As I reported in a previous blog, on September 11, 2017, DK Law Group, LLP filed a case against Mecta Corporation and Somatics, LLC, the two manufacturers of shock devices. The Complaint alleges that both Defendants, as the only two manufacturers that make and deliver shock devices, wholly failed to comply with the FDA’s requirements applicable to medical device manufacturers.
Namely, the FDA and its governing law, the Food, Drug and Cosmetic Act (FDCA) require that all medical device manufacturers, whenever they encounter “information reasonably suggesting death or serious injury” that their devices “may have caused” or to which they “may have contributed,” must investigate the information, evaluate the cause of the event, and submit all “reasonably known information” to the FDA. “Reasonably known” information is information that can possibly be gathered through testing and evaluation of the device or by contacting anyone, including user facilities and manufacturers, that are subject to the FDA’s reporting requirements.
If a manufacturer falls short of these requirements, or does not have a system in place for the timely investigation and/or reporting of adverse events (deaths or serious injuries), they cannot manufacture or deliver their devices for use in the United States under 21 U.S.C. section 331. Defendants have encountered thousands of allegations of serious brain injury resulting from ECT, and know of the existence of entire support groups of ECT victims. Despite that, Defendants have never properly investigated, evaluated, or reported a single adverse event allegation.
As a separate violation of the FDCA, ECT devices access the market under the “substantial equivalence” market access provision of the FDCA — meaning the devices have to be substantially the same, in terms of safety and effectiveness-related technological characteristics, as pre-1976 ECT devices, in order to evade the typical “premarket approval” (proof of safety and effectiveness) requirement for Class III medical devices. Defendants stated in their argumentation over “class certification” (discussed below) that their devices are new and technologically improved, such that they are more safe and effective than 1980’s devices. This obliterates any claim to “substantial equivalence” that Defendants may have had, and Plaintiffs’ position is that this renders invalid their devices’ market access, proving that their devices are, and have been, “adulterated” and/or “misbranded” — meaning “illegally marketed” in legalese.
Somatics, LLC also utilizes an unregistered contract manufacturer to manufacture all of their devices. This also renders their devices illegally marketed, on separate grounds.
Had Defendants complied with FDA regulations, they would have prevented injury to shock victims two separate ways:
1) If Defendants had complied with the “Medical Device Reporting” (MDR) requirements of the FDCA (21 U.S.C. 360i, 21 C.F.R. 803.50) they would have reported, tested, and evaluated the cause of thousands of allegations of serious brain injury resulting from ECT. Honest, good-faith reporting would have required that Defendants inform the FDA that ECT was causing tens of thousands of concussive brain injuries. The FDA would then have published the reports in its MAUDE database, which is the database intended to inform the relevant professional communities of the risks inherent in FDA-regulated products. Psychiatrists, then, bearing a legal duty to convey the information in the MAUDE database to patients, would have complied with the law by consulting the MAUDE database and relaying a warning of concussive brain injury to patients prior to administering shock.
2) If Defendants had complied with the “adulteration” and/or “misbranding” provisions of the FDCA (21 U.S.C. 331), prohibiting the manufacture and delivery of adulterated and/or misbranded devices entirely, Defendants never would have manufactured or delivered the devices that caused injury to Plaintiffs in the first instance.
Therefore, Defendants are liable for all unwarned brain injury caused by their devices.
Between September of 2017 and early March of 2018, both sides were making their arguments for “class certification,” or why the case should (or should not) proceed as a class action, rather than as a series of individual cases (see “Shock Class Action – Case Update“). The District Court set a hearing date for March 12, 2018, where the parties were prepared to argue their positions in open court regarding why the case should, or should not, proceed as a class action.
Just before March 12, 2018 the date scheduled for the class certification hearing, the Central District Court took the Class Certification hearing off its calendar and declared that it would be basing its ruling solely on the papers the parties submitted. Shortly thereafter, the Court issued an Order denying class certification. The primary rationales for denying class certification were: (1) mini-trials for each individual would be required after all the common issues were resolved, rendering a class action unmanageable, and (2) based on the severity of the alleged injuries, claimants would want to exercise control over their individual damages determinations.
Plaintiffs also put forth an argument for “partial certification,” in which certain questions common to everyone can be resolved all at once, such as (1) Defendants’ violation of FDA regulations, (2) whether ECT causes gross structural brain pathology, and (3) whether this lawsuit would intrude upon the FDA’s regulatory scheme. The Court thought these questions were “very discrete” such that the time saved through resolving these questions on a common basis would be “insignificant.” In concluding its ruling, the court stated that an individual verdict followed by settlements would be equally efficacious.
The attorneys for the ECT victims strongly disagree with the Court’s assessment, for the following reasons:
1. The Ninth Circuit and other federal Courts of Appeals expressly approve of separate mini-trials after a class trial as a method of managing a class action, so mini-trials alone cannot be the basis for a finding of a lack of class manageability.
2. The severity of some claimants’ injuries is far from the only relevant factor in determining whether shock victims would prefer to proceed individually or as a class. Plus, as the District Court stated, there would be mini-trials after the class trial anyway, which would allow claimants to exercise control over their individual damages determinations.
3. The common issues here are not “very discrete” — they determine the outcome of the whole case — and the time saved through class resolution would be colossal.
4. The last four decades of regulatory noncompliance by Defendants, and the availability of individual lawsuits for that entire period, shows that individual litigation is an insufficient means of resolving this problem.
As a result, Plaintiffs’ counsel have now petitioned the Ninth Circuit Court of Appeals for permission to appeal the District Court’s ruling denying class certification. The Ninth Circuit will overturn the ruling only if they find that the District Court “abused its discretion.” While counsel for Plaintiffs hope the Ninth Circuit sees the manifest error in the District Court’s ruling, they are now proceeding individually on behalf of the five named Plaintiffs as a test-run to see how these cases will play out. If successful, all other similarly situated ECT victims can follow with identical actions.
The Road Ahead
While, clearly, evidence of traumatic brain injury caused by ECT is well-known, for purposes of the litigation each of the named Plaintiffs will now need to undergo specialized neuro-psychological testing to ascertain, measure and establish the extent of brain damage caused by ECT for the upcoming trial, where the all-too-familiar disinformation from ECT device manufacturers will appear in full force. As is typically the case with many ECT patients, careers have been ruined and financial pressures only add to the long road of recovery. Accordingly, well-needed donations for their expenses of litigation, including the necessary neuro-psychological testing for each Plaintiff, are now being sought to help the victims of ECT in challenging the shock manufacturers in this litigation.
If you would like to help fund this cause, please follow this link. Know that every dollar and cent contributed counts immeasurably. It will be used to further this litigation to help offset the tremendous challenge of taking on this ethically necessary, legally cutting-edge and timely shock litigation against an industry that will spare no effort or expense in attempting to defeat these claims.
Specific questions regarding the litigation are welcomed in the comments below or at [email protected]
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
To measure damage you need a before electroshock testing, to gauge the after effects, and who does this pre testing? ( to show evidence of harm, it is against the interest of those making money from electroshock) The court is rigged in favour of the defendants.
Plaintiffs’ position is that any inability to prove ECT’s causation of TBI conclusively results from Defendants’ noncompliance with the Food, Drug and Cosmetic Act, so it would be unfair for Plaintiffs to bear the burden of proof on the issue of causation of traumatic brain injury.
Thank-you for this update. What is the time frame for rejecting or allowing the appeal?
Yes, with no pre- ECT/TBI testing done, it is pretty likely the victims you are representing won’t be able to prove their injuries. Their “deficits” will be blamed on their “mental illness”, on drugs they have taken, on anything but shock.
Not sure there are electrical injury specialists and neurologists who are willing to testify in this case.
A psychiatrist I spoke with the other day stated neuropsychologists never connect the damages to shock bc they don’t want to point the finger at their brain damaging colleagues and that nothing is definitive enought to make the clear connection.
What time frame do you envision for the start of proceedings on behalf of the five plaintiffs identified so far?
The Court of Appeals has complete discretion to determine the timing of a decision, so it is up in the air.
There are certainly at least some neuropsychologists willing to testify that inducing a grand mal seizure through application of electricity to the cranium causes brain injury, but they are expensive.
I believe the trial date is currently scheduled for October of this year, but that could change.
Sir Rodney Gallens Report on the rape drugging and torture of NZ children with ECT
Posted on March 27, 2018 by kiwijustice2blog
Sir Rodney Gallens Report
We have all seen the same thing. Victims complain of aftereffects of ECT, such as cognitive confusion or memory loss. We got the same response. “It’s an underlying mental illness.” I happen to recall these doctors even had the nerve to try to convince me I had been confused all my life! If we don’t improve they lock us up in State. “Severe Mental Illness.”
However, I see Atty Karen’s point here. Will they be able to get away with making these bogus claims in court under oath? They may have lied to us knowing we were confused. They could get away with it while we were in a vulnerable state (and while there were no witnesses to challenge them). But in front of a judge is another matter.
Not impressed with the Justice system judges if they rule like the first one did in this case.
Not impressed by the jury that decided Dr. Dadi, eminent cardiologist lost his memory, his ability to speak five languages, his medical skills because of “mental illness” rather than brain frying ECT.
The brain damaging psychiatrist had experts and his lawyers giving evidence “ECT doesn’t do that”. And the jury bought that.
It is difficult when the public has listened to the poster children happy with their shocks- like Kitty D., Sherwin Nuland, Carrie F., Julie Hersh, Carol Kivler.
How does one explain that? Maybe ppl who are victims just had “bad ECT” given by incompetent doctors and are the “rare” malpractice case? Right.
Most victims have been left permanently dazed, traumatized, cognitively impaired and unable to fight the powerful and immoral shock industry and the doctors who brain damage ppl for a living.
I lost my $90,000 career I had
excelled in for 30 years; I now am on disability, severely brain injured. It took almost two years to recover any functioning and then I could not find a lawyer to take my case.
Truth, the object of Medical Mal is for the perps to deliberately put the person into a daze or traumatize the person just long enough (or prolong incarceration and drugging) so that by the time the victim gets his/her wits together and realizes it’s time to sue, the statute of limitations has just passed. And how long do we get? Not long.
I attempted to edit an earlier comment and ended up making a duplicate – whoops. See the real comment below.
I understand your frustration. However, this ruling is no reason to lose faith in the justice system. Class certification for this case was a long shot from the beginning.
The real battle, oddly enough, will be convincing a jury of brain injury resulting from electrically-induced grand mal seizure. The outcome here will depend on the quality of the neuropsychological testing and expert testimony we can muster – hence the gofundme link (if successful, it would be a huge help).
It is also worth noting that this is NOT a medical malpractice claim requiring proof that the doctor “breached the ordinary standard of care” among doctors. This is a product liability case against the device manufacturers, requiring only that the product (ECT devices) present a risk that the defendants failed to report to the fda (traumatic brain injury). That’s why we like this case more than an ordinary med mal.
Since the theory of liability is the same for everyone, convincing one jury of one plaintiff’s injury would likely discourage the defense’s further attempts to defend these claims, and open the floodgates for settlement. That’s what we are going for here.
Yes, I think I was looking at the med mal side of things, the wrong lens in this case.
(Black humor in suggesting these are real doctors and would be meeting a “standard of care” in “treating/electrocuting their patients/victims.)
Really difficult to go up against these corrupt individuals who have all these financial resources to throw at defending their right to keep injuring vulnerable ppl for the billions this scam generates.
And, would the size and number of potential settlements impact this industry or would it just look at it like Big Pharma settling suits in the hundreds (for drug damages or illegal off label advertising) of millions as part of the cost of “doing business”?
A few thoughts:
this ruling is no reason to lose faith in the justice system
Not this particular ruling perhaps. But hopefully by now most reasonable people will have lost any residual faith in the “justice” system long ago, and their strategic vision is no longer clouded by illusions of true justice ever being attainable under the current system of rule. This is highlighted by the fact that a positive decision may rest upon the ability of the plaintiffs to raise the funds to secure expert testimony — a problem not faced by the defense, which no doubt has comparatively limitless funds at its disposal. So as usual, we get what we pay for.
This is not a criticism, just a caution. I’m all behind this and all similar legal efforts, and extend best wishes to all involved.
Thank you again for this clarification.
I just cannot comprehend how any jury could not make the connection between multiple electrical injuries paired with grand mal seizures and brain damage.
Probably an average 13 year old with basic knowledge of science would know this.
Juries are probably contaminated by ppl listening to the pro-ECT propaganda that is advanced by the unscrupulous shock doctors and torture device manufacturers.
I believe the last case used Peter Breggin, but obviously his testimony didn’t sway uninformed and uneducated jurors.
I hope you do have success and open the floodgates, not just for settlement but for the abolition of this destructive and barbaric procedure.
I see the first donations are popping up on go fund me. That is great.
I share your sentiments. We are doing our best – currently brainstorming ways to increase visibility and efficiency of the crowdfunding effort.
Thank you for the update and for your work. Severely brain damaged with innumerable losses. I know am just one survivor among many. To see people fight for those who cannot themselves– for that, there are few words of adequate respect or gratitude.
Are billboards (electronic or regular) too cost prohibitive to be used? Ads online or in print newspapers?
I see gofundme for my puppy needs an operation generating thousands, so why is this not getting that interest?
We will be reaching out to other psychiatric reform communities soon to promote the crowdfunding effort’s visibility.
I don’t think electronic billboards would be cost-prohibitive. I’ll be sure to check the rules of professional conduct to make sure we’re good with such a move, and run it by DK. Thanks for the suggestion.
I didn’t quite understand what was being said here
Has the case actually been settled? Have the plaintiffs won?
I made an account to support the victims of shock. These plaintiffs ARE NOT making bogus claims or conjuring up side effects. ECT destroyed my life. I was a 4.0 Masters Degree holding, beautiful woman in my 30’s when I was shocked. I immediately was fired from my job as a pharmaceutical rep because I forgot my product knowledge. NO ONE CAN SAY WE ARE LYING. UNLESS you have been SHOCKED. Keep your mouth shut!!! I am smashing radios with a hammer because I can’t learn a new job! I have a Master’s degree!!! I’m suicidal most days and scared all the time. I am one of 300 ECT survivors!!! THree hundred ECT victims who sought help got shocked and left worse… most on disability, some dead from suicide. I didn’t understand most the legal jargon above but I comprehended enough to say why would 300 people choose life on disability, “assistance” being treated like garbage, afraid of homelessness over stability and career. We wouldn’t. I dare any person who doubts a victim to get a few shocks. Then you may speak on the side effects of ECT. I want to die every day. Tell me I deserve to feel like this? I deserved the world and I am on disability reading comments from people who don’t know any better. I PRAY AND support David Karen 100 percent. THANK YOU FOR FIGHTING FOR US. THANK YOU.