Physician Liability at the Opioid Treatment Program

I’ve been thinking about writing this blog post for several years but hesitated because I fear it will make some people angry. But I want to write about all aspects of opioid use disorder and its treatment with medications, and liability concerns are part of treatment at OTPs.

In a way, it’s sad that physicians worry about anything but the well-being of the patient sitting in front of them. In another way, maybe accountability keeps providers from getting too far out of the mainstream.

This blog post is specifically about methadone induction and physician liability.

In 2001, when I first started working at an opioid treatment program, OxyContin had already established its reign of destruction. I worked for a non-profit program with satellite programs in seven small towns. All these programs were relatively new. What I saw at those programs was appalling. I was amazed at the extent of OxyContin use disorder in these locations. Patients were taking large amounts of oxycodone each day.

In one moderate-sized town, twenty to thirty patients would arrive early, hoping to get admitted to treatment with methadone. (That non-profit program didn’t offer buprenorphine until long after 2010.)

It was overwhelming.

I asked the administration to limit intake days to twenty intake patients per day, to have enough time to do an adequate job for each patient. My requests were not honored. Some weeks I worked 7am to 7pm and saw thirty or more patients. I left dog-tired and worried if I had done a good enough job.

Back then, physicians working to treat opioid use disorder talked about the unprecedented opioid firepower of extended- release oxycodone that was being used as an immediate-release drug. All our patients knew how to remove the time-release coating from OxyContin. They crushed it to snort and inject.

Because of the high prescription strength of OxyContin, which was sold as single doses as high as 160mg tablets, we all thought methadone starting doses would have to be adjusted upwards to account for the extreme physical opioid tolerance. Often, we started patients at 30mg and had them return later that first day for a second dose of 10mg, for a total of 40mg on the first day. Then we increased their dose by 5mg every day or every other day if they reported withdrawal symptoms. We justified this approach, saying these were special circumstances.

We harmed patients with this dosing strategy.

Some patients, probably slower metabolizers of methadone, could not handle that rapid methadone induction, despite their reports of using large amounts of OxyContin. Or they may have exaggerated about their opioid tolerances, to deadly effect.

Some of the families of deceased patients brought wrongful death lawsuits against the non-profit program and the physicians who had prescribed the methadone.

I wasn’t named in any lawsuits but the medical directors both before and after me were. This wasn’t because I was so smart, but rather because I heard an important ASAM (American Society of Addiction Medicine) lecture by Thomas Payte, M.D., that changed my prescribing habits and decreased the aggressiveness of my induction orders.

I bought the recordings from an ASAM conference sometime in the early 2000’s, maybe 2004 or 2005. During his presentation, Dr. Payte warned against starting methadone too high, or going up too fast. He said methadone induction deaths were rare and devastating. He said rapid inductions sooner or later result in overdoses. He used a term, “bubble-gum addict” which I think meant a patient who claimed to have severe opioid addiction but really only used occasionally or relatively small amounts. He said these “bubble-gum addicts” were at high risk because they exaggerated their tolerance to the physician.

After hearing that lecture, I stopped giving first-day total doses of 40mg, for the most part. I stopped giving orders for daily dose increases. And I watched as my colleagues went through malpractice cases brought by families of patients who died from methadone overdose.

Both the non-profit opioid treatment program and individual physicians had four wrongful death lawsuits filed against them. All the deceased patients had been started at more than 30mg on the first day, and their doses had been increased daily, faster than the prevailing guidelines. The medical examiner said the cause of death for all four patients was methadone intoxication. I felt that in two of the cases, there were clearly other factors, but that didn’t matter. The medical examiner’s pronouncements are final.

The families of the decedents had their worst nightmares come true: their loved ones with opioid use disorder passed away from their disease, and ironically, they were killed by people who said they were trying to help. I can only imagine the deep sense of betrayal and anger the families must have dealt with.

The lawsuits also troubled the lives of the physicians who were named. It was a long, drawn-out process for all four of the cases. I saw probably only a fraction of the emotional toll it took on these excellent providers who, with the best of intentions, wanted to take the methadone dose up quickly to prevent withdrawal and retain patients in treatment. The lawsuits took a toll on the administrators for this non-profit organization. Their reputation and the reputation of the organization was questioned in newspapers across the state. Indeed, the deaths made front-page news in the Charlotte Observer.

All four lawsuits were settled in favor of the families. I have no idea how much the settlements were and I’m sure there were non-disclosure agreements on the settlements. The two physicians named in these lawsuits both left the field of Addiction Medicine right after the lawsuits.

Lately, even at the recent conferences I’ve virtually attended, I’ve heard lecturers talk about how they recommend higher starting doses of methadone and faster rates of increase for methadone induction, due to the higher potency of fentanyl that patients are using. It’s exactly what I heard in the early 2000’s about induction in patients using high doses of OxyContin.

For sure, fentanyl is more potent than Oxycodone. Fentanyl and its analogues are dosed in micrograms, while oxycodone is dosed in milligrams. And we know that patients who are retained in treatment with an adequate dose are less likely to die from an opioid overdose.

And yet …I wonder if there’s an ultimate price to be paid by some patients if we go that fast on every patient. I haven’t forgotten lessons from the past.

Certainly, we know some factors can make induction more dangerous for some patients: current use of any sedating medications or drugs; health issues like sleep apnea or COPD; recent period of abstinence from opioids, and other factors. Those patients should be started at lower doses and increased more slowly.

But what about the new patient with no prior treatment history, healthy in other ways, who says he’s injecting a gram of heroin mixed with fentanyl per day? Is he going to be retained in treatment with a high starting dose and rapid rate of increase or is he born with the genes that make him a slow methadone metabolizer, likely to die on day five of his methadone induction?

Some tests exist that give genetic information about whether a patient might be a slow metabolizer. For now, I don’t have access to such tests. If I did, I would need that data before giving the first dose. If any readers are using these tests, I’d like to hear from them.

But here’s the thing that will anger people: it is not in the physicians’ best interest to start patients at high doses. Physicians aren’t usually blamed if the patient drops out of treatment and dies using fentanyl on the street. But physicians most certainly have been – and will be – blamed if the patient dies during induction, no matter what the cause. If were other drugs in the decedent’s system, it doesn’t matter, because malpractice lawyers say the physician should have taken that into account and started at a lower dose.

There’s one medical malpractice lawyer in our state who specializes in methadone overdose cases. She was the lawyer for all four families in the lawsuits I mentioned above.

Heeding advice from Sun Tzu (“Know thy enemy”), this lawyer was once invited to an addiction medicine conference to talk about what mistakes lawyers look for when suing a physician. Her talk was interesting to me but probably not for obvious reasons. As I listened to her talk, I realized lawyers look at only one side: the risk of giving a certain medicine, or dose of medicine, or treatment. She never talked about the risk of NOT giving medicine.

Medical professions who work in this field must take a much broader view. We know people with opioid use disorder who do not get treatment with medication die at a rate at least three times that of people who do get medications for treatment. Knowing this, it’s unconscionable not to do all we can to provide treatment, and to provide it quickly.

Providers will continue to try to thread a needle: we want to give enough methadone to ease our patients’ suffering but not enough to kill them. We will continue to make the best judgments that we can, with information from the patient, from collaterals, old records, urine drug screen results, the physical exam with any withdrawal signs, and any other data we can get.

15 responses to this post.

  1. I completely agree. I think our consensus statements help us. We are more aggressive with induction orders with people who were recently on methadone but otherwise we follow ASAM guidelines. We have never had an induction death. (Knock on wood). Being too conservative does harm – but you are right, you will not get sued over it! Great blog!


  2. Posted by Charles E on January 22, 2023 at 4:57 pm

    Dr. Burson, I love your blog. It’s rare that a physician opens up to the lay public. I just wanted to comment that, about 15 years ago (before I went on buprenorphine), I tried to get on a methadone clinic. My heroin usage wasn’t astronomic but wasn’t small either. Man, that doc put me on 10 mg! And he left a note not to increase my dosage. That was the one and only contact I have had with methadone maintenance. I wished afterwards that I actually had upsold my usage. I can easily see why patients do it.


  3. Posted by Daniel Strickland Sr. on January 22, 2023 at 5:40 pm

    Thanks, Jana. When I started working prn in an OTP (2010) I had done my 8 hours of X waiver training, but that didn’t cover methadone. So my real training was with Dr. Chip Roberts of Colonial Metro (now New Season) who went through a 4 hour Powerpoint with me. I recall what he preached, almost as a mantra: “Start low; go slow.” Have never forgotten it. Of course, with experience, one can fine tune any mantra. As Dr. Morse said, we also have not lost any patients during induction. In fact, in reviewing the few cases of patient deaths, they all have missed many days of dosing, and the tox eval shows polypharmacy problems.
    We just gotta keep on doing the best we can.


  4. Posted by David G. on January 22, 2023 at 6:09 pm

    Always insightful commentaries. I hired Dr. Payte in 2001 to be the Medical Director of National Specialty Clinics. I took over a national methadone company that had a penal colony mentality and transitioned it to a clinical mentality. I had a great management team who replaced certain doctors and Program Directors with those who understood that we treated patients, not “clients” and that we were a medical treatment organization. Dr. Payte was key to setting the tone with our physicians.

    We never had a patient death (out of 2000 patients in treatment) from dosing issues for the 3 years I was CEO. I give ALL of the credit to Dr. Payte. He was also a heck of a nice guy.

    You are of the same mold, Dr. Burson. Incredibly conscientious and total conviction for your patients. It is admirable.


  5. Posted by William Taylor, MD on January 22, 2023 at 6:18 pm

    There’s now some enthusiasm for allowing office-based physicians to prescribe methadone for OUD. Any practitioner undertaking to do so would be well advised to read your column……about 10 times. Despite what happened, OTPs are far and away the safest place to initiate methadone and reach a stable dose.


  6. Posted by Dominique D Leveque MSN RN CPNP FNP-C APRN on January 23, 2023 at 3:52 pm

    In my current practice, we use pharmacogenomics with almost every patient, save those that are self-pay. We have found the results to be helpful as we also offer and require psychiatric care and mental health counseling in our MAT program. Instead of using every medication, trial and error, we focus on meds most likely to be helpful, thanks to the pgx results.. Not only are psych meds screened but also many meds for other health conditions. The company we use, also tests for DNA in all urine specimens. Is very difficult to try to trick us on urine results when we have their DNA; patients are made aware of all testing on their first visit so there is no surprise. Genotox Laboratories out of Austin, Texas, is the company with whom we work and have been very pleased. I do tell all my patients pharmacogenomics is not foolproof and is meant to be a guideline, another tool in the health toolbox.
    Keep up the good information in your blogs; I look forward to them and share with others.


    • How do you use the genetic information to guide methadone/buprenorphine induction?


      • Posted by Dominique D Leveque MSN RN CPNP FNP-C APRN on January 24, 2023 at 2:43 pm

        The genetic testing takes 14 – 21 days for the results so no, not specifically. We use the pgx more for psych meds and others. IF, in the addiction section, we find information for caution of any meds, we would make changes. For an induction, yes, it would take too long, awaiting results.

      • Yes if only the data could help us to see who may be a slow metabolizer by day 1. By day 14 we are – hopefully – well into the induction process.

  7. and how much does it cost and who pays for it in your state? if medicaid doesn’t pay for it — who will? is there peer reviewed articles on this ?


  8. Posted by George Bartels on January 24, 2023 at 12:36 pm

    Thanks, Jana. Very helpful. I keep being tempted to speed things up a bit for obvious reasons but lessons from the past are critical. At my age, I should know this but we all need reminders!


  9. Posted by Dominique D Leveque MSN RN CPNP FNP-C APRN on January 24, 2023 at 2:52 pm

    We are in Indiana and Indiana Medicaids will not cover the cost but we haven’t had any Medicaid patient have to pay, anything, nor receive a bill. Genotox is covered by commercial insurance and Medicare. For private pay, cost is $199 but I hear they give discounts for larger groups. Peer review articles? I’ll have to research. As I mentioned previously, pgx is not foolproof, not a guarantee, but a guideline.


  10. What a wonderful post Dr! Probably one of if not the best one I’ve read so far. As is always the case I’m surprised at your insight and your ability to put yourself in the patient’s position. Yes it’s unnerving to know that does started too low for a severe opioid addiction could mean someone will later overdose and die. It’s also disturbing when doses of methadone start out too high right from jump street and people die. However, there’s other tragic consequences to providing a high dose of methadone to those “bubble gum” addicts. Becoming hooked on a schedule two opioid narcotic could easily drain the life out of an otherwise healthy person. It’s a depressant. Like all depressants methadone can cause sedation. Lethargy, vomiting etc. Which could in theory wind up causing other health concerns. For lack of a better example pancreatitis… Then don’t forget that as time marches on. There’s a steep price mentally to pay as a person realized that they’re being provided too much methadone without justification. Dosing too high could cause the survivors to spend the rest of their lives battling the consequences of being prescribed methadone without a legitimate reason to do so. It’s always a great comfort to me knowing that you are looking out for all kinds of addicts. Bubble gum to hard core ones alike. We’re all better off. Thank you


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