In reference to Med Mal Reviewer's point #3...the dilemma that he refers to regarding keeping track of authoritative recommendations for screening is only going to get worse and our ability to recommend and order the appropriate screenings through a patient's insurance is only going to diminish as the present anti-science/anti-research/anti-ACA administration continues to dismantle many of the public health agencies, programs, and insurance requirements that we have depended on for these purposes.
"The USPSTF is not being dissolved, but its authority and the future of free preventive care access under the ACA are being challenged in the courts."
As a pediatrician, it is my fear that our current anti-vax Secretary of HHS will find a way to overturn the requirement of insurance companies to cover preventive care visits, screenings, and childhood vaccinations with no out-of-pocket cost to patients and their children.
Although Infectious disease doctors are internist by training, i find it troubling to have them shoulder the burden and responsiblity of anything outside of their specialty training and focus. There is simply too much information out there for anyone one doctor to know and know well outside of their training. It would be a ridiculous and unjust standard to hold doctor's responsible for the medical knowledge outside of their specialty. I can imagine internist being called for not knowing surgical standards. This is just another example of a malpractice lawyer seeing dollar signs from a tragedy and contributing to the fall and ruin of medicine.
I'm still a bit confused on who was supposed to be managing his cirrhosis in all of this... I think that person probably should shoulder the liability (if any). Was there a PCP? A GI doctor? Court records should have addressed this issue but were silent, which is a failure by the experts and the attorneys involved.
I agree. The court summary wasnt very helpful. If there was no GI or PCP involved, then the fault may lie with the patient for not establishing care with one....
Contributory negligence is a fascinating topic if you're into legal history... it used to be that any degree of contributory negligence resulted in a defense verdict by default. Even if the plaintiff was only 0.01% negligent (by not getting a PCP or some minor issue), it was an automatic defense verdict. This was pretty common until the 1970s-1980s when most states switched to comparative negligence.
I'll venture to say that whomever diagnosed/discovered the cirrhosis was liable for management, including either HCC screening or referral to hepatology/GI for follow up.
Interesting case. As a GI doc, we always see these patients and screen them per guidelines; the AASLD guideline was definitely in effect those years by the way, and were only updated in 2023 as you note. Here's the 2015 one: https://onlinelibrary.wiley.com/doi/pdf/10.1002/hep.27950
Perhaps in other areas of the US the ID docs will follow them, but I think they should then follow the AASLD guideline as well, if they want to follow these patients who not only have an infection per se, but also liver disease. The patient absolutely should have had ongoing screening - which would have lowered his morbidity if not mortality.
Hi there- to offer some clarification- HCV is a virus that can cause fibrosis. The top of the fibrosis scale is cirrhosis, and it’s at that point when the risk for developing HCC increases to the point where routine screening is warranted. So it’s like 2 different, but related diseases. If a clinician is not adept at recognizing sequela of a disease (or does not k ow how to manage) they need to send to a specialist that would. And document that they did and what could happen if the patient doesn’t go.
HCC is difficult to detect with ultrasound. Adding AFP helps but still the yield is low. Unfortunately guidelines have boxed us in and opened us up for legal issues if not followed. There are literally thousands of guidelines on just about everything these days. Must a physician know them all? What if guidelines differ between specialties? More money for the lawyers.
As an ID doc myself: I don't have the expertise to say where standard of care begins, but in 2017 failing to screen a patient with cirrhosis due to HCV would at least be seen as an error.
There's some leeway here to argue whether or not the patient had cirrhosis (biopsy F3 technically means no cirrhosis yet, imaging isn't truly diagnostic but the biopsy probably was either undercalled or had a sampling error here), but tbh I don't think that's really a great defence. Most likely it just wasn't considered.
That said, there is some merit to the defence argument that the damage due to that error is limited. Especially for disease that was stage 4 at diagnosis, there's a very real possibility that screening would not have revealed this at a curable stage.
Years ago I took a course on testing methodology and research. One of the takeaway lessons that stuck with me was "screening is hard to do". Screening tests are often ineffective in not only catching disease, but, more importantly, in changing outcomes.
Also, to chime in with other commentators: how is it possible that, over the years of treatment, there was no PCP involved? I've noticed over the years that many patients have a tendency to consider their sub specialist their PCP (i.e. an asthmatic who sees a pulmonologist thinks of them as the primary doctor), and the specialist does not always discourage that practice. Conversely, many specialists develop tunnel vision, and forget to think in terms of comprehensive care. I'm approaching retirement, and work in UC; I think that one of the most valuable aspects of my care is to make PCP referrals.
I am imagining a whole tidal wave of cases related to low dose CT lung cancer screening. I think the evidence for value of the LDLCSCT is pretty low for longevity of smokers. The evidence for how much it helps trial lawyers is still out, but I'm ready to put my nickel down.
Totally agree... and the population of smokers is a lot bigger than the population of hep C patients so there will be a lot of opportunity for the plaintiffs bar.
I am a PCP and also treat Hepatitis C in clinic, sometimes including cases with advanced fibrosis/cirrhosis as we are a fairly rural practice. Getting patients to undergo even ultrasound every 6 months is REALLY a challenge.
I think my take away from this would be to document document document that you ordered it and encouraged them to complete their imaging.
Really fascinating how much the guidelines are changing now with the advent of DAA’s and ubiquitous availability of non-invasive, highly sensitive imaging.
I'm particularly impressed by the patient's ability to make his September 2017 appointment despite passing away in January 2017 (according to the first plaintiff expert).
Ha! I missed that. Send the bill to the afterlife. I see a surprising number of little typos like that for an expert and attorney who are making insane hourly rates.
Hep C and HCC in an adult is far from my field of expertise, but the concept of “effectively cured” after 16 years of struggling against a difficult to manage disease seems overly optimistic in terms of the original disease and potential long-term effects of that disease and its treatment. “Remission” seems like a more apt concept. Guidelines or not – someone like that needs close surveillance. That’s common practice for any number of chronic difficult illnesses. I get it that it can be hard to know who should own that surveillance, but the specialists could have talked to each other. Would closer surveillance have made a difference? As usual, that’s hard to know, but it’s easy to imagine that it would have improved the patient’s likelihood of more timely detection and treatment – and that’s usually better.
My impression is that if you cure the hep C prior to fibrosis or cirrhosis setting in, there may not be any need to screen for HCC? Since we just got these highly effective hep C drugs in the last decade, there's going to be a big population of people that did actually develop fibrosis/cirrhosis from it (at least to a mild degree) but are also "cured". Hopefully in the future all these cases get caught before cirrhosis and this becomes a much less frequent thing.
Wonderful case! As a liver NP where HCV treatment was my bread and butter during this timeframe, missing cirrhosis and subsequent screening for HCC/decompensations was my biggest fear for non-hepatology providers treating for HCV. As David Neiblum posted the HCV guidelines below, I will also share the cirrhosis guidelines from that time that clearly state that those with cirrhosis need q6m HCC screening, and that HCV compounds likelihood of HCC development. https://journals.lww.com/hep/fulltext/2005/11000/management_of_hepatocellular_carcinoma_.29.aspx
It's always so nice when readers have specific expertise that is relevant to one of these cases! Thanks for finding this link, it's exactly what I was looking for and struggling to find!
In reference to Med Mal Reviewer's point #3...the dilemma that he refers to regarding keeping track of authoritative recommendations for screening is only going to get worse and our ability to recommend and order the appropriate screenings through a patient's insurance is only going to diminish as the present anti-science/anti-research/anti-ACA administration continues to dismantle many of the public health agencies, programs, and insurance requirements that we have depended on for these purposes.
E.g.--
https://www.medscape.com/viewarticle/save-uspstf-2025a1000cv8
"The USPSTF is not being dissolved, but its authority and the future of free preventive care access under the ACA are being challenged in the courts."
As a pediatrician, it is my fear that our current anti-vax Secretary of HHS will find a way to overturn the requirement of insurance companies to cover preventive care visits, screenings, and childhood vaccinations with no out-of-pocket cost to patients and their children.
Although Infectious disease doctors are internist by training, i find it troubling to have them shoulder the burden and responsiblity of anything outside of their specialty training and focus. There is simply too much information out there for anyone one doctor to know and know well outside of their training. It would be a ridiculous and unjust standard to hold doctor's responsible for the medical knowledge outside of their specialty. I can imagine internist being called for not knowing surgical standards. This is just another example of a malpractice lawyer seeing dollar signs from a tragedy and contributing to the fall and ruin of medicine.
I'm still a bit confused on who was supposed to be managing his cirrhosis in all of this... I think that person probably should shoulder the liability (if any). Was there a PCP? A GI doctor? Court records should have addressed this issue but were silent, which is a failure by the experts and the attorneys involved.
I agree. The court summary wasnt very helpful. If there was no GI or PCP involved, then the fault may lie with the patient for not establishing care with one....
Contributory negligence is a fascinating topic if you're into legal history... it used to be that any degree of contributory negligence resulted in a defense verdict by default. Even if the plaintiff was only 0.01% negligent (by not getting a PCP or some minor issue), it was an automatic defense verdict. This was pretty common until the 1970s-1980s when most states switched to comparative negligence.
I'll venture to say that whomever diagnosed/discovered the cirrhosis was liable for management, including either HCC screening or referral to hepatology/GI for follow up.
They reference a biopsy that diagnosed the cirrhosis... seems like that person would be the most likely to be responsible.
Interesting case. As a GI doc, we always see these patients and screen them per guidelines; the AASLD guideline was definitely in effect those years by the way, and were only updated in 2023 as you note. Here's the 2015 one: https://onlinelibrary.wiley.com/doi/pdf/10.1002/hep.27950
Perhaps in other areas of the US the ID docs will follow them, but I think they should then follow the AASLD guideline as well, if they want to follow these patients who not only have an infection per se, but also liver disease. The patient absolutely should have had ongoing screening - which would have lowered his morbidity if not mortality.
Thanks for the comment and link!
Do I get a gold star? https://natap.org/2011/HCV/24684_ftp-1.pdf
Actual guidelines here I just thought that was too good not share: https://pmc.ncbi.nlm.nih.gov/articles/PMC3084991/
Yes! Gold star for you!
Hi there- to offer some clarification- HCV is a virus that can cause fibrosis. The top of the fibrosis scale is cirrhosis, and it’s at that point when the risk for developing HCC increases to the point where routine screening is warranted. So it’s like 2 different, but related diseases. If a clinician is not adept at recognizing sequela of a disease (or does not k ow how to manage) they need to send to a specialist that would. And document that they did and what could happen if the patient doesn’t go.
Very helpful, thanks for clarifying!
HCC is difficult to detect with ultrasound. Adding AFP helps but still the yield is low. Unfortunately guidelines have boxed us in and opened us up for legal issues if not followed. There are literally thousands of guidelines on just about everything these days. Must a physician know them all? What if guidelines differ between specialties? More money for the lawyers.
As an ID doc myself: I don't have the expertise to say where standard of care begins, but in 2017 failing to screen a patient with cirrhosis due to HCV would at least be seen as an error.
There's some leeway here to argue whether or not the patient had cirrhosis (biopsy F3 technically means no cirrhosis yet, imaging isn't truly diagnostic but the biopsy probably was either undercalled or had a sampling error here), but tbh I don't think that's really a great defence. Most likely it just wasn't considered.
That said, there is some merit to the defence argument that the damage due to that error is limited. Especially for disease that was stage 4 at diagnosis, there's a very real possibility that screening would not have revealed this at a curable stage.
Thanks for the insight! I think the fact that there were decent arguments on both sides here is why it settled.
Years ago I took a course on testing methodology and research. One of the takeaway lessons that stuck with me was "screening is hard to do". Screening tests are often ineffective in not only catching disease, but, more importantly, in changing outcomes.
Also, to chime in with other commentators: how is it possible that, over the years of treatment, there was no PCP involved? I've noticed over the years that many patients have a tendency to consider their sub specialist their PCP (i.e. an asthmatic who sees a pulmonologist thinks of them as the primary doctor), and the specialist does not always discourage that practice. Conversely, many specialists develop tunnel vision, and forget to think in terms of comprehensive care. I'm approaching retirement, and work in UC; I think that one of the most valuable aspects of my care is to make PCP referrals.
I am imagining a whole tidal wave of cases related to low dose CT lung cancer screening. I think the evidence for value of the LDLCSCT is pretty low for longevity of smokers. The evidence for how much it helps trial lawyers is still out, but I'm ready to put my nickel down.
Totally agree... and the population of smokers is a lot bigger than the population of hep C patients so there will be a lot of opportunity for the plaintiffs bar.
I am a PCP and also treat Hepatitis C in clinic, sometimes including cases with advanced fibrosis/cirrhosis as we are a fairly rural practice. Getting patients to undergo even ultrasound every 6 months is REALLY a challenge.
I think my take away from this would be to document document document that you ordered it and encouraged them to complete their imaging.
Really fascinating how much the guidelines are changing now with the advent of DAA’s and ubiquitous availability of non-invasive, highly sensitive imaging.
I can definitely see it being a challenge, especially in a patient population that stereotypically has a lot of social issues. Documentation is key!
I'm particularly impressed by the patient's ability to make his September 2017 appointment despite passing away in January 2017 (according to the first plaintiff expert).
Ha! I missed that. Send the bill to the afterlife. I see a surprising number of little typos like that for an expert and attorney who are making insane hourly rates.
Going through the legal system for a divorce, I was absolutely floored by how slow, sloppy, and well-paid it is relative to pathology.
Hep C and HCC in an adult is far from my field of expertise, but the concept of “effectively cured” after 16 years of struggling against a difficult to manage disease seems overly optimistic in terms of the original disease and potential long-term effects of that disease and its treatment. “Remission” seems like a more apt concept. Guidelines or not – someone like that needs close surveillance. That’s common practice for any number of chronic difficult illnesses. I get it that it can be hard to know who should own that surveillance, but the specialists could have talked to each other. Would closer surveillance have made a difference? As usual, that’s hard to know, but it’s easy to imagine that it would have improved the patient’s likelihood of more timely detection and treatment – and that’s usually better.
My impression is that if you cure the hep C prior to fibrosis or cirrhosis setting in, there may not be any need to screen for HCC? Since we just got these highly effective hep C drugs in the last decade, there's going to be a big population of people that did actually develop fibrosis/cirrhosis from it (at least to a mild degree) but are also "cured". Hopefully in the future all these cases get caught before cirrhosis and this becomes a much less frequent thing.
Wonderful case! As a liver NP where HCV treatment was my bread and butter during this timeframe, missing cirrhosis and subsequent screening for HCC/decompensations was my biggest fear for non-hepatology providers treating for HCV. As David Neiblum posted the HCV guidelines below, I will also share the cirrhosis guidelines from that time that clearly state that those with cirrhosis need q6m HCC screening, and that HCV compounds likelihood of HCC development. https://journals.lww.com/hep/fulltext/2005/11000/management_of_hepatocellular_carcinoma_.29.aspx
Thank you again for posting this.
It's always so nice when readers have specific expertise that is relevant to one of these cases! Thanks for finding this link, it's exactly what I was looking for and struggling to find!