Thursday, November 15, 2018

Litigation Update: ECT Device Manufacturer Issues Warning of "Permanent Brain Damage"

Connor M. Karen November 15, 2018 

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 or send an email to Justice for ECT victims has been long delayed, and we think we can help bring it to you.

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Connor M. Karen
Connor M. Karen, Esq. is a graduate of UC Davis School of Law, California Bar admittee, and winner of the 2017 national law student class action writing competition hosted by American Association for Justice. Connor's entry was a paper on class certification of injuries caused by violations of FDA regulations. Connor and Jim Truxaw, Esq. conceptualized and drafted the linked litigation documents.

Thank You Mr Karen and MIA.

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