FDA Advisory Panel Recommends Banning Shock Therapy at Judge Rotenberg Center

Video of Electronic Shock Treatment Played at Trial Helps Turn the Tide on Judge Rotenberg Center

As described by an article in New York magazine in April of 2012:

"For years, the state of New York has been sending troubled kids to a notorious 'school' in Massachusetts known as the Judge Rotenberg Center, where students who don't follow the rules receive painful electric shocks. The 'treatment' at the center has nothing to do with electroconvulsive therapy, where people with severe depression are induced into having seizures under anesthesia — it's behavior modification for troubled children, and the Rotenberg Center is the only place in America that uses this approach."

Now, after two years of in-depth reporting and a significant medical malpractice settlement between the Center and Cheryl McCollins (the mother of a former patient who filed a lawsuit when her 18-year-old autistic child, Andre, received 31 skin shocks, while strapped to a four-point restraint board for 7 hours resulting in PTSD), change has finally come.

As the New York article points out, she was not the first parent to sue.

"But McCollins and her lawyer have accomplished something that no one else has managed to do: show the public exactly what it looks like when a student is being shocked."

The disturbing video played a big part in illuminating the inhumane practice, reaching a settlement in the trial, turning public opinion and moving an FDA advisory panel to hold a hearing this week and make a recommendation to ban the practice. See the investigative report by Fox Undercover's Mike Beaudet below.




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Alarm Fatigue Issue Gets FDA Attention

A series of investigative articles by The Boston Globe's Liz Kowalczyk and a high profile lawsuit involving Massachusetts General Hospital regarding the death of a patient when a cardiac monitor was not responded to by nurses, helped to raise the issue of "alarm fatigue" at hospitals nationwide (as we reported in November 2011). That lawsuit was brought by Lubin & Meyer, which settled for $850,000 (see story).

At the time the settlement was made public, Attorney Andrew C. Meyer, Jr. was quoted:

“Much to Mass. General’s credit, they recognized the error and tried to do right by the family. They are in good faith trying to prevent the problem from occurring in the future. The family was appreciative.’’

Now the FDA is getting involved by strengthening its review of medical devices before they go to market. According to this report in The Boston Globe...

"The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from manufacturers seeking permission to sell their medical devices, including heart and oxygen monitors. Alarms on such monitors and on medication pumps, ventilators, and beds already blare endlessly in hospitals, and one of the FDA’s top device officials indicated that he wants to keep new products that do not serve an important function from needlessly adding to the cacophony."

The article quotes Dr. William Maisel, deputy director and chief scientist at the Center for Devices and Radiological Health,

“The FDA could do everything right, but if the health care community is not doing its job, that won’t be enough.’’ Many of the patient safety lapses with ventilators are “not a malfunction of the alarm but the use of the alarm. Someone turned the volume down or didn’t hear it.’’

For more follow up on the issue of alarm fatigue, see the article: FDA Working To Trim Hospital ‘Alarm Fatigue’

For Kowalczyk's investigative series, see: Alarm Fatigue series

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