any kickback, bribe, or rebate)' to induce a person to

'recommend . . . ordering any . . . service . . . for which payment

may be made in whole or in part under a [f]ederal health care

program.'" Guilfoile v. Shields, 913 F.3d 178, 188-89 (1st Cir.

2019) (alterations in original) (emphasis added) (quoting 42

U.S.C. § 1320a7b(b)(2)(B)).

The indictment alleged that from 2012 to 2019, the three

defendants paid surgeons millions of dollars in bribes through a

sham consulting program. The program was purportedly intended to

compensate the surgeons for their time in providing technical

feedback about SpineFrontier's products. According to the

indictment, however, the surgeons did not in fact provide

consulting services. Instead, Chin and Humad paid them substantial

sums of money to induce them into ordering and using

SpineFrontier's devices in surgeries subsidized by federal

healthcare benefit programs. Humad allegedly calculated each

payment based on both the volume of surgeries that the surgeon

- 3 - performed using SpineFrontier's devices and the amount of revenue

those surgeries generated for the company.1

During the development of its consulting program,

SpineFrontier engaged an outside law firm, Strong & Hanni PC, to

provide opinion letters about the legality of the proposed

consulting agreements with surgeons. Chin and Humad subsequently

distributed the opinion letters to surgeons to encourage them to

participate in the program.

According to the opinion letters, Strong & Hanni had

determined that the proposed consulting agreements complied with

governing federal healthcare law, "subject to [certain]

assumptions and qualifications" listed in the letters. Those

"assumptions and qualifications" included that:

(i) All documents examined are complete, authentic, accurate and the . . . formation of the proposed [consulting agreements is] in accordance with applicable state and federal law; and

(ii) The compensation to be paid pursuant to . . . the [a]greement will be for bona fide services by the [c]onsultant consistent with fair market value, in arms'-length transactions; and

1 On April 1, 2025, the grand jury issued a superseding indictment charging Chin and Humad with one count of conspiracy to violate the AKS and three counts of substantive AKS violations based on the same underlying conduct. The superseding indictment is now the operative indictment in Humad's criminal case, but because it postdates the district court's waiver order and includes substantially similar allegations, we describe only the initial indictment.

- 4 - (iii) The parties will perform and implement the [a]greement as it is drafted, and the compensation agreed upon and actually paid to the [c]onsultant . . . will not be determined in a manner that takes into account the volume or value of any referrals or business.

The record before us is unclear about the extent of

Strong & Hanni's involvement in the consulting program. The

parties to this appeal contend that the firm was involved

throughout the duration of the program. For example, SpineFrontier

suggests that counsel attended company meetings and helped the

company make its required public disclosures of the consulting

payments.

In any event, the parties began to litigate whether the

defendants could rely on a so-called "involvement-of-counsel"

defense at trial to argue that they lacked the necessary

willfulness to violate the AKS.2 In an order issued in June 2024,

the district court indicated that it was inclined to find a waiver

if any of the three defendants planned to "argue or introduce

evidence [at trial] of their attorneys' involvement to negate the

mens rea the government must prove." The court explained that it

would permit the defendants to highlight the involvement of "other

persons," without regard to their professions, and still preserve

2 The dispute developed after the district court rejected the government's motion to impose a waiver of SpineFrontier's attorney-client privilege as to all communications related to the consulting program based only on the distribution of Strong & Hanni's opinion letters.

- 5 - the privilege. But it warned that any attempt to argue a lack of

mens rea based on Strong & Hanni's role in the consulting program

would entitle the government to probe the communications between

those attorneys and the defendants.

Because the defendants had yet to confirm that they would

rely on an involvement-of-counsel defense at trial, the district

court concluded that there was no waiver at that time, but it put

into place procedural guardrails to prevent any potential

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