For Immediate Release: 23 August 2017
Contact: Dr. Linda Lagemann, Liaison to the Petitioners (415-640-7343)
Attorney Jonathan Emord and his co-counsel Kendrick Moxon have filed a Supplement to their Citizen Petition of August 2016, protesting the FDA’s Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give “shock-treatment.” The reclassification would make it easier for doctors to give the treatment. Shock treatment is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo’s Nest. More recently it was portrayed in the TV series Homeland when given to the star, destroying her memory and intelligence. Memory loss and brain damage are the central issue in the attorneys’ filing.
For 40 years, the FDA has been responsible to ensure evaluation of the shock devices, which send up to 460 volts through a person’s brain. Although federal law and FDA orders in the 1970s required manufacturers of these devices to prove they were both safe and effective, the FDA never enforced the order. This, according to Mr. Moxon, has “allowed millions of persons over decades to be permanently damaged.” He further states “Rather than enforce the law now, the FDA has proposed to simply change the law by reclassifying the devices, so no proof of safety or effectiveness need ever be provided.”
The original Citizen Petition was filed on behalf of 5 persons damaged by electroshock treatments. It requests that ECT be banned from the market or, at the least, that the Proposed Order be withdrawn as the manufacturers have never done pre-market clinical trials to prove it is a “safe and effective” device. No other treatment in medicine is so subject to objection and protest by patients – so much so that when the reclassification was proposed, thousands of patients, deeming themselves to be victims of the treatment, objected.
Mr. Emord, who has successfully litigated against the FDA more times than any other attorney in the US, stated “The FDA has utterly ignored clear-cut evidence of brain damage, memory loss and death resulting from ECT treatments. ECT is barbaric and should be removed from the market.” It is only fair to note that even the manufacturers have stated that a “risk” of the device is brain damage and severe memory loss.
The attorneys claim there are substantial conflicts of interest with ECT device manufacturers and the studies referenced by the FDA to support its proposed “declassification” of ECT devices. Mr. Moxon says “The 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. Worse, the FDA ignored contrary studies by researchers who did not have conflicts of interest.”
This is shaping up to be a David and Goliath scenario with individuals damaged by ECT on one side and the FDA, under pressure from the industry that profits from ECT, on the other.
Mr. Emord stated that the proposed reclassification is a radical and irrational departure from FDA’s prior precedent demanding rigorous clinical proof of safety before Class III devices (deemed the highest risk) are reclassified to permit more common use. He expects a challenge to the FDA’s proposed order would be upheld in federal court, if the FDA attempts to move forward with the proposed reclassification.
Review or download the Supplement to the Citizen Petition through the link below: