v.
Aetna, Inc.
For the First Circuit
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 plans provided coverage (and, thus, reimbursement) for the
- 3 - Conformis system from 2011 until September of 2018, when Aetna released a revised policy for "Unicompartmental, Bicompartmental, and Bi-unicompartmental Knee Arthroplasties" (Policy 0660 or the Policy). The Policy recharacterized Aetna's view of customized TKRs, taking the position that "Aetna considers customized [TKRs] experimental and investigational because [their] effectiveness has not been established." The Policy did not explain the reason for recharacterization, although the Policy's background section included summaries of certain studies evaluating different types of TKRs.
Separately, Aetna's website provides a glossary of terms, which defines "experimental services or procedures" and "investigational services" as "newer drugs, treatments or tests. They are not yet accepted by doctors or by insurance plans as standard treatment. They may not be proven as effective or safe for most people."
Aetna's unexplained recharacterization of the Conformis system had profound financial consequences. Aetna does not either cover or reimburse for treatments that it characterizes as "experimental and investigational" except in instances marked by special circumstances.
Conformis has contracts with more than 2,100 healthcare providers (including hospitals, group purchasing organizations, and integrated delivery networks). It also maintains
- 4 - relationships with other healthcare providers who have, according to the complaint, "routinely prescribed or otherwise provided the Conformis System." After Aetna reversed course and changed its position through the issuance of Policy 0660, Conformis saw a significant reduction in the number of Aetna-covered patients receiving the Conformis system. Some orthopedic surgeons have stopped ordering the Conformis system for patients covered by Aetna. And to avoid uncertainty about reimbursement, some orthopedic surgeons have stopped ordering the Conformis system for a wider universe of patients, including those covered under other insurance plans.
The pleadings contain a vivid example of the Policy in practice. The Conformis system was prescribed for one patient, John Michael Schaub, but Aetna denied coverage only days before Schaub's scheduled surgery. At the time, Schaub had health insurance through an employer-sponsored plan administered by Aetna (which contracts with eviCore Healthcare to handle patient claims). Following the denial of coverage, an eviCore surgeon explained to Schaub's surgeon that, while he considered the Conformis system very effective, his "hands were tied by Aetna's Policy." Various representatives of Aetna confirmed to Schaub in subsequent telephone calls that it was Aetna's policy to no longer
- 5 - afford reimbursement for the Conformis system. Schaub went ahead with the procedure despite Aetna's denial of coverage.[1] Conformis sent Aetna a letter in April of 2019, requesting that Aetna reconsider its policy revision. Conformis provided additional studies in support of the Conformis system's efficacy and widespread acceptance. In response, Aetna released a policy supplement, which included summaries of some of the additional studies, noting instances in which the authors had recommended further research. The president of AAHKS also wrote to Aetna after the policy change to express his "concern . . . because the custom implants in question are FDA approved, have been in use for many years and have peer-reviewed published studies that should support their continued use." That concern was heightened because some of the scientific literature cited in the Policy's background section as relating to customized TKRs did not involve the assessment of customized TKRs at all. But Aetna dug in its heels. Conformis sent a second letter in January of 2020, demanding that Aetna, among other things, cease and desist from treating the Conformis system as experimental and investigational.
[*517]To narrow the scope of our inquiry, we leap-frog ahead and start by analyzing the second element of a product disparagement claim. That element requires that each of the challenged statements be "of and concerning" the complaining party's products or services. A plaintiff may show that a statement is "of and concerning" it by proving either "(1) that the defendant intended the words to refer to the plaintiff and that they were so understood or (2) that persons could reasonably interpret the defendant's words to refer to the plaintiff and that the defendant was negligent in publishing them in such a way that they could be so understood." HipSaver, 984 N.E.2d at 766 (quoting ELM Med. Lab'y, Inc. v. RKO Gen., Inc., 532 N.E.2d 675, 679 (Mass. 1989), abrogated on other grounds by United Truck Leasing Corp. v. Geltman, 551 N.E.2d 20, 23 (Mass. 1990)); see Eyal v. Helen Broad. Corp., 583 N.E.2d 228, 231 (Mass. 1991) (emphasizing disjunctive character of standard). Conformis relies mainly on the first modality — a modality that has been described as "subjective." Eyal, 583 N.E.2d at 231.
We first come to grips with the Policy statement. Admittedly, that statement does not refer to Conformis by name. Instead, it refers only to "customized [TKRs]." But a common- sense reading of the Policy is required, and such a reading leaves Having established which statement is at issue, we turn to the first element of product disparagement: the requirement that a plaintiff show that the challenged statement is false. See HipSaver, 984 N.E.2d at 763. For a statement to be false, though,
[*518]- 14 - it would need first to be factual. In the context of claims for defamation, for example, non-factual statements — commonly called "opinions" — are not actionable because they cannot be proven false. See Lyons v. Globe Newspaper Co., 612 N.E.2d 1158, 1161 (Mass. 1993); King v. Globe Newspaper Co., 512 N.E.2d 241, 243 (Mass. 1987).
The Massachusetts Supreme Judicial Court (the SJC) has yet to address whether the same analysis extends to a claim for product disparagement. See HipSaver, 984 N.E.2d at 765 n.11 (declining to resolve whether "mere opinions that imply no misstatement of objectively verifiable fact" can qualify as product disparagement (quoting W.L. Prosser & W.P. Keeton, Torts § 128, at 967 (5th ed. 1984))). We must, therefore, "endeavor to predict how [the SJC] would likely decide the question." In re PHC, Inc. S'holder Litig., 894 F.3d 419, 428 (1st Cir. 2018) (quoting Butler v. Balolia, 736 F.3d 609, 613 (1st Cir. 2013)).
We draw on the permissible sources that customarily inform such a prediction. See id.; Blinzler v. Marriott Int'l, Inc., 81 F.3d 1148, 1151 (1st Cir. 1996). We are persuaded that the striking similarity between product disparagement and defamation, see HipSaver, 984 N.E.2d at 762, and the First Amendment considerations that circumscribe both torts, see Restatement (Second) of Torts, supra at § 623A cmts. c-e, would cause the SJC to apply, in product disparagement cases, the same
- 15 - analytic modality that it has used in defamation cases. Other courts that have considered the question have reached the same conclusion. See, e.g., Advanced Tech. Corp. v. Instron, Inc., 66
F. Supp. 3d 263, 269 (D. Mass. 2014); Dulgarian v. Stone, 1994 WL 879631, at *4 (Mass. Super. Ct. Feb. [3], 1994). a
This means, of course, that a statement of fact can be actionable as product disparagement, but a statement of opinion cannot. Accordingly, we must address the threshold question of whether the Policy statement is fact or opinion before determining whether it is false. The determination of whether a statement is fact or opinion is a question of law "if the statement unambiguously constitutes either fact or opinion," but a question of fact "if the statement reasonably can be understood both ways." Scholz v. Delp, 41 N.E.3d 38, 45 (Mass. 2015) (quoting King, 512 N.E.2d at 244). At the pleading stage, then, a statement that can reasonably be understood as either fact or opinion is sufficient to survive a motion to dismiss.
Whether a statement is fact or opinion is determined by whether the statement would be understood by a reasonable reader as containing "objectively verifiable facts." Id. at 45 (quoting Levinsky's, Inc. v. Wal-Mart Stores, Inc., 127 F.3d 122, 131 (1st Cir. 1997)); see Lyons, 612 N.E.2d at 1162. That approach requires us to "examine the statement in its totality in the context in
- 16 - which it was uttered or published." Scholz, 41 N.E.3d at 45-46 (quoting Cole v. Westinghouse Broad. Co., 435 N.E.2d 1021, 1025 (Mass. 1982)). The factors to be considered comprise "all of the circumstances surrounding the statement, including the medium by which the statement is disseminated and the audience to which it is published"; "all the words used, not merely a particular phrase or sentence"; and any "cautionary terms" employed. Lyons, 612 N.E.2d at 1162 (quoting Fleming v. Benzaquin, 454 N.E.2d 95, 100 (Mass. 1983)).
The district court concluded that a reasonable reader could interpret the Policy statement as either fact or opinion. See Conformis, 2021 WL 1210293, at *8. We agree that the statement could plausibly be read as either an expression of fact or as an opinion. A reasonable reader could interpret this statement as a statement of fact because such a reader could interpret it as a verifiable assertion that the Conformis system is "not clinically effective and not accepted by doctors and insurance providers as a standard treatment." Our reasoning follows.
Whether a statement is fact or opinion depends on whether "in a given context it reasonably can be understood as having an easily ascertainable and objectively verifiable meaning." Levinsky's, 127 F.3d at 129. Put another way, the inquiry turns on whether the statement has a meaning capable of being proven or The next element of product disparagement is that the defendant "knows that the statement is false or acts in reckless disregard of its truth or falsity." HipSaver, 984 N.E.2d at 768 (quoting Restatement (Second) of Torts, supra at § 623A). This element "mirrors what has been termed 'actual malice' in the defamation context," without regard to whether the plaintiff is a public figure. Id. at 767, 768 n.14. A defendant acts in reckless disregard if it "entertained serious doubts as to the truth of [its] publication." Id. at 767-68 (quoting St. Amant v. Thompson, 390 U.S. 727, 731 (1968)).
[*519]Because "direct evidence of actual malice is rare," it may be shown through inference and circumstantial evidence. Sindi v. El-Moslimany, 896 F.3d 1, 16 (1st Cir. 2018) (quoting Levesque v. Doocy, 560 F.3d 82, 90 (1st Cir. 2009)). By way of example, actual malice "may be found where a publisher fabricates an account, makes inherently improbable allegations, relies on a The remaining elements of a product disparagement claim are inextricably intertwined. In combination, they require a showing that "pecuniary harm to the plaintiff's interests was intended or foreseeable" and that the disparagement "resulted in special damages in the form of pecuniary loss." HipSaver, 984 N.E.2d at 763. The special damages requirement limits a plaintiff's recovery to the "'pecuniary loss that results directly and immediately from the effect of the conduct of third persons' acting in response to the alleged disparagement." Id. at 772 (quoting Restatement (Second) of Torts, supra at § 633(1)(a)). In the product disparagement context, a plaintiff typically establishes those damages by identifying "a specific loss of sales to identifiable customers." Id. But where, as here, the disparaging statement has been "widely disseminated," the plaintiff may show by circumstantial evidence "that the loss [of the market] has in fact occurred" and that no other factor caused that loss. Id. at 772-73 (alteration in original) (quoting Restatement (Second) of Torts, supra at § 633 cmt. h).
[*520]- 31 - The district court determined that the plaintiff had adequately alleged these intertwined elements. Conformis, 2021 WL 1210293, at *8. We agree with that determination. To this end, Conformis alleges that orthopedic surgeons told its sales team that they would no longer prescribe the Conformis system due to Aetna's shift in policy. For pleading purposes, those reports indicate lost sales to identifiable customers. So, too, Conformis plausibly alleges that the "widespread dissemination" of the Policy caused its sales to suffer a "significant dropoff." Given Aetna's prominent position within the health insurance market, it was foreseeable that Aetna's recharacterization of the Conformis system as "experimental and investigational" and, thus, ineligible for coverage, would result in a plummeting sales curve. In light of these averments, Conformis has plausibly alleged the pecuniary harm and special damages elements. That ends this aspect of the matter. We hold that Conformis has plausibly alleged a claim for product disparagement as to the Policy statement. For pleading purposes, Conformis's allegations suffice to "remove the possibility of relief from the realm of mere conjecture." Hamann v. Carpenter, 937 F.3d 86, 92 (1st Cir. 2019) (quoting Tambone, 597 F.3d at 442). It follows that the district court erred in granting Aetna's motion to dismiss the product disparagement claim. - 32 - B We turn next to the claims of tortious interference with contractual and advantageous relations. We treat these claims separately.
To defeat a motion to dismiss a claim for tortious interference with contractual relations, a plaintiff must plausibly allege that "(1) [it] had a contract with a third party; (2) the defendant knowingly induced the third party to break that contract; (3) the defendant's interference, in addition to being intentional, was improper in motive or means; and (4) the plaintiff was harmed by the defendant's actions." Psy-Ed Corp. v. Klein, 947 N.E.2d 520, 536 (Mass. 2011) (quoting G.S. Enters., Inc. v. Falmouth Marine, Inc., 571 N.E.2d 1363, 1369 (Mass. 1991)).
In an effort to satisfy the first element, Conformis alleges that it "has contracts with more than 2,100 healthcare providers (e.g., hospitals, group purchasing organizations, and integrated delivery networks) under which Conformis supplies the Conformis System." It is not necessary at the pleading stage to furnish "a high degree of factual specificity," Grajales, 682 F.3d at 47, so Conformis's allegations may be sufficient to satisfy the first element of tortious interference with contractual relations — that the plaintiff had a contract with a third party.
- 33 - But Conformis stumbles at the next step: it fails to provide any further details about those contracts. Even under the lenient plausibility standard, a plaintiff must furnish enough detail about the obligations of the alleged contracts to allow a reasoned determination as to whether the second element — breach of contract — is alleged. Cf. Tel. Answering Serv. of Bos., Inc. v. New Eng. Tel. & Tel. Co., 267 N.E.2d 918, 918-19 (Mass. 1971) ("Where the gist of the action, whatever its form and however stated, is failure to perform a duty arising out of a contract, . . . it is essential to state with substantial certainty the facts showing the existence of the contract and the legal effect thereof" (internal alteration and quotation marks omitted) (quoting Pollock v. New Eng. Tel. & Tel. Co., 194 N.E. 133, 136 (Mass. 1935))). Conformis's claim for tortious interference with contractual relations, as pleaded, does not satisfy this requirement. Thus, we uphold the district court's dismissal of that claim.
Conformis's parallel claim for tortious interference with advantageous relations (sometimes described as business relations) stands on a different footing. To defeat a motion to dismiss such a claim, a plaintiff must plausibly allege that "(1) [it] had an advantageous relationship with a third party (e.g., a present or prospective contract or [business] relationship); (2)
- 34 - the defendant knowingly induced a breaking of the relationship; (3) the defendant's interference with the relationship, in addition to being intentional, was improper in motive or means; and (4) the plaintiff was harmed by the defendant's actions." Hamann, 937 F.3d at 93 (second alteration in original) (quoting Blackstone v. Cashman, 860 N.E.2d 7, 12-13 (Mass. 2007)). In connection with such a claim, plausible allegations of a "probable future business relationship anticipating a reasonable expectancy of financial benefit will suffice" to satisfy the first element. Am. Priv. Line Servs., Inc. v. E. Microwave, Inc., 980 F.2d 33, 36 (1st Cir. 1992).
With respect to this claim — as with respect to its claim for tortious interference with contractual relations — Conformis alleges the existence of "contracts with more than 2,100 healthcare providers," as well as relationships with "non-contracted healthcare providers [who] have routinely prescribed or otherwise provided the Conformis System since it received FDA clearance in 2011." The question, then, is whether these allegations suffice, for pleading purposes, to satisfy the first element of the advantageous relations tort.
Aetna says that we should answer this question in the negative. It labors to draw comparisons between this case and the decisions in Singh v. Blue Cross/Blue Shield of Massachusetts and
- 35 - Laser Labs, Inc. v. ETL Testing Laboratories, Inc. We think that these comparisons are strained and, ultimately, unhelpful. In Singh, we held that the allegation that unspecified patients either left or failed to sign up for the plaintiff's medical practice was too "speculat[ive]" and non-specific to withstand a motion for summary judgment. 308 F.3d 25, 48 (1st Cir. 2002). In Laser Labs, the district court held that merely alleging business relationships with "several" unspecified customers was insufficient to withstand summary judgment. 29 F. Supp. 2d 21, 23 (D. Mass. 1998). The case at hand, though, differs both in its procedural posture and in substance. In Singh and Laser Labs, bare allegations of advantageous relations were deemed insufficient to withstand summary judgment. See Singh, 308 F.3d at 48; Laser Labs, 29 F. Supp. 2d at 23. A plaintiff is held to a less demanding standard at the motion to dismiss stage, "with a record yet to be fleshed out with evidence." Vázquez-Ramos, 55 F.4th at 297. It need not establish the existence of a genuine issue of material fact but, rather, may rest on allegations as long as those allegations "create a reasonable expectation that discovery may yield evidence of [the defendant's] allegedly tortious [interference]." Hamann, 937 F.3d at 92 (second alteration in original) (quoting García- Catalán, 734 F.3d at 103). - 36 - Conformis has made this modest showing. It alleges the existence of sustained relationships, contractual and non- contractual, with a constituency of healthcare providers during the extended period of time that the Conformis system has been on the market. Such allegations are plausible, and we deem them sufficient to show the existence of business relationships "anticipating a reasonable expectancy of financial benefit." Am. Priv. Line Servs., Inc., 980 F.2d at 36. Of course, the plaintiff also must plausibly allege that the defendant knew of the advantageous relations and intentionally interfered with them, causing economic harm. See Hamann, 937 F.3d at 93; see also Sindi, 896 F.3d at 26; Ayash v. Dana-Farber Cancer Inst., 822 N.E.2d 667, 690 (Mass. 2005). In this context, intentionality requires that the defendant "either desired to bring about the harm to the plaintiff or [] kn[ew] that this result was substantially certain to be produced by his conduct." Restatement (Second) of Torts ch. 37, intro. note (Am. L. Inst. 1979). Here, Conformis plausibly alleges that its leading position in the market for customized knee replacements, its letters to Aetna urging reconsideration of the Policy, the articles Aetna reviewed, and the claims submitted on behalf of Aetna's subscribers combine to ground a reasonable inference that Aetna not only knew of the existence of Conformis's advantageous relations but also must have known that its interference — the recharacterization of - 37 - the Conformis system as experimental and investigational and therefore ineligible for coverage — was virtually certain to result in economic harm. We think these allegations are sufficient to lift this claim above the realm of mere speculation. Giving due weight to the "cumulative effect" of Conformis's factual averments, Ocasio- Hernández v. Fortuño-Burset, 640 F.3d 1, 14 (1st Cir. 2011), it is nose-on-the-face plain that Aetna must have been aware that Conformis had advantageous relations that were almost certain to be disrupted by Aetna's recharacterization of the Conformis system. It would be too much to demand — at the pleading stage — that Conformis allege more specific facts about Aetna's knowledge and intent. See Rodríguez-Reyes, 711 F.3d at 56 ("For pleading purposes, circumstantial evidence often suffices to clarify 'a protean issue such as an actor's motive or intent.'" (quoting Anthony, 952 F.2d at 605)). We hold, therefore, that Conformis's allegations with respect to this element of its advantageous relations claim are plausible. Last — but far from least — Conformis must plausibly allege that Aetna's interference with its advantageous relations "was improper in motive or means." Hamann, 937 F.3d at 93 (quoting Blackstone, 860 N.E.2d at 13). We agree with Aetna that no improper motive has been proffered. After all, it is settled that purely financial motives will not normally sink to the necessary - 38 - level of impropriety. See id. at 90; King v. Driscoll, 638 N.E.2d 488, 495 (Mass. 1994). And here, Conformis's complaint explicitly states that "Aetna's motive for excluding coverage for the Conformis System . . . was purely financial." But the failure plausibly to show an improper motive does not sound the death knell for Conformis's claim of tortious interference with advantageous relations. Conformis may still carry its pleading burden on this element of the tort by plausibly alleging improper means. See Geltman, 551 N.E.2d at 23-24. In this context, improper means refers to whether the defendant "violated a statute or a rule of common law[,] . . . used threats, misrepresented any facts, defamed anyone, or used any other improper means" in interfering with the business relationship. Id. at 24. The allegations of the complaint plausibly allege improper means. In considering whether Conformis has plausibly alleged improper means, the decisive data point is that Conformis — as we have explained, see supra Part II(A) — has pleaded a plausible claim for product disparagement. This same showing does double duty, serving to satisfy the "improper means" element. See Geltman, 551 N.E.2d at 24.
We summarize succinctly. Although we uphold the district court's dismissal of Conformis's claim for tortious
- 39 - interference with contractual relations, we reverse its dismissal of Conformis's claim for tortious interference with advantageous relations. Conformis has plausibly alleged the necessary elements of the latter claim.
C
This brings us to Conformis's challenge to the dismissal of its claim for unfair or deceptive trade practices. See Mass. Gen. Laws ch. 93A. To state a claim for unfair or deceptive trade practices under chapter 93A, a commercial plaintiff must plausibly allege "1) that the defendant engaged in an unfair method of competition or committed an unfair or deceptive act or practice, as defined by [Mass. Gen. Laws ch.] 93A, § 2, or the regulations promulgated thereunder; 2) a loss of money or property suffered as a result; and 3) a causal connection between the loss suffered and the defendant's unfair or deceptive method, act, or practice." Auto Flat Car Crushers, Inc. v. Hanover Ins. Co., 17 N.E.3d 1066, 1074-75 (Mass. 2014). The plaintiff's allegations must plausibly show that the defendant's actions fell "within at least the penumbra of some common-law, statutory, or other established concept of unfairness" or were "immoral, unethical, oppressive, or unscrupulous." Ruiz v. Bally Total Fitness Holding Corp., 496 F.3d 1, 11 (1st Cir. 2007) (quoting PMP Assocs., Inc. v. Globe Newspaper Co., 321 N.E.2d 915, 917 (Mass. 1975)).
- 40 - The parties agree that the viability of this claim at the motion-to-dismiss stage depends on the viability of the claims for product disparagement and tortious interference. Because we have determined that some of those claims survive Aetna's motion to dismiss, see supra Parts II(A), (B)(2), we reverse the district court's dismissal of Conformis's chapter 93A claim. III We need go no further. For the reasons elucidated above, the judgment of the district court is Affirmed in part and reversed in part. No costs. - 41 -