Question: A new patient with severe back pain sought treatment at the Ease-Your-Pain Clinic, a facility run by medical specialists. Following a history and physical, he was given a prescription for high-dose oxycodone. Shortly after filing the prescription, he became unresponsive, and toxicology studies postmortem revealed elevated blood levels.
In a wrongful death lawsuit against the doctor and clinic, which of the following statements is best?
A. A wrongful death lawsuit deals with a special type of malpractice in which criminal sanctions are likely.
B. The facts here fall within the domain of common knowledge, or res ipsa loquitur; so the case will not have to depend on an expert witness.
C. Substandard care is clearly evident from the fact that this opioid-naive patient was prescribed a much higher than usual starting dose of the drug.
D. The elevated blood levels indicate that the cause of death was an opioid overdose.
E. To prevail, the plaintiff has the burden of proving, by a preponderance of evidence and through expert testimony, that the defendant’s breach of duty of due care legally caused the patient’s death.
Answer: E. Criminal prosecution for homicide is quite different from a civil lawsuit for wrongful death, requiring state action with proof beyond reasonable doubt and a showing of intent. It is rare in medical malpractice cases, which require expert testimony to prove breach of duty and causation.
Choices C and D are incorrect, as the facts given are deliberately brief and vague. For example, the medical history may have revealed this patient to be a chronic user of opioid drugs rather than being opioid naive, thus the need for higher dosing. In addition, we cannot be certain of the actual cause of death; opioid levels obtained in body fluids postmortem may be difficult to interpret and are apt to be higher in chronic users (see Dallier v. Hsu, discussed below).
We are currently in the throes of an epidemic of opioid deaths involving both illicit street drugs such as heroin and synthetic fentanyl, as well as FDA-approved controlled substances such as morphine and codeine derivatives. Overdose now exceeds motor vehicle accidents as, with nearly 100 Americans dying every day from an opioid overdose.
In an earlier column, we drew attention to physician and manufacturer criminality associated with opioid prescription deaths.1 In this article, we will focus on the civil liability facing doctors who treat patients afflicted with pain.
The onslaught of warnings, caution, and threats of criminal prosecution has prompted Medicare and pharmacy chains to impose restrictions on opioid prescriptions. Even more troubling, doctors are increasingly cutting back or stopping entirely their prescriptions. As a result, some patients may resort to desperate measures to obtain their drugs.
A recent article in the Washington Post draws attention to this situation.2 It tells the story of a 49-year-old trucker who had been taking large amounts of prescription opioids ever since hip surgery left him with nerve damage. Because no doctor nearby would write an opioid prescription, he had to drive 367 miles to his old pain clinic each month for a refill. According to the article, chronic pain patients may turn to unregulated alternatives such as kratom, and some have threatened suicide.
Citing data from the IQVIA Institute for Human Data Science, the article reported that the annual volume of prescription opioids shrank 29% between 2011 and 2017, even as the number of overdose deaths climbed ever higher. The drop in prescriptions was greatest for patients receiving high doses, most of whom had chronic pain.
Failure to treat pain can constitute substandard care. In Bergman v. Eden Medical Center, an Alameda County jury in California turned in a verdict against an internist charged with elder abuse and reckless negligence for failing to give enough pain medication to a patient dying of cancer.3 William Bergman was an 85-year-old retired railroad worker who complained of severe back pain. During his 6-day stay at the hospital, nurses consistently charted his pain in the 7-10 range, and on the day of discharge, his pain was at level 10. He died at home shortly thereafter.
After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict, and awarded $1.5 million in general damages. That amount was subsequently reduced to $250,000 because of California’s cap on noneconomic damages. The Bergman case is notable for being the first of its kind, and it squarely put physicians on notice regarding their duty to adequately provide pain relief.
At the same time, prescribing opioid drugs that result in harm can be the basis of a successful claim – if the plaintiff can prove the tort elements of negligence. However, this may be harder than it looks.
For example, a Connecticut malpractice case alleging negligent opioid prescriptions resulted in a judgment in favor of the defendant.4 The patient had a congenital skeletal deformity called Madelung’s disease, and she suffered from many years of severe pain requiring chronic opioids such as oxycodone, methadone, morphine, fentanyl, and hydrocodone, in combination and with other types of medications for anxiety, sleep problems, and depression. She was not a compliant patient and had a history of inconsistent pill counts and urine tests, and a history of stockpiling and hoarding pills.
Following a recent fracture of her right arm and shoulder, she visited several doctors for narcotic prescriptions before consulting the defendant doctor, who concluded that hers was an emergency and urgent situation. He believed that if he did not prescribe medications to address her pain, she would engage in unsafe drug-seeking behaviors. Accordingly, the doctor prescribed the following: methadone, 40 mg, 4 pills per day; extended-release morphine sulfate, 60 mg, 2 per day; alprazolam, 1 mg, 3 per day. Within hours of filing her prescription, she began to stumble, developed slurred speech, and then became unresponsive and died.
The court was unpersuaded that the requisite standard of care was to contact the patient’s prior treaters or pharmacy, or to obtain her current records to determine her level of drug naiveté or tolerance, or that the defendant should have initiated treatment with starting doses of drugs. It held that that reflected “a narrow textbook approach to the practice of pain management and ignores the role of patient-physician interaction.”
Based on all the evidence, the patient’s tolerance for opiates had greatly escalated, and her level of pain remained at 10 on a scale of 10. The defendant had independently assessed the patient, determined her needs, and ruled out that she was opiate naive. Based on all the circumstances, he prescribed morphine, methadone, and alprazolam. The morphine prescription of 60 mg extended release every 12 hours was not lethal to her and was not her first opioid analgesic. The court ruled that the plaintiff had failed to sustain the burden of proving causation, there being no finding that the patient took more medications than prescribed or overdosed. It was unimpressed by the various calculations offered by the experts on postmortem drug levels and causation.
A recent report from the Doctor’s Company, a major malpractice carrier, reviewed 1,770 claims closed between 2007 and 2015 in which patient harm involved medication factors.5 In 272 of those claims (15%), the medications were narcotic analgesics, most often prescribed in the outpatient setting and involving methadone and oxycodone. The Centers for Disease Control and Prevention has recently published treatment guidelines noting that long-term opioid use among patients with chronic pain increased the likelihood of addiction and overdose and had uncertain benefits. They discouraged doses higher than the equivalent of 90 mg of morphine.6
While it is true that opioid-related malpractice lawsuits are not infrequent, stopping entirely the prescribing of controlled narcotic analgesics in the name of “first do no harm” is simplistic and misguided.
It is better to adopt widely recommended strategies in opioid prescribing, recognizing that, as Howard Marcus, MD, chair of the Texas Alliance for Patient Access, has said, “It is possible to prescribe opioids responsibly and safely for patients with chronic pain who do not obtain sufficient relief and reasonable function with nonopioid treatment. However, to do so, it is necessary to have adequate knowledge of the pharmacology of opioids, risk factors, and side effects. Safe opioid prescribing requires thorough patient evaluation, attention to detail, and familiarity with guidelines and regulations.”7
To this might be added the suggestion that, in tough cases, one should make a referral to a pain specialist skilled in the use of such drugs.