Litigation Update: ECT Device Manufacturer Issues “Permanent Brain Damage” Warning

Connor M. Karen
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Hi everyone. As you may have heard from Dr. Breggin’s recent update, after the judge told us that the case wasn’t a class action, our case on behalf of ECT victims Jose Riera and Deborah Chase settled favorably on the eve of trial. In a development that we didn’t expect, Somatics, LLC has now issued a warning of “permanent brain damage” in its new risk disclosures of October 19, 2018. I wanted to talk a little bit about the implications and how this might affect litigation going forward.

First, you might be curious if this warning (the words “brain damage” buried in the middle of a laundry list paragraph of risks) is enough to shield the manufacturer from future liability. The answer to that is maybe. In product liability law, the adequacy of the warning of a particular risk is a “question of fact” for a jury to decide at trial. That means that even if a jury decides that a manufacturer has included warning of a particular risk, the jury could decide that the warning was insufficient in that it wasn’t prominent enough, the text was too small, not enough attention was given to it, etc.

In my opinion, with respect to the unavoidable risk of brain injury that ECT presents, there needs to be a standalone page with huge red font and a hazard symbol that states “ECT, necessarily the application of sufficient electricity to the cranium to induce a major motor seizure, presents an unavoidable risk of injury to the brain, and both the efficacy and safety of the treatment remain intensely controversial to this day.” We will keep bringing cases against ECT device manufacturers until either the manufacturers start providing that warning, or a jury states that their warning of brain damage is adequate.

That being said, their disclosure will still have effects on future litigation. First, my father DK and I think that this makes the case of anyone who underwent ECT within the statute of limitations — two years before 10/19/18, their date of disclosures — MUCH stronger, as they spent the entire litigation vehemently denying that brain injury was even a possible result of ECT. They basically put their foot in their mouth. (You still might have a good case if you underwent the “treatment” outside the statute of limitations — the arguments just take on a different nature, and we have to take a good look at your case to know whether we can help.)

Also, we think this makes individual medical malpractice cases against psychiatrists and hospitals much stronger. Somatics, LLC’s new disclosure would appear to take the legal force away from their claim that brain damage doesn’t occur from ECT, and winning medical malpractice cases over failure to give informed consent seems to me to be much more of a possibility.

One more interesting point to note: on page 4 or 5 of their disclosures, they state that the FDA “Approved” the Thymatron in 1984. This is false, as the Thymatron was grandfathered in as “substantially equivalent” to a pre-1976 ECT device through the “premarket notification” process, NOT given official premarket approval by the FDA. Further, the FDA’s regulations state:

“Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” 21 C.F.R. sec. 807.97.

In essence, Somatics, LLC is representing to the public that the FDA has approved its device based on premarket notification, which the FDA’s regulations state is misleading, and constitutes misbranding. Misbranding is significant — if your device is misbranded, it can’t be manufactured or distributed. I’m not sure exactly how this will play out, but you can be sure we will be thinking of creative ways to get the Thymatron’s misbranding in front of future judges to see what shakes out.

I’m happy to answer any questions anyone has here in the comments. I’m also considering doing an AMA on Reddit soon.

If you suffer injury from electroconvulsive shock therapy, please fill out the questionnaire on ectjustice.com or send an email to [email protected]. Justice for ECT victims has been long delayed, and we think we can help bring it to you.

35 COMMENTS

  1. Much praise and admiration for your law firm and Dr. Breggin for this great work!
    It is great progress that patients will now be informed of the risk of permanent brain damage before they can give a proper and well-informed consent to having life-altering treatments.

    • It is quite likely that doctors will minimize and downplay this warning, characterize it as 1% of people and still convince the drug poisoned, desperate, and vulnerable ppl that this is their “last resort” and “worth the minuscule risk”.
      The only way to insure safety is to ban the procedure and manufacture of devices of torture- SHOCK machines.

  2. Has the FDA not been dragging it’s feet for three full years on an attempt to have ECT given a Class II certification, (for certain ‘indications’), putting it in the same level of hazard as an electric toothbrush?
    Should the FDA not act on the new information they now have as a result of your litigation, Somatics admission, and the problem of “misbranding” which you have pointed out??
    Why is a jury trial ruling required before patients are fully protected with the type of ADEQUATE
    Warning you suggest? This warning should be part of consent forms and hospital “information” websites.
    It seems bizarre that hospitals and doctors should be able to keep assaulting patients, causing repeated TBI’s.
    I hope your efforts lead to a complete ban on this lunatic procedure, the electrical lobotomy.
    If Somatics has issued this warning, how can Mecta not follow suit, given its devices of torture operate on the same principles?
    It still is difficult to believe it has taken 80 years for the truth about shock to be exposed in a court of law.
    If the device is indeed “misbranded”, meaning its manufacture, distribution, and sale are illegal, who or what group or organization should file suit to address the question?

  3. Isn’t there a problem with simply listing “permanent brain damage” without a clarification as to what that could manifest itself as? As in “patient could lose 10-30 IQ points, career skills, decades of memory, be unable to make new memories or learn new material, have trouble multi-tasking, suffer personality changes, become apathetic or hostile…” is the “permanent brain damage” going to be described in terms of the way it can impact the victim’s future quality of life?? Is it going to be stated some patients will need cognitive rehabilitation like that given to car accident victims??

    • Maybe we should require all “ECT” patients to listen for an hour to a panel of survivors who have been damaged by the process before they can agree to it. Though it seems so odd – if a person has a seizure, doctors will take immediate and extreme measures to bring it to an end, because they know it’s damaging to the brain. Why would inducing a seizure be any less damaging?

  4. Thank you for this work you’re doing— it has given me so much hope even though I will never have my day in court as the statute of limitations ran out almost a decade ago and my medical records were destroyed long before that.

    When I received ECT in 2001, I was given information about potentially serious side effects which I completely forgot after one or two treatments, and was only given abbreviated consent after stating that I give my doctor permission to perform electroshock and follow basic aftercare protocol.

    At the same time, doctors and support staff endlessly downplayed the risk of ECT.

    Kind of like a, “yeah were legally required to tell you about the bad stuff but don’t worry, type of thing.”

    At one point my shock doctor even told me it was safer than riding in a car before a treatment!

    This created a false sense of security and led me to continue damaging my brain.

    When I experienced severe brain damage from ECT I tried getting help from my doctors which was repeatedly denied.

    They kept telling me “ECT doesn’t do that,” even though they originally acknowledged the occasional, rare case of brain damage but they made no effort to order testing to see if I was one of those rare few with lasting damage.

    Eventually, I was able to get testing for another reason, and even with documentation showing chronic encephalopathy, no working memory and slowed processing, I still can’t get a single doctor to acknowledge that ECT is the cause— This includes a neurologist and dementia specialist!

    “ECT doesn’t do that,” belief seems to have infiltrated every branch of medicine and this experience still seems to be the norm for shock survivors looking for help.

    One day I hope to walk into a doctors office and get acknowledgment at the very least and help at most instead of gaslighting, These lawsuits and voluntary disclaimers seem to bring survivors closer to this.

    My question:

    Will these changes lead to 1. Doctors forced to disclose risks without downplaying them, 2. Doctors required to take claims of injury seriously and order appropriate testing and rehabilitative support should test show abnormalities or will this just give them another layer of protection from liability and they can keep dismissing us until we give up or statute of limitations run out?

    Thank you again.

    Jane

  5. A curious but interesting story. Back when I got my B3 professionally adjusted, it was by a guy recommended to me by several ex-patients. He was a former shock doc- an internist by training (not a shrink), he was moving into my neck of the woods, seeking an environment where he could practice therapeutic fasting as devised by Theron Randolph, who’d trained him by putting him through a fast of his own. When he got to his new hospital, the executive staff wouldn’t have anything to do with fasting, telling the 70-year old doctor that this was too dangerous to perform in their hospital’s psych ward (apparently thinking ECT was a safer procedure). Fortunately, he wasn’t a psychiatrist by training (actually he was an internist), because he didn’t even curl his patients’ toes, besides keeping them on mega B3 during the procedures to save their long-term memories.

    • We’re in a bizarre place when passing electricity through someone’s head and intentionally inducing a seizure is considered more dangerous than having someone try a fasting program or vitamin B3. They probably meant it was more dangerous for THEM, as they can’t be sued for inducing convulsions, since it’s “standard practice,” whereas if something went wrong with someone who is fasting on their advice, they could get in legal trouble. Or maybe they are simply so blinded to the dangers of electrocution that it genuinely seems safer?

  6. Well done to this young lawyer and his father !

    The drug and shock device companies are like the gun manufacturers..the guns don’t do anything unless a human points it at someone and pulls the trigger. This is what the doctors do with drugs and electric for a lot of money. It is they who – also – have go to be held to account !

  7. I was curious to know how many hospitals in the UK are using machines made by Somatics LLC. I think most hospitals in the UK use American machines but I don’t know how it splits between MECTA and Somatics. We have our own ECT manufacturer, Ectron, a company with a sinister history in intensive ECT, but I think they nowadays make machines more for export. Anyway the first example I came across of use of a Somatics machine was Berrywood Hospital in Northampton who have a 144 page protocol on ECT. It even has a bit about the toilet facilities. Only one mention of brain damage though “… there is no evidence that even prolonged courses of ECT result in brain damage…” They do say however that seizures over 90 seconds “may be associated with neuronal damage leading to long-term memory impairment”. I wonder who decided that 89 seconds is fine and 90 seconds isn’t.

  8. So, I KNOW this isn’t the main focus of this article, but I can’t help but think that there are many drugs that deserve the “may cause brain damage” label as well. I haven’t looked – is that done on the “antipsychotics” information sheets? I doubt it, but could be wrong. In my sample size of one (me) I KNOW it has occurred. I still struggle with poor focus and reading comprehension, as well as other lasting iatrogenic issues.

    • You’re right, msmonique. That’s what tardive dyskinesia’s all about- neural damage brought on by drug-induced manganese deficiency, which is why proper treatment can reverse it in its early stage without much trouble, but not so effectively when it becomes chronic. It doesn’t say much for Big Pharma, which could probably prevent much of the nonsense by adding. 2mg. Mn to every tablet of their antipsychotic drugs in the manufacturing process.

    • They pretty much all cause at least temporary damage to the brain. That’s how tolerance occurs and why there are “discontinuation effects” (AKA withdrawal) for essentially all of these drugs. With antipsychotics, we KNOW there is long-term neurological damage. It is suspected that SSRIs and especially Benzos cause cognitive impairment that lasts well beyond the use of the drugs, and may be permanent.

  9. WHY has the FDA failed to do the right and ethical things to protect consumers from injury by ECT devices? Is it peopled by individuals open to bribery or with cozy ties to manufacturers and the APA or just no clue what they are doing?

    Why aren’t there effective groups lobbying their representatives to bring forward legislation to ban this procedure?

    Can the statute of limitations be voided if a “misbranded” device was used on a victim?

    Is this type of suit engendering interest nation wide?
    What would it take to get shock banned?

  10. Looking over the update on the Thymatron posted to The web site, I found in very small print, a statement stating that “rarely, there is more permanent memory loss or permanent brain damage”.
    How can they get away with “rare” if they made no inquiries, filed no complaints or records of injury??
    Since there are ECT survivor groups with hundreds of victims of brn dmg and formal testimonies to the FDA counting in the thousands, and since no proper testing was done to determine the actual characteristics of the brn dmg and its manifestations, so brn dmg was missed (like using a feeble MMSE dementia instrument), how can they say “rare”. Think surveys showed at least half ppl injured or impaired in some way.
    When does the litigation involving Kendrick Moxton, ECT, and the FDA go to trial?
    Thank-you again for all you have done.
    I wrote the Boston Spotlight team suggesting this needed to be exposed- not even a comment. Wrote 60 Minutes to tell them they missed perm brain injury in their pro-shock interview with the obviously cognitively impaired Kitty D.
    Why is the media not making this horrific scandal front page news?