The US Food and Drug Administration sought to forbid such instances of the use of electric shock technologies in 2020 after a federal court ruled earlier this month that a Massachusetts school for students with mental and behavioral issues can continue to use these devices.
Electric Shock Devices Ruled Illegal Treat Self-Harm By The Federal Appeals Court
An electric stimulation device (ESD) was administered to a patient who put himself, and sometimes others, at risk of severe injury when he or she often put themselves and others at risk. Despite concerns from the FDA and critics, proponents, including students’ parents, believe that the practice is an established and medically acceptable alternative.
According to the FDA, ESDs present a substantial risk of illness or injury in certain contexts and were banned in March of that year. The FDA ban only applied to the use of ESDs for self-injury and aggression, yet they may still be used for treating addiction to nicotine, among other things.
An appeals panel in Washington, D.C. ruled 2-1 on July 6 that the FDA’s ban interfered with physicians’ authority to practice medicine by violating federal law, allowing Judge Rotenberg Education Center in Canton, Massachusetts to continue offering its electric shock therapy.
An important question on the legal record was whether the FDA would be able to partially or completely ban a device if a device was already authorized, and depending on how that device was being used. In addition to approving and regulating drugs, the FDA regulates medical devices.
They don’t address other petitioners’ arguments, such as whether the ban was arbitrary and capricious or whether substantial evidence supported FDA factual determinations because they conclude that the FDA does not possess the statutory authority to ban a medical device.
The Massachusetts court wrote that the state already “played a very active role” in the center’s use of ESDs. State regulators concluded in a 2018 report that the center met most of the state’s requirements while making recommendations for how to improve human rights at the center.
It is suspected that JRC used aversive restraints and electroshocks. Last year, the Justice Department announced it was investigating JRC. CNN has spoken with the Department of Justice to find out how the investigation is going.
In a statement, JRC’s Parents Association commended the court and these judges for their thoughtful deliberations and decisions. The fight to preserve life-saving treatment of last resort and keep our loved ones alive continues.
The court’s decision, said attorney Mike Flammia, was a support of the relationship between patients and their doctors, despite the medical debate regarding the use of ESDs to treat self-injurious behavior.
The treatment is only used at one school
Based on the decision below, Judge Rotenberg Educational Center continues to provide electric shock therapy in this manner, even manufacturing its own devices that are regulated both by the state and the federal government. A “graduated electronic decelerator” is used as a last resort by nearly 20 percent of the school’s approximately 300 students.
In Flammia’s opinion, those clients will bang their heads until they suffer a stroke, or lose their sight because their retina dislodges. When they feel threatened, they will attack with violence. JRC was their only life before coming here. They lived a life of constant mechanical and chemical restraint and isolation in all the other hospitals and programs before they came to JRC.
Flammia, who said he has received shock therapy himself, mentioned that JRC and the state have a written agreement under which a GED must be approved by a court first.
Upon submitting a claim to the court, Flammia and the ruling require multiple healthcare practitioners to verify no other treatments were effective and provide other safeguards, among other factors.
Director of the National Leadership Consortium on Developmental Disabilities at the University of Delaware, Nancy Weiss, told CNN the process is just a rubber stamp. TM Weiss has been a vocal critic of JRC, describing shock therapy as “torture” since the early 1990s.
People with serious behavioral issues are supported by every state. All states have non-profit organizations or some for-profit entities that serve these people humanely and effectively, she told me, adding that there is not enough oversight when shocks are used.
In Flammia’s opinion, the only person who can give a shock to a student is a psychology or behavior analyst licensee.
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