The FDA has the undisputed power to ban a medical device entirely; but if it approves the device, it may not ban certain uses. That was the surprising holding of a recent D.C. Circuit panel decision written by Judge David Sentelle, joined by Judge Gregory Katsas. Chief Judge Srinivasan dissented.
Here’s the core of Judge Sentelle’s reasoning for the majority:
[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. States may hold elections for state judges or they may not, but the First Amendment prohibits them from “conduct[ing] elections under conditions of state-imposed voter ignorance.” Republican Party of Minn. v. White, 536 U.S. 765, 788 (2002) (quoting Renne v. Geary, 501 U.S. 312, 349 (1991) (Marshall, J., dissenting)). States can regulate dentists or allow them to participate in an unregulated market, but they cannot permit dentists to anticompetitively self-regulate in defiance of the Sherman Act. N.C. State Bd. of Dental Exam’rs v. FTC, 574 U.S. 494, 505–06 (2015). Congress may provide Medicaid funds to states or it may not, but once states have relied upon those sizeable funds, it cannot condition their receipt on an expansion of Medicaid without running afoul of the Tenth Amendment. See Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 581–83 (2012) (opinion of Roberts, C.J.). As a final example, and most relevant to this case, the Attorney General may ban all uses of certain controlled substances, but he cannot prohibit specific uses that states regard as legitimate medical practice. See Gonzales v. Oregon, 546 U.S. 243, 272–73 (2006). In this case too, no one disputes that section 360f permits the FDA to ban a device completely. The FDA could even decline to approve a device in the first instance. The problem is that once the FDA approves a device and then tries to ban it for specific uses, it defies the limitation that section 396 imposes. Just as in other contexts, section 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.
No. 20-1087, The Judge Rotenberg Educ. Ctr., Inc. v. FDA (July 6, 2021).
Dissenting, Chief Judge Srinivasan faulted this holding as counterintuitive and even perverse:
There is no dispute that the FDA has power under the statute to ban a medical device altogether—i.e., across all its potential uses. The issue in this case is whether the FDA can exercise its banning authority in a more tailored fashion: rather than ban a device across the board, can the agency ban the device for a particular intended use while allowing it for other uses? One can readily envision why the FDA might wish to do so. Suppose a device has been approved to treat two distinct conditions, meaning it has two intended uses. When treating the first condition, the device proves to be of limited effectiveness and poses an acute risk of injury. But when treating the second condition, the device proves highly effective and presents only a negligible risk of injury. The FDA presumably would want to ban the device for the first intended use but permit it for the second. And it is hard to perceive why Congress could want to deny the agency that middle-ground option. Why force the agency to make an all-or-nothing choice—either abolish a highly beneficial use so it can stamp out a highly risky one, or stomach the highly risky use so it can preserve the highly beneficial one?
The textual analysis in both opinions is thorough and interesting. Among other things, the opinions present a classic clash between one side (the majority) inclined to resolve an interpretive question under Chevron’s first step and another side (the dissent) raising hard questions about congressional intent under Chevron’s second step.
What we found perhaps most interesting, however, was the majority’s refusal to infer that an agency receiving a greater power from Congress also received a lesser power in the bargain. That logic may tempt practitioners. Indeed, it convinced the Chief Judge Srinivasan in this very case. But as the majority’s examples show, it’s a logic that does not always follow. And here it was not enough to carry the day.
