A recent federal ban on electric-shock devices may be overturned if the D.C. Circuit agrees with parents who trumpet their use in treating aggressive behavior.
WASHINGTON (CN) — The D.C. Circuit appeared set Friday to reverse a federal ban on electric-shock devices, which are used to treat self-injurious or aggressive behavior in only one facility in the entire nation: the Judge Rotenberg Educational Center in Massachusetts.
From Mother Jones and Mass Live to a 2012 video that shows a teenager being shocked and screaming for help, the center has had a slew of media attention for punishing autistic and emotionally troubled kids and adults with painful electric shocks since the 1980s. The center has also been through years of litigation with the commonwealth of Massachusetts.
Following pressure from disability rights advocates who call the practice “torture,” the Food and Drug Administration took the rare step to ban the devices, called graduated electronic decelerators, in May 2020. The agency has only banned two other medical devices since 1983.
“Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage,” the FDA said in a statement last year. “In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain.”
For some desperate parents, however, shock therapy is the only hope for their severely disabled children who would engage in self-injurious behavior without it.
“Patients who receive it are those who have proved resistant to all other therapies,” said Max Stern, counsel for Luis Aponte, during oral arguments at the D.C. Circuit on Friday morning. Aponte is one of the parents or guardians for 55 patients at the center who receive treatment from the devices.
“They have seen their health restored, their lives changed or saved from this treatment,” Stern told judges. “The GED is not hazardous; it’s simply unpopular with advocates who don’t like the thought of it. But there’s no legal basis to ban a device to get the advocates and their sympathizers peace of mind.”
In their brief, the petitioners say that students are only recommended for the shock devices if several other forms of treatment have failed. Such recommendation, furthermore, must come from a psychologist and win approval by both a peer review committee and human rights committee.
“Over 200 JRC patients have received GED treatment during the last 25 years; many responded so well they were able to return home, and some even live independently and support themselves, marry, and raise families,” the brief states.
Stern said that the FDA banned the devices without reviewing all of the available data and information. What’s more, the FDA only banned the device for certain uses, but not for other uses like to stop smoking or nail biting.
The different uses, FDA explained in the 2020 regulation, “present different benefit-risk profiles” and warrant different treatment.
“This is the FDA getting involved in the practice of medicine,” Michael Flammia, counsel for the Rotenberg Center told judges.
For the most part, the judges seemed to agree. In a 45-minute standoff with counsel for the FDA, Daniel Aguilar, U.S. Circuit Judges David B. Sentelle and Gregory G. Katsas challenged the agency’s claim that it could ban a device for only one use without running afoul of the practice-of-medicine statute.
“If a health care practitioner has had this device for a long, long time… then the FDA comes along and says its a banned device… can the health care practitioner continue to administer that device in the same way?” asked Katsas, a Trump appointee.
“I think that’s going to depend on whether or not—” Aguilar began.
“You’re not going to get an answer by me that has a ‘so long as’ or ‘ifs’ in it,” interrupted Sentelle, a Reagan appointee. “We know what the facts are; this is not a hypothetical. You answer on these facts or I’m going to take your answer as, ‘no they can’t keep using it.’”
“Your honor, I’m trying to give you an answer —”
“I don’t think you’re trying hard enough,” Sentelle retorted.
Aguilar asserted that the FDA has discretion to treat different uses as different devices.
“The FDA has the ability to slice up those uses and say one of them is really a different device and therefore can be banned, and there is no practice of medicine that is beyond your authority,” Katsas said.
“No, I don’t think so, your honor,” Aguilar responded.
In the government’s brief, Aguilar wrote that the agency has consistently and uncontroversially regulated medical devices based on their intended use, and such actions do not fall under the umbrella of regulating the practice of medicine.
“The case argued today in the D.C. Circuit demonstrates that FDA is improperly seeking to regulate the practice of medicine, something that Congress has made clear is beyond FDA’s power,” said the New Civil Liberties Alliance in a statement after oral arguments. The NCLA filed an amicus brief in support of the center.
“That regulating authority belongs to state governments alone. And the Massachusetts courts have repeatedly determined that the medical treatment at issue here is safe and effective — indeed the only effective treatment for some patients.” (Emphasis in original.)