[1] In response, the United States Congress amended the Food, Drug, and Cosmetic Act to expand FDA's authority to ban such devices.
[2] Matthew Israel created the GED to replace the older punishments of spankings, pinches, and muscle squeezes, but continued to use restraints, sensory deprivation, and the withholding of food.
While the school advertises its behavior modification program as safe, effective, and backed by science, these claims are disputed by independent experts, and the device is often condemned as a form of torture.
[3] Before it made use of electric shocks, the school used pinches, spankings, muscle squeezes, and a wide variety of other methods of aversive intervention including punitive restraints, sensory deprivation, and the withholding of food.
Matthew Israel reported that one student was shocked by the SIBIS over 5,000 times in a day without producing the desired change in behavior.
Israel asked the manufacturer of the SIBIS, Human Technologies, to build a device that delivered stronger shocks, but they refused.
[4] In 1994, the United States Food and Drug Administration (FDA) cleared the device for the treatment of self-harming behavior, as they considered it "substantially equivalent" to the SIBIS.
In response, Congress amended the Federal Food, Drug, and Cosmetic Act to expand FDA's authority and allow them to ban a medical device for a particular use; irrespective, of any other approved use.
[5] According to James Eason, a professor of biomedical engineering at Washington and Lee University, the GED's lowest shock setting is about twice the threshold that pain researchers consider tolerable to most adult humans.
The agency also found that the GED could cause both physical and psychological harm, including: pain, burns, tissue damage, depression, fear, and aggression.
Furthermore, they concluded that the GED device may have caused one resident to enter a catatonic state, and that it can in some cases worsen the behaviors that it claims to treat.
Residents report that they were sometimes awoken by shocks at night, which were administered for reasons including nighttime incontinence, tensing up while asleep, and having broken a rule earlier in the day.
[citation needed] At the time of the ban, the JRC was the only institution in the United States using electric skin shocks to control behavior.
Greg Miller, a teacher's assistant at the JRC, reported that on one occasion, he saw a girl with cerebral palsy shocked for moaning and reaching out to hold a staff member's hand.
But if it works here, why shouldn't it be used elsewhere?In 2002, Andre McCollins, an autistic student from New York City, was restrained on a four-point board and shocked 31 times with the GED over the course of seven hours.
[25][failed verification] The day after the incident, McCollins' mother had to drive him to the hospital, as he was unable to speak and had third-degree burns on many parts of his body.
[27] After the center received a phone call alleging that two of its residents had misbehaved earlier that evening, staff woke them from their beds, restrained them, and repeatedly gave them electric shocks.
[10] The Judge Rotenberg Center filed a lawsuit against the FDA, and in July 2021, the DC Circuit Court overturned the ban, meaning that the school can still use the devices.
I pray to God to forgive me for putting my son through that.Other parents have expressed support for the device, saying that it helped them control their child's behavior.
One parent, Marguerite Famolare, claimed that all she had to do was show her son the remote control and "He'll automatically comply to whatever my signal command may be, whether it is 'Put on your seatbelt,' or 'Hand me that apple,' or 'Sit appropriately and eat your food.
In 2006, the family of Evelyn Nicholson sued the school over the use of electric shocks, claiming that the treatment was inhumane and violated her civil rights.
[36] In March 2020, the GED was banned by the FDA on the grounds that the devices present an "unreasonable and substantial risk of illness or injury.
"[37] However, the ban was subsequently overturned in July of the following year on the grounds that the FDA was seeking to interfere with the practice of medicine, which is regulated by states.