Opinion ID: 169651
Heading Depth: 4
Heading Rank: 1

Heading: The Terms Experimental and Investigational

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.