Devices

Attorneys Press FDA on Electroshock Devices

Attorneys Jonathan Emord and Kendrick Moxon have filed a supplement to their 8/2016 petition to FDA protesting the agency’s proposed order to reclassify and make more readily available the electroconvulsive therapy (ECT) devices used in electroshock treatments. They say the reclassification would make it easier for doctors to give the treatments that Emord describes as “barbaric.”

According to the attorneys, although federal law and agency orders in the 1970s required manufacturers of the devices to prove they were both safe and effective, FDA never enforced the requirement. “Rather than enforce the law now,” Moxon says, “FDA has proposed to simply change the law by reclassifying the devices, so no proof of safety or effectiveness need ever be provided.”

The 2016 petition was filed on behalf of five persons claiming damage from electroshock treatments. It asks that the devices be banned from the market or, at the least, that the proposed order be withdrawn as manufacturers have never done pre-market clinical trials to prove they are safe and effective devices.

“FDA has utterly ignored clear-cut evidence of brain damage, memory loss, and death resulting from ECT treatments,” Emord says. “ECT is barbaric and should be removed from the market.” According to the attorneys, even the device manufacturers say that a device risk is brain damage and severe memory loss. The attorneys also say there are substantial conflicts of interest with ECT device manufacturers and the studies referenced by FDA to support its proposed declassification of ECT devices.

“FDA used junk science to propose reclassifying ECT machines out of the most dangerous category of all devices, in which it has been classified since 1978,” Moxon says. “Worse, FDA ignored contrary studies by researchers who did not have conflicts of interest.”

Emord projects that if the agency attempts to move forward with the proposed reclassification, a challenge would be upheld in federal court.

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