Forensic Expert expert report sheds light on ECT’s lack of safety testing, treatment standards, and device makers’ effort to avoid legal consequences – Thelen, vs. Somatics, LLC, and Elektrika

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If you’re considering ECT, please understand both US-made ECT devices (sold internationally) are facing multiple pending lawsuits because there are many patients living with documented permanent injuries and, sadly, even patients who died.

Before I had ECT, I assumed that if a doctor ordered a treatment, it was because the treatment was FDA-approved. Little did I know, ECT devices were FDA registered, not FDA approved. I never even knew there was a difference. Approval requires safety testing and dosing consensus standards. ECT devices were grandfathered into use. 

Medical Expert Testimony shows a lack of safety testing.

In 2022, Dr. Janet Arrowsmith, a medical device expert, filed a forensic expert witness report in the Thelen v. Somatics, LLC case based on subpoenaed FDA records. Her report details how the modern Thymatron device used in ECT was only ever safely tested on 2 dogs. It was never safety tested on humans, and it was NEVER tested for efficiency in treating our symptoms. 

Our doctors want us to believe ECT is “safe” and it’s “effective,” but the reality is National and international medical device regulators have no evidence of neuropathology studies that demonstrate safety, nor do they have dosing consensus standards to ensure easily replicated effective results. 

You may think memory loss is ECT’s only side effect, but it’s so much more. This is a repetitive Traumatic Brain Injury and repetitive electrical trauma. 

Delayed Electrical Injury is very real. 

Your psychiatrist may have told you there’s “no evidence of brain damage” or “no evidence of long-term permanent memory loss.” There’s a reason for that, and it’s likely different than you expect: This forensic expert witness report details how there was no evidence of serious adverse events because the device manufacturer has been willfully negligent in reporting serious adverse events identified in research studies, literature, by patients and doctors since October of 1984!

On top of that, the only reason the device is in use is that it was grandfathered in without any safety testing or dosing consensus standards based on rigid safety testing. Given by doctors untrained in biophysics or histopathology of electrical injury… so they have no specialist training in how to choose your dose.

ECT Device Makers Neglect patient safety.

This Forensic expert witness report was submitted to the court in 2022 for the Thelen v Somatics (ECT device manufacturer) case. Dr. Janet Arrowsmith—a physician and medical device expert, combed through FDA records and emails between the co-inventors. Her detailed report paints a vivid portrait of Dr. Abrams and Dr. Swartz’s willful negligence with regard to their Thymatron device and the FDA. (This willful negligence extends beyond the US FDA to the UK MHRA, which says the Thymatron device is not registered with the MHRA at all–nor has it ever been.)   

FDA records reveal device makers’ efforts to avoid legal consequences.

In Arrowsmith’s report, she details subpoenaed FDA records and email exchanges between Dr. Abrams and his co-inventor on how to avoid legal consequences for marketing a device.

Please note that when they submitted their device to the FDA, they did so with a single “study” which gave a single shock treatment to a dalmatian dog and the following day gave a shock to the “liter mate,” concluding that because the dogs equally acted liter mates after their respective treatments, it proved the safety of the device.

There were no structured assessments of psychiatric symptoms or neuro-cognitive, visual, motor, cardiovascular, neurovascular, or any other form of assessments—just eyeballing the behavior of two dogs.

It gives us a glimpse into the regard device inventors have for patients undergoing this procedure. 

They’ve built a career, an entire medical practice, and institutional treatment based on a single, unpublished study of two dalmatian litter mates.

As someone living with the long-term neurodegenerative consequences of ECT’s delayed, diffuse electrical injury, this report angered me. I share it with you here so that perhaps you’ll pay more attention to a physician who worked at the FDA than you will to any doctor who says ECT is “safe” when there are ZERO safety studies on record with the US FDA other than that of a dog and his brother who were six shock treatments… I had more than 115. As a human, my life is more complicated than barking and tail-wagging. Yet… here we are.

Read More from this lawsuit

Other Thelen v Somatics, LLC forensic expert witness testimonies from Dr. Bennett Omalu (neuropathologist who first identified chronic traumatic encephalopathy in US football players), Dr. Kenneth Castleman (NASA biophysicist (ret.), Dr. John Read (British Psychologist/ECT researcher) is accessible through our website here. Or by going directly to the court records through this link

Hopefully, this information can better support your efforts to make an informed treatment choice. 

FORENSIC EXPERT EXPERT REPORT of Janet Arrowsmith, M.D., Jeffrey Thelen, vs. Somatics, LLC, and Elektrika

Sarah P. Hancock

Sarah Price Hancock, MS, CRC, lived for nearly two decades misdiagnosed with severe "treatment resistant" mental illness. She was given 116 bilateral ECT treatments and now lives with Delayed Electrical Injury's Myoneuroal Disorder. Sarah holds a Master’s in Rehabilitation Counseling and taught for four years in San Diego State University’s Rehabilitation Counseling program. She is the Co-Founder and Trustee of the Ionic Injury Foundation. She also hosts The Emotional Self-Reliance Podcast and guest lectures on psychiatric recovery.