Photo of Bexis

With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”

That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the “F.4th”).  The FDA made a back-door move to prohibit an off-label use it didn’t think was safe using what it claimed was its power to “ban” a device under 21 U.S.C. §360f.  Not so fast, held the District of Columbia Circuit.  To do so would run afoul of another portion of the FDCA, 21 U.S.C. §396, which forbids the FDA from interfering with the practice of medicine.

The medical devices in question were electroshock therapy machines.  We don’t claim to know anything about electroshock therapy, and it seems like a blunt instrument from the days of unanesthetized amputations and leeches, but according to the American Psychiatric Association, it is “highly effective for the relief of major depression.”  So we’re not going to comment any further on the medicine.  The FDA came to the conclusion that, for a different group of patients, those suffering from “self-injurious or aggressive behavior,” use of these medical devices was not sufficiently effective to overcome the risks of the procedure.  81 Fed. Reg. 24,386 (FDA April 25, 2016).  We use “procedure” advisedly, since the FDA thus purported to ban, not the devices, but their use for this particular form of treatment.

On a “petition for review,” the plaintiffs − who were persons who performed and/or wished to receive the banned treatment – skipped the district court altogether and challenged the FDA’s action directly in the District of Columbia Circuit.  2021 WL 2799891, at *2.

The FDCA gives the FDA the power to “ban” medical devices (and also drugs):

Whenever the [FDA] finds, on the basis of all available data and information, that − (1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury . . . [it] may initiate a proceeding to promulgate a regulation to make such device a banned device.

21 U.S.C. §360f(a)  (omitting irrelevant subpart b).  However, in 1997, Congress specifically deprived the FDA of the power to regulate the practice of medicine by prohibiting off-label uses of medical devices:

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.

21 U.S.C. §396.  Congress continued the power of the FDA to contraindicate uses in its review processes, but not the power to prohibit doctors from exercising their independent medical judgment to treat their patients:

This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations.


Section 396 thus “ensures that once the FDA permits a device to be marketed for one use, health care practitioners have the flexibility to draw on their expertise to prescribe or administer the device for any condition or disease, not just the use the FDA approved − in short, to practice medicine.”  2021 WL 2799891, at *3 (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)).  Thus §396 “protects the liberty of doctors and patients to use approved devices in any manner they wish.  Id. (citing Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1344 (10th Cir. 2015)).  We’ve commented many times about the FDA’s inability to regulate the practice of medicine.

Given the express limits imposed by §396, the FDA’s “greater” power to ban a medical device altogether under §36f did not include the “lesser” power to ban that same device for a particular disfavored medical use.

[W]e are not persuaded that because the FDA possesses the “greater” power to completely ban a medical device, it must have the “lesser” power to tailor a ban to only certain uses.  Courts regularly recognize that a greater power does not imply the existence of a lesser power, especially when the exercise of that claimed lesser power uniquely offends some external constraint. . . .  The problem is that once the FDA approves a device and then tries to ban it for specific uses, it defies the limitation that [§]396 imposes. Just as in other contexts, [§]396 operates as an external constraint − preserving the ability of physicians to make professional judgments about off-label uses − that prevents the FDA from exercising a lesser power merely because it possesses a greater one.

Rotenberg, 2021 WL 2799891, at *5 (citations omitted).  The FDA’s bootstrap argument, that its purported “ban” meant that the devices in question was no longer “legally marketed” for that use under §396, was thus “unpersuasive.”  Id. at *4.   “[T]hat construction would allow the FDA to escape the constraints of [§]396 whenever it bans a device,” which directly affronts that section’s provision that “nothing in this chapter” gives the FDA power to interfere with medical practice.  Id. at *5.

Furthermore, the FDA’s backdoor attempt to restrict medical practice runs afoul of federalism concerns.  Rotenberg recognized the same point Bexis made in his recent off-label use law review article:  “off-label medical practice is not regulated at the federal level” and “[t]he right to practice medicine is subject to the paramount police power of the state.”  James Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 10 (2021) (quotation marks and footnotes omitted).

[W]e require an explicit authorization from Congress before we will permit an agency to regulate in an area that alters the balance of powers between states and the federal government. . . .  States, not the federal government, traditionally have regulated the practice of medicine.  Choosing what treatments are or are not appropriate for a particular condition is at the heart of the practice of medicine. . . .  The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions.

Rotenberg, 2021 WL 2799891, at *6 (citations omitted).

You might ask, what about judicial deference to the FDA’s interpretation of its own organic statute?  Apparently, the FDA never argued so-called “Chevron deference” in the Rotenberg case.  Id. at *3 (‘the FDA did not invoke Chevron deference or even cite the case in its briefing”).  That didn’t stop the dissenting judge from going there, id. at *9 (Srinivasan, C.J., dissent), but that raises an interesting conundrum for the FDA going forward.

Does the FDA want Rotenberg to be the case – and off-label use the subject – that potentially topples the entire agency deference edifice?  We note Rotenberg’s citation to the Caplinger case.  As we’ve pointed out before, Caplinger was written by Justice Gorsuch, who just so happens to be the Supreme Court’s primary proponent of reconsidering Chevron, U.S.A., Inc. v. National Resources Defense Council, Inc., 467 U.S. 837 (1984), in particular, and agency deference in general.  Particularly given what Congress had to say in §396, Rotenberg would not seem to be fertile ground for an administrative agency’s claim of Chevron deference.

Stay tuned.