Genus Medical Technologies LLC v. Food and Drug Administration

The federal Food, Drug, and Cosmetic Act (FDCA) defined “device” to include any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that is used to diagnose, cure, mitigate, treat, or prevent disease, and does not achieve its purpose either through chemical action within the body or metabolization. Devices were a narrower category than “drugs,” which the FDCA defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” The Food and Drug Administration (FDA) (defendant) had different regulatory schemes for drugs and devices. The different regulatory requirements meant that developing and marketing a product as a device was generally less expensive than developing and marketing the same product as a drug. Genus Medical Technologies LLC (Genus) (plaintiff) manufactured contrast agents known as Vanilla SilQ. Vanilla SilQ was a barium-sulfate oral solution that aided the visualization of the gastrointestinal tract during x-ray examinations and other radiologic procedures. When a patient swallowed Vanilla SilQ, the solution coated the inside of the patient’s gastrointestinal tract and made the coated areas appear lighter on the x-ray. Genus sought FDA approval to distribute Vanilla SilQ as a device. Although the FDA found that Vanilla SilQ appeared to meet the FDCA’s definition of device, the FDA ultimately notified Genus that Vanilla SilQ products would be classified and regulated as drugs. The FDA explained that because some contrast agents did not meet the definition of device but met the definition of drug, the FDA had chosen to regulate all contrast agents as drugs to ensure uniformity. Genus asked the FDA to reconsider the classification of Vanilla SilQ, but the FDA refused. Genus then challenged the FDA’s classification decision in federal district court. The district court granted summary judgment in Genus’s favor and vacated the FDA’s decision after concluding that the FDCA unambiguously required that products meeting the definition of device be regulated as devices. The FDA appealed.