On May 31, Thelen v. Somatics LLC, and Electrika, Inc. went to jury trial in Tampa, Florida. This was the latest in dozens of lawsuits filed in the United States claiming that electroconvulsive therapy (ECT) device manufacturers and distributors have been negligent in their duty to warn patients about the known risks associated with their products—most notably, neurocognitive decline and permanent brain damage.
What the Thelen lawsuit alleged
Between May 2014 and July 2016, the plaintiff, Nebraska resident Jeffrey Thelen received approximately 95 ECT treatments for depression.
The machine used on Mr. Thelen was the Thymatron System IV, manufactured and distributed by Somatics, a company founded in the 1980s by Richard Abrams, M.D. and Conrad Swartz, M.D. Electrika, the co-defendant, is a manufacturer and exclusive supplier of Thymatron ECT devices for Somatics.
ECT did not improve Mr. Thelen’s depression, according to the complaint. Instead, he suffered “severe and permanent short term and long-term memory loss and cognitive deficits, a constant state of panic and depression due to his inability to focus, concentrate, and remember or learn new things.” In addition, he reports “significant impairment in his day to day functioning, he is often confused, is unable to finish sentences, and has difficulty caring for himself on a daily basis.”
Prior to receiving ECT, Mr. Thelen had worked in the tree-trimming and removal industry. After the treatments, he lost all memory of the skills and abilities required for his trade. He is now permanently disabled and unable to work. The lawsuit sought compensatory damages for lost wages, pain and suffering, health care costs, and more.
Similar to previous ECT trials, questions of informed consent were central. The complaint states: “Had Mr. Thelen been warned concerning the risk of brain injury or permanent neurocognitive decline, he would not have consented to ECT treatment.”
A dangerous loophole
Failure to warn cases such as Thelen require the plaintiff’s attorneys being able to prove that manufacturers were aware of the risks and dangers of their medical devices, and withheld that information intentionally from the public. In the complaint, Somatics was said to have “knowingly and intentionally concealed adverse event information” that was “material to medical providers and patients.”
Besides concealing the risks of ECT, Somatics was alleged to have overstated the safety and efficacy of its device, making “intentional affirmative misrepresentations to the public, patients, the medical community, including Plaintiff’s medical providers, that its Thymatron ECT Device was ‘the safest and most effective treatment for severe depression.’”
There is no evidence to back up Somatics’ above assertion, yet the device maker continues to be protected by a dangerous regulatory loophole.
ECT devices, including the Thymatron machine used on Mr. Thelen, have never received FDA approval. Instead, they have been “grandfathered in,” a provision that allows Class III devices that happened to be on the market before the Medical Device Amendment was enacted in 1976, to remain so until FDA finalizes rulemaking requiring a premarket approval application, or PMA, from device manufacturers.
FDA approval of PMAs is based on clinical trials proving safety and effectiveness of Class III devices presenting a risk of illness or injury. The two existing ECT device makers, Somatics and MECTA, have yet to be required to do so. Dr. Abrams, Somatics’ co-founder, said in a 2018 court deposition “We’re not in the business of doing studies of traumatic brain injury. We sell Thymatrons.”
The Thelen case alleged that Somatics’ misrepresentations extended to claims that its device did not cause “brain injury, permanent memory loss; or any long-term or persistent effects on intellectual abilities or memories, counter to a well-established evidence base.”
In 2018, two years after Mr. Thelen’s ECT treatment was concluded, Somatics settled a similar “failure to warn” case, Riera v. Somatics, LLC. At this point, the company revised its website for the first time to acknowledge potential risks: “ECT may result in anterograde or retrograde amnesia. Such post-treatment amnesia typically dissipates over time; however, incomplete recovery is possible. In rare cases, patients may experience permanent memory loss or permanent brain damage.”
“Such warnings and indeed even more conclusive warnings concerning permanent memory loss and brain injury should have been given by Defendants to medical professionals and the public decades ago when such risks were first reported and were known to Defendants,” the Thelen complaint reads.
The verdict and next steps
On June 8, the jury found that Somatics placed its device on the market “without adequate instructions or warnings to the physician who prescribed the ECT treatment” to Mr. Thelen. However, the jury disagreed that the lack of warning was a “proximate cause of damage” to him. No damages were awarded.
The paradoxical verdict can be attributed to the Court’s failure to admit key evidence about the laws of electromagnetism and how the human brain is impacted by electricity at the cellular level.
ECT survivor and activist Sarah Price Hancock, who has been closely tracking the case, told Mad in America, “I was just baffled when the Court threw out the laws of electromagnetism. It’s akin to denying the existence of the law of gravity in a case about a bridge collapse.”
She noted that one expert who testified, Dr. Bennet Omalu, was cut off every time he mentioned that seizures cause brain damage. He was not permitted to speak to the effects of electrical injury that he has seen under a microscope.
In a statement released shortly after the verdict, lead trial lawyer Bijan Esfandiari said, “While disappointed about the outcome, Jeffrey is grateful to have had his day in court to expose the dangers of ECT in the hopes of preventing others from experiencing similar injury caused by ECT. We intend to appeal on numerous evidentiary issues and will continue to fight for Jeffrey and others harmed by Somatics’ failure to warn.”
Mr. Thelen’s attorneys filed a motion for a retrial on July 7, according to documents accessed through DocketBird. The basis for the retrial motion appears to be the Court’s refusal to admit vital scientific evidence regarding the effects of ECT on brain cells.
While more developments are soon to come, Price Hancock views the Thelen verdict as a partial win. “The jury agreed that the manufacturer ‘failed to warn.’ That’s huge. It’s a step in the right direction.”
MIA Reports are supported, in part, by a grant from The Thomas Jobe Fund.
Editor’s Note, August 18, 2023: The Wisner Baum law firm has made a daily trial summary, trial transcripts, and depositions available here.