No. 21-1951

CONFORMIS, INC.,

Plaintiff, Appellant,

v.

AETNA, INC. and AETNA LIFE INSURANCE COMPANY,

Defendants, Appellees.

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

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

Before

Barron, Chief Judge, Selya and Lipez, Circuit Judges.

Anthony P. La Rocco, with whom Jeffrey S. King, Adam R.D. Paine, Robert F. Pawlowski, and K&L Gates LLP were on brief, for appellant. Sarah M. Harris, with whom Whitney D. Hermandorfer, Mihir Khetarpal, Williams & Connolly LLP, Stephen LaRose, Kierstan Schultz, and Nixon Peabody LLP were on brief, for appellees.

January 23, 2023 SELYA, Circuit Judge. An epigram, popular among children in the last century, teaches that "[s]ticks and stones will break my bones, but words will never harm me." G.F. Northall, Folk-Phrases of Four Counties 23 (1894). That folk wisdom, though, has scant purchase in the commercial world. This case, in which the plaintiff advances claims for product disparagement and related torts, illustrates the point.

The district court, ruling on a motion filed pursuant to Federal Rule of Civil Procedure 12(b)(6), dismissed the plaintiff's amended complaint for failure to state a claim upon which relief could be granted. The plaintiff appeals. Concluding, as we do, that some of the plaintiff's claims are sufficiently plausible to warrant further proceedings, we affirm in part and reverse in part.

I

We briefly rehearse the relevant facts and travel of the case. As this appeal follows the allowance of a motion to dismiss under Rule 12(b)(6), we draw the facts from the amended complaint and its attachments. See Lanza v. Fin. Indus. Regul. Auth., 953 F.3d 159, 161 (1st Cir. 2020).

Plaintiff-appellant Conformis, Inc. (Conformis) is a medical device company that designs and manufactures customized hip and knee replacements, including the Conformis iTotal Knee Replacement System (the Conformis system). The Conformis system

- 2 - is a customized total knee replacement (TKR) designed to improve upon the limitations of uniform, off-the-shelf knee replacements.

The Conformis system received clearance from the federal Food and Drug Administration (FDA) in February of 2011, through the premarket notification process elaborated in 21 U.S.C. § 360(k). Over 100,000 patients have received the Conformis system, and it is covered by over 90% of commercial payors as well as the Centers for Medicare and Medicaid Services (CMS).

Various clinical studies have concluded that customized TKRs in general, and the Conformis system in particular, exhibit favorable patient outcomes when compared to off-the-shelf TKRs. Studies also suggest that although customized TKRs may be more expensive than off-the-shelf models on the front end, the total cost may be lower due to fewer complications. The Conformis system has been endorsed by the American Association of Hip and Knee Surgeons (AAHKS). It also has a 5A rating from the Orthopaedic Data Evaluation Panel in the United Kingdom — a rating that indicates strong evidence of favorable outcomes assessed against national clinical best practice guidelines.

Defendant-appellee Aetna, Inc., together with its wholly owned subsidiary, Aetna Life Insurance Company (collectively, Aetna), is one of the leading providers of health insurance and third-party health plan administration in the United States. Aetna's