Digesting a majority opinion by The Honorable David B. Sentelle

U.S. Court of Appeals for the District of Columbia Circuit

No. 20-1087, decided July 6, 2021

Judge Sentelle had no role in WLF’s selecting or editing this opinion for our Circulating Opinion feature. The full opinion is available HERE.

Introduction: On March 6, 2020, FDA published a rule banning the use of electric stimulation devices for treating mentally disabled patients who injure themselves. A facility in Massachusetts both manufactures such devices and uses them on self-harming patients petitioned the D.C. Circuit for review of the rule. In the 2-1 decision authored by Judge Sentelle, the court analyzed the tension between two sections of the Food, Drug, and Cosmetic Act: §360f, which authorizes FDA to ban medical devices, and §396, which bans FDA’s regulation of the practice of medicine.

The court concluded that FDA lacks the authority to prohibit specific uses of an otherwise legal device. Section 360f does not empower FDA to “place a device in an intermediate state of ‘banned in some uses,’” Judge Sentelle wrote. He also noted that the plain language of §396 “demonstrates that FDA does not have the authority to limit practitioners’ use of a device for a particular purpose.”

This WLF Circulating Opinion presents in full Judge Sentelle’s reasoning that FDA’s attempt to ban an “off-label” use of the stimulation devices upends the constitutional balance between federal and state powers. Because States have traditionally regulated the practice of medicine, Judge Sentelle explains, Congress must make their intention to “’alter the usual constitutional balance . . .unmistakably clear.’” “’This principle applies,’” Judge Sentelle emphasizes, “’with equal force to the so-called modern administrative state.’”

SENTELLE, Senior Circuit Judge

B. Federalism concerns

While our analysis thus far has focused on the text of section 396, the statute’s role in preserving the balance of powers between the federal government and the states provides further support for our conclusion. “The Constitution created a Federal Government of limited powers.” Gregory v. Ashcroft, 501 U.S. 452, 457 (1991). “[T]he general government is not to be charged with the whole power of making and administering laws. Its jurisdiction is limited to certain enumerated objects, which concern all the members of the republic, but which are not to be attained by the separate provisions of any.” The Federalist No. 14 (James Madison). Courts have recognized this bedrock principle since the earliest years of the republic. See Marbury v. Madison, 5 U.S. (1 Cranch) 137 (1803) (“The powers of the legislature are defined, and limited; and that those limits may not be mistaken, or forgotten, the constitution is written.”) (Marshall, C.J.).

The Tenth Amendment instructs us that the powers which the Constitution does not delegate to the federal government belong to the states. U.S. Const. amend. X. The very structure of the Constitution underscores the balance of powers between the federal and state governments “[w]ith its careful enumeration of federal powers and explicit statement that all powers not granted to the Federal Government are reserved.” United States v. Morrison, 529 U.S. 598, 618 n.8 (2000). Congress may legislate on naturalization, bankruptcy, patents, and copyrights, for example, U.S. Const. Art. I, § 8, but cannot generally mandate individuals purchase particular goods or regulate the practice of law. See NFIB, 567 U.S. at 557–58, (opinion of Roberts, C.J.); Am. Bar Ass’n v. FTC, 430 F.3d 457, 471–72 (D.C. Cir. 2005). As a result, before we will construe a statute to permit federal action in an area that is traditionally the province of state law, we require Congress to make its intention to “alter the usual constitutional balance between the States and the Federal Government … unmistakably clear in the language of the statute.” Will v. Michigan Dep’t of State Police, 491 U.S. 58, 65 (1989) (internal quotations omitted).

“This principle applies with equal force to the so-called modern administrative state.” Michigan v. EPA, 268 F.3d 1075, 1081 (D.C. Cir. 2001). Federal agencies are creatures of statute. They possess only those powers that Congress confers upon them. Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988). If no statute confers authority to a federal agency, it has none. If Congress has forbidden an agency from taking an action, the agency cannot so act. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132–33 (2000). Accordingly, federal agencies like the FDA are doubly restricted: they may only exercise powers Congress has delegated to them, and that delegation itself must be a lawful exercise of Congress’s constitutional authority. Just as we require a clear statement when interpreting a statute in the first instance, we 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. See Am. Bar Ass’n, 430 F.3d at 471–72. In American Bar Association, a federal agency, in that case the Federal Trade Commission, attempted to regulate the practice of law. We held that it could not do so absent explicit authorization by Congress. See id. In this case, the Food and Drug Administration attempts to regulate the practice of medicine, not only without explicit authorization from Congress, but in the face of an explicit congressional command not to do so.

States, not the federal government, traditionally have regulated the practice of medicine. See Gonzales, 546 U.S. at 275. Choosing what treatments are or are not appropriate for a particular condition is at the heart of the practice of medicine. See State v. Miller, 542 N.W.2d 241, 246 (Iowa 1995); State v. Smith, 233 Mo. 242, 135 S.W. 465, 469 (Mo. 1911). Indeed, Massachusetts has taken a very active role in regulating the Center’s use of electrical stimulation devices. See Judge Rotenberg Educ. Ctr. v. Comm’r of the Dep’t of Dev. Servs., Dkt. No. 86E-0018-GI, at 2–8 (Bristol, Mass. Prob. & Fam. Ct., June 20, 2018). Therefore, before we would permit the FDA to dictate whether practitioners may administer electrical stimulation therapy to self-injuring and aggressive patients, we would require an explicit statement from Congress to that effect. Will, 491 U.S. at 65; Am. Bar Ass’n, 430 F.3d at 471–72. When Congress chooses to authorize the FDA to explicitly list what conditions a physician can use a drug or device to treat, it does so. E.g., 21 U.S.C. § 333(e) (requiring human growth hormone to be approved for a particular purpose). In this case, we have quite the opposite of an explicit authorization—an explicit statement from Congress that the FDA cannot act. Section 396 explicitly limits the power of the FDA. The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions.