Oregon ECT Device Manufacturer Dismissed Severe Harm to Patients, According to FDA Inspection Documents Just Released 

Oregon-based electroconvulsive therapy (ECT) device manufacturer ignored reports of severe harm to patients, including death.

Thanks to documents just released from a recent Freedom of Information Act request, Food and Drug Administration (FDA) inspection reports are now available showing that MECTA, a Lake Oswego, Oregon-based electroconvulsive therapy (ECT) device manufacturer, flouted FDA instructions, ignored reports of severe harm to patients (including death) and, in fliers, obscured the fact that their machines are classed as “high-risk” by the FDA.

 

The Freedom of Information Act request was submitted on behalf of the Citizens Commission on Human Rights, a mental health watchdog founded in 1969 by the Church of Scientology and the late Professor of Psychiatry Emeritus Dr. Thomas Szasz.

ECT, a highly controversial procedure, involves shooting up to 450 volts of electricity through the brain—33 times the amount employed in the kind of torture administered to Abu Ghraib prisoners. According to the FDA, ECT can cause cognitive impairment, memory impairment, prolonged seizures, dental trauma, manic symptoms, pulmonary complications, worsening of psychiatric symptoms, and death. The procedure has a death rate of 243 per 10,000 and was described as torture “in the guise of rehabilitation” in a 2013 report published by the United Nations High Commissioner for Human Rights Committee Against Torture. One third of ECT patients experience permanent memory loss and many suffer a steep drop in IQ.

According to FDA documents, in 2001, MECTA was found to have fliers using the words “safe and effective,” while not disclosing their machines are categorized as Class III by the FDA, the highest risk category available. Further, MECTA was found to have submitted no Medical Device Reports (MDRs) of adverse events, though these are mandated by FDA regulations.

In 2007, MECTA was found to have ignored MDRs highlighting memory loss and other severe adverse events sent them by the FDA. MECTA’s president, Robin Nicol, dismissed these. “Ms. Nicol stated the firm did not believe in the validity of the complaints,” reads the FDA report.

MECTA further ignored a woman’s death from ECT, filing no MDR on the incident. Nicol claimed it was “the first adverse event the firm has received,” in spite of other MDRs forwarded them by the FDA and outstanding lawsuits against the company.

ECT devices have never gone through standard clinical trials to establish safety and efficacy, though the FDA gave device manufacturers a 30-month time frame to do so in April of 1982. Thirty-four years later, this has never been done. Nevertheless, in December 2015, the FDA issued a proposed order to down-classify the device used to deliver electroshock therapy, a move followed by a wave of public outcry. Constitutional attorney Jonathan Emord recently filed a Citizen Petition with the FDA to prevent this reclassification on behalf of five individuals who were damaged by electroshock.

A feature-length exposé on electroconvulsive therapy, ECT device manufacturers and FDA corruption was published this month by award-winning journalist Ajay Singh in the latest edition of Freedom Magazine.

The Citizens Commission on Human Rights is dedicated to eradicating abuses committed under the guise of mental health and enacting patient and consumer protections.