The Court of Appeals has overturned the ban on using electric shock devices to manage students with intellectual disabilities and uncontrollable behavioral problems. The U.S. Food and Drug Administration (FDA) sought the ban in 2020, but the appeals court ruled that the controversial technique could remain in a recent 2-1 decision.
In Canton, Massachusetts, Judge Rotenberg Education Center has been doing shock therapy to stop its students from harming themselves or from exhibiting aggressive behavior. The center is the only special school in the U.S. that still believes electric shock devices could help modify the behavior of kids as young as five years old or adults with underdeveloped intellectual abilities.
Parents of the students also favor the shock treatment as it keeps their children from self-harm. Dad Larry Mirro, whose son has autism, said that he noticed a substantial change in Billy's behavior after six months of shock treatment at the center.
Mirro said that Billy's self-harm habits led to his blindness, so he decided to put his son at the Massachusetts facility. The father said that before he subjected the boy to the treatments, he researched and tried the electric shock devices. Mirro described the sensation as similar to a bee sting.
Why FDA Banned the Devices
In March 2020, the FDA published a ruling against electric shock devices amid complaints from advocates and other family members who have had negative experiences. The agency said that it found "weak evidence" on the device's effectiveness. Instead, the FDA said that the devices bring "unreasonable and substantial risk of illness or injury," such as tissue damage, burn on the skin, post-traumatic stress disorder, anxiety, and depression.
The device, which has been marketed in the U.S. for more than 20 years, works as an attachment on the arms and legs that connect to a backpack. It is controlled via remote, sending a jolt of electricity that is felt on the skin. It is also used in many rehabilitation centers for people trying to quit smoking or overcome substance abuse.
The FDA's ban, however, is specific to treating behavioral issues. According to reports, some 45 to 50 people receive shock therapy at the Massachusetts center.
The FDA also said that it rarely issues a ban on medical devices, but treatments and medical advancements for people with intellectual disabilities and behavioral problems have been better in the last two decades, providing parents more options for their children.
An Interference on Medical Practices
According to the Court of Appeals, the FDA "lacks the statutory authority" to ban a medical device with a specific use. The court also recognized that Massachusetts has regulatory guidance in place, through the Department of Developmental Service, for centers that conduct shock therapy.
In a statement, Judge Rotenberg Educational Center Parents Association said that they welcome the ban's overturn as the FDA only interfered with the medical treatments of their kids. The group also reiterated that a court ruling in 2018 found the use of electric shock devices at the center to be "humane, safe, and highly effective."
Members of the American Association on Intellectual and Developmental Disabilities (AAIDD), on the other hand, said that they are disappointed with the Court of Appeals' decision, believing that its implementation remains dangerous and painful for the kids.
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