$60M Lumbar TFESI Settlement

[drusso]

Jury reaches ‘record’ $60M verdict in case over botched interventional procedure

The case dates to 2019, when 64-year-old David Gangaram visited a Long Island outpatient clinic for an image-guided lumbar epidural steroid injection.

radiologybusiness.com

"Plaintiff attorneys contend that Iadevaio used “improper, inappropriate and poor image quality” fluoroscopy during the procedure. He also purportedly failed to obtain lateral and oblique imaging to properly ascertain the needle position prior to performing the procedure, according to court documents. Adimey and colleagues also contend the physician failed to use the safer “interlaminar approach” to administering the injection, and they charge that Iadevaio used the drug Kenalog, rather than the correct Dexamethasone. The former can come with rare but serious complications including loss of vision, stroke, paralysis and death, according to FDA warnings."

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[oneforfighting]

Lumbar TFESI not cervical

 

[BoardingDoc]

I really want to know what actually happened in these cases. Did the guy actually use Kenalog? Did he use contrast before injecting? Really what I want to know is: if you take the time to make sure you use non-particulate, you get a good contrast shot, you snap another pic after to make sure the contrast isn't washing away / intravascular.... is there any realistically likely chance that you're going to wind up like this guy?

 

[Ducttape]

issues:
1. deep sedation
2. kenalog for TFESI apparently by assumption as there was anterior spinal artery infarction. there have been very few reports of dex causing anterior spinal artery infarction but enough from particulates to have been noted already by all major pain societies
3. need to have at least 2 images. i cant confirm, but the site seems to suggest that only 1 image was available for review.



to your question - yes possibly. he is not the first doctor sued for this. there is a reason that ASA doesnt recommend deep sedation or particulate steroids for TFESI.

it is important to discuss with your patient, establish good rapport prior to injection, and have a documented in-depth convo and shared decision making prior to using unsafe practices.

 

[gaspasser127]

I completely agree about avoiding deep sedation for injections in general

But how would avoiding deep sedation have changed the outcome of this case?

 

[Ducttape]

patient awareness and feedback to something wrong during injection.

ASA closed claims case clearly demonstrate that there is increased incidence of vertebral artery infarction with cervical TFESI and under deep sedation.

 

[Agast]

patient awareness and feedback to something wrong during injection.

ASA closed claims case clearly demonstrate that there is increased incidence of vertebral artery infarction with cervical TFESI and under deep sedation.

It’s not a cervical spine case

drusso just got too excited for a chance to rattle some cages and posted without reading the actual article he was linking

 

[DOctorJay]

It’s not a cervical spine case

drusso just got too excited for a chance to rattle some cages and posted without reading the actual article he was linking

perhaps the author/editor could have picked a lumbar image instead of cervical

 

[drusso]

It’s not a cervical spine case

drusso just got too excited for a chance to rattle some cages and posted without reading the actual article he was linking

Fixed it. My bad...I knew it was lumbar, but the stock image stuck in my brain. You can return to your tranquil cages...

 

[Asclepius186]

I agree with not using deep sedation for lumbar TFESI, but I don’t see how that could have contributed to the outcome in this case? Injecting an artery would be painless until the deed is done. At that point there is no going back.

 

[Ducttape]

It’s not a cervical spine case

drusso just got too excited for a chance to rattle some cages and posted without reading the actual article he was linking

agree.
i was specifically noting those were the 2 situations that the closed claims database was particularly dogmatic.

I agree with not using deep sedation for lumbar TFESI, but I don’t see how that could have contributed to the outcome in this case? Injecting an artery would be painless until the deed is done. At that point there is no going back.

the closed claims database is a database of anesthesia complications that were settled out of court. i dont believe they parsed out whether sedation specifically was linked to spinal artery infarct, but that overall of those cases with significant severe complications, deep sedation was much more likely to have been used.

it didnt seem to be a contested point by the plaintiffs attorneys.

 

[paindoc503]

"Attorneys presented evidence during trial that the findings of a spinal angiogram conducted after the injury were inconsistent with the medication listed in the physician's notes. Instead, Adimey and colleagues contend that a different medication—Kenalog, which is not recommended in this instance—was used"


This is the most notable part of this case to me. The doctor documented that he used dexamethasone in his notes. Despite this, the attorneys are trying to say that he used kenalog instead. How would they know its kenalog based on an angiogram? How do they know it was specifically kenalog and not something like depo?

 

[au bon pain]

While it sounds like there’s some red flags in this case, the bottom line is that unfortunate **** can happen to anyone—patient and doc alike.

I would love it if Trump started to push for federal-level tort protection for doctors as well as some sort of national risk pool that would be used to review +/- pay out suits that aren’t lowered on appeal.
This kind of thing is waaaay overdue and right now is the ideal time to make it happen while Republicans have both houses and the White House. Democrats will never do this.

 

[clubdeac]

While it sounds like there’s some red flags in this case, the bottom line is that unfortunate **** can happen to anyone—patient and doc alike.

I would love it if Trump started to push for federal-level tort protection for doctors as well as some sort of national risk pool that would be used to review +/- pay out suits that aren’t lowered on appeal.
This kind of thing is waaaay overdue and right now is the ideal time to make it happen while Republicans have both houses and the White House. Democrats will never do this.

Error

 

[clubdeac]

"Attorneys presented evidence during trial that the findings of a spinal angiogram conducted after the injury were inconsistent with the medication listed in the physician's notes. Instead, Adimey and colleagues contend that a different medication—Kenalog, which is not recommended in this instance—was used"


This is the most notable part of this case to me. The doctor documented that he used dexamethasone in his notes. Despite this, the attorneys are trying to say that he used kenalog instead. How would they know its kenalog based on an angiogram? How do they know it was specifically kenalog and not something like depo?

Wow if he really used dexa and it’s documented in his note AND the MAR then I think he should sue them for 100 million. He followed standard of care and got taken to the cleaners based on a bunch of lies

 

[Ducttape]

he lost. how is he supposed to sue them? the court case was his forum to prove his innocence and he couldnt convince the jury.


the plaintiffs probably showed the spinal artery infarct and then expert opinion that the infarct could only have been to kenalog and convinced the jury that he fudged the records.

maybe they looked at other records that showed that he primarily used kenalog for other injections...


fwiw, depo is also a medication of concern in use with TFESI. both particulates.

 

[hopefulgasman]

Aren't meds scanned or don't yall enter med orders for billing before the procedure? Kenalog was probably ordered or identified somewhere, dex was written in the note, now he looks like a liar in front of a lay jury = no sympathy, and drawing the ire of said jury

 

[Agast]

I’m fairly certain the op report was dictated after the patient already exhibited signs of neurological damage and therefore should be taken with a grain of salt. What can’t be manipulated is the nursing record or saved fluoro images.

 

[Baron Samedi]

I wonder if the lot number of the steroid was recorded and cross-referenced

 

[paindoc503]

he lost. how is he supposed to sue them? the court case was his forum to prove his innocence and he couldnt convince the jury.


the plaintiffs probably showed the spinal artery infarct and then expert opinion that the infarct could only have been to kenalog and convinced the jury that he fudged the records.

maybe they looked at other records that showed that he primarily used kenalog for other injections...


fwiw, depo is also a medication of concern in use with TFESI. both particulates.

That is exactly my point regarding the depo.
How do they know it wasnt depo that caused the infract and not kenalog?
its just oddly specific

 

[Ducttape]

its because kenalog is the steroid that has the black box warning, not depo, and much easier to get a jury to agree that an egregious error was committed.

 

[bedrock]

its because kenalog is the steroid that has the black box warning, not depo, and much easier to get a jury to agree that an egregious error was committed.

Agree with this. In a world without lawyers I’d only use kenalog and dex.
In America, I would use only depo and dex.

 

[bedrock]

Neither article includes the level of the TFESI. I’d like to know that.

 

[Status Sciaticus]

and this is why I use dex in all my TFESIs. May not last as long, but atleast I wont have my life ruined trying to do the right thing.

 

[scv]

It’s simply not worth the risk

 

[clubdeac]

Damn I might have to switch to dex for all TFESIs…

 

[au bon pain]

I’ve been using dex+ns only for the last several years. Patients do a-ok and lack of injectate shenanigans makes everyone happy.

 

[Laryngospasm]

Only dex here as well…although I think a case could be made for particulate below L3. In my office the nurse notes what meds are used and how much not just me in my note. I wonder how they were able to say he used Kenalog? This is the opposite of “if it’s not charted it didn’t happen” which is how we are told to protect ourselves. Something fishy about it. Would also like to know the level.

 

[Status Sciaticus]

Only dex here as well…although I think a case could be made for particulate below L3. In my office the nurse notes what meds are used and how much not just me in my note. I wonder how they were able to say he used Kenalog? This is the opposite of “if it’s not charted it didn’t happen” which is how we are told to protect ourselves. Something fishy about it. Would also like to know the level.

If he changed the med from kenalog to depo after the fact, theres a key-log audit trail in all EMRs.

 

[Dr. Ice]

I can’t use dex..I might as well not work or just do interlams all day

 

[Snowmen96]

Pretty much all the studies that have compared Dex to particulates have shown Dex to be non-inferior for lumbar TFESI. The best designed study was actually really close to showing Dex being superior to particulates.

The noninferiority of the nonparticulate steroid dexamethasone vs the particulate steroids betamethasone and triamcinolone in lumbar transforaminal epidural steroid injections - PubMed

This retrospective observational study reveals no evidence that dexamethasone is less effective than particulate steroids in lumbar TFESIs performed for radicular pain with or without radiculopathy.

pubmed.ncbi.nlm.nih.gov

 

[Taus]

I can’t use dex..I might as well not work or just do interlams all day

?

 

[Agast]

No one else remembers the dexamethasone shortage? What’s your backup plan when/if that happens again

 

[Dr. Ice]

Dex sucks. I cringe every time I use it above L3 because I genuinely know its inferior.

Lots of folk around me using kenalog for tfesi..I see it all the time in procedure notes.

I wonder if practice patterns over time dictate what to use. The guy replacing me in my current practice is known almost exclusively for scs and kypho. So much so that they market the **** out of it for him. Unfortunately he’s stepping into a predom geriatric practice that just wants their q 6 month epidural and be done with it. He uses dex, but is thinking about granny falling on ice and salivating to cement her, so I’m sure he hedges the safer choice of dex vs what he’s gonna get eventually from stim and kypho. In my area, most insurances still cover chronic radic for scs, doesn’t have to be failed back. I’ve noticed those that exclusively use dex here bank on it sucking, the surgeons freaking them out about surgery and the patients going back to have scs after the surgeon documents patient wouldn’t benefit from surgery. Maybe it’s one big Ponzi scheme…

Sucks for the 60 mill lawsuit for that guy. We hear about these every now and again.

 

[lobelsteve]

Dex sucks. I cringe every time I use it above L3 because I genuinely know its inferior.

Lots of folk around me using kenalog for tfesi..I see it all the time in procedure notes.

I wonder if practice patterns over time dictate what to use. The guy replacing me in my current practice is known almost exclusively for scs and kypho. So much so that they market the **** out of it for him. Unfortunately he’s stepping into a predom geriatric practice that just wants their q 6 month epidural and be done with it. He uses dex, but is thinking about granny falling on ice and salivating to cement her, so I’m sure he hedges the safer choice of dex vs what he’s gonna get eventually from stim and kypho. In my area, most insurances still cover chronic radic for scs, doesn’t have to be failed back. I’ve noticed those that exclusively use dex here bank on it sucking, the surgeons freaking them out about surgery and the patients going back to have scs after the surgeon documents patient wouldn’t benefit from surgery. Maybe it’s one big Ponzi scheme…

Sucks for the 60 mill lawsuit for that guy. We hear about these every now and again.

You know? Observation bias. Literature says otherwise. And how often are you above L3? 1% of ESI? And any tfesi should be Dex.

 

[clubdeac]

Dex sucks. I cringe every time I use it above L3 because I genuinely know its inferior.

Lots of folk around me using kenalog for tfesi..I see it all the time in procedure notes.

I wonder if practice patterns over time dictate what to use. The guy replacing me in my current practice is known almost exclusively for scs and kypho. So much so that they market the **** out of it for him. Unfortunately he’s stepping into a predom geriatric practice that just wants their q 6 month epidural and be done with it. He uses dex, but is thinking about granny falling on ice and salivating to cement her, so I’m sure he hedges the safer choice of dex vs what he’s gonna get eventually from stim and kypho. In my area, most insurances still cover chronic radic for scs, doesn’t have to be failed back. I’ve noticed those that exclusively use dex here bank on it sucking, the surgeons freaking them out about surgery and the patients going back to have scs after the surgeon documents patient wouldn’t benefit from surgery. Maybe it’s one big Ponzi scheme…

Sucks for the 60 mill lawsuit for that guy. We hear about these every now and again.

I hate dex too. Lots of patients with 3-12 months relief with depo. They come back once to twice a year. Maybe I’ll try dex for the next 6 mos and report back

 

[Agast]

It took some searching but I found the court records

Document List

Basically this guy had done many ESIs on Gangaram and clearly wrote that he used 80mg of Kenalog for each injection, even the month before (how he was able to do so many TFESI so close together is beyond me). The next month he does the same injection and has a complication and magically dexamethasone is the injectate of choice. I’m sure it pissed off the jury that the doctor tried to lie, if he had been more honest maybe the $$$ would have been lower.

 

[Agast]

 

[Agast]

BTW no one should be defending this guy. His needle placement looks like absolute sheet, no contrast pattern and it’s not surprising he eventually hurt someone.

 

[Agast]

Like what even is the point of this being the only image you save (2/2019 not the day of the incident)