This month we look at a case involving an issue that is in the news daily – opioid prescribing. Opioids can provide substantial pain relief, but can also result in dependency, addiction, overdose, and even death, meaning that prescribers need to be judicious in deciding if opioids are the best option for their patients.
The patient, Mr K, 37, was a married father of a young daughter. He had been seeing his primary care physician, Dr W, for 7 years. In 2008, the patient, who worked in construction, slipped and fell injuring his lower back. A visit to the chiropractor didn’t resolve the pain, so Mr K went to Dr W that February complaining of significant pain. The physician ordered x-rays, a muscle relaxer, and ibuprofen as needed. The x-rays came back normal, but the patient called the next week complaining that the ibuprofen wasn’t working, and the pain was limiting his ability to do his work. He asked for a pain reliever. Dr W wrote a prescription for 30 hydrocodone pills, with one refill, to be taken as needed every 6 hours.
A month later, Mr K called Dr W and requested a refill, explaining that he needed to take double the number of pills to control the pain. The doctor refilled the prescription.
In April 2008, Mr K came to Dr W’s office complaining of continued back pain, and a worsening of pain by the end of the work day, which was helped by taking 2 to 3 hydrocodone pills. Dr W refilled the prescription and ordered an MRI. A few weeks later Mr K called to ask about the MRI results and again reported having to take more than the prescribed dose of hydrocodone for it to work. Dr W referred Mr K to an orthopedic surgeon who said the MRI did not show a need for surgery. Mr K also got a second opinion from another surgeon who said the same thing.
In July 2008, Mr K called Dr W and reported increasing the amount of hydrocodone and then trying to decrease it but that it caused him to “feel very bad, shaky, nose running, sweating, weak, yawning and moody.” When he took the medicine, he told the doctor, he felt better within an hour. “I think I need help,” Mr K told the physician.
The doctor had him come in the following month and noted that Mr K was doing better with the back pain and was taking hydrocodone 6 times a day with plans to wean back in a week. The physician noted that the plan was for Mr K to continue the hydrocodone but cut himself back on how often or how many pills he took. Dr W did not change the prescription.
In February 2009, when Dr W was on vacation, Mr K saw another physician in the same practice. This physician recommended switching from hydrocodone to extended-release oxycodone. He prescribed it to Mr K and told him to follow up with Dr W. A week later he saw his regular physician who noted that Mr K was still having pain but was tolerating the oxycodone extended-release tablets well with no adverse effects. The patient reported that the extended-release oxycodone was wearing off faster than he would like and had not eliminated the pain. Dr W continued to prescribe the hydrocodone in addition to the extended-release oxycodone.
This pattern continued, with the patient continuing to complain that the medication didn’t help as well as it used to. In August 2009, Dr W discussed possible adverse effects and risk of dependence, but both patient and clinician agreed that the benefits outweighed the risks. By October 2009, Dr W added an immediate-release oxycodone to the hydrocodone and extended-release oxycodone being prescribed. This went on through 2010 and 2011. By 2012, Mr K was having serious problems at home, with his job and with his relationship with his family. In May of that year, Mr K and his wife went to see Dr W to discuss weaning Mr K off opioids. Mr K told the physician that the pills were ruining his life. Dr W noted in the file that the patient was tolerating the medicine well and had no new adverse effects.
Over the next few months, the pharmacy called Dr W concerned about the large amount of opioids being prescribed to Mr K. At this point, Dr W began trying to taper down Mr. K’s immediate-release oxycodone. Eventually Mr K’s withdrawal symptoms became so bad that he had to be admitted to a rehab facility where he was diagnosed as having severe opioid use disorder.
Mr K recovered, but he and his wife divorced, and he lost his job as a result of the opioid use. He eventually sought the counsel of an attorney and sued Dr W and his practice.
The case went to trial. At trial, the parties stipulated that in 2008 Mr K was taking an average daily dosage of 49 morphine milligram equivalents (MME). In 2009 it was up to 208 MME and by 2010 it had reached 545 MME. By 2012, Mr K was prescribed on average 1555 MME – almost 40 opioid pills per day between 3 prescriptions.
Plaintiff’s experts testified and described these doses as “excessive,” “colossal,” “reckless,” “extraordinary,” and “astronomical.” The experts faulted Dr W – saying there was no legitimate medical purpose to prescribe opioids in these amounts for this length of time. The plaintiff’s experts also pointed out that Dr W failed to conduct a risk and benefit assessment that would meet the standard of care, nor did he have any system in place to adequately monitor Mr K’s use of opioids. During the experts’ testimony, there were several mentions of a “nationwide opioid epidemic.”
At the end of the trial, the jury found Dr W liable, and awarded Mr K $900,000 in damages and $15 million in punitive damages. Dr W immediately appealed, arguing that allowing references to an “opioid epidemic” was highly prejudicial and irrelevant and its only purpose was to mislead the jury to believe that they should hold Dr W accountable for the epidemic.
The appeals court disagreed with this argument and affirmed the judgment of the jury. It held that the information about an opioid epidemic was relevant in this case. “All of this evidence was probative of the critical issue for finding Defendants’ conduct to be negligent, which required a determination of how their conduct compared to what others in the profession were doing under similar circumstances. It was even more probative of facts related to Plaintiffs’ request for punitive damages, which required a determination of whether Defendants knew or should have known that there was high degree of probability of injury to Mr K or others from prescribing him these unusually high amounts of opioids. Defendants’ knowledge of the existence and extent of the epidemic — the amount and rates at which people were being prescribed, becoming addicted to, overdosing on and dying from opioids prescribed by other doctors in this country — was probative of whether Defendants’ conduct rose to the level of reprehensibility contained in the punitive damages instruction.” Ultimately, the court agreed that it had.
Use great care when prescribing opioids and explore other, less dangerous, options if possible. If you do need to prescribe opioids, it’s essential to conduct a risk assessment with the patient before prescribing anything. Risks and benefits should be continually re-assessed at an office visit each time a dosage is increased. Patients on pain management medications must be monitored regularly to assess pain levels and functioning, and to check for side effects and behaviors suggesting addiction. All of this – the risk assessments, monitoring, and discussions with patients – should be documented in the patient’s medical records.