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Genus Medical Technologies LLC v. United States Food and Drug Administration

United States District Court, District of Columbia

December 6, 2019

GENUS MEDICAL TECHNOLOGIES, LLC, Plaintiff,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant.

          MEMORANDUM OPINION

          JAMES E. BOASBERG UNITED STATES DISTRICT JUDGE

         Those drinking the contrast agent Vanilla SilQ before undergoing an X-ray or other imaging procedure likely spend no time pondering the central issue in this case: is this barium-sulfate product a drug or is it a medical device?

         Plaintiff Genus Medical Technologies, LLC manufactures Vanilla SilQ products - a line of contrast agents that are used to image structures or fluids within the body. Defendant Federal Drug Administration has authority to regulate medical products like Genus's to assure their safety and efficacy. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the agency can regulate products as, inter alia, drugs or devices. The regulatory path the FDA chooses - that is, whether it treats a product as a drug or a device - implicates significantly different pre-market review and post-market compliance requirements under the Act and implementing regulations. Drugs are subject to a more rigorous regimen, which costs its sponsor considerably more money.

         The FDA here concluded that although the Vanilla SilQ products appeared to qualify as devices under the FDCA, they were also drugs and could be regulated accordingly. Plaintiff responded with this suit, and the parties have now cross-moved for summary judgment. Finding the agency's action to be inconsistent with the Administrative Procedure Act and the FDCA, the Court will grant Plaintiff's Motion for Summary Judgment and deny the FDA's Cross-Motion.

         I. Background

         To provide context for the factual background, the Court first sets out the statutory scheme.

         A. Statutory Framework

         The FDCA, 21 U.S.C. § 301 et seq., grants the FDA, as the designee of the Secretary of Health and Human Services, the authority to regulate medical products, including “drugs” and “devices.” Id. §§ 321(g)-(h), 393. The Act, in relevant part, defines “drug” to include:

articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

Id. § 321(g)(1). It defines “device” in part, conversely, to mean:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-- . . .
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, . . . and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Id. § 321(h).

         Comparing these definitions yields two conclusions that are relevant here: first, all FDA-regulated diagnostic “devices” meet the “drug” definition. That is because of the overlap in the intended-use portions of their definitions. Id. §§ 321(g)(1), (h) (drugs and devices both include articles “intended for use in the diagnosis” of disease). Second, the critical difference between the two is that the device definition includes two exclusionary clauses. Specifically, a device, unlike a drug, neither achieves “its primary intended purposes through chemical action within or on the body of man” nor is “dependent upon being metabolized for the achievement of its primary intended purpose.” § 321(h); see also ECF No. 17 (Joint Appendix (JA)) at FDA213 (FDA guidance refers to these portions as “exclusionary clauses”).

         1. Regulatory Schemes

         The statutory distinctions between a drug and a device have meaningful and practical consequences. For starters, the FDA has established separate bureaucratic centers that oversee the pre-market review and post-market regulation of drugs as opposed to devices. The Center for Drug Evaluation and Research (CDER) has primary jurisdiction over drugs, while the Center for Devices and Radiological Health (CDRH) has primary jurisdiction over medical devices. See 21 C.F.R. § 3.5; Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health, U.S. Food & Drug Admin. (Oct. 31, 1991), https://www.fda.gov/combination-products/classification-and-jurisdictional-information/intercenter-agreement-between-center-drug-evaluation-and-research-and-center-devices-and. Each center has its own requirements for marketing authorization.

         To market new prescription drugs, for example, a sponsor - generally the manufacturer - must submit a new-drug application demonstrating that the drug is safe and effective for its proposed use. See 21 U.S.C. § 355(a)-(b). This process requires an extensive series of safety and effectiveness trials before approval. Id. § 355(b). If the prospective drug is the “same as” an existing drug already on the market, however, the sponsor can obtain approval through the less onerous abbreviated new-drug application process. Id. § 355(j). This abbreviated process requires proof that the drug in question has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id.; 21 C.F.R. § 314.94(a).

         By contrast, devices are reviewed and classified into three categories based on the risk they pose to the public. Class I devices are low risk - i.e., they “present no unreasonable risk of illness or injury” - and “are subject only to minimal regulations by ‘general controls.'” Medtronic, Inc. v. Lohr, 518 U.S. 470, 476-77 (1996) (quoting 21 U.S.C. § 360c(a)(1)(A)). Class II devices “are potentially more harmful”: “[A]lthough they may be marketed without advance approval, manufacturers of such devices must comply with federal performance regulations known as ‘special controls.'” Id. at 477 (quoting 21 U.S.C. § 360c(a)(1)(B)). Lastly, high-risk devices are designated as Class III. See 21 U.S.C. § 360c(a)(1)(C). To introduce a new Class III device into the market, “the manufacturer must provide the FDA with a ‘reasonable assurance' that the device is both safe and effective.” Medtronic, 518 U.S. at 477 (quoting 21 U.S.C. § 360e(d)(2)). To provide a “reasonable assurance, ” the manufacturer undergoes a pre-market approval process, which requires “detailed information regarding the safety and efficacy” of its device. Id.

         Additionally, significant cost differences exist in both the development and the continued sale of drugs and devices. Plaintiff avers that the cost of seeking clearance to market its products as devices is estimated to be $60, 000, whereas seeking approval to market them as drugs could be over half a million dollars in addition to a continuing annual cost north of $186, 000. See ECF No. 9 (Plaintiff's MSJ), Exh. 8 (Declaration of John E. Powers), ¶¶ 31-33.

         2. Requests ...


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