In 2017, over 70,000 Americans died from a drug overdose — and over 48,000 of those deaths were caused by an opioid overdose. These staggering and tragic figures have heightened scrutiny of the roles opioid manufacturers, distributors, and even individual healthcare providers played in the dramatic rise of opioid addiction and opioid-related deaths since the late 1990s. With that scrutiny came a wave of lawsuits, both nationally and locally, detailing the havoc that opioids wreaked on American cities, towns, and families.
Nationwide litigation in brief
States, counties, cities and towns, emergency medical services rescue squads, and even hospitals are suing pharmaceutical companies like McKesson, Teva Pharmaceuticals, Johnson & Johnson, and Purdue Pharma, the creator of OxyContin. One of the central allegations in these lawsuits is that many of these companies knew how addictive opioids were, yet each company continued to aggressively market opioids as “non-addictive.” Many of the plaintiffs seek to recover costs they have expended in fighting the opioid epidemic — for many state and local governments, that includes foster care costs for children whose parents have died or are incapacitated due to opioid addiction. While these lawsuits mainly focus on manufacturers of opioids, healthcare professionals who prescribe opioids have increasingly come under scrutiny as well.
Physician Case Study: Koon v. Walden, M.D.
Though lawsuits against individual physicians are rare, some have succeeded. In October 2017, the Missouri Court of Appeals upheld a $16.7 million plaintiff’s verdict where the jury found a physician liable for overprescribing opioids to the patient, causing him to become addicted. After injuring his back in 2008, plaintiff Brian Koon saw his primary care physician, defendant Henry Walden, M.D., who prescribed hydrocodone. When Koon complained of more pain to Walden, and stated he was taking twice the prescribed amount, Walden prescribed more pills. Koon continued to complain that the pain had worsened, and Walden continued to prescribe more pills, even when he did not see Koon in the office. In August 2008, Walden noted that Koon was taking six hydrocodone pills a day.
In February 2009, Koon was prescribed oxycontin by another doctor at Saint Louis University. When Koon saw Walden for a follow-up, Walden continued to prescribe hydrocodone in addition to the oxycontin. In August 2009, for the first time, Walden discussed with Koon the possible adverse effects and risks of dependence. By October 2009, Walden prescribed immediate-release oxycodone in addition to the hydrocodone and oxycontin already being prescribed to Koon. He continued to prescribe all three opioids at the same time in increasing amounts during 2010 and 2011. When Koon ran out of medication, he would call Walden, and the prescription would be refilled — and sometimes the dose increased — without Walden’s talking to Koon or Koon’s wife. Sometimes, Walden would prescribe morphine to fill the gaps in prescriptions that could not be refilled early.
In 2008, Koon’s average daily dose of opioids was 49.67 milligrams MED. By 2012, Koon was prescribed, on average, 1,555.94 milligrams MED a day. Koon went from a prescription for six pills a day to almost 40 pills of opioids a day between the three prescriptions. The court found that such evidence showed that Walden’s “decision to prescribe these amounts for this length of time was done in conscious disregard of, and with complete indifference to, Koon’s safety and the safety of others.” The court found this to be tantamount to intentional wrongdoing, and upheld the punitive damage award of $15 million.
Takeaways from Koon, and Board regs
While Virginia’s medical malpractice cap prevents awards like the $16.7 million verdict the jury awarded Koon, Koon’s case shows that juries are sensitive to the opioid epidemic, and to how individual healthcare providers may play a role. In response to the opioid epidemic, the Virginia Board of Medicine developed opioid and controlled substance prescribing standards. In reviewing these standards, and considering Koon’s case, here are some key takeaways and tips for healthcare providers when prescribing opioids:
- Check the Prescription Monitoring Program: Before initiating pain management with an opioid for chronic or acute pain, healthcare providers must query the PMP in addition to performing a medical history, physical examination, and a mental status examination. For chronic pain patients, the provider must continue to query the PMP every three months. There are many additional requirements when initiating and/or prescribing opioids which may be found in the prescribing standards, but the PMP is the first, necessary step.
- Screen: Before initiating opioid treatment for chronic pain, the provider must conduct a urine drug screen or serum medication level. Once treatment has begun, the provider must order and review a urine drug screen or serum medication levels randomly at least once a year, at the provider’s discretion. If prescribing buprenorphine for addiction treatment, the provider must conduct a urine drug screen or serum medication level prior to initiating treatment, then at least every three months for the first year of treatment, and at least every six months thereafter.
- Communicate: Before initiating opioid treatment for chronic pain, the provider must discuss with the patient the known risks and benefits of opioid therapy; the responsibilities of the patient during treatment; and an exit strategy for the discontinuation of opioids, if not effective. This contributed to Koon’s large verdict, as Walden failed to do this until he had already prescribed Koon opioids for one and one-half years.
- Document: Every step of prescribing an opioid must be documented clearly in the medical records, with extra care to follow the board standards, especially relating to chronic pain management. For example, this documentation should include, among other information, applicable records from past providers, a treatment plan, documentation of informed consent including a written treatment agreement signed by the patient, and the provider’s expected outcomes for the patient.
- Evaluate: Regularly evaluate the patient for opioid use disorder, and assess the continued use of the current treatment plan. Watch for signs of opioid addiction or dependency, including patterns of early refills, asking for higher doses, taking multiple doses at once, and exhibiting a loss of control over the ability to take the medication as prescribed.
Meghan R. Murphy is an attorney in the Richmond, Virginia, office of Hancock, Daniel & Johnson PC. She practices medical malpractice defense litigation.