A blog on practice in the Nation’s second-most powerful court

“We must give effect to the specific over the general”

If you’re a litigator, you’ve probably invoked the specific-controls-the-general canon at one time or another.  Whether you’ve prevailed with that argument is another question; it seems like it’s rarely a tie breaker.  It was, however, in a recent case decided by the D.C. Circuit.  No. 20-5026, Genus Med. Tech. v. FDA (Apr. 16, 2021).

The issue was basic: “whether the [FDA] enjoys discretion to classify as a ‘drug’ a product that meets the statutory definition of a ‘device.’  The FDA claim[ed] that, if a medical product satisfies the statutory definitions of both a ‘drug’ and a ‘device,’ the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime.” 

Not so fast, held the D.C. Circuit:

The FDA does not dispute that the FDCA’s definition of a “device” is drawn more narrowly than its definition of a “drug.” Indeed, as we discussed above, the set of products that satisfy the device definition is necessarily encompassed by, but narrower than, the set of products that satisfy the drug definition.  Moreover, the general-specific canon is particularly appropriate where, as here, the provisions at issue are “interrelated and closely positioned” as “parts of the same statutory scheme.”  RadLAX Gateway Hotel, 566 U.S. at 645 (alteration adopted) (quoting HCSC-Laundry v. United States, 450 U.S. 1, 6 (1981) (per curiam)).  Thus, the device definition’s instrument and mode-of-action clauses make it a classic candidate for application of the canon that the specific governs the general, and to the extent the drug and device definitions conflict, it is the narrower definition—the device definition—to which we must give effect.  See D. Ginsberg & Sons, Inc. v. Popkin, 285 U.S. 204, 208 (1932) (“Specific terms prevail over the general in the same or another statute which otherwise might be controlling.”).

“The only question,” the court continued, “is whether the two definitions are truly in conflict.” 

For its part, the FDA thought the provisions could be harmonized:

[A]ccording to the FDA, the general-specific canon is inapplicable here because it is “most frequently applied to statutes in which a general permission or prohibition is contradicted by a specific prohibition or permission” or where “a general authorization and a more limited, specific authorization exist side-by-side.”  RadLAX Gateway Hotel, 566 U.S. at 645.  The FDA argues that there is no such contradiction here because the provisions in question are definitions as opposed to authorizations or prohibitions and both definitions can be given simultaneous effect.  There is “no reason,” according to the FDA’s opening brief, that “the statute must be read so that a given product qualifies as either a ‘drug’ or a ‘device,’ but not both.”  Appellant’s Br. 24 (emphasis in original).

But according to the panel, “the FDA is mistaken”:

In theory, it may be possible for a product to satisfy both definitions at once.  What the FDA omits, however, is that the FDCA’s statutory definitions are meaningful only insofar as they carry concrete regulatory consequences.  As discussed, the FDCA elaborates distinct regulatory regimes for drugs and devices.  And each scheme is mandatory: The FDCA prohibits the sale of “any new drug” not approved under the regime for drug approvals. 21 U.S.C. § 355(a) (emphasis added).  Similarly, all new Class III devices are “required” to satisfy the pre-market review regime for devices, id. § 360e(a), and Class I and Class II devices must meet other distinct requirements, see id. § 360c.  Nor can the Secretary circumvent these requirements. Id. § 355(c)(1) (Secretary “shall” either approve new-drug application pursuant to drug regime or deny application); § 360c(b)(1) (Secretary “shall” classify “all” new devices intended for human use into three device classes).  In short, it is not textually possible to say that an item is a drug (or device) but need not be regulated as such.  And no one suggests that the FDCA requires products meeting both definitions to be regulated both as drugs and devices, which would create a breathtaking example of statutory redundancy.

The statute, then, is clear: a product may be regulated as a drug or a device, but not both, and while a single product may simultaneously satisfy the linguistic elements of two definitions, it is not possible for the FDA to give simultaneous effect to both.  Thus, this is precisely the sort of setting in which we must give effect to the specific over the general.  To do otherwise would be in violation of the “settled” principle that “[h]owever inclusive may be the general language of a statute, it will not be held to apply to a matter specifically dealt with in another part of the same enactment.”  Fourco Glass Co. v. Transmirra Prods. Corp., 353 U.S. 222, 228 (1957) (quoting Clifford F. MacEvoy Co. v. U.S. ex rel. Calvin Tomkins Co., 322 U.S. 102, 107 (1944)).

Got that?  It was not enough that the definitions of drug and device overlapped.  Because (a) one definition (device) was narrower than another (drug), and (b) each definition triggered mandatory, mutually exclusive regulations, the FDA could not treat as a drug a product that satisfied the narrower definition of device.  That product had to be a device.  Otherwise, the specific would not control the general.

Keep this canon in mind, then, especially when you’re faced with competing statutory definitions.