GENUS MEDICAL TECHNOLOGIES LLC v. UNITED STATES FOOD AND DRUG ADMINISTRATION
1:19-cv-00544
D.D.C.Dec 6, 2019Background
- Genus Medical Technologies manufactures "Vanilla SilQ," an oral barium-sulfate contrast agent used for diagnostic imaging; barium sulfate is inert, not absorbed or metabolized when used as a contrast agent.
- FDA inspected Genus, issued a Warning Letter concluding the products are "drugs" and "new drugs," and cited misbranding concerns, exposing Genus to drug-approval requirements.
- Genus submitted a Request for Designation (RFD) to the Office of Combination Products (OCP) asking to be regulated as devices; OCP responded that the products meet the drug definition and assigned regulation to CDER while noting they also appear to meet the device definition.
- Genus sued under the Administrative Procedure Act, seeking a declaration that FDA must regulate Vanilla SilQ as devices; both parties moved for summary judgment (administrative-review posture).
- Central legal tension: FDCA device definition excludes articles that achieve their primary purpose by chemical action or metabolization — Genus argues Vanilla SilQ falls within the device exclusion and thus must be regulated as a device; FDA contends overlapping definitions permit agency discretion to treat certain diagnostic products as drugs for uniformity.
- The district court vacated FDA’s designation and remanded, holding the statute unambiguously requires that products meeting the device definition be regulated as devices.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether OCP's RFD response was deficient for failing to "classify" the product | OCP failed to use the word "classify" or explicitly label Vanilla SilQ a "device," so Genus's recommended device classification should become operative | OCP's written statement identified CDER as the regulating component and explained rationale, satisfying §360bbb‑2(b) | OCP's letter satisfied the statutory requirement; not deficient |
| Whether FDA has statutory discretion to treat a product that meets the device definition as a drug | The device-definition exclusionary clauses plainly control; if product does not act via chemical action or metabolization, it must be a device | Because drug and device definitions overlap for diagnostics, FDA has discretion to decide regulatory pathway and may treat some diagnostic products as drugs for consistency | Court held Congress's text is unambiguous at Chevron step one: if a product meets device definition, it must be regulated as a device; FDA lacks such broad discretion |
| Whether Chevron deference supports FDA's interpretation | Statute's text is clear; no deference necessary | Statute is ambiguous; deference under Chevron required for FDA's reasonable interpretation | Court resolved the issue at Chevron step one (statute clear) and declined to defer to FDA |
| Whether legislative history/case law supports FDA's uniform-treatment rationale (e.g., Bacto‑Unidisk, Bracco) | Legislative changes enabling combination-product regulation and some precedent do not permit overriding the device exclusion; Vanilla SilQ is not a combination product | Historical overlap and prior case law justify regulating contrast agents uniformly as drugs | Court rejected FDA's reliance on drafting history and cited cases, finding them inapposite or superseded by later statutory structure and definitions |
Key Cases Cited
- Chevron U.S.A., Inc. v. Nat. Res. Def. Council, 467 U.S. 837 (1984) (two‑step framework for judicial review of agency statutory interpretation)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary-and-capricious standard for agency action)
- RadLAX Gateway Hotel, LLC v. Amalgamated Bank, 566 U.S. 639 (2012) (specific statutory provisions govern over general ones)
- United States v. Article of Drug, Bacto‑Unidisk, 394 U.S. 784 (1969) (earlier broad construction of "drug" pre‑1976 device regime)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (description of distinct device regulatory framework)
- Bracco Diagnostics, Inc. v. Shalala, 963 F. Supp. 20 (D.D.C. 1997) (district‑court discussion of FDA treatment of similar products; prelim injunction context)