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.