By David Orentlicher
In its regulation of medical devices, the U.S. Food and Drug Administration (FDA) may ban devices that pose “an unreasonable and substantial risk of illness or injury.” But earlier this month, the U.S. Court of Appeals for the D.C. Circuit decided that the FDA may not issue a partial ban of a medical device.
The case, Judge Rotenberg Educational Center v. FDA, addressed the use of electrical stimulation devices to treat self-injurious or aggressive behavior, as in patients with serious intellectual or developmental disabilities.
In March 2020, the FDA attempted to prohibit this use of electrical stimulation (or electrical shock) because of the risks it poses to patients. As the FDA observed, persons with self-injurious or aggressive behavior may have “difficulty communicating pain and other harms caused by” electrical stimulation, and consent to the use of electrical stimulation is typically made by a third party, limiting the patient’s control over use of the device.
In other settings, including smoking cessation treatment, or treatment of substance use disorder, the FDA permits the practice. Hence the partial, rather than total, ban of electrical stimulation devices.
But by a 2-1 vote, the Judge Rotenberg Educational Center court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision. This provision precludes the FDA from limiting or interfering with a health care practitioner’s authority “to prescribe or administer any legally marketed device to a patient for any condition or disease.” In the majority’s view, once the FDA permits use of a medical device, it must defer to the states for regulation of decisions regarding which patients are appropriate candidates for the device.
As the dissent observed, however, such a result does not reflect a fair reading of the practice of medicine statutory language. If the FDA has prohibited use of a device for a particular purpose, the device would not be a “legally marketed device” for that purpose.
Moreover, the majority’s interpretation puts the FDA in a very problematic position, as the dissenting judge illustrated with a hypothetical device that could be used for treating two conditions:
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?
Hence, one would expect that the power to totally prohibit the use of a device because of its risk to patient welfare would include the power to partially prohibit use of a device because of its risk to patient welfare.
The Judge Rotenberg Educational Center majority also cited federalism concerns and the traditional role of states in regulating medical practice. But, Congress’ Commerce Clause power surely reaches the regulation of medical devices. And, as the dissent observed, the FDA intrudes less on state authority when it partially prohibits use of a device rather than totally prohibiting its use.
In addition, the majority’s federalism analysis ignores an important principle that the U.S. Supreme Court has established in its decisions regarding health care regulation — if the federal government wishes to prevent a harmful health care practice, it should regulate practitioner conduct directly.
For example, when the FDA was concerned about off-label uses of drugs, lower courts rejected FDA regulations limiting the ability of pharmaceutical companies to promote off-label uses. Instead, as the U.S. Court of Appeals for the Second Circuit observed, the FDA could turn to practitioner conduct-based measures to address inappropriate off-label prescribing, such as creating “ceilings or caps on off-label prescriptions,” or, “where off-label drug use is exceptionally concerning,” prohibiting “the off-label use altogether,”
But in Judge Rotenberg Educational Center, the D.C. Circuit precluded exactly what the Second Circuit recommended. The FDA wanted to distinguish between appropriate and inappropriate use of a device, and tried to prohibit the inappropriate use altogether.
Fortunately, the FDA can seek a correction of this misstep in Judge Rotenberg Educational Center through review by the full D.C. Circuit or by the Supreme Court.