We think arguments like the one you’re making have a chance of gaining some traction in the courts, for the purpose of expanding the time during which an ECT victim can bring suit. A couple of the clients that had cases dismissed on statute of limitations grounds are making those arguments on appeal right now, to be resolved in the coming months.
I think the FDA should have taken action as soon as it became apparent that ECT device manufacturers were not investigating or reporting complaints of injury in the early 1980’s. The FDA has demonstrated that it will require substantial pressure before it begins enforcing its own regulations re ECT.
I agree that a jury trial shouldn’t be required before patients are given adequate warning, but alas.
I’d expect MECTA to follow suit soon, but who knows.
We are still figuring out the best way to address the misbranding issue. Ideally the FDA would do something about it, but it appears private lawyers will be the ones who will have to raise the issue with the courts.
I agree, this whole issue is one of the most bizarre things I have ever encountered. It seems that right when the FDA announced it would regulate ECT devices in the late 1970’s and require premarket approval, the industry began taking the position that brain damage cannot occur from application of electricity to the cranium. It seems the incentive provided by insurance programs which cover ECT, coupled with the threat of tort liability for failure to warn, were enough to keep that lie in place for decades.
They have appealed their dismissal – we will see what happens. DK’s firm will be bringing the viable cases we can find from among the inquiries we receive, so spreading the word is important.
By the end of the suit, there were only two. The rest were dismissed, because the Court held that the other plaintiffs fell outside the statute of limitations.
The court actually made clear it’s not a class action. These were just two individual cases, but the legal theory is the same for everyone (failing to warn of brain damage). It was also only Somatics, LLC that settled – the plaintiffs didn’t use MECTA devices.
Yes, that appears to be the page. Whether that’s enough to cover them legally in the future is a question for a jury. However, it won’t do anything to protect them from the cases of victims who underwent ECT in the past.
They are probably trying to shift the blame to the doctors, and legally, this will have the effect of shifting some of the liability to the doctors. I think medical malpractice cases for failing to warn of brain injury should be easier now.
Somatics, LLC has included “permanent brain damage” in its risk disclosures on its website after our litigation. I’m happy to offer more information here, through my email at [email protected], or through [email protected].
One of the defendants got dismissed since the plaintiffs didn’t use their machine. The plaintiffs settled against the remaining manufacturer-defendant. There are no trials currently pending, but DKLG is examining leads for potential new cases.
The lawsuit was initially directed at both Mecta and Somatics. One defendant was dismissed (the plaintiffs didn’t use their machines), and the lawsuit against the other settled before trial.
Rule of thumb is that victims have two years from the date of treatment to file suit. There may be exceptions, and we’d encourage people to reach out even if they are outside the two years, as there are arguments to make for extending the time period.
You are right. The defense submitted what’s called a “Motion for Summary Judgment” or arguments for why the District Court should dismiss the case outright based on an alleged deficiency in the evidence supporting the Plaintiffs’ cases.
The parties submitted their evidence, and the District Court judge ruled that Plaintiffs had presented evidence to the point where trial is necessary on the issues of whether brain damage is a risk associated with ECT, whether Plaintiffs suffered brain damage, and whether the defendant-manufacturer properly warned of the risk of brain damage. The defendant was willing to agree to a settlement for a confidential sum in order to avoid trial.
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 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.
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.
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.
Our position is that all of the individual Plaintiffs should withstand that defense for exactly the reasons you state: the consent forms are deficient and Plaintiffs did not get adequate warning of concussive brain injury, permanent memory loss, cognitive dysfunction, etc.
It is absolutely not assumed that patients sign up for any untoward outcome in risky medical procedures. In California, physicians (and psychiatrists) have no discretion to withhold warning of any unavoidable risk of serious injury or death – they must explain the risk in lay terms to patients. Even if the risk is stated in a consent form (which, for ECT, the risk of concussive brain injury is not), a jury might find that warning of the risk was too inconspicuous, insufficiently communicated, or otherwise inadequate in some way.
The crux of this action is that these federal adverse event reporting requirements that apply to ECT devices are designed to deliver adverse event information to medical providers/psychiatrists, and therefore prevent defects in the communication or warnings given to patients. The reported information shows up (always) in a federal medical database called the Medical and User Facility Device Experience (MAUDE) database, which serves as a hub of adverse event information that the medical professions use and discuss in order to ascertain risks inherent in the use of medical devices ranging from dental floss to ECT. Here is a link to the database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Plaintiffs’ position is that, if Defendants’ regulatory compliance were not deficient (it is), adverse event information would have appeared on MAUDE and would have been discussed within the psychiatric community (as would be expected of a responsible psychiatric community) and the informed consent procedures given to patients would not be as deficient with respect to warnings as they are. In that way, Defendants’ regulatory noncompliance caused, without informed consent, concussive brain injury, permanent memory loss, and all of the associated pathology, to the class.
Our position is that their comparison of this action to Akkerman v. Mecta Corp. is meritless.
You are not wasting my time at all. I intended to start a conversation with this post.
Near the end od our class certification motion, there is a discussion of two proposed methods of class notice. One involves essentially a HIPAA exception for litigation in conjunction with a protective order (more thorough but less likely to satisfy the Court for class certification purposes) or mailers to known class members in conjunction with a “PR blitz” (more likely to satisfy the court, in my opinion, but who knows).
I think you’re right about volunteers being capable of doing much of the leg work with respect to class notice.
If a class is certified, we will have to provide notice to the California class anyway, which would entail publicity. In that case (or if we proceed to trial on behalf of our five plaintiffs after denial of class certification) we intend to set up a Patreon account to hopefully help generate the financial muster to cover adequate expert testimony and fuel the debate on an even playing field against such powerful institutional forces. While DK Law Group, LLP is no slouch of a firm, and we have very strong evidence in support of our positions, we are up against a juggernaut here.
Next update will be after the certification decision, win or lose.
The unusual part of this Complaint is that it is seeking class certification for personal injuries. Normally, class actions involving product defects seek a remedy for the diminished dollar value of the product or cost of repair (or some other easily-measured metric of economic loss).
Here, we are seeking class certification of a case involving physical injuries, and are arguing that this is the rare situation involving physical injury in which class certification is proper.
It has happened in other cases before (asbestosis cases, atrocities by the Marcos regime, etc.) but only rarely.
Plaintiffs assert that the extraordinary circumstances and significant common questions surrounding ECT devices make this the rare situation where personal injuries are appropriately certified for class treatment.
We are absolutely seeking damages. The sought damages are pain, suffering, inconvenience, emotional distress, lost earnings, lost earning capacity, medical expenses, and punitive damages for those injured in California.
Our contention is that, while individual damages are variable, defendants’ conduct and the scientific/regulatory issues concerning the devices are common among every single class member, warranting a two-phase class action.
If a class is certified, anyone who suffered an injury from for which there was an inadequate warning would be an appropriate plaintiff, so long as he or she is willing to come forward. She would just have to acknowledge it.
The timing of the certification decision is within the discretion of the judge. Sometimes the judge will order extensive discovery before holding a hearing on certification, sometimes the judge won’t. It is variable.
With respect to the statute of limitations, it depends on what a jury thinks. If a jury says the defendants’ conduct made it impossible for a plaintiff to reasonably know the facts giving rise to his or her claim, or acted in ways that would make it intrinsically unfair for them to assert statute of limitations as a defense, they may be precluded entirely from asserting it. Our position is that this would be the appropriate result.
A denial of class certification would have no preclusive effect on any case other than ones asserting the same theory on behalf of the same plaintiffs in California.
Actually, physical injuries are rarely certified for class treatment. Almost all class actions involve economic injury.
A “bifurcated” class action is one split into two parts. Here, it would be split into two phases if all goes well: issues common to everyone first, then individualized ones later.
Those are questions that I can’t answer just yet. Tomorrow is the Scheduling Conference in which the District Court will narrow and clarify the issues and give us an idea of how the case will proceed.
The amount of plaintiffs and the value of any potential settlement will depend on the court’s view of the issues, most particularly the statute of limitations. It will also likely depend on the outcome of a class trial, if the court certifies the action in the coming months (years? Courts vary in the amount of time spent deliberating over class certification).
They would assert this point to shift some of the blame to third parties, so they aren’t the only entities responsible in the event of a massive judgment. This would be way down the road, though – a lot has to happen before we get to that point.
I’m sorry to hear about the injury you suffered, truth.
I meant to point out that the defense is asserting that all those psychiatrists who administered ECT are proper codefendants.
Plaintiffs assert that, to the extent a psychiatrist contributed to a class member’s injury, the manufacturers can sue him or her separately to satisfy a judgment against the manufacturers in this action.
We were under the impression that one hundred thousand was the number as well. Apparently, we were mistaken. As Defendants have written that section of the Joint Report, it suggests that psychiatrists induce major motor seizures through application of electricity to the crania of one million separate patients per year within the United States alone.
I promise we will do everything we can to work up the case to the best of our ability. Ultimately, the factual questions are for the jury, and the legal questions are for the judge.
Hey, thanks!
We think arguments like the one you’re making have a chance of gaining some traction in the courts, for the purpose of expanding the time during which an ECT victim can bring suit. A couple of the clients that had cases dismissed on statute of limitations grounds are making those arguments on appeal right now, to be resolved in the coming months.
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I will be doing an Ask Me Anything on Reddit about this on December 16, 2018 at 6am Pacific Time, for anyone interested.
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Jane,
To answer your questions, yes, we aim for those results, and think that more cases will move us in that direction.
Connor
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I think the FDA should have taken action as soon as it became apparent that ECT device manufacturers were not investigating or reporting complaints of injury in the early 1980’s. The FDA has demonstrated that it will require substantial pressure before it begins enforcing its own regulations re ECT.
I agree that a jury trial shouldn’t be required before patients are given adequate warning, but alas.
I’d expect MECTA to follow suit soon, but who knows.
We are still figuring out the best way to address the misbranding issue. Ideally the FDA would do something about it, but it appears private lawyers will be the ones who will have to raise the issue with the courts.
I agree, this whole issue is one of the most bizarre things I have ever encountered. It seems that right when the FDA announced it would regulate ECT devices in the late 1970’s and require premarket approval, the industry began taking the position that brain damage cannot occur from application of electricity to the cranium. It seems the incentive provided by insurance programs which cover ECT, coupled with the threat of tort liability for failure to warn, were enough to keep that lie in place for decades.
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Replying to “Rosalee”
I have a copy of the Court’s Order. If you’d like to email me at [email protected], I can send it to you.
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They have appealed their dismissal – we will see what happens. DK’s firm will be bringing the viable cases we can find from among the inquiries we receive, so spreading the word is important.
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You’re not wasting my time at all!
I think it would be smart for MECTA to start warning. I don’t think the disclosure will totally absolve them from liability, at least not for a while.
There will be an upcoming post that will clarify things.
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By the end of the suit, there were only two. The rest were dismissed, because the Court held that the other plaintiffs fell outside the statute of limitations.
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The court actually made clear it’s not a class action. These were just two individual cases, but the legal theory is the same for everyone (failing to warn of brain damage). It was also only Somatics, LLC that settled – the plaintiffs didn’t use MECTA devices.
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I agree.
No, psychiatrists and hospitals have a duty to specifically warn of brain damage and its consequences.
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Yes, that appears to be the page. Whether that’s enough to cover them legally in the future is a question for a jury. However, it won’t do anything to protect them from the cases of victims who underwent ECT in the past.
They are probably trying to shift the blame to the doctors, and legally, this will have the effect of shifting some of the liability to the doctors. I think medical malpractice cases for failing to warn of brain injury should be easier now.
Report comment
Somatics, LLC has included “permanent brain damage” in its risk disclosures on its website after our litigation. I’m happy to offer more information here, through my email at [email protected], or through [email protected].
Report comment
One of the defendants got dismissed since the plaintiffs didn’t use their machine. The plaintiffs settled against the remaining manufacturer-defendant. There are no trials currently pending, but DKLG is examining leads for potential new cases.
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The lawsuit was initially directed at both Mecta and Somatics. One defendant was dismissed (the plaintiffs didn’t use their machines), and the lawsuit against the other settled before trial.
Rule of thumb is that victims have two years from the date of treatment to file suit. There may be exceptions, and we’d encourage people to reach out even if they are outside the two years, as there are arguments to make for extending the time period.
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You are right. The defense submitted what’s called a “Motion for Summary Judgment” or arguments for why the District Court should dismiss the case outright based on an alleged deficiency in the evidence supporting the Plaintiffs’ cases.
The parties submitted their evidence, and the District Court judge ruled that Plaintiffs had presented evidence to the point where trial is necessary on the issues of whether brain damage is a risk associated with ECT, whether Plaintiffs suffered brain damage, and whether the defendant-manufacturer properly warned of the risk of brain damage. The defendant was willing to agree to a settlement for a confidential sum in order to avoid trial.
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This wasn’t our case, but I’d like to know as well. Could be useful.
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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.
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🙂
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I share your sentiments. We are doing our best – currently brainstorming ways to increase visibility and efficiency of the crowdfunding effort.
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Truth,
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.
Connor
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Truth,
I attempted to edit an earlier comment and ended up making a duplicate – whoops. See the real comment below.
Connor
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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.
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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.
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Our position is that all of the individual Plaintiffs should withstand that defense for exactly the reasons you state: the consent forms are deficient and Plaintiffs did not get adequate warning of concussive brain injury, permanent memory loss, cognitive dysfunction, etc.
It is absolutely not assumed that patients sign up for any untoward outcome in risky medical procedures. In California, physicians (and psychiatrists) have no discretion to withhold warning of any unavoidable risk of serious injury or death – they must explain the risk in lay terms to patients. Even if the risk is stated in a consent form (which, for ECT, the risk of concussive brain injury is not), a jury might find that warning of the risk was too inconspicuous, insufficiently communicated, or otherwise inadequate in some way.
The crux of this action is that these federal adverse event reporting requirements that apply to ECT devices are designed to deliver adverse event information to medical providers/psychiatrists, and therefore prevent defects in the communication or warnings given to patients. The reported information shows up (always) in a federal medical database called the Medical and User Facility Device Experience (MAUDE) database, which serves as a hub of adverse event information that the medical professions use and discuss in order to ascertain risks inherent in the use of medical devices ranging from dental floss to ECT. Here is a link to the database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Plaintiffs’ position is that, if Defendants’ regulatory compliance were not deficient (it is), adverse event information would have appeared on MAUDE and would have been discussed within the psychiatric community (as would be expected of a responsible psychiatric community) and the informed consent procedures given to patients would not be as deficient with respect to warnings as they are. In that way, Defendants’ regulatory noncompliance caused, without informed consent, concussive brain injury, permanent memory loss, and all of the associated pathology, to the class.
Our position is that their comparison of this action to Akkerman v. Mecta Corp. is meritless.
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You are not wasting my time at all. I intended to start a conversation with this post.
Near the end od our class certification motion, there is a discussion of two proposed methods of class notice. One involves essentially a HIPAA exception for litigation in conjunction with a protective order (more thorough but less likely to satisfy the Court for class certification purposes) or mailers to known class members in conjunction with a “PR blitz” (more likely to satisfy the court, in my opinion, but who knows).
I think you’re right about volunteers being capable of doing much of the leg work with respect to class notice.
Connor
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Your point is well taken.
If a class is certified, we will have to provide notice to the California class anyway, which would entail publicity. In that case (or if we proceed to trial on behalf of our five plaintiffs after denial of class certification) we intend to set up a Patreon account to hopefully help generate the financial muster to cover adequate expert testimony and fuel the debate on an even playing field against such powerful institutional forces. While DK Law Group, LLP is no slouch of a firm, and we have very strong evidence in support of our positions, we are up against a juggernaut here.
Next update will be after the certification decision, win or lose.
Connor
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The unusual part of this Complaint is that it is seeking class certification for personal injuries. Normally, class actions involving product defects seek a remedy for the diminished dollar value of the product or cost of repair (or some other easily-measured metric of economic loss).
Here, we are seeking class certification of a case involving physical injuries, and are arguing that this is the rare situation involving physical injury in which class certification is proper.
It has happened in other cases before (asbestosis cases, atrocities by the Marcos regime, etc.) but only rarely.
Plaintiffs assert that the extraordinary circumstances and significant common questions surrounding ECT devices make this the rare situation where personal injuries are appropriately certified for class treatment.
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We are absolutely seeking damages. The sought damages are pain, suffering, inconvenience, emotional distress, lost earnings, lost earning capacity, medical expenses, and punitive damages for those injured in California.
Our contention is that, while individual damages are variable, defendants’ conduct and the scientific/regulatory issues concerning the devices are common among every single class member, warranting a two-phase class action.
Connor
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Metal is my favorite genre. It helped me make sense of the world.
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If a class is certified, anyone who suffered an injury from for which there was an inadequate warning would be an appropriate plaintiff, so long as he or she is willing to come forward. She would just have to acknowledge it.
We will do our best.
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The timing of the certification decision is within the discretion of the judge. Sometimes the judge will order extensive discovery before holding a hearing on certification, sometimes the judge won’t. It is variable.
With respect to the statute of limitations, it depends on what a jury thinks. If a jury says the defendants’ conduct made it impossible for a plaintiff to reasonably know the facts giving rise to his or her claim, or acted in ways that would make it intrinsically unfair for them to assert statute of limitations as a defense, they may be precluded entirely from asserting it. Our position is that this would be the appropriate result.
A denial of class certification would have no preclusive effect on any case other than ones asserting the same theory on behalf of the same plaintiffs in California.
Thanks for your words of encouragement.
Connor
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Pablo,
Actually, physical injuries are rarely certified for class treatment. Almost all class actions involve economic injury.
A “bifurcated” class action is one split into two parts. Here, it would be split into two phases if all goes well: issues common to everyone first, then individualized ones later.
Connor
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Those are questions that I can’t answer just yet. Tomorrow is the Scheduling Conference in which the District Court will narrow and clarify the issues and give us an idea of how the case will proceed.
The amount of plaintiffs and the value of any potential settlement will depend on the court’s view of the issues, most particularly the statute of limitations. It will also likely depend on the outcome of a class trial, if the court certifies the action in the coming months (years? Courts vary in the amount of time spent deliberating over class certification).
In short, we don’t know yet.
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They would assert this point to shift some of the blame to third parties, so they aren’t the only entities responsible in the event of a massive judgment. This would be way down the road, though – a lot has to happen before we get to that point.
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I’m sorry to hear about the injury you suffered, truth.
I meant to point out that the defense is asserting that all those psychiatrists who administered ECT are proper codefendants.
Plaintiffs assert that, to the extent a psychiatrist contributed to a class member’s injury, the manufacturers can sue him or her separately to satisfy a judgment against the manufacturers in this action.
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Bramble,
We were under the impression that one hundred thousand was the number as well. Apparently, we were mistaken. As Defendants have written that section of the Joint Report, it suggests that psychiatrists induce major motor seizures through application of electricity to the crania of one million separate patients per year within the United States alone.
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I promise we will do everything we can to work up the case to the best of our ability. Ultimately, the factual questions are for the jury, and the legal questions are for the judge.
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Truth,
You may be interested in both sides’ expressed views in section 6 of the Joint Report, entitled “Additional Parties.”
Connor
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Thanks Bramble. I know it sounds like a bunch of jargon. I’d be happy to explain anything, if you’d like.
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