"Many children and families have long awaited this historic news," said Lubin & Meyer attorney Benjamin Novotny, who represented McCollins at trial. "It is encouraging that the FDA is following the United Nations' footsteps and labeling this practice for what it is, torture."
The disturbing video evidence presented at trial, helped to reach a settlement, mount public outrage and move an FDA panel to hold a hearing to consider banning the practice of aversive electronic shock treatments. That hearing led to a recommendation to ban the practice, and now — two years later — the FDA has issued a proposal to ban the devices.
"The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.
In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health."The proposed rule is available online at www.regulations.gov for public comment for 30 days.
See our previous posts on this subject:
- FDA Advisory Panel Recommends Banning Shock Therapy at Judge Rotenberg Center
- Lubin & Meyer Lawsuit Prompts CBS News Investigation
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