Opinion ID: 169651
Heading Depth: 3
Heading Rank: 2

Heading: TMJI's Allegations

Text: The heart of TMJI's complaint is that Aetna and CIGNA defamed it by calling its products experimental and investigational. In response to Aetna's and CIGNA's defense that they were only expressing opinions, TMJI argues that within the medical community the terms experimental and investigational have definite meanings based on objective criteria, and that statements labeling its devices as experimental and investigational are therefore not mere matters of opinion but are assertions of fact. Aplt. Br. at 13-14. In support of this contention TMJI's appellate briefs discuss three cases and cite several more in a footnote. They also point to some FDA definitions and a definition retrieved through an Aetna website. We are not persuaded. The first case discussed by TMJI is Leonhardt v. Holden Business Forms Co., 828 F.Supp. 657 (D.Minn.1993). Plaintiff Penelope Leonhardt had sought coverage for an autologous bone marrow transplant (ABMT) to treat her cancer. The administrator of her group health plan denied the treatment on the grounds that ABMT was experimental and investigational. Id. at 662. Ms. Leonhardt sought a preliminary injunction enjoining the administrator from denying coverage because the procedure had to be performed promptly if she was to benefit fully. See id. First, the district court found that the administrator's actions in denying coverage had violated the terms of the plan. Not only did the plan not include an exclusion for investigational procedures, but the administrator had failed to advise Ms. Leonhardt of what deficiencies her application had to overcome to be successful on appeal, id. at 668 (brackets and internal quotation marks omitted), and had improperly denied her (1) the right to submit evidence supporting her position that the treatment was not experimental and (2) the right to challenge the evidence on which the administrator had relied, see id. at 669. The district court then considered what the appropriate remedy should be. Although it acknowledged that it would ordinarily remand to the administrator for reconsideration, it said that to do so in this case would be inappropriate because time was of the essence and the administrator's conduct call[ed] into question its ability to process [Ms.] Leonhardt's claim impartially, id. at 670. Therefore, it analyzed whether Ms. Leonhardt had satisfied the standards for granting a preliminary injunction. In addressing whether she was likely to succeed on the merits of her claim, the court step[ped] into the shoes of the Plan administrator [and made] a de novo determination of whether [Ms.] Leonhardt's proposed ABMT treatment [was] experimental under the Plan definition. Id. The court did not, as TMJI's argument would suggest, simply apply the definition of experimental purportedly recognized throughout the medical community. Rather, it applied the Plan's definition of experimental medical procedure as a procedure that `is (a) not proven in an objective manner to have therapeutic value or benefit, (b) restricted to use at medical facilities capable of carrying out scientific studies; or (c) of questionable medical effectiveness.' Id. at 670-71 (quoting the Plan). The court found that the definition had not been satisfied because the treatment had achieved partial or complete remission in 80% of patients treated, the treatment was not restricted to medical facilities capable of carrying out scientific studies, and the plaintiff was a good candidate for the treatment. The court rejected the administrator's proffers intended to show that the treatment was experimental. An affidavit from a Dr. Altman stated that ABMT would be considered experimental until the medical community is presented with at least two randomized, controlled studies indicating a significant statistical and practical increase in the disease-free survival and overall survival rate for patients undergoing [ABMT] as opposed to patients undergoing standard therapy. Id. (internal quotation marks omitted). The other support for the administrator's position was a report from a medical research information clearinghouse concluding that ABMT treatment for Ms. Leonhardt's type of cancer was experimental. The court did not reject this evidence on the ground that the expert and the report used a definition of experimental contrary to accepted usage. Its reason for rejecting the evidence was simply that the Plan used a different definition. See id. at 671 (Although this may be Dr. Altman's understanding of the term `experimental,' it is not the definition articulated in the Plan.). Leonhardt thus does not support TMJI's contention that the term experimental has a single, universal definition. The other opinion discussed in TMJI's opening brief is Bucci v. Blue Cross-Blue Shield of Connecticut, Inc., 764 F.Supp. 728 (D.Conn.1991). The defendant insurer had denied plaintiff's request for coverage of a combination of high-dose chemotherapy (HDCT) and ABMT treatment for her breast cancer. The basis for the insurer's denial was that plaintiff's policy excluded coverage for services `which are experimental or investigational in nature; meaning any treatment, procedure . . . drugs, drug usage . . . not recognized as accepted medical practice,' id. at 729 (quoting policy, ellipses in original), and that HDCT/ABMT for breast cancer fell into this category. Although the court noted the substantial risks of the treatment and the limited data on its effectiveness, see id. at 730-31, it ordered the insurer to cover the treatment. For our purposes, two components of the court's analysis are salient. First, the court did not define experimental or investigational, but merely applied the policy's definition of these terms. See id. at 729. Second, in construing the term accepted medical practice in the policy definition, it apparently felt compelled to minimize the plan administrator's discretion in determining coverage by selecting an objective meaning. See id. at 732-33. It appeared to believe that the only possible definition of accepted medical practice meeting that standard was that a procedure may be found not to constitute accepted medical practice only where there is no reasonably substantial, qualified, responsible, relevant segment of the medical community which accepts the procedure as properly within the range of appropriate medical treatment, under the circumstances of the case, as judged by the standards of the medical community. Id. at 732. Thus, the court was hardly providing what it thought to be a definition of experimental or investigational generally accepted in the medical community. The third case discussed by TMJI, White v. Caterpillar, Inc., 765 F.Supp. 1418 (W.D.Mo.1991), is mentioned only in the reply brief. It, too, provides TMJI no support. In that case the plaintiff sought a preliminary injunction after her insurer denied her request for coverage of HDCT/ABMT treatment. The opinion provides no definition of the term investigational, nor does it quote any plan provision using the term. Rather, the plan's standard for coverage appears to have been whether the procedure was a generally accepted surgical operation, id. at 1420 (internal quotation marks omitted), although the administrator had denied coverage on the ground that the procedure did not meet that standard because the procedure was investigational, id. (internal quotation marks omitted). This case hardly suggests that the term investigational has a universally understood definition. Likewise, the cases TMJI cites in a footnote in its opening brief do not support the contention that the terms experimental and investigational have definite meanings in the medical community. TMJI also relies on definitions of investigational device and investigation in the FDA regulations governing Investigational Device Exemptions. 21 C.F.R. pt. 812. Under the regulations the maker of medical devices may obtain approval to conduct clinical investigations of devices to determine [their] safety and effectiveness. Id. § 812.2(a). An approved device may be shipped for the purpose of conducting investigations without complying with the usual performance and marketing standards. Id. Section 812.3 defines investigational device as a device . . . that is the object of an investigation. Id. § 812.3(g). Investigation is defined as a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. Id. § 812.3(h). These definitions may be suggestive of general usage, but they do not purport to be universally applicable. For regulations to provide adequate guidance they must use terms with precision. Often, however, no common word has such a precise meaning, so the regulation must use an imprecise word and give it a precise definition. This process is a common one. For example, this circuit uses the adjective unpublished to refer to opinions with no precedential force even though such opinions are widely published in the usual meaning of the term. Accordingly, we view the FDA definitions as authoritative only in the special context of the regulations in which they are used. Finally, TMJI relies on a definition that it obtained through Aetna's website for health-care information, http://www. intelihealth.com. To the extent that TMJI is suggesting that Aetna has adopted that definition for its coverage policy bulletins, we are not persuaded. First, all the website does is provide a link to the Merriam Webster Medical Dictionary; the definitions are not ones provided by Aetna itself. Second, the definition referenced is not a definition of experimental or investigational. Rather, it is the following definition of investigational new drug: a drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and efficacy first by clinical investigators and then by practicing physicians using subjects who have given informed consent to participateabbreviation IND ; also called investigational drug.  Aplt.App. at 322. Again, the definition is an effort to explain the meaning of a technical term used by the FDA for regulatory purposes. See 21 C.F.R. § 312.3 (defining IND and investigational new drug ). It does not purport to be, and should not be read as, a universal definition of the term investigational, or even as providing the sole meaning in a medical context. Contrary to TMJI's assertion, several courts have expressly stated the view that the terms experimental and investigational do not have a settled meaning in the insurance-coverage context. See Heasley v. Belden & Blake Corp., 2 F.3d 1249, 1260 (3d Cir.1993) (in insurance context, term experimental is resistant to precise definition); Dahl-Eimers v. Mut. of Omaha Life Ins. Co., 986 F.2d 1379, 1383 (11th Cir.1993) ([i]n the context of a major medical insurance policy, the term `experimental,' . . . is ambiguous when it is undefined.); Johnson v. Dist. 2 Marine Eng'rs Beneficial Ass'n, 857 F.2d 514, 516 (9th Cir.1988) (In the context of modern medicine, the term `experimental' seems clearly ambiguous on its face.); Reed v. Wal-Mart Stores, Inc., 197 F.Supp.2d 883, 888-89 (E.D.Mich.2002) (terms experimental and investigational used in insurance plan are ambiguous); Steil v. Humana Kansas City, Inc., 124 F.Supp.2d 660, 665 (D.Kan. 2000) ( experimental is ambiguous in medical context); Nichols v. Trustmark Ins. Co., 1 F.Supp.2d 689, 699 (N.D.Ohio 1997) (terms investigational and experimental used in insurance plan were ambiguous). More importantly, it is apparent from the cases that the terms are not applied, as TMJI would have us believe, only to medical procedures and devices that are undergoing research. In particular, perhaps as the result of growing concern that new, expensive treatments are no better than old standbys, it is apparently unremarkable for plan definitions and independent experts to consider a treatment to be experimental or investigational until it has established its superiority to current treatment. See Martin v. Blue Cross & Blue Shield of Va., Inc., 115 F.3d 1201, 1208 (4th Cir.1997) (plaintiff's expert agreed with administrator that whether treatment was experimental or investigative depended on whether it produced better outcomes than standard alternatives); Hendricks v. Cent. Reserve Life Ins. Co., 39 F.3d 507, 513 (4th Cir.1994) (professor of medicine testified that because cancer treatment had no demonstrated survival advantage over conventional therapy, it was investigational); Pinckney v. Blue Cross Blue Shield of Tenn., Inc., No. 3:05-00962, 2007 WL 108886, at  (M.D.Tenn. Jan.9, 2007) (plan defines services as experimental or investigational if further research is necessary in order to define safety, toxicity, efficacy, or effectiveness of that Service compared with conventional alternatives); Reed, 197 F.Supp.2d at 889 (one of defendant's experts defined terms investigational and experimental as whether a sufficient number of clinical trials had been performed to demonstrate that the therapy is either inferior, equivalent, or superior to standard treatment); Nichols, 1 F.Supp.2d at 698 (plaintiff's expert stated that treatment was not experimental or investigational because its effectiveness had previously been established to be superior to any other known therapy) (internal quotation marks omitted); Leonhardt, 828 F.Supp. at 671 (defendant's expert stated that procedure will be considered experimental until the medical community is presented with at least two randomized, controlled studies indicating a significant statistical and practical increase in the disease-free survival and overall survival rate for patients undergoing this therapy as opposed to patients undergoing standard therapy) (internal quotation marks omitted). In short, neither the authority cited by TMJI, nor any we have found, supports its contention that experimental and investigational have definite meanings in the medical community. Because there is no universally accepted definition for these terms, we must discern their meanings from the context in which the defendants use them. We begin with the Aetna bulletin.

CPB 28 addresses Aetna's coverage determinations for treatment of TMJ syndrome and TMJ disorders. It contains several statements about TMJI's products that TMJI alleges are defamatory. We proceed to put these statements in context to determine whether they are actionable. In our quotations from CPB 28, we have italicized the allegedly defamatory statements. The bulletin begins with an Important Note stating the sources on which Aetna has relied in reaching the conclusions the bulletin sets forth. The note reads, in part: This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aplt.App. at 177. The bulletin then cautions readers that a conclusion in CPB 28 that Aetna considers a procedure to be medically necessary does not mean that the procedure is covered for a specific policy holder  rather, individual coverage determinations can be made only with reference to the individual's benefit plan, as the individual benefit plan controls over any determination made in the bulletin. Although not stated expressly, the implication of this statement is that a treatment determined in the bulletin not to be medically necessary will never be covered, but the specific circumstances determine whether there is coverage for a treatment that can be medically necessary. The next section, entitled Policy, sets forth Aetna's medical-necessity determinations. Following that section is the Background section, which explains the bases for those determinations. We now explore these sections in some detail. The Policy section lists several nonsurgical treatments that Aetna considers medically necessary. For example, the use of intra-oral devices such as bite guards is considered medically necessary when the patient has documented evidence of difficulty chewing because of TMJ pain or limited joint functionality. Physical therapy is considered medically necessary without the need to demonstrate pain or lack of functionality, but documentation of need is required before coverage will be provided for more than a six-week course of 14 sessions. Various categories of drugs are also considered medically necessary to treat different types of TMJ-related pain, as are relaxation and behavior-modification therapies. Treatment in specialized pain centers, however, is considered medically necessary only for those few individuals who have been unresponsive to less comprehensive interventions. Id. at 179. Other medically necessary pain-management techniques include acupuncture, injecting pain medication into the joint, and dry needling (sticking a needle into TMJ-related muscles without injecting any substance). Surgical management options are much more restricted. The bulletin reminds readers that any request for surgical intervention must be reviewed by the Oral and Maxillofacial Unit and will be granted only when the patient has been unresponsive to nonsurgical treatments and surgery is the only remaining option. Acceptable surgical interventions include arthrocentesis (surgically flushing fluid from the TMJ joint and stretching it), arthroscopy (using an instrument to diagnose and repair the joint), and joint-reconstruction surgery. The bulletin describes TMJ implants as the most invasive surgical option. Regarding such surgery, CPB 28 states: Aetna considers the TMJ Concepts prosthesis medically necessary when used as a salvage device for treatment of end-stage TMJ disease, when no other viable therapeutic alternatives are available. The use of the Christensen TMJ Fossa-Eminence Prosthesis System (partial TMJ prosthesis) and the Christensen TMJ Fossa-Eminence/Condylar Prosthesis System (Christensen total joint prosthesis) are considered experimental and investigational. Id. (emphasis added and internal quotation marks omitted). In other words, use of the TMJ Concepts device is strictly circumscribed, whereas TMJI's devices are not considered medically necessary under any circumstances because Aetna has determined that they are experimental and investigational. TMJI's devices are not unique in this regard. The list of treatments that Aetna will not cover because it has determined them to be experimental and investigational includes 10 diagnostic procedures and 16 nonsurgical management treatments. Four surgical treatments are considered experimental and investigational for diagnosis and treatment of TMJ disorders : . . .  Christensen total TMJ prosthesis  Modified condylotomy [(surgical division of the condyle)] or intraoral vertical ramus osteotomy [(cutting of the ramus)] . . . when submitted with a diagnosis of internal derangement of the temporomandibular joint  Treatment of alveolar cavitational osteopathosis . . .  Partial temporomandibular joint prostheses. Id. at 179-180 (emphasis added). The Background section contains a comprehensive explanation of Aetna's Policy decisions. The thrust of the discussion is that caution should be used in treating TMJ dysfunction, and surgery of any kind is an option of last resort. The bulletin explains that the causes of TMJ dysfunction are generally unknown, but that it is thought to be the result of trauma to the joint. The cause of some TMJ trauma is obvious, such as extreme force applied to the joint (as may occur in an accident), whereas other causes, such as stress, anxiety, and sleep disorders, create the damage over time. According to the bulletin, because of a paucity of evidence-based outcome research and lack of consensus on the appropriate management of [TMJ dysfunction], id. at 180-81, there is wide variation in how clinicians treat TMJ dysfunction. It states that there is a lack of [s]cientifically valid clinical trials for most TMJ therapies and there is no objective, generally accepted diagnostic approach for identifying TMJ dysfunction. Id. at 181. As general support for its limitations on coverage, the bulletin quotes the National Institutes of Health's (NIH) recommendation that TMJ therapies be CONSERVATIVE & REVERSIBLE. Id. The Background section then proceeds to discuss specific surgical treatments. A number of surgical techniques are considered experimental and investigational because of a lack of evidence supporting their efficacy. For example, it states: Aetna considers modified condylotomy to be experimental and investigational. There are no controlled studies of modified condylotomy. Controlled studies are important because, according to an NIH Consensus Conference, up to 90 percent of TMJ patients['] symptoms resolve spontaneously. In addition, the literature on modified condylotomy comes almost exclusively from a single group, raising questions about the generalizability of findings. Furthermore, disc displacement is extremely common, and there is no direct evidence that disc displacement is a cause of TMJ symptoms. Id. The discussion of the partial- and total-joint devices is lengthy: A partial TMJ prosthesis consists of a meniscectomy and placement of a metallic glenoid fossa metal prosthesis (Christensen fossa-eminence prosthesis, TMJ, [sic] Inc., Golden, CO) in place of the meniscus, such that a natural condyle articulates with a metal fossa prosthesis. There is inadequate evidence from published clinical outcome studies of the safety and effectiveness of partial joint prostheses in the treatment of [temporomandibular disorders]. The U.S. Food and Drug Administration Dental Products Advisory Panel reviewed clinical studies of the Christensen fossa prosthesis, and advised the FDA to approve the total prosthesis, but to not approve the partial joint prosthesis because of a lack of clinical data on its safety and effectiveness. The information submitted to the FDA on the safety and effectiveness of the partial TMJ prosthesis is limited and has not been published in a peer-reviewed journal. In an editorial, Laskin (2001), former editor-in-chief of the Journal of Oral and Maxillofacial Surgery, the official journal of the American Association of Oral and Maxillofacial Surgeons, commented on the data on the partial TMJ prosthesis presented to the FDA Dental Products Advisory Panel: At that meeting [of the FDA Dental Products Advisory Panel where the partial TMJ prosthesis was considered] the FDA staff presentation expressed concern regarding the lack of data on the effect of the natural condyle articulating against a metal fossa, the limited number of patients with long term follow-up, and the broad diagnosis of internal derangement as an indication for its use. The panel expressed similar concerns about these issues, as well as the fact that the registry data provided in support of the product did not include all the patients treated and the sample size was insufficient for each of the individual indications. They recommended clarification of the patient inclusion criteria in the clinical study, evaluation of failures and additional patient follow-up, more clearly defined indications for use of the device, and that a power analysis of the clinical data be done to place the PMA in an approvable form. However, despite these criticisms, and the panel's opinion that adequate safety and effectiveness data for the given surgical indications were lacking, the device was approved by the FDA for distribution in February 2001. Laskin (2001) concluded that there are insufficient data to answer questions about the safety and effectiveness of the partial TMJ prosthesis. For example, how reliable are clinical data based on a registry that did not include all patients treated with the device, in which there was a very small number of total patients with serial data and even smaller numbers in each diagnostic sub-category, and where in 1 group of 97 patients with a diagnosis of internal derangement and/or inflammatory arthritis, only 30% (12 subjects) had a follow-up of 3 or more years and 70% were either lost to follow-up, withdrawn, or potentially lost to follow-up. How can one make an informed decision with such information? Aetna considers the Christensen total joint prosthesis experimental and investigational because it has not been shown to be as effective as the TMJ Concepts total joint prosthesis. An evaluation study has reported significantly better post-surgical outcomes with the TMJ Concepts total joint prosthesis than the Christensen total joint prosthesis. Wolford, et al. (2003) reported the results of a study comparing the Christensen total joint prosthesis (TMJ, Inc., Golden, CO) with the TMJ Concepts total joint prosthesis (TMJ Concepts Inc., Camarillo, CA) in 45 patients, 23 of whom were treated with the Christensen prosthesis, and 22 of whom were treated with the TMJ Concepts Prosthesis. The investigators reported that, although subjects treated with either total joint prosthesis showed good skeletal and occlusal stability, the subjects treated with the TMJ Concepts Prosthesis had statistically significant improved outcomes compared to subjects treated with the Christensen prosthesis with respect to [various indicators]. The investigators concluded [a]s a result of our study, it appears that [TMJ Concepts Prosthesis] provides a more biologically accepted and functional prosthesis than the [Christensen prosthesis] for the complex TMJ patient. Id. at 181-82 (emphasis added). Finally, the bulletin concludes with a list of 57 references on which Aetna based its TMJ treatment-coverage determinations.
Aetna is subject to liability only for those statements in CPB 28 that are false statements of fact or expressions of opinion that imply the existence of undisclosed defamatory facts. See Restatement §§ 565, 566. TMJI challenges as defamatory three statements in CPB 28 regarding TMJI's total-joint prosthesis and five regarding its partial-joint prosthesis: (1) [t]he use of the . . . Christensen TMJ Fossa-Eminence/Condylar Prosthesis System (Christensen total joint prosthesis) [is] considered experimental and investigational, Aplt.App. at 179; (2) Aetna considers the [Christensen total TMJ prosthesis] experimental and investigational for diagnosis and treatment of TMJ disorders, id. ; (3) Aetna considers the Christensen total joint prosthesis experimental and investigational because it has not been shown to be as effective as the TMJ Concepts total joint prosthesis, id. at 182; (4) [t]he use of the Christensen TMJ Fossa-Eminence Prosthesis System (partial TMJ Prosthesis) . . . [is] considered experimental and investigational, id. at 179; (5) Aetna considers [partial TMJ prostheses] experimental and investigational for diagnosis and treatment of TMJ disorders, id. ; (6) [t]here is inadequate evidence from published clinical outcome studies of the safety and effectiveness of partial joint prostheses in the treatment of [temporomandibular disorders], id. at 181; (7) there is a lack of clinical data on [the partial-joint prosthesis's] safety and effectiveness, id. ; and (8) [t]he information submitted to the FDA on the safety and effectiveness of the partial TMJ prosthesis is limited and has not been published in a peer-reviewed journal, id. Statements 1, 2, and 3 are formulations of Aetna's determination that TMJI's total-joint device is experimental and investigational, while statements 4 and 5 express its determination that the partial-joint device is also experimental and investigational. Statements 6, 7, and 8 provide support for its determination regarding the partial-joint device. CPB 28 nowhere provides an explicit definition of the terms experimental and investigational. Thus, its explanation in the Background section of why it has determined that certain treatments are experimental and investigational amounts to its definition of those terms as they are used in the bulletin. For example, the bulletin states that Aetna considers the Christensen total joint prosthesis experimental and investigational because it has not been shown to be as effective as the TMJ Concepts total joint prosthesis. Id. at 182. In other words, when Aetna says that the total joint prosthesis is experimental and investigational, it is saying that the total-joint prosthesis has not been shown to be as effective as the TMJ Concepts prosthesis. The statement that the prosthesis is experimental and investigational therefore is defamatory only if it is defamatory to say that the prosthesis has not been shown to be as effective as the TMJ Concepts prosthesis. In our view, this latter statement is not defamatory because it is not provably false. Different people will make different judgments on whether a product has been shown to be as effective as another. Some may require only one study; others may require the gold standard of a double-blind study, or even multiple such studies. Moreover, TMJI does not even contend that it was false to say that its product has not been shown to be as effective as the TMJ Concepts product. Instead, TMJI complains that comparing its prosthesis to TMJ Concepts' custom prosthesis is like saying a Mercedes-Benz is not as good as a Rolls Royce; one is assembly-line produced and the other custom built but both are superior machines. Aplt. Br. at 29. But whether the comparison is an appropriate one is beside the point. It is not defamatory to say that a Mercedes rides less smoothly than a Rolls Royce just because a better comparison would be between a Mercedes and a Jaguar. Thus, statements 1, 2, and 3, expressing Aetna's determination that TMJI's total-joint device is experimental and investigational because it has not been shown to be as effective as the TMJ Concepts product, are not actionable because they are not provably false. Similarly, neither statements 4 and 5, that Aetna considers TMJI's partial-joint prosthesis experimental and investigational, nor statement 6, that there is inadequate evidence of the device's safety and effectiveness, are actionable. Statement 6 amounts to Aetna's explanation of why it has reached the determination it makes in statements 4 and 5: There is inadequate evidence from published clinical outcome studies of the safety and effectiveness of partial joint prostheses in the treatment of [TMJ disorders]. Aplt.App. at 181. To say that the partial-joint prosthesis is experimental and investigational is thus to say that there is inadequate evidence supporting the device's safety and effectiveness. Again, such a statement is not defamatory because it is not provably false. As noted above, whether one considers evidence to be adequate is a matter of individual taste. See Info. Sys. & Networks Corp. v. City of Atlanta, 281 F.3d 1220, 1228 (11th Cir. 2002) (statement that company was fired because its performance was inadequate was one of opinion not capable of being proved false). Statement 7, that there is a lack of clinical data on [the partial-joint device's] safety and effectiveness, Aplt.App. at 181, is a paraphrase of the FDA Dental Products Advisory Panel's recommendation that the FDA not approve the partial-joint prosthesis. To the extent that Aetna may be arguing on appeal that it cannot be liable for this statement because it was merely repeating a determination made by others, it is incorrect. Comment b to Restatement § 578 makes clear that one who republishes a defamatory statement may be liable to the same extent as the original speaker because each publication causes a new harm to the plaintiff's reputation. But a republisher is liable only if the original statement is defamatory, and in this instance the statement is not. To say that there is a lack of clinical data in this context is not provably false. Like the statement that there is inadequate evidence supporting the device's safety and effectiveness, whether there is a lack of clinical data is a statement of opinion. Reasonable people may differ on how much data from clinical studies they require before they are satisfied that such data are no longer wanting or deficient. We recognize that in some circumstances to say that there is a lack of data is to imply that any such data are absent, and that whether such data were in fact absent could then be proved true or false. But that implication could not follow from the context in which Aetna's statement appears. The sentence containing the allegedly defamatory statement also states that the FDA panel reviewed clinical studies of the prosthesis. Id. A few lines after the sentence are (1) a quotation from Laskin explaining the panel's recommendation that a power analysis of the clinical data be done, id. (emphasis added), and then (2) Laskin's conclusion that the data on the partial prosthesis were insufficient because how reliable are clinical data based on a registry that did not include all patients . . .? Id. at 182 (internal quotation marks omitted). In this context no reasonable reader could infer that lack of clinical data means absence as opposed to insufficiency. Because Aetna's statement that there is a lack of clinical data cannot be proved false, it is not actionable. The last statement in CPB 28 of which TMJI complains is Aetna's statement that [t]he information submitted to the FDA on the safety and effectiveness of the partial TMJ prosthesis is limited and has not been published in a peer-reviewed journal. Id. at 181. The first part of this sentence, that the information submitted to the FDA on the safety and effectiveness of the partial TMJ prosthesis is limited, is not defamatory because it is not capable of being proved false. To say that information is limited is simply another way of saying that information is inadequate or lack[ing]. But the statement that the information submitted to the FDA on the safety and effectiveness of the partial TMJ prosthesis . . . has not been published in a peer-reviewed journal is susceptible of being proved false. To make that determination, one would need only to look at the information submitted to the FDA and investigate whether that same information had been published in a peer-reviewed journal. Nevertheless, TMJI has no claim based on this statement because it does not allege that this statement is false. What it does allege is that [t]he bulletins state that there are no published peer-reviewed studies of its prostheses, Aplt. Br. at 28 (emphasis added), and that this statement is inaccurate because such studies do exist. But this allegation distorts the record. CPB 28 does not state that there are no peer-reviewed studies of the prostheses; it states only that [t]he information submitted to the FDA on . . . safety and effectiveness, id. (emphasis added), was not published in a peer-reviewed journal. TMJI has not challenged the accuracy of that statement. TMJI may be arguing that Aetna's statement, even if literally true, is nonetheless defamatory because it omits a relevant material fact (namely, that peer reviews of its devices exist), and therefore carries a defamatory implication. The Restatement does not address this situation, but a leading treatise notes that liability can be found if the publication gets the facts right but the gist wrong: [I]f the defendant juxtaposes a series of facts so as to imply a defamatory connection between them, or creates a defamatory implication by omitting facts, he may be held responsible for the defamatory implication, unless it qualifies as an opinion, even though the particular facts are correct. On the other hand, the defendant who states all the particular facts correctly, does not omit facts necessary to put them in context, and does not juxtapose the facts in a farfetched way to create libelous implications, is not liable. W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 116A, Supp. at 117 (W. Page Keeton ed., 5th ed.1984, Supp. 1988) (footnotes omitted); see Memphis Publ'g Co. v. Nichols, 569 S.W.2d 412 (Tenn.1978) (news article that plaintiff was shot when assailant found her husband with plaintiff at plaintiff's house improperly implied adulterous relationship because plaintiff's husband and other guests were also present). We believe that Colorado would tightly cabin liability in this context. In Living Will Center, 879 P.2d 6, the Colorado Supreme Court stated that the omission of what the plaintiff considered to be relevant information would not convert an otherwise nonactionable statement into a defamatory one. The defendant had broadcast a report stating that the plaintiff's product was not worth its purchase price. The plaintiff argued, among other things, that because the broadcast in which the statement appeared had failed to describe its product fully, the statement was defamatory. The court disagreed, stating, [W]e . . . fail to see how providing limited, though accurate, information about the [product] can be regarded as a defamation of [plaintiff] under the facts of this case. Id. at 15. In this case the context of the allegedly libelous statement was a discussion explaining why the FDA advisory committee recommended against approval of the TMJI partial-joint prosthesis. The omitted facts would not affect the gist of this discussion. The bulletin hardly juxta-pose[d] the facts in a far-fetched way to create libelous implications. Keeton et al., supra, Supp. at 117. As the court said in Living Will Center, we fail to see how [the omission] can be regarded as a defamation of [TMJI]. Living Will Ctr., 879 P.2d at 15.
Having disposed of the statements in CPB 28, we turn to TMJI's allegations that CIGNA published defamatory statements about TMJI products in its TMJ-surgery bulletin, CPN 156. That bulletin states that CIGNA HealthCare does not cover partial joint replacement with the Christensen Fossa Eminence Prosthesis (TMJ Implants, Inc.) Partial TMJ Replacement System because it is considered experimental, investigational, or unproven, Aplt.App. at 194, and that [t]here is insufficient evidence in the published medical literature to establish the clinical efficacy or long-term outcome of implantation of partial TMJ prostheses, id. at 197. TMJI complains that saying that its partial-joint devices are considered experimental, investigational, or unproven, id. at 194, is defamatory. The bulletin does not otherwise define the terms experimental, investigational, or unproven ; we must therefore discern their meanings from the context in which they are used. Once again we italicize the allegedly defamatory statements in our quotations from the bulletin. The bulletin begins with a paragraph instructing the reader on how to use the bulletin. Like Aetna's bulletin, it tells readers that their individual benefit plans always control in the event of a conflict between a statement of coverage in CPN 156 and one in the individual plan. It informs readers that some benefit plans exclude TMJ treatment altogether. It then states that CIGNA covers arthrocentesis, arthroscopy, and arthrotomy (open-joint surgery) when certain listed medical-necessity criteria are met. For such a procedure to be covered, pain must have persisted despite at least six months of scientifically recognized non-invasive therapies, including pain medication, intra-oral devices, and physical therapy. Id. at 193. In addition, clinical examinations must document specific joint conditions for each treatment. The bulletin then states: CIGNA . . . covers arthrotomy with total prosthetic joint replacement using The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis for temporomandibular disorder when ALL the following medical necessity criteria are met and indication for surgery is confirmed by MRI, CT or corrected tomogram:  inflammatory arthritis involving the TMJ not responsive to other modalities of treatment  recurrent fibrosis and/or bony ankylosis not responsive to other modalities of treatment  failed tissue graft  failed alloplastic joint reconstruction  loss of vertical mandibular condylar height due to bone resorption, trauma, developmental abnormality or pathologic lesion CIGNA . . . does not cover partial joint replacement with the Christensen Fossa Eminence Prosthesis  (TMJ Implants, Inc.) Partial TMJ Replacement System because it is considered experimental, investigational, or unproven. Id. at 194 (emphasis added). The bulletin does not discuss TMJI's total-joint prosthesis. CPN 156 then provides a General Background that describes the anatomy of the TMJ and sets forth several symptoms that may indicate the presence of TMJ disorders, including pain in the face or jaw, headaches, dizziness, limited mouth opening, and clicking or popping sounds. It discusses the prevalence of TMJ disorders, noting that [a] majority of the general population have at least one sign of TM[J disorders]. Id. The bulletin states that [t]here is no widely accepted standard test to diagnose TM[J disorder], id. at 195, but that physical examination combined with reported symptoms generally provides sufficient information for a diagnosis. Regarding treatment options the bulletin states that [n]on-invasive, reversible therapies are used in the initial treatment of [TMJ disorders]. Id. These include pain-control drug therapies, physical therapy, and intra-oral appliances. When these conservative therapies are unsuccessful, surgical options may be considered. In discussing surgical treatment, the bulletin states that the most invasive surgical technique to treat TMJ disorders is arthrotomy, id. at 196, which can involve total  or partial-joint reconstruction with prosthetic implants. Because [t]here is inadequate guidance in the published medical literature regarding patient-selection criteria for these procedures, this surgical option should be considered only when all appropriate conservative treatment has failed and minimally invasive surgery . . . is not indicated. Id. CPN 156 explains that there are two FDA-approved prosthetic systems, the TMJ Concepts system and TMJI's devices. The TMJ Concepts device is approved for total-joint reconstruction in certain patients but should only be considered for end-stage [TMJ disorders] when no other medical or surgical options are available. Id. As to TMJI's partial-joint prosthesis, the bulletin acknowledges that the FDA approved it in 2001 for use in patients with any of five indications and that a retrospective study reported that patients who had received the implant experienced significant pain relief. But it notes that the study also advised that rigorously controlled prospective studies were needed to investigate the procedure. Id. at 197. CIGNA thus concludes that [t]here is insufficient evidence in the published medical literature to establish the clinical efficacy or long-term outcome of implantation of partial TMJ prostheses. Id. (emphasis added). The bulletin ends with a list of 20 references relied on for the information and determinations in the bulletin. As with the Aetna bulletin, the terms experimental, investigational, or unproven take on meaning only as the CIGNA bulletin explains why a procedure or device merits those adjectives. The bulletin's statement that there is insufficient evidence in the published medical literature to establish the clinical efficacy or long-term outcome of implantation of partial TMJ prosthesis amounts to its definition of those terms as they are used in CPN 156. In other words, in the context of the bulletin, to say that the partial-joint prosthesis is experimental, investigational, or unproven is to say that there is insufficient evidence supporting its efficacy. The statement that evidence is insufficient, however, is not defamatory because it is not provably false. As we said in the discussion of the Aetna bulletin, people may differ on the quantity or quality of information that they require before they deem it sufficient. The challenged statements in CPN 156 are therefore not defamatory.