Case Files 21: Rady Children’s Part 5
Andrea and Dr. Bex also highlight the complexities of medical malpractice, particularly in neurosurgery, emphasizing the risks associated with experimental procedures and the importance of informed consent. They also explore a darker side of medicine—where financial incentives might be shaping decisions more than patient outcomes and niche specialists become gatekeepers to high-risk surgeries. The conversation culminates in a whistleblower complaint that reveals systemic issues within the field.
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Transcript
True Story Media.
Hello, it's Andrea.
And today, Dr.
Becks and I are taking a little detour on the windy road of the Ready Children's case to discuss one of the doctors at the center of it, New York neurosurgeon Dr.
Paolo Bolognese.
To say that this case just keeps getting stranger is an understatement.
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Many of you know that I have a new book out this year called The Mother Next Door, Medicine, Deception, and Munchausen by Proxy, which I co-authored with friend of the show, Detective Mike Weber.
Did you know that it's also an audiobook that I narrated?
All true.
You can find the Mother Next Door Ears Edition anywhere you find audiobooks.
Now, here's a sample.
Unlike with Hope, there was no carefully crafted facade of a loving mother doing her best.
Brittany's abuse was in plain sight, observable by all who interacted with her.
But no one knew what to do.
It seemed impossible to prove that Alyssa didn't have these medical issues.
And after all, why weren't the doctors doing something?
But even if people in Britney's life suspected she was mistreating Alyssa, they had no idea what she was truly capable of.
And the darkness in Brittany would shock them all.
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Well, hello, Dr.
How are you doing?
Hi, Andrea.
I am good.
This has been a fun one.
Let's just say that.
Well, to give listeners a little behind the scenes for
how we got into this mess of a topic, so there is a doctor called Dr.
Paolo Bolognese.
He's Italian, if you couldn't put that together on your own, but he is in New York and he came up in the Rady Children's lawsuit that we have been covering, where he is positioned as a credible doctor who is on their side.
And we'll get into that a little bit more, how he, the role he played in this case.
And in Bex's research, she came across some rather alarming things.
Just on a quick Google, you will see that there is one of the first, I did that this morning just to see how accessible this information is.
And on the very first page of his results, there's a headline that talks about how he has 20 malpractice lawsuits against him.
And so we thought, let's do a little deep dive on this doctor.
And
my researcher turned up more than 40 lawsuits.
And we do not believe that we have all of them.
So needless to say, there is a lot to say about this particular doctor.
So that is just to say, we do not know the status of all these lawsuits.
However, they are remarkably similar in their allegations.
So we are going to talk about that.
We are going to, and we are going to talk about how this fits into the Rady Children's lawsuit.
For now, we will definitely be covering this case as it unfolds.
And we have found about 20 million rabbit holes to go down just in our brief four episodes that we have done so far.
So, um, just to give a reminder, if you have not been following along with us on Rady Children's, you will still be able to understand what's going on today.
So, this lawsuit is on behalf of Madison Meyer, who is now in her 20s, and her two parents, Dana Gaske and William Meyer,
who are suing Rady Children's, among other defendants in this case.
They are alleging that there was a very large conspiracy against the two of them that involved
both falsely accusing and falsifying evidence of Munchausen by proxy abuse over a period of time.
And also, importantly,
they are alleging that their child was induced to make allegations of sexual assault by a psychiatrist or psychologist implanting memories of sexual assault in her while she was in the hospital, which then led to a suicide attempt where she left a note that said she would rather die than return to her parents.
So again, Meyer and Gasquet are alleging that this entire thing was a conspiracy amongst the child protection workers in San Diego, the clinicians at Rady Children's, and even the treatment center where Madison went to after her suicide attempt.
So a very large precedent setting in the history of the world, if true set of allegations.
But what we're talking about today is Dr.
Paolo Bolognese.
So Dr.
Bex, if you could kick us off with what does Dr.
Bolognese do and talk about his,
this thing that he specializes in, this Chiari malformation.
So Dr.
Bolognese actually did his training, as Andrea said, kind of obviously.
He grew up in Italy and did his training there
and graduated, it looks like, from medical school in 1986.
And then after that,
in the 90s, he came out to New York to work with a specific neurosurgeon named Thomas Millerat, which will come up a couple times during our discussion today.
He did do a neurosurgery residency and a fellowship in the management of Chiara malformation here in the United States.
This does happen with, you know, foreign medical graduates or graduates of medical schools outside of the United States will decide to come over to the United States or go vice versa to other countries and do a follow-up residency fellowship to then be able to practice in the United States or in another country.
And so that's what he did.
And his specialization or the thing he seemed to focus on during his training is management of something called a Chiari malformation.
And when he came over and after he did all his training is when he and Dr.
Millerat formed what was called the Chiari Institute.
So that is where a bulk of these cases come from that we're going to talk about today is when they were working or when he was working at the Chiari Institute.
Currently, he is working at a location called the Chiari EDS Center.
So this is where his story or his
specialization in the Chiari malformation kind of
takes hold or starts to kind of come to what he is now, where he is linking things like Chiari malformations, which we can talk about, tethered cord, and other neurologic issues with Ehlers-Danlos syndrome.
So that he has really,
he's kind of evolved into what sounds like a neurosurgeon who very much works with patients who have both connective tissue disorders or things like Ehlers-Danlos, and then potentially also these neurologic issues.
And so that's why now he's the head of what is called the KiRe EDS Center.
So working with both of those things in conjunction.
But I think the start of our story, and what we're going to focus on, is more his work at the Chiari Institute with Dr.
Millerat.
Yeah, and so it sounds like this connection with EDS has been kind of an evolving part of his work.
So, he was at the Chiari Institute with this other doctor
until September of 2014
and then established the Chiari Neurosurgical Center, which eventually becomes the Chiari EDS Center.
What do we we know about the sort of peer-reviewed science around this idea that there's a connection between EDS and
Chiari malformation and tethered cord syndrome, which has become the focus of his work?
So, a Chiari malformation is a very, I mean, it's a very well-known entity in medicine, just to be clear.
It is the idea of your cerebellum, which is your posterior brain.
It helps control all of your movements, and it sits kind of right here at the back of your skull.
So, the idea is that it can actually slip or basically start to what we call herniate through the hole at the bottom of our skull.
So the idea is your brain stays within your skull and then comes your spinal cord.
The idea of a Chiari malformation being affiliated with connective tissue disorder, Ehlers Danlos, if you kind of think about it, in your head, you can kind of come up with how that could make sense because both involve some kind of a weakness or structural weakness.
So I think the concept came from if there's ligament laxity in that area and all these these other things that go along with Ehlers-Danlos, is there a chance that they'd be at higher risk of that kind of slipping happening?
Or is it one of those things that it's a correlation, but is it really a causation?
So that's kind of two of the words we use in medicine where correlation is the two seem to have some interplay with each other.
And maybe you do see one a little bit more in the other.
But true causation that this child has a Kiari malformation because they have Ehlers-Danlos is where we're lacking a lot of information.
A lot of it is case studies and very small, what we call cohort studies, so very small number of patients.
And what we're missing is something called a randomized controlled trial or a large randomized controlled trial.
And there are things in medicine that that's difficult to do.
And so a lot of it comes down to, you know, there are neurosurgeons who believe in this connection.
There are centers that very much focus on this connection, but it is still very much case study-based.
If you look up the articles that are out there, the ones I could find seem to have at least one of these physicians that pops up in these cases about, you know, as part as one of the authors.
So it's kind of, it does seem to be a smaller circle of neurosurgeons.
And I want to make a point that there's something we call consensus.
When we like review articles or look back
at studies that are done, one of the things we talk about is standard of care or consensus.
It's not always that the American Association of Neurosurgeons came out and said, this is the gold standard for this condition.
But if you asked a bunch of neurosurgeons who are practicing standard of care medicine, they would agree that this is a procedure or that this is the standard.
And so it hasn't gotten to the point that maybe it's actually officially become a guideline, but it is something that is agreed upon based based on knowledge, based on research, based on what is out there in the literature, that this would be something that is there.
And that's what's missing, that true like consensus or guideline on this connection.
Got it.
Okay.
And yeah, I think those are important caveats.
And I think, you know, when we're talking about conditions like Eller Stanlos, and certainly in my research and your research for this case, and just the feedback that we've gotten from listeners, we have heard from so many people who suffer from EDS.
And and also and POTS, which is another one that came up in this case.
And I'm certainly getting the impression and we're going to dig deeper into the EDS stuff
and the connection to this case, but I certainly get the impression that this is something that is emerging as being a more common diagnosis than it was previously thought.
And that happens all the time, right?
I think so much of this confusion can happen.
And unfortunately, so much of this opportunism in some cases can happen because things are not well understood and because people are not getting diagnosed and they're not getting good care.
And then that kind of can leave this vacuum and leave people to, you know, and I think like I want to put the caveat that like experimental treatments are not always bad, right?
That is how we get to good treatments.
And, you know, as long as they're done safely and ethically, that is how medicine evolves.
And so I think like that's all worth,
that's all very worth caveating.
So before we get into
Dr.
Bolognese,
can you explain?
So we've covered the chiari malformation.
What about this piece of the tethered cord?
What does that mean and how is it thought to be related to EDS?
So a tethered cord refers to at the end of our spinal cord.
It's kind of weird to think about, but the little, the nerves at the end of our spinal cord called the conus or that lowest point or the phylum terminale is another term that you'll hear used.
It's free floating in our spinal fluid.
So like if you watch it on dynamic imaging, the little nerves at the bottom of your spinal cord are kind of floating in your spinal fluid.
So the concept is a tethered cord is where those nerves, instead of being kind of allowed to free float and send off their signals, they can actually tether or attach to the side of the spinal canal itself.
So what we think of most cases is primary tethered cord, meaning a child who is born with a tethered cord.
And that is usually associated with other things like spina bifida, which my cousin suffers from.
so i know a lot about it just from my family and he also had a tethered cord
or kids who are born where that phylum is thick for some reason meaning it's it's got like extra tissue or it's thickened or it's more fatty and that obviously doesn't allow those nerves to float around as much as they want to or can and then also something called a sinus tract where there's actually things don't close up like they're supposed to and so there's openings where they shouldn't be.
All of that can be associated with a primary tether cord.
There is something called a secondary tethered cord, meaning you get it or develop it later in life.
In most cases, that is related to scarring from previous surgeries, traumas, tumor resections, anything where you actually get in that area and could cause scar tissue.
Once someone has scar tissue in a certain area, they are at risk then of later.
symptoms or complications.
And so a tethered cord causes, if you think about it, because of where it is, it's all issues kind of from your waist down.
So it's numbness, shooting pains in your legs, typically bowel and bladder issues because of the location of that.
You can have issues with how you walk.
And the way we diagnose it in medicine, the standard of care gold standard is an MRI.
And it's what's called a static MRI, meaning you're just taking pictures for in one moment in time.
And you may see the actual tethering of the cord.
If you look it up, the pictures are kind of cool, but it's actually tethered, or you will see that that area is thickened compared to other patients.
So, this, if it makes sense, talking about Ehlers, Danlos, and Chiari malformation, the idea is, again,
if all of your ligaments are lax and if there's issues with how your collagen forms or how all of those tissues form, In EDS, could they be at higher risk of allowing this cord to kind of be more thickened or be more tight?
Or over time,
there is some, there are some neurosurgeons who say that it could kind of tether secondarily because of all the stress due to this underlying disorder.
What is different, I think, about tethered cord versus Chiari
is they are calling something, what's called an occult tethered cord, O-C-C-U-L-T occult.
that the idea is the MRI is normal, so you don't see the tethering, you don't see the thickening.
And the idea is because they're having the symptoms of a tethered cord, they can still benefit from a procedure untethering the cord.
Okay, so it's more of a clinical diagnosis.
Right.
And it sounds like from my research that, so we have tethered cord, real thing, subject of medical consensus, a cult tethered cord, presumably no connection to witches, and also maybe not a subject of medical consensus.
That's where the differing views come.
I think true classic tethered cord, true classic Kiari, there is a lot of research on, although again, the randomized controlled studies are maybe a little bit lacking, but much more long-term data, studies, things to show.
And a lot of the cases are asymptomatic, watch and wait.
High enough risk, you may intervene preemptively to prevent symptoms.
Low risk.
Incidental finding, meaning you do an MRI because
the kid fell and hit his his head and you find a KiRi but no symptoms, you may watch and wait.
And then if imaging shows it, symptoms go along with it, concern for long-term symptoms, at that point, it becomes more of the surgery becomes much more the standard of care.
If you look at it, most times a KiRi repair or a tethered cord repair are considered elective procedures because the decision is made that the benefit of the surgery, right, would overcome the risk of the surgery.
So even though it's technically, it's not emergent, you don't have to do it today or something bad might happen, but the idea is it is now recommended because you're having the symptoms.
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Morning decisions.
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This is context that makes a lot of sense to me because, you know, when you have like the symptoms of a chiropractor malformation, you know, this is one of those things where it sounds like some people have this malformation, no symptoms, no problems, just might be walking through their life not knowing they have this.
And then for others, it can cause headache, neck pain, unsteady gait, you know, and can obviously those things can be debilitating.
So,
you know, it sounds like it's kind of a range.
I've had kids who can't swallow.
They, they develop aspiration, dysphagia.
Those are the more severe cases.
And those are the ones I've seen actually diagnosed much earlier and younger.
And even those are difficult because you're doing, I I mean, again, guys, this is neurosurgery.
I mean, I just want to put that out there.
Like, this is brain and spinal cord.
This is everything without it.
I mean, so scary, right?
Yeah.
And I know that, like,
I know that there's a lot of conversation, which actually my producer, Greta, also flagged for me is that there is a lot of conversation within the medical community.
And I've even kind of watched this evolve.
You know, both of my grandfathers were doctors and my sister was also at one point a medical professional,
for those who don't know.
And, you know, she had this back surgery when we were teenagers.
And I just remember like when we were talking about sort of this concept, and I actually had a back injury when I was in college that was a sports injury, right?
And I saw PT for it.
And like, it's obviously like having back pain is very, you know, and then I had another one where I like fell off a rock climbing wall and crushed the facets in my back.
And like, you know, for both of those, again, that was actually really painful.
But like for both of those things, I just ended up doing PT and that was very effective for me.
But I know that sort of there's been, you know, in the last 20 years, like a lot of shifting conversations about having surgery on your back for pain because
it's so high risk.
You know, you could be having a lot of pain and there wouldn't necessarily be anything on an MRI.
And it's just very, very complex.
So I won't get out of my lane here, but this makes sense, I think, in a context.
But I think having that full approach is a very important piece that
if they are not in the right place to have, I'm talking more in the more elective elective versions, but like if they're not in the right place to go through a major surgery, that could have devastating outcomes.
You know, if the pain was not managed before, the question is, how will we manage the pain after?
Because there may be a period of time where pain is worse.
And so.
Patients with Ehlers Danlos, to be fair, because of all the laxity and everything, they do live with chronic pain.
A lot of them do.
And so, but that changes your tolerance to pain as well.
So post-operative pain is going to be different than preoperative pain.
I'm not saying better or worse.
It may be different.
And so I think always prepping anyone going into this kind of a major surgery for what this might look like, what our plans are to manage it, and really making sure it's that whole, the whole team approach.
And I'm not talking more tests, more of this.
I'm talking behavioral health, maybe if it's appropriate, a pain management team, if it's appropriate.
If we prepare ahead of time, I feel like the outcomes are better after
versus promising things or someone coming into it thinking this is going to change everything and change my whole life.
But honestly, if you still have Ehlers-Danlos, some of your chronic pain may still be there.
And I think being very upfront about that, that maybe we're hoping this, whatever it is, might work, but understand that there's still all these other things playing into it.
Yeah.
Yeah, that's good context.
So, in terms of how
Dr.
Bolignes
shows up in this case,
in the lawsuit, he is very much presented as a respected neurosurgeon who first evaluates Madison in 2019.
So
she had this diagnosis previously of Ehlers downlose, but Dr.
Paulo Bognese is called out as confirming this diagnosis of EDS and then adding the additional diagnoses of POTS and fibromyalgia, which is a chronic pain disorder.
So it also says that he ruled out any signs of medical child abuse.
So this is something that comes up in a lot of these cases.
And I will say there are several other doctors that are named as sort of ruling out or not seeing signs.
The exclusion criteria.
Right.
So an individual doctors were saying like one individual doctor, especially when a child is seeing, you know, many doctors, one individual doctor not seeing signs of medical child abuse.
is not in any way exculpatory.
It is, you know, one piece of a thousand piece puzzle.
So just because you have some doctors that either don't believe that medical child abuse exists
or find the parents credible or didn't have a bad experience with the parents, like maybe the parents saw that doctor and they didn't do any of those behaviors with that particular doctor.
If they're not reviewing the entire medical record, then they are not qualified to say whether or not medical child abuse is happening.
But this doctor definitely plays a very prominent role in this case, and he performed what's called a celiac plexus block that was was to help alleviate some of Madison's pain.
So Bex, can you explain what that procedure is?
So there is something called median arcuate ligament syndrome.
These all have these acronyms.
So it's MALS, it's M-A-L-S.
The idea is...
In our abdominal cavity, we have a lot of things that are supposed to develop and form and be in the right place and not compress anything else.
The problem is anytime you have blood vessels, nerves, ligaments, organs, all in one place, there's a chance that one will impinge on the other and cause problems, kind of in very general terms.
And at times of, let's say, rapid weight gain, rapid weight loss, there are times where things may shift.
The argument is made that if you have Ehlers Danlos, so you do have that laxity, that things may kind of shift or move.
maybe more than in other people.
And again, it's all kind of a perfect storm, meaning some of these things, most of these things that I just mentioned, at any given point in a person's life, they may have one of these, but your body overcompensates.
And again, you may just incidentally find out that you had one of these things.
Now, in this case, it's a ligament, so part of the diaphragm, which is what helps you breathe, and it compresses what is called the celiac artery that
gives blood flow, I guess, to your intestinal tract.
The idea is if that band or that ligament is kind of pushing on the artery, it would decrease blood flow to your intestines and potentially cause pain or symptoms.
So the idea is if you do this, what is called a celiac plexus block, you are going to block those nerves, potentially the pain goes away.
So it can be one way to quote unquote diagnose this is if you do this block and your pain goes away, it kind of indicates that maybe that was the cause.
It's kind of, if I numb that area and it feels better, maybe that is the cause.
Now, what's interesting to me is a neurosurgeon doing this was is a, I mean, I've had, I know a pain management doctor who does it, GI doctors who do it.
And I know this was like a multidisciplinary team in New York, but it sounds like this was Dr.
Bulgnesi who did it.
That was just an interesting piece because to me, this is more of like a GI diagnosis.
But so this was one where he did the treatment, proved it worked, and therefore kind of said she probably had it.
Interestingly, there are some studies that show 25% of people, if you did scans, would have this compression with no symptoms at all.
So asymptomatic.
Interesting.
So we've got kind of a case here of, and I think this is true, like bodies are just imperfect.
And
one of those things that like, I mean, I remember when I had had an MRI, when I had one of my, again, not super serious, but like one of my back injuries.
And I found out that I have like a genetic thing where there's too many nerves like in one bundle.
And they're like, like oh that's something that could cause pain but like i've had it all my life and i haven't had back pain except for when i've had these sports injuries so like i was like oh that's interesting but it's like you can see how oh there's just so many things that could be going on in your body and for some people they cause pain and for other people they're completely asymptomatic same thing with like genetic predispositions we had a bunch of testing on uh when i was pregnant with my son because we had like a weird test result everything turned out fine he's fine he's beautiful he's perfect he's almost three um but you know we went down this whole rabbit hole talking to the genetic uh counselor and just like, Oh, do you want to test for this?
Do you want to test for this?
Do you want to test for that?
And I was like, No, thank you.
I would like to sleep before I, you know, like not
just stress myself out.
And so, I think it's like it's amazing that we have access to such, you know, to such information.
And it also like can be anxiety-inducing and at worst, you know, give sort of a reason to continue doing procedures on someone that does not need to.
Yeah,
and that this and that this child is surgical, yeah, yeah, it couldn't could not be more serious, right, than getting brain and spinal surgery.
Uh, I think we have enough information to say that the allegation that this was a giant conspiracy of the hospital and all these other people is wild as an allegation.
Um, and certainly, like, Madison is increasingly fitting this picture where she has, you know, this collection of rare things, she has the worst possible symptoms, she needs the most invasive procedures, and we are taking her to a doctor across the country who is not a doctor, I would let within 100 yards of one of my children.
And now we are going to talk about why.
So as we were digging into this,
we unearthed more than 45 lawsuits
that we have our hands on.
A bunch of these record requests are still open, so we may find more.
We will follow up.
So before we get into what's in these malpractice suits, the majority of them are malpractice suits,
I want to just give us a little context for malpractice.
And Bex, I would love, of course, your opinion on this as well, because this is something that doctors deal with in America.
We have to think about, unfortunately, in the world.
Yeah, yeah.
You know, every year, only 7.5%
of physicians get a malpractice claim, and only about 17% of these claims result in a payout to the patient.
So most claims are either dropped, dismissed, or resolved without any kind of payment.
But importantly for this story, some specialties get sued a lot more than others and neurosurgery is at the top of this list.
So these numbers are pretty interesting.
I was going to say something because neurosurgery is at the top and pediatrics is actually near the bottom, which is interesting.
That was interesting.
And I was like, well, I think there's some people who are out to change that.
But yeah, that is interesting.
And what do you like, Bex, when you see that?
So OBJYNs were also at the top.
And I'm kind of assuming that's just because pregnancy is something where a lot of complications can happen.
I think it's just like when you look at the specialties that get sued so much, it's where there's really high stakes and where outcomes can be bad, regardless of how good your team is, right?
Right.
It's not a fault of an OB guy every time there's something that happens, it's the circle of life, it's everything that goes into what a pregnancy means.
Um, and so I agree with that.
I think neurosurgery makes sense.
Like I said, this is your brain and your spinal cord, it controls everything else.
So, again, outcomes, it is a high risk, but a high reward also when things go right because of what you may regain.
But there's also what may come after.
And I think thoracic surgery is another one.
That's heart major blood vessels, again, makes sense.
Lungs and then Ob-Gyne, the least are psychiatry, pediatrics.
Pediatrics is interesting to me.
It makes me think, I think there's, I don't know if there's shorter stories or like there's a longer, like adults if you think about it they come in with a lot more comorbidities and a lot more other things that may put them at higher risk of of outcomes happening um versus a child who hopefully when you're coming into this has a pretty clean slate or like there's not so many other factors playing in but i would think the pediatric suits that are there at least from what are much more devastating because it is a child that is potentially harmed slash you know had something bad happen well yeah and i think like in general um and again this is just my reflection, but like, people usually feel good about their pediatricians.
People do not feel good about seeing child abuse pediatricians.
So, obviously, this was not, this was not segmented out
as a subspecialty.
So, I think we don't have, you know, I don't think we can assume that that.
pediatric data includes child abuse pediatricians, which are, which is a much smaller subspecialty.
But so, in, you know, in these statistics, the average payout in 2022 was about 379,000.
So, I think we probably see big numbers in these.
Again, you know, this is only 17% of them end up with some kind of payout.
And it said higher payouts tend to be associated with surgical error or delayed diagnosis.
So something really serious and probably like very provable would be my guess.
So with neurosurgeons, I thought this was really interesting.
So it's just a little under 20% of practicing neurosurgeons in the U.S.
get a malpractice claim each year and is the highest of all the subspecialties.
And by age 65, nearly all neurosurgeons will have been named as a defendant in at least one malpractice claim.
So that said,
Paolo Balignesi is still very much in the minority here.
So yes, so over an entire career, if you're a neurosurgeon, you practice for decades, you know, it's likely that you will face a couple of claims.
However, if you have more than five or 10, you are already in a very small percentage.
If you have 11 claims, that will put you in the 95th percentile.
So, 40 plus known claims, and he's not elderly.
I can't remember what age he is.
You know, this is a late middle-aged people.
He's still practicing.
He's still practicing.
And this puts him, I mean, this puts him in a very, very small percentage of people to get sued this much.
So, in looking at these lawsuits, we're not going to go by them one by one.
And one, one or two of these, I think we will do a deeper dive on because these are really interesting cases.
But the claims across these lawsuits really paint paint a very consistent picture.
And so, this is coming from, I don't think that we have any reason to believe these plaintiffs are in some kind of conspiracy with each other.
So, the fact that this is not a class action lawsuit, so
you know, these are individual claimants, and the
things that he's being accused of.
So, this is all alleged, but the things he's being accused of are remarkably consistent.
So, these are the things that came up again and again: that he was performing medically unnecessary and experimental neurosurgeries,
that he was misdying.
Can I comment on that?
I have like a little note.
Absolutely.
Yep.
I was going to say that the word experimental, just so I think people kind of understand it goes back to what we were saying about these ideas not being maybe validated, meaning they're newer procedures, which does happen anytime a new procedure comes out.
There may not be those bigger trials to say, but that probably means that most of them are not what you would consider standard of care.
And what happens is that also means that insurers are not going to be potentially paying for these because if an insurer sees there are alternatives to treatment and this is an experimental procedure, it may not be covered.
And so experimental is not always a bad thing.
It's how medicine happens sometimes, meaning you have to go through a stage.
The other thing is, is whether you're kind of disclosing that this is something experimental when you're doing it.
But I think just to be clear, like these American Association of Neurological Surgeons, all of them, there are guidelines on the things that are done the most frequently.
There are places where they don't have guidelines yet, but there's still that consensus among neurosurgeons.
And then there's the experimental, and that can be for many reasons, but that it does, that word experimental does come up.
a couple times at least in these cases.
Yeah.
And I think it's more the whole picture that comes through for these lawsuits.
So it's not just the experimental neurosurgeries.
The other thing that comes up a ton in these lawsuits is misdiagnosing patients to justify doing the procedures.
The other thing that comes up is failure to disclose the surgical risks and that these are experimental treatments, right?
So as you said, you know, experimental treatments are a part of medicine, but you would, again, that should be something that is like a last resort after you've tried the rest of, you know, and you're really like in a desperate situation
and there's nothing else left to try.
And certainly, a doctor who's doing that should disclose to you, you know, we've seen promising results with XYZ, you know, or however they couch it, but like it should be informed consent, right?
And that's important in medicine of all branches, all fields, but specifically surgical.
I mean, informed consent is very established.
The idea that you are disclosing the facts, you're telling them why you're doing it, you're telling them the benefits, you're telling them risks, and you're telling them the alternatives.
And to me, that piece of this is experimental should be part of that.
Saying the words, there may be risks we don't even yet know about, right?
When you're talking about it, if only so many have been done.
We want to make sure that the parent or the patient is voluntarily agreeing so that at the end, when they're signing consent, it's not because they feel like they have to or like their hand is being forced, that they are actually doing it because they are choosing the procedure and that they aren't, you know, there isn't some other, you know, motive of the physician or of the person signing the consent, that they're doing this voluntarily, you know, without any other motive than they understand the procedure and that's what they want.
And I think in pediatrics, this still gets me a little bit in the terms of the child is not consenting, the parent is consenting, which is,
yes, that's how we work in this country.
That is who signs for things.
But just keep in mind that the people receiving consent in some of these cases was not even the patient themselves.
Yeah.
And then, I mean, this becomes really layered when you're talking about possible victims of munchausen by proxy, because then, like, yes, for a patient, for a non-abusive parent, right, you would, then the question is, was that parent properly informed of the risks and able to make the best decision for their child?
And then, when you add the layer of that parent, might not be interested in what's best for their child and they might have their own ulterior motives, that then adds just this other layer of complexity that is so dark
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So, the other two claims that came up across these lawsuits were using unapproved medical devices, notably this infused device, without consent.
So presumably using something that they did not let patients know was not, you know, was not an approved medical device, which is a lot more in terms of ketamine, where it's FDA approved in very specific situations, but not in all situations.
And what it sounds like, at least from my reading, is that they were using it, what we call off-label,
but they were not being informed necessarily that, yes, the FDA does approve it for certain things, but not for this specific consideration is what it sounds like.
Again, like using things off-label is something that happens all the time.
I've been prescribed something off-label that was very effective.
And it's sort of like one of those things where you want to be able to give people the best available care as long as there's good information about it, even if it's, you know, not yet FDA approved, because that's, it can be a lengthy bureaucratic process.
But certainly something that patients should be informed of.
And then the last one, which I think is kind of the cherry on the Sunday of this whole thing, is engaging in deceptive marketing and misinformation, including through the website.
And so I think this whole thing is sort of
looks like a worst case scenario of what can happen in our for-profit medical system.
You know, these procedures were very expensive.
The most frequently quoted number was $55,000.
And again, because they're experimental, they're not going to be covered by insurance in a lot of cases.
So there was, you know, these details of them telling patients that they could try to submit it to their insurance to get covered, but often that they did not get it covered.
So these patients are paying out of pocket for these very, very expensive procedures.
And again, when you have that much of a profit motive, it really calls into question
why
they are doing these things outside of the realm of what, you know, of medical consensus.
Are they operating under their Hippocratic oath to do no?
And it's become everything they're doing.
Like their whole
life, this is everything.
It's not one of their things they do.
Yes.
So it sounds like, yeah, can you tell us a little bit more about that, Bex?
Of like, this is not a procedure that they do in very specific circumstances.
It sounds like that is, and I mean, even just the side, the number of lawsuits that are associated with this speaks to that, right?
You know, it's giving the picture of everyone who walks through a door gets this diagnosis and gets recommended to have this procedure, which is very concerning.
And I think that's, that's what I try to explain to people that's so hard is a niche practice where this is all they do.
A doctor who did all of their research on one genetic condition, it's named after them.
There's one, like that's everything.
To be fair, I say this all the time that I want to keep a bit of a, I need like a sounding board for cases of Munchausen by proxy abuse because of course I do all my research.
It's everything I do.
So I love that I have residents and teammates and other people that do other things and they can have their own opinions and ideas.
And this idea of a multidisciplinary approach, I think, is so important because once you get so niche, It's a little bit hard to see, what is it, the forest for the trees or whatever, that, you know, you assume if someone's there, there's already certain things that line up.
And then you're doing your whatever review and then doing your testing.
But again, all of that can be clouded by them being there kind of in the first place, if that makes sense.
Like they walk through the door, there must be something bringing them there.
And once we get into clinical diagnoses, these ones that there is not a gene test for, that even though there is a test like an MRI for, these ones don't meet that normal criteria.
It becomes very subjective.
And that's when I get a little bit worried that whether intentional or unintentional, it is easier to see the thing that you work on every single day.
It's a bias, like no matter what.
And so you have to have that grounding.
But if your entire center institute, everyone, this is all they ever see and this is all they do.
And then it leads to the surgery that brings in, to be fair, more money.
And then there's the follow-ups.
And then that's your research.
You know, there's these centers that it's also, they're the ones.
doing the research on this niche medication, niche surgical procedure.
So then their results become the research that then furthers more, that then brings more to their clinic.
It's this cyclical thing where nobody is outside of this niche.
Yeah, no, it's all, it's all true.
And so that another thing that sort of came up again and again in these lawsuits was this idea that patients, including children, were being used as test subjects, which is dark.
And the idea that they're doing these procedures as part of their research and then using their own research to uphold them doing these procedures.
And I think it also just like, you know, unfortunately, like, again, I think that we see, many of us see where this is the worst system
to have,
where like medicine is a business, right?
And I think because these are, as you said, elective procedures,
it's not to say that no one who has these conditions could ever have surgeries, but this place in particular, I mean, it starts to sort of cross over into this idea of, you know, like a ketamine clinic, like Dr.
Kirkpatrick's, right?
And especially when you're treating stuff that is very real, but also very subjective and very based on the reports of a patient or, uh, or a caregiver, right?
Where you're talking about things like chronic pain, um, where there's just a lot of like abuse that can happen by doctors who are profit motivated.
And there are a lot of these, you know, maybe same considerations about risks and informed consent and all that kind of thing.
But with that said, like, if you have a business and you're building a business off doing this procedure, as these people appear appear to have then you're sort of looking at uh it sort of becomes a relationships of clients instead of patients and i think that that really fundamentally changes things
and when you are looking at someone who the allegations are this sinister and disturbing then you need to look at okay why why would someone who's a neurosurgeon do this and in this case there is a pretty clear-cut financial motive um So the money piece comes up in a bunch of these lawsuits.
And the majority of the lawsuits we found had to do with the Chiari Institute, which is where Balangesi was until 2014, but there are several that have to do with his work afterwards.
And again, we do not believe that we have found all of these.
So TBD on that.
But, you know, that they were out of network for major insurance plans.
And so that, you know, there was times where they could get partial reimbursement, but also that the surgeons' fees were billed separately and often exceeded what insurance would cover, and that they paid substantial out-of-pockets, amounts sometimes exceeding $50,000 per surgery.
So, in multiple of these complaints, the families allege that they were required to pay tens of thousands of dollars up front or were billed exorbitant amounts post-operatively for procedures that were later deemed unnecessary or experimental.
So, I think that if we are to,
you know, posit a motive, I think follow the money and that appears appears to be there.
And of course, as a physician, I want to believe there was a point at which they saw some connection between Ehlers-Danlos and these things, and they felt like they were the ones that were maybe having worse outcomes or maybe weren't getting the care they needed.
I worry about parents, patients who are just looking for answers and reasons for why do I hurt so bad every day?
Why are my headaches so bad all the time?
And they find this website and it seems like the freaking like light from heaven goes on, and you're like, oh my God, this is me.
So you go and they offer something.
And it's not until you're what, five, I mean, some of these people had greater than 20 surgeries done, you know, that like, how many surgeries are you like, oh, what did I do?
You know, if you really still believe in this.
And then there's also the flip of that, where there are parents and are patients who are specifically finding these places because they know you don't have to go through the same pipeline or series of events to get there.
And he says he reviews the medical records.
Maybe that is to make sure you've done X, Y, and Z, but that's not clearly delineated here.
And we know specifically from other cases we've reviewed that it's going to the extreme.
There's no timeline that makes sense.
Like that, how in eight weeks a child has a GJ tube when they were a healthy baby eight weeks ago.
Like that timeline, there was not enough time to give things time to work and so I think it's and it's just the extreme the extremity of these things is just cannot be cannot be left unsaid yeah and I think you know this all uh just a couple of like quotes about this financial piece you know that they're saying that uh you know from one of them from the virture complaint plaintiffs paid out of pockets for multiple surgeries recommended under false pretenses.
Defendants intentionally billed outside of insurance coverage to shield from review.
From the Talbot complaint, surgeries were promoted and charged as innovative treatments, often excluded from insurance plans due to lack of scientific support.
So it's kind of a two-way thing, right?
Like you're getting the cash payments and not having to go through insurance companies and have them approve the amounts, et cetera.
And also, this is kind of shielding the fact that you're not doing as much due diligence.
And there was also a claim in here about that they lied, that they were funded by a study from the NIH that didn't exist.
So there are a lot of just like, you know, a lot of sort of fraud claims in these, a lot of things about deceptive marketing.
So really just looking at this as functioning like a business that is doing.
extremely invasive surgeries on people, which is obviously very disturbing.
Yeah, before we get into the Whistbler complaint, so a couple of things that came up as this experimental piece of it was
the morphometrics and this other thing called the TCI specialist.
And another piece that came up again and again in the lawsuits was that the person who was reviewing the images was actually not licensed as a radiologist.
And this is the person that came up with this thing that is called the TCI special.
So Bex, what do we know about these two elements?
So again, because of the way some of these things are being diagnosed, the idea is we're steering a little bit off of...
the standard of care for diagnosis, but then follow that up with steering off the standard of care for the treatment, even if the diagnosis was something that everyone agreed upon.
So the diagnosis is made
in these cases, it seems, some of the ones that came up in the lawsuits,
based on what's called morphometrics.
And the idea is basically measurements.
And to be fair, there are things like, for instance, endocrinology is the most mathematical specialty we have.
It's like, if the glucose is this, you increase the insulin to this.
It's a very like if then, very objective, like if a doctor really likes that stuff, endocrine seems to be like a good fit for them.
And then there are parts of medicine that aren't so clear-cut.
So what we want to do as physicians is we want to make it make sense.
We want to make it objective.
And so we try to find measurements, angles, things that everyone can agree upon.
The thing is, everyone, it's how you measure it too.
So it's, are you on the exact middle image of the exact MRI on the exact slice that everybody is looking at?
And if you put 20 radiologists, 20 neurosurgeons in the room, would they all get the same measurement?
Because technically,
you could just shift the next to the next picture or the next picture, and it's going to make that angle or measurement look bigger or smaller.
So it's still based on how the pictures were taken, the position the patient was in, who is doing the measuring.
And again, if that person is not licensed at all, it's even becomes more questionable.
But there are all these different angles that they mention and lines and distances.
And I think the ones that are the most studied are what I talked about before, that if your spinal cord cord hangs lower than L2, most physicians, most neurosurgeons would say it deserves looking into to see if there is a tethering that's causing it to pull down.
And then the herniation, if the Chiari drops below five millimeters and you put a room full of neurosurgeons, most are going to agree that that is a Chiari malformation.
Then you get into all these different ones.
angle measurements
for how much that area is being compressed and all of that.
It sounds very mathematical.
and so there is reason to believe that people are like, Great, if this gives us a measurement, that makes our lives easier.
Because if they meet that measurement, then most would agree.
The thing is, it's not there yet.
Those measurements are not to the point.
Those more, um, the measurements that are not reviewed as much in the studies is going to be very operator-dependent, very doctor-dependent.
And if you look them up, the studies that have documented them are by Thomas Millerat, Paolo Bolognese, and this Masao Nishikawa.
And so if they're the ones doing the studies and they're the ones doing the measurements, and if it's a certain measurement, it means they qualify for a surgery, and then that means they do the surgery.
I'm just saying it needs to be, there needs to be, I keep saying this word grounding, but there needs to be an objective outlier, a person who is not benefiting from all this that is doing the measurements.
Because if that person is also benefiting, I mean, I'm just going to say you're human and there's going to be some, you know, inherent bias versus it being measured by an outside entity.
In light of dozens of lawsuits, you know, to that effect, I think,
you know, we can, we can assume that there was.
And so what is the TCI special exactly?
So they're using, so they're using morphometrics is like they're using this measurement that
they came up with and are, you know, this is like what they decided is this.
So no, again, like when you talk about peer-reviewed, like it's not peer-reviewed outside the 3Profit motive, right?
So
not, again, the subject of medical consensus.
So what about the TCI special?
So it's named that because of the Chiari Institute, but the idea is you correct everything
in one fail swoop.
So the idea is you do a Chiari decompression, which is where you remove the bone that is basically causing the pressure on the brainstem.
So just because the brainstem is a little bit lower, the problem is it's trying to fit through a tiny little hole, and that's where the pressure comes in.
So, you relieve it.
That is the procedure of choice.
When someone truly has a Chiari and truly is symptomatic, you do a decompression.
But the idea is they do that in association with what is called a cranial cervical fusion.
You attach the skull to the spinal cord, so you fuse it together using either rods or, you know, there's all different ways to do it.
But they basically join it, they fuse it.
So, it's not so,
it doesn't have as much mobility, which indirectly could cause symptoms.
And then you do what's called an odontoid resection, which is part of your second cervical vertebrae.
It sounds like they either realign it or they actually resect part of that vertebrae because the idea is it is also causing compression.
The thing is, I looked it up, the risk of any KRE decompression is like one to 5%,
but up to 10% can have something called a CSF leak, where afterward, your spinal fluid can kind of be leaking because you're opening up a space that has fluid inside of it.
So like 10% could have a leak.
The fusion has a 1 to 4% chance of risk or of some bad outcome, but it's much higher the higher in the spine you go, which makes sense.
So the cervical spine, if you damage, I mean, anyone who knows, if you injure or break something in your neck, you're from there down.
If you do something in your lumbar spine, it's from there down.
So the idea is the higher the fusion, the higher the risk because it controls so much more.
And then, the odontoid resection is a piece that is not very well reviewed or well-studied, so we don't even know the risk factors.
But so, the people who are kind of naysayers of this, or the neurosurgeons who kind of say something about this doesn't feel right, is because you're taking multiple risky procedures, putting them into one procedure under one anesthesia session, and then that there's really no consensus on why you got there in the first place, let alone consensus to do all of these things.
And then that there were probably,
most neurosurgeons would say there were other alternatives to some of these things, meaning have those other pathways been followed?
Have they tried bracing for the instability instead of going straight to a fusion?
And because the diagnosis comes into question, I think it just makes.
each of these individual pieces more concerning.
And then when you do them all together, even more concerning.
Got it.
Yeah.
And I mean, this is actually, you know, in a number of these lawsuits, part of the damages that they were claiming is that, you know, they, that some of these patients had, you know, again, had to have multiple follow-up surgeries and had really, really bad symptoms and side effects because of issues with the surgeries, because of infections, because of,
you know, there's in this whistleblower claim, there's something about, you know, a piece of mesh being left in someone's brain.
I mean, just really, really disturbing stuff.
So, you know, like I said, we're going to get into a couple of the specific cases involving children in follow-up episodes.
You know, some of these are really interesting.
And,
you know, but I think this all begs the question, right?
With this person's reputation, which again is very findable, you know, we did public records requests to find this, many of the lawsuits, but it's been covered.
It's, you know, do you know that one of the HHSA calls made in Madison's case, someone did quote saying that they want to take her to this New York neurosurgeon who has multiple malpractice claims against him.
That was actually, it was actually brought up.
That's interesting.
Okay.
So, this actually did play.
So, like, the other doctors were concerned.
Yeah.
And I mean, I certainly like,
I think I would be extremely concerned if a patient of mine wanted to see this doctor
because he has this many claims against him.
And I think this is, you know, the context I put this in is like when a high-profile man is accused of sexual harassment or sexual assault, right?
If it's one person, then you say, okay, well, what's the evidence?
You know, what do we, we need to know more?
Disturbing if true.
If it's 30 people, uh that appears in a different light.
If it's 30 people who are all saying the exact same thing and independently of each other telling a very similar story about a pattern of behavior, that looks very different.
And it is a kind of no smoke without fire kind of situation.
So certainly just the number of lawsuits, how similar the claims are across all these different claimants certainly stands out.
So this turned out to be a very long episode.
So we are going to do it in two parts.
So that is it for today and we will be back next week with the second part of our episode about Dr.
Paolo Balagnacy.
This episode of Nobody Should Believe Me case files was hosted and executive produced by me, Andrea Dunlop.
Dr.
Becks is my co-host.
Mariah Gossett is our supervising producer.
Greta Stromquist is our producer and editor.
Aaron Ajay is our fact-checker.
And thanks also to Nola Carmouche for administrative support.
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