Genus Medical Technologies LLC v. FDA
994 F.3d 631 (2021)
Rule of Law:
The Federal Food, Drug, and Cosmetic Act (FDCA) does not grant the Food and Drug Administration (FDA) discretion to classify as a "drug" a medical product that unambiguously meets the statutory definition of a "device"; instead, when a product satisfies both definitions, the more specific device definition governs over the general drug definition, requiring regulation as a device (except for combination products).
Facts:
- Genus Medical Technologies (Genus) began manufacturing its "Vanilla SilQ" product line in 2015, which is an oral solution used as a contrast agent in medical imaging to enhance visualization of the gastrointestinal tract during X-ray examinations.
- Vanilla SilQ's key ingredient, barium sulfate, is an inert metal salt that coats the gastrointestinal tract, facilitating X-ray absorption, and does not achieve its primary intended purposes through chemical action within or on the body or through metabolization.
- In June 2016, the FDA conducted a three-day inspection of Genus's distribution facility.
- On May 2, 2017, the FDA issued a warning letter to Genus, notifying them that their products constituted "drugs" within the meaning of the FDCA.
- On September 6, 2018, the FDA responded to Genus, stating that while Vanilla SilQ appeared to meet the device definition, it also met the drug definition, and the FDA had a long-standing practice of regulating all contrast agents consistently as drugs.
- Genus subsequently submitted a Request for Designation (RFD) to the FDA's Office of Combination Products (OCP), formally requesting that Vanilla SilQ be classified as a device.
- The OCP issued an official Designation Letter echoing the FDA's previous reasoning, classifying Vanilla SilQ as a drug based on the uniform regulation of all contrast agents.
Procedural Posture:
- Genus Medical Technologies (Genus) filed a lawsuit in the United States District Court for the District of Columbia.
- The district court granted summary judgment in favor of Genus, concluding that the FDCA unambiguously requires a product meeting the device definition to be regulated as such.
- The district court vacated the FDA’s classification of Vanilla SilQ as a drug and remanded the matter to the FDA for further proceedings.
- The United States Food and Drug Administration (FDA) appealed the district court's decision to the United States Court of Appeals for the District of Columbia Circuit.
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Issue:
Does the Federal Food, Drug, and Cosmetic Act grant the Food and Drug Administration discretion to classify a medical product as a "drug" if that product also satisfies the statutory definition of a "device"?
Opinions:
Majority - Karen LeCraft Henderson
No, the Federal Food, Drug, and Cosmetic Act (FDCA) does not grant the FDA discretion to classify as a "drug" a medical product that unambiguously satisfies the statutory definition of a "device." The court affirmed the district court's grant of summary judgment to Genus, finding that the FDCA unambiguously forecloses the FDA's interpretation. The majority applied the "specific governs the general" canon of statutory construction, reasoning that because the device definition is narrower and more specific than the drug definition (particularly due to its "instrument clause" and "mode-of-action clauses"), it must prevail when a product meets both. The court rejected the FDA's argument that the 1990 Safe Medical Devices Act (SMDA) amendment, which removed an exclusionary clause from the drug definition, granted broad discretion to classify devices as drugs; instead, it found the amendment's purpose was to facilitate the regulation of "combination products" that are both drugs and devices. The court highlighted the FDCA's distinct and mandatory regulatory regimes for drugs and devices, noting the differing pre-market review, approval processes, and ongoing regulations, which would be undermined if the FDA had such sweeping classification discretion. The court was troubled by the FDA's inability to articulate a limiting principle for its asserted discretion, emphasizing that Congress does not make fundamental changes to regulatory schemes in vague terms.
Concurring - Pillard
Judge Pillard concurred in the judgment, agreeing that the FDA misread the statute by claiming a fully subsuming drug definition, but disagreed with the majority's conclusion that the statute unambiguously eliminates all overlap between drug and device definitions. Judge Pillard argued that the 1990 SMDA amendment, by removing the express exclusion of devices from the drug definition, did create some definitional overlap, particularly for "combination products," and that the text should be respected. However, Judge Pillard criticized the FDA for ignoring the "instrument clause" in the device definition (e.g., "instrument, apparatus, implement, machine"), which provides specific criteria for device classification beyond just the mode-of-action exclusions. The FDA's failure to consider this clause and to make factual findings on whether Vanilla SilQ truly satisfies all aspects of the device definition (instrument clause included) meant its decision was not reasoned. Judge Pillard emphasized that classification often requires the FDA's expert judgment in "gray areas" where terms are qualitative and imprecise, and that Congress allows for some such judgment, but the FDA must explain its choices by accounting for all relevant statutory factors, which it failed to do here.
Analysis:
This case significantly limits the FDA's discretion in classifying medical products, particularly when a product clearly fits the statutory definition of a "device." It reinforces the principle that specific statutory provisions override general ones, even in regulatory contexts where agencies might seek flexibility for administrative convenience. Future cases involving products that could plausibly be classified as both drugs and devices will likely face stricter scrutiny, requiring the FDA to demonstrate a more rigorous application of all definitional elements, rather than relying on a general power to choose. This ruling ensures that the distinct regulatory pathways Congress established for drugs and devices are preserved and applied based on the product's actual statutory classification.
