WASHINGTON (CN) — A federal appeals court on Tuesday overturned a Food and Drug Administration ban on the use of electric shock devices to treat overly aggressive kids at a Massachusetts institution for people with developmental disabilities.
Parents of students at the Judge Rotenberg Educational Center who are treated by the method brought the case directly to the D.C. Circuit after the FDA “took the rare step” to ban the devices, called graduated electronic decelerators, in May 2020. The agency had only banned two other medical devices since 1983, but was under pressure from disability rights advocates who called the practice “torture.”
But parents said that the devices, which are used to treat self-injurious or aggressive behavior, are the only option left for their disabled children. They further argued the method doesn’t harm the students, despite it spurring widespread media attention and mountains of litigation after a video showing a teenager screaming for help from the painful shocks went viral in 2012.
“Patients who receive it are those who have proved resistant to all other therapies,” said Max Stern, counsel for Luis Aponte, a parent of one of the 55 patients who currently receive the treatment, during oral arguments in April.
The Judge Rotenberg Educational Center is the only facility in the country to use the method for self-injurious or aggressive behaviors, but other health care practitioners use the device to treat drug, alcohol and tobacco additions, as well as inappropriate sexual behaviors following traumatic brain injuries.
But the agency only banned the device for treating aggressive and self-injurious behaviors, which is why the FDA’s rule didn’t stand up to the D.C. Circuit judges.
Writing for the 2-1 majority, Senior U.S. Circuit Judge David B. Sentelle said the agency lacks the statutory authority to ban a medical device for a particular use, according to an FDA statute. The agency can ban a device completely but it can’t pick and choose the conditions, the court ruled.
“The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions,” wrote Sentelle, a Ronald Reagan appointee, who was joined in the majority by U.S. Circuit Judge Gregory G. Katsas, appointed by Donald Trump.
“We 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,” he added, describing several examples where this rule applies. “Congress may provide Medicaid funds to states or it may not, but once states have relied upon those sizable funds, it cannot condition their receipt on an expansion of Medicaid without running afoul of the Tenth Amendment.”
What’s more, the majority found the FDA's approach upsets the balance of power between the federal and state governments by allowing the federal government to regulate the practice of medicine, when states have traditionally held that responsibility.
But in a dissenting opinion, Chief U.S. Circuit Judge Sri Srinivasan said the opposite is true: allowing partial bans further preserves the balance of power between the state and federal governments.
“It is hard to see how allowing the agency to fashion a less intrusive ban would give rise to a more significant federalism-based concern,” wrote Srinivasan, a Barack Obama appointee. “In fact, recognizing the FDA’s ability to tailor a ban to a device’s most problematic uses will enable the agency to avoid affecting state regulation of the practice of medicine more than is necessary.”
Srinivasan argued that the FDA has more than an all-or-nothing banning power. In fact, the riskier the device, the greater the FDA’s power to regulate it, he said.
“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?” Srinivasan wrote.
When making the decision to ban the electric shock device for treatment of aggressive behavior, the FDA found that the device poses a number of health risks: from physical injuries like burns, tissue damage and severe pain, to psychological damage like anxiety, panic and post-traumatic stress disorder.
When used to treat smoking, the smoker typically controls the device or communicates harmful symptoms to their health care provider, Srinivasan noted. But at the Judge Rotenberg Education Center, students with developmental or intellectual disabilities don’t control the devices and might be unable to communicate their pain.
Since the primary purpose of the Federal Food, Drug and Cosmetics Act is to protect consumers from dangerous products, it’s reasonable for the FDA to impose a ban that targets the device’s most dangerous uses, Srinivasan said.
“Against that backdrop, the agency’s authority to fashion a partial ban on a device is unexceptionable," he wrote.
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