Opinion ID: 78288
Heading Depth: 3
Heading Rank: 1

Heading: Custom device exemption

Text: The MDA exempts custom devices from premarket approval. A custom device is one that necessarily deviates from an otherwise applicable performance standard or requirement prescribed by or under section 360e of this title if (1) the device is not generally available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and (2) such device (A)(i) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated) and is to be made in a specific form for such patient, or (ii) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated), and (B) is not generally available to or generally used by other physicians or dentists (or other specially qualified persons so designated). 21 U.S.C. § 360j(b). Stated differently, 21 C.F.R. § 812.3 tracks the statutory language for the most part but breaks down the custom device requirements into a list format: Custom device means a device that: (1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist; (2) Is not generally available to, or generally used by, other physicians or dentists; (3) Is not generally available in finished form for purchase or for dispensing upon prescription; (4) Is not offered for commercial distribution through labeling or advertising; and (5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice. 21 C.F.R. § 812.3(b) (emphasis added). As a threshold matter, we note that the district court considered issues outside the scope of the definition of a custom device. In particular, the district court noted that the Government did not present any evidence to indicate that the ankle devices were potentially dangerous. Endotec, 2008 WL 1909164, at ; see id. (addressing all the medical devices in general and providing that [i]t is noteworthy that throughout the duration of these proceedings, the FDA has not alleged that Defendants have harmed any individual by manufacturing or distributing medical devices and has not alleged that any of Defendants' devices are dangerous or that their use poses any risk). In support, the district court relied upon Contact Lens Manufacturers Association v. Food & Drug Administration, 766 F.2d 592 (D.C.Cir.1985), in which the Contact Lens Manufacturers Association (CLMA) filed suit to challenge the FDA's withdrawal of its own proposal to transfer certain contact lenses from Class III to Class I. See id. at 594. The district court's reliance on Contact Lens for the proposition that the party seeking injunctive relief under the FDCA must demonstrate dangerousness or actual harm with respect to a medical device is misplaced for two reasons. First, by requiring the Government to show dangerousness or actual harm, the district court effectively shifted the burden of persuasion as to the custom device exemption from the Appellees to the Government. And second, notwithstanding the former, the custom device definition does not require any showing of dangerousness or actual harm from the Government. In noting that the Government did not present any evidence to indicate that the ankle devices were potentially dangerous, Endotec, 2008 WL 1909164, at , the district court cited a passage in Contact Lens, in which the FDA expressed concern with regard to the safety and effectiveness of soft contact lenses. See Contact Lens, 766 F.2d at 595. That passage, however, related to the D.C. Circuit's discussion of the reclassification of the contact lenses. See id. The D.C. Circuit did not discuss or even make any mention of dangerousness or actual harm with respect to the custom device exemption but instead limited its analysis thereto to the five prongs of the custom device definition. See id. at 598-99. Contact Lens, therefore, does not lend support to any requirement that the party not claiming protection of the custom device exemption must demonstrate potential dangerousness or actual harm caused by the disputed medical device. The district court concluded that the ankle devices distributed by Endotec beyond the scope of the IDE clinical study constituted custom devices and hence were exempt from premarket approval. The Government argues that the district court abused its discretion in concluding that the ankle devices qualified as custom devices. Specifically, the Government asserts that the ankle devices fail each prong of the definition of a custom device. We conclude that the district court erred with respect to one prong of the custom device definition and, because a device must meet all five prongs of the custom device definition, we decline to address the remainder. A custom device is a device that [i]s not offered for commercial distribution through labeling or advertising. 21 C.F.R. § 812.3(b)(4); 21 U.S.C. § 360j(b) (providing that a custom device is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution). The district court found that [the Appellees] did not offer the custom ankle devices for commercial distribution through advertising or labeling. [11] Endotec, 2008 WL 1909164, at . In doing so, the district court addressed only the advertisements on Endotec's website and Dr. Buechel's private practice website. See id. (Any references to ankle devices on Endotec's website or on Dr. Buechel's private practice website refer to the B-P Ankle, and not the unique ankle devices at issue in this case.). The district court, however, failed to address another advertisement raised by the Government. Based on our review of that advertisement as well as the advertisement on Dr. Buechel's website, we conclude that the Appellees advertised the purported custom ankle devices for commercial distribution in violation of the custom device definition. First, the Appellees advertised the custom devices through a July/August 2006 edition of Orthopaedic News, containing an advertisement for Endotec customs. [12] The subsequent text refers to, inter alia, custom ankle devices as Endotec's speciality. On its face, the advertisement offers custom ankle devices by Endotec for commercial distribution. By its own language, this advertisement cannot be attributed to the B-P Ankle device as it explicitly refers to Endotec customs, which we read as a reference to custom ankle devices, not the B-P Ankle. Such a reference constitutes an impermissible advertisement of a custom device. Endotec offers no explanation to the contrary, except to assert that the Federal Register allows them to advertise custom devices of a generic type. However, even if we were to endorse a generic type exception to the prohibition against advertisement for commercial distribution, this advertisement is anything but generic. On the contrary, the advertisement specifically refers to Endotec custom ankle devices. Second, the district court found that any advertisement on Dr. Buechel's medical practice website (South Mountain Orthopaedic Associates) referred to the B-P Ankle, not the custom ankle devices. See Endotec, 2008 WL 1909164, at . We do not quarrel with the district court's factual finding that the website literally refer[red] to the B-P Ankle. The face of the advertisement on the website speaks for itself. See R., Ex. 11. [13] The Government agrees. See Br. For Appellant at 36. However, we disagree with the district court's conclusion that, because the website referred to the B-P Ankle by name only, the Appellees did not violate the commercial distribution prong of the custom device definition because, as the district court also found, Dr. Buechel's reference to the B-P Ankle on his website necessarily included the purported custom ankle devices manufactured and distributed by Endotec. The district court found that Dr. Buechel implanted B-P Ankles as surgeon specials until 2002 when [the] FDA issued its warning letter to Endotec. Endotec, 2008 WL 1909164, at  (emphasis added). Specifically, the district court found that Dr. Buechel ... had implanted 218 ankle devices as `surgeon specials.' Id. at . According to the Appellees, surgeon specials is a term used by Endotec to refer to a device made to a surgeons [sic] specifications, to be used only in that surgeons [sic] practice and not for general distribution. Appellees' Resp. Br. And Principal Br. at 12 (quotation marks and citation omitted). The district court found that surgeon specials, as that phrase is used by the Appellees, and the purported custom ankle devices manufactured and distributed by the Appellees, are one and the same. See Endotec, 2008 WL 1909164, at  (The specific ankle devices at issue are all the ankle devices that are distributed for use in patients beyond the 109 patients enrolled in an approved IDE clinical study and all ankle devices [the Appellees] describe as `customs' or `surgeon specials. ') (emphasis added). Therefore, according to the district court's finding that Dr. Buechel implanted B-P Ankles as surgeon specials, the advertisement of the B-P Ankle on Dr. Buechel's website encompassed the advertisement of surgeon specials, or the purported custom ankle devices. [14] Our conclusion is further bolstered by the fact that Dr. Buechel was not an approved investigator under the IDE clinical study of the B-P Ankle and, as such, he could not even implant the B-P Ankle. See id. at  (Dr. Buechel admitted that he is not a clinical investigator for the B-P Ankle and that means he cannot implant B-P Ankles pursuant to the approved IDE.). Such an advertisement of a purported custom ankle device violates the commercial distribution prong of the custom device definition. In defense of the advertisement, the Appellees do not echo the district court's finding that the advertisement referred only to the B-P Ankle. Rather, they provide another explanation: a disclaimer on the website advising that the B-P Ankle is only available through the compassionate use program cures any violation of the prohibition against the commercial distribution of custom ankle devices. [15] We disagree. The Appellees fail to direct us to any statute, rule, or case that allows for a disclaimer exception to the commercial distribution prong and they bear the burden to demonstrate that their device constitutes a custom device. Moreover, we refuse to allow a disclaimer to shield the Appellees from what otherwise constitutes blatant advertisement of their purported custom ankle devices. Such a rule would render the commercial distribution prong of the custom device definition ineffective and meaningless. Given the nature of the custom device definition, either of the advertisements of the custom ankle devices, standing alone, removes the ankle device from the protection of the custom device exemption. Accordingly, we find that the Appellees have failed to carry their burden as to the commercial distribution prong.