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.

18 COMMENTS

    • I do not know how relevant is for THIS particular case expert testimony, but a lot of expert testimony has been questioned as quackery, and a lot of judges have been skeptical of admitting evidence on those grouds. There are even scientific guidelines written by the judiciary and the DOJ, as far as I remember, that question that: the scientific validity of expert testimony. One of the final achievements of Obama, was precisely starting the roling down of quackery as blood stain analysis, bite marks AND forensic psychiatry and psychology…
      One assumes that a judge was negligent or that put his or her’s ideology in a particular decision, but the sad fact is, that lot of what judges do, as far as I understand, I am no lawyer and not giving advice or analysis, is actually based on precedent or on guidelines written by a “superior”. And this review does not provide the argument under which THE particular judge probably ruled as inadmissible that particular piece of evidence.
      I am not saying it wasn’t wrong, what among other things I am saying is this review does not provide the argument for not admitting that evidence and it might be because the science behind the expert testimony is irrelevant, follows precedent or ironically does not meet scientific standards. Just saying the science of convulsive brain actvity is not relevant to ECT DAMAGE is not an argument, it is a statement, as I wore red or blue today, it rained today, as opposed to it rained today because I wore blue…
      Which, I admit, from what is written in this review is difficult to accept, but, it’s possible, and does happen: as in blood stains, bite marks, and psychological/psychiatric forensics and psychological profiling…
      “The paradoxical verdict CAN be attributed to the Court’s FAILURE to admit key evidence…” but ‘…the jury disagreed that the lack of warning was a “proximate cause of damage” to him.’.
      The case at the begining of this review was, as far I understood, about the lack of warning and the jury, apparently said, that lack of warning BY the company was inmaterial to the damages to THE patient…
      As odd, ironic and contradictory as that sounds, when I reverse the order of the statements seems at least plausible, and the “can be attributed” to me stands out as a red herring, a distraction of the inability to prove the link between the damages and the lack of warning… by the company. I imagine if the company is actually NOT obliged to do so and that was PROVEN in this court, or a previous decision, let alone a law or god forbids the constitution. Or else it was an OBLIGATION by the PERSONEL using the equipment. This ECT equipment to my mind is not a bycicle to be used by a child under the, I hope, care of an adult…
      And it could be because the docs, making use of my fantasy prone mind, that were supposed to be THE ones to warn the patient did not do that: warn the patient. Specialy because using that peculiar piece of equipment requires knowledge, dexterity and caring, that somehow the company “revealed” when it said it was not in the bussiness of doing clinical experiments…
      Just me fantasizing, not making factual statements.
      I can see the analogy of suing a company for providing knives to the surgeons without warning them, the patients. that a surgeon can cut an artery when using one of those, when it was precisely the obligation of surgeons to use knives as scalpels and not as knives, for treating patients not to harm them. I even can imagine a company might be restricted in doing that kind of warming when the collegiate bodies os psychiatrists actually promoted the idea that it was ‘safe and effective’, and ‘does not cause harm’. The company, I fantasize might put itself in jeopardy for sladering not only the good ol’ competent docs, but the colegiate body that printed such statements, even if arguments. ‘Scaring patients’ out of a ‘needed’ and ‘life saving procedure’. I imagine no reasonable company is going to do that, particularly if is not it’s obligation and it alienates it’s customers…
      And in this case, precisely they use ECT precisely to cause convulsions…
      Like suing a fire arm manufacturing company because it failed to warn a gunned down victim because the police didn’t warn the victim that it could cause on him or her a hole that caused a specific damage, when fire arms are manufactured with state approval to actually do that, and it is left to the “discretion” of the police how to use, or warn about the damages that it can cause.
      Not advocating for guns or ECT, just thinking about how to explain the apparent contradiction, as narrated here…

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      • I think I understand what you’re saying. I’ll have to do more reading about the case. I’m not as sharp as I used to be…I don’t have the intellectual stamina I once had — ironically, that’s in part because I had ECT.

        I agree that a lot of “expert testimony” — like bite mark experts and forensic psychiatrists and psychologists — should not be allowed. It always burns me up when the prosecution hires someone to evaluate a person on trial for something criminal, and the so-called experts diagnoses the defendant with a personality disorder, sociopathy or something else scary sounding. I think too many juries are swayed by that kind of thing, just like too many people in the general population believe that psychiatry is based on science or anything objective.

        I was curious why the ECT machine manufacturer was being sued and not the doctor, or not both manufacturer and doctor. I have to do more reading about the case.

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  2. Just read the post discussing the “Partial Win for ECT Justice” on Mad in America. It’s encouraging to see progress being made in the advocacy for Electroconvulsive Therapy (ECT) accountability and informed consent. The legal and ethical dimensions highlighted in the article are thought-provoking, shedding light on the importance of patient rights and transparency. Kudos to Mad in America for covering such significant developments in mental health treatment discussions.

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  4. Reading the wisnerbaum.com narrative of the trial is sadening and quite unpleasant and upsetting. Some of the testimony refered there sounds of the kind “I believe nicotine is not addictive”.
    Just curious if given the ECT machines used after 1976 probably worked different at least because of the sine wave, short pulse, ultra short pulse, should after that date require clinical studies? It does the same, cause convulsions, but it does it differently, so how different is different enough to since then require approval after clinical trials?.
    And the doc’s testimony that, per wisnerbaum.com, lied, violated the instructions from the, I imagine, Judge, through the company’s lawyer, got aggresive with the lawyer, given the lies, aggresivenes and failure to follow instructions should have not been used by the jury. But that’s a legal question and I am no lawyer.
    And it’s odd, in the literature they say the new way ECT machines work makes irrelevant the damages studies before some 1970/1980/1995’s studies, to discard that it’s brain damaging. But!, apparently that’s not enough to require clinical trials to approve this NEW ECT machines, grandfathered, grandchildrened or whatever.
    I did an informal pubmed search, and recently, after 1995, I could find just one article from 2005 (in english from a russian one from 2004 from the Russian Academy of Sciences) that shows, as I understand, that ECT does kill neurons with the electrical current in the mice hypocampus, as a sugested mechanism, since the neurons don’t kill themselves when shocked (they don’t die of apoptosis, they probably, IMO, by excitotoxicity). And that made me aware that I forgot that some hypocampus neurons apparently keep being born in the hypocampus, o my memory, oh, my hypocampus :).
    But apparently, the “literature” put a spin without quoting THAT reference after 2005. I think only one paper in pubmed made a reference to this article and not sure it’s a relevant quotation.
    The ECT safety/efficacy reviews that psychiatrists read should quote THIS paper. Seems to me a very BAD omission from the papers that psychiatrists are most likely to read at some point. And probably prospective victims of ECT too!, but they are not gonna get that from “clinical reviews”, not even all?, some?, most other research articles. But in my experience, taking into account the state of my memory, pubmed does not work as good as it used too…
    That kind of citation omission is one of the markers that whatever paper one is reading is a bad one!: It omits basic relevant references that confirm or disprove, even as suggestions, whatever the paper one is reading AFFIRMS or DENIES. It’s to say the least BAD SCIENCE, from what I’ve read…
    Aa far as I know residents have a bad time in teaching/research sessions, i.e. academic sessions, if they MISS that about the paper they are reading or reviewing. That it misses a reference THIS paper SHOULD have included. How is it that psychiatrists in training after 2005 REVIEW clinical reviews about ECT and didn’t do their HOMEWORK?, well, dunno…
    The 2005 paper hasn’t been replicated either, nor followed up to find out what the CONSEQUENCES for mice are because of ECT with “modern” ECT protocols. Do mice forget at some point how to feed themselves inside the lab after 96 ECT sessions?.
    Around that time, 1995 to 2005, hehehe, apparently the “literature” started to suggest that “whatever” ECT does to the brain, it might me a good thing!. And I can imagine that because hypocampus neurons “regrow”, killing them, following the ECT champions/promoters can’t be that bad!. Even if the regrow, might be part of THE problem with ECT. But hey!, probably most of what I knew about the hypocampus is probably unreliable 😛
    But in the peripheral nervous system AXON regrowth gone wrong (not neuron regrowth) can be bad for the patient. It can give the patient to regain some function, some unusual movement and feeling signs and symptoms. But I am not sure how that would work for autobiographical memory.
    So, yeah, it’s still shocking even if its called ECT…

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  5. One more thing: odd in a shocking kind of way that psyhciatrists can’t meassure autobiographical memory with the SAME tools they use to make other diagnoses because apparently putting in the DSM “autobiographical memory collapse” is TOO difficult. I mean, common!, depression, anxiety etc. is WAY easier!?. Like TOO WAY EASIER!?
    It’s just tickboxes!, I am shocked, shocked! they can’t invent a formulaire with the RELEVANT check boxes because its TOO difficult!.
    I guess in this case, maybe only in this case, they are REALLY REALLY trying to be responsible, somehow, to someone, to something…

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    • I wonder if they don’t want to talk about autobiographical memory loss in patients because it would force them to see their patients as humans beings, with histories, triumphs, failures, losses, dreams, families, careers, aspirations…

      I think that would be really uncomfortable for a lot of psychiatrists. They would rather think of patients as malfunctioning machines that need a jump start.

      Imagine if they actually had to have conversations with parents who couldn’t remember years of their children’s lives because of ECT. Maybe that would change something. I don’t know.

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      • Well, it could be bad to somehow rub on psychiatrists’ faces the damage they’ve caused in a way there is no other way to look at, or point at to deny it.
        But as responsible physicians, when confronted with such a clinical picture, the responsible thing would be to reach the bottom of the research papers to explain adequately what I as a clinicain already saw in one patient. Let alone two or more. It’s so devastating. And no face rubbing needed, it’s a duty…
        And I mean really look all the way to the bottom, what you narrated is heart breaking “even” for the physician.
        That decades past and they are still as a group and community denying it could happen, when they already saw it could, makes me doubtfull they see it as you narrated.
        But I might be wrong, I hope I am.
        Sounds to me more like about the liability for the psychiatric community if it becomes convincing enough for everyone else to see it.

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      • Actually it’s way worse. That guideline written by the APA and published in 2001 is quoted by the FDA when it informs the company that ECT could cause catastrophic damage. And inability to do your old job, that relies on that kind of memory. Since 2001.

        And there is some comment about bribery in the emails from the trial. There are also some email exchanges where they actually tried to set up experiments/clinical trials. But apparently the kicker was the need for a control group.

        So they really omited putting that kind of harm in the manual, deliberately and with knowledge, even the FDA told them, apparently. They didn’t fail, they tried, were succesfull and got caught.

        And I guess the fact that the jury said yes on the failure to warn and no, that didn’t cause harm, is actually the opposite of what law case and jurisprudence from the Supreme Court of Nebraska established for strict liability when a learned intermediate, i.e. a physician, is using the equipment on the patient. Similar in Canada and other places. No causation proof is needed, just the failure to warn and the damage.

        So the simple jury verdict speaks, exagerating meself, of miscarriage of justice…

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  6. I, too, hope finally at some point the victim and his lawyers prevail.
    If for nothing else to my mind it will force companies that make ECT and everyone using one to mitigate the “risks” being an inherently dangerous machine and procedure.
    Like sealtbealts, airbags or helmets for driving, cycling, skating, etc.
    Although I feel compelled to say to me is more like harms, not risks, sounds to me not like an inherently risky or dangerous procedure, but an inheritely harming one. Hence the need to mitigate the harm, not just the risk.
    Maybe that’s why the reluctance to admit a defective product claim in this case, AFIU, I am no lawyer not giving legal opinion nor analysis.
    If I follow why strict liability is what it is now, it will force everyone involved in ECT to mitigate the “risks”/the harms, and that could require clinical studies, or better yet, to my mind, as my not so bright opinion: stop using it if no risk mitigation, or harm mitigation exists.
    If just warning this might cause death, amnesia, etc., is not enough.
    As if puting the label of warning/caution/dangerous (even the skull and bones!) on the machine, in the manual, etc., is not enough.
    Maybe they’ll invent a new DANGER symbol for ECT machines! in the course of abandoning it or banning it, like chemical danger, electricity danger, corrosive danger, radiological danger, fumes danger, etc.
    An ECT danger symbol!.
    I hope I am not dreaming.
    I changed my mind a lot about what I read at MIA about this case. Now I can infer more corruption than I originally thought, even possible…
    Thanks! 🙂

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  7. I can imagine the effect, the impact, of teaching primary school kids, K12, highschool, university, med school, medical residents, the meaning of the ECT danger symbol. As I imagine they do some of the other ones.
    Student: Teacher? what does that symbol mean?
    Teacher: It means it could cause death, permanen amnesia, permanent brain damage, etc…

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  8. That, the ECT symbol, might even finally force the government to make laws and regulations about it, just to KNOW where to put the ECT danger label.
    Like “dangerous electric shocks” ahead in highways to the ECT suite.
    I guess/dream that’s why apparently internally the company mentioned “tobacco labels/warnings”.
    But speculating, it would be more like radiological risk labels. “It has to be seen from 6mts”, “outside the rooms where exposure is of such labels for the general public”. “Personnel EXPECTED to be exposed to such radiation levels per year should wear a dosimeter, at all times when less than such meters away from the radiaton source when the barrier is UNDER such efficacy, even if the radiation source is turned off”. “The equipment has to be certified once every year by a physicist certifed in ECT danger according to the standards set forth by the ECT comission..”, etc.
    A whole lot of things to know about it’s dangerousness, just to put a label.
    It could force the government not only to know about it, admit its dangers, to study it, to understand it, but to make legislation about it. If allowed to continue it’s use.
    Yickes!.
    Talk about importance of a case, to my law naive and dreamy mind.
    I see it more and more like a tobacco case with a touch of ionizing radiation.
    I’ll light two candles as my way of praying, even if I am not religious…

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  9. Even more like X-ray regulations if in fact, after the government carefully studies it, it turns out that like X-rays there is no SAFE LOW EXPOSURE LEVEL.
    That is: when even a tiny, tiny increase in exposure to ECT above “background”, which in this case means above NO exposure, increases the risk of a bad outcome.

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