Opinion ID: 78288
Heading Depth: 3
Heading Rank: 2

Heading: ide

Text: The Government contends that the district court erred in refusing to enjoin the Appellees from manufacturing and distributing the B-P Ankle until they fully complied with the IDE regulations. Specifically, according to the Government, the evidence demonstrates that the Appellees' repeatedly violated the requirements of the IDE clinical study, including Dr. Feldman's implantation of 10 ankle devices beyond the scope of the IDE clinical study and Dr. Buechel's implantation of 217 ankle devices, even though he was not an investigator under the IDE clinical study. The Appellees respond that, after receipt of the AIP and March 2002 warning letter, it took remedial measures to obtain compliance with the IDE clinical study on the B-P Ankle and the FDA lifted the AIP. The FDCA provides for an investigational device exemption in 21 U.S.C. § 360j(g) to remove what would otherwise be a catch-22: a Class III device may not be shipped in interstate commerce until it has been approved by the FDA, but, to obtain the test data needed for approval, a device has to be shipped in interstate commerce to physicians who will test the device in patients under controlled circumstances. Accordingly, the IDE exemption lifts the prohibition on shipment in interstate commerce of an unapproved Class III device and permits the investigational use of unapproved devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices pursuant to protocol imposed by the FDA. 21 U.S.C. § 360j(g). To obtain an IDE exemption, a manufacturer must satisfy the requirements of 21 U.S.C. § 360j(g) as well as 21 C.F.R. § 812.20. The district court's own findings of fact intimate that the Appellees manufactured and distributed the B-P Ankle device in violation of the IDE clinical study: 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. However, Dr. Buechel implanted B-P Ankles as surgeon specials until 2002 when FDA issued its warning letter to Endotec. Since 2002, Dr. Buechel has only implanted what he describes as custom ankle devices. Dr. Buechel admitted that in April 2007, he implanted an ankle device in which all the component numbers began with `05,' indicating that it was the standard B-P Ankle. Dr. Buechel offered that the particular situation must have been an emergency situation. In other situations, Dr. Buechel used components that had been originally manufactured for another patient because it offered the patient the best fit. Endotec, 2008 WL 1909164, at . In other words, Dr. Buechel admitted that he implanted the B-P Ankle device on an undetermined number of occasions before the March 2002 warning letter. This admission demonstrates a violation of the IDE clinical study requirements in that Dr. Buechel was not an approved investigator under the B-P Ankle IDE clinical study. The Appellees nevertheless argue that they have implemented remedial measures since the March 2002 warning letter. This argument fails to convince us for two reasons. First, the Appellees do not identify specifically what remedial measures. [16] And second, even if they had enacted remedial measures, such subsequent action does not somehow ameliorate their past violations of the B-P Ankle IDE clinical study. In addition, Dr. Buechel's admission that he implanted a B-P Ankle device on one occasion after the March 2002 warning letter belies their remedial measures argument insofar as such measures proved ineffective on at least that one occasion. The district court's decision not to enjoin the Appellees' manufacture and distribution of the B-P Ankle relied upon findings irrelevant to whether they complied with the IDE clinical study of the B-P Ankle. The district court determined that Endotec had not violated 21 U.S.C. §§ 351(i) and 331(q)(1), [17] finding that, since the March 2002 warning letter, [Endotec] ha[s] been in substantial compliance regarding the B-P Ankle. Endotec, 2008 WL 1909164, at . Despite the Appellees' faulty record-keeping, the district court appeared to base its conclusion on two points: (1) the Government had alleged neither that the B-P Ankle was unsafe or dangerous nor that the Appellees' actions caused any harm to any patient; and (2) the FDA's stringent regulations strict interpretation of procedural requirements are resulting in technological innovation being stymied, rather than advanced. Id. at . Neither consideration, however, represents a valid reason in support of its finding that the Appellees did not violate the requirements of the IDE clinical study of the B-P Ankle. First, similarly to the custom device exemption, neither the statute providing for the IDE exemption nor the applicable regulations require the Government to allege, much less to prove, that a device (alleged to exceed the scope of an IDE) is unsafe or dangerous. The district court cited no authority for the new dangerous requirement and the Appellees fail to cite to any binding or persuasive case law in support thereof. [18] We find the Sixth Circuit instructive here: It is not the government's burden to prove that a product is not safe and effective. FDCA regulations exist to allow the public to assume that marketed devices have received the imprimatur of FDA approval. To circumvent the law by marketing illegally without approval is to deceive the public both as purchasers and users of the device. United States v. Universal Mgmt. Services, Inc., Corp., 191 F.3d 750, 763 (6th Cir.1999). We decline to impose a dangerousness requirement as to the IDE exemption. By punishing the Government for failing to prove the dangerousness of the ankle device, the district court held the Government to a standard that it need not meet. Second, the district court's commentary that the FDA's interpretation of the MDA stymies, rather than advances, innovation fails to justify its ruling. See Endotec, 2008 WL 1909164, at . Congress crafted the IDE exemption to advance innovation: The purpose of [the IDE exemption] is to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose. 21 U.S.C. § 360j(g)(1); 21 C.F.R. § 812.1(a). However, fostering innovation does not require the elimination of all burdens on medical device manufacturers.... Webster v. Pacesetter, Inc., 171 F.Supp.2d 1, 14 (D.D.C.2001). The district court noted that the evidence presented at trial showed that the B-P Ankle provided greater benefits to patients than the alternatives available in the United States. Endotec, 2008 WL 1909164, at . In this statement, the district court exceeded the proper scope of its inquiry by addressing the medical benefits of the B-P Ankle device versus other alternative ankle devices as opposed to confining its inquiry to the alleged violations of sections 351(i) and 331(q)(1) by the manufacture and distribution of the B-P Ankle beyond the scope of the IDE clinical study. It is not within the province of the district court (or, this Court, for that matter) to weigh the medical pros and cons of a certain medical device  that is best left to the FDA. Accordingly, we conclude that the district court employed faulty reasoning in finding that the Appellees had not violated sections 351(i) and 331(q)(1). Considering that the district court is better acquainted with the evidence and the parties, we remand to give the district court another opportunity: (1) to consider whether the Appellees violated sections 351(i) and 331(q)(1) through the manufacture and distribution of the B-P Ankle outside the IDE clinical study based on the record evidence; (2) to consider, in the first instance, whether this issue as to the IDE clinical study is now moot in light of the fact that the FDA has lifted the AIP; and (3) to resolve any other issues related to the IDE clinical study that the district court deems appropriate.