Practice of Medicine

Article

Manufacturers, Distributors and Physicians in the Crosshairs of Opioid Litigation

September 26, 2019

A MagMutual Risk Consultant Perspective

According to data from the National Vital Statistics System, approximately 70,237 overdose deaths occurred in the United States in 2017.[1] Drug poisoning deaths have outnumbered deaths by firearms, motor vehicle crashes, suicide and homicide.[2] Against the backdrop of this public health crisis, some predict that opioid litigation will look like the tobacco litigation of the 1990s[3] – and pharmaceutical companies, distributors and individual physicians are getting caught in the crosshairs.

In early 2019, Purdue Pharma agreed to pay the state of Oklahoma $270 million rather than face trial on charges of misleading marketing practices and misrepresentation regarding Oxycontin.[4] Many state and local jurisdictions are seeking to recover some of the costs associated with combatting the epidemic. Other companies entangled in litigation include Johnson & Johnson and CVS. According to Bloomberg Law, “In all, more than 1,800 state and local governments have filed opioid-related lawsuits. Penalties and settlements could run into the tens of billions of dollars, rivaling big tobacco payouts of the 1990s.”[5]

Although the medical community has implemented guidelines for safer prescribing in recent years, individual physicians are also finding themselves in this wave of litigation. Physicians are often faced with a dilemma: balancing the need to provide compassionate and safe care to patients in pain with the risks associated with prescription pain medications. The Federation of State Medical Boards developed a model policy that addressed fears about treating patients with opioids, stating:

Physicians should not fear disciplinary action from the Board for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice, when current best clinical practices are met.[6]

Nonetheless, there has been a significant increase in litigation against prescribers.

In 2016, a St. Louis jury issued one of the first mega-verdicts in an opioid-related malpractice claim. The case was filed by Brian Koon, a city parks worker who became addicted to prescription opioids. Over the course of three years, Mr. Koon was prescribed 37,000 pills for lower back pain. At one point, the prescription totaled almost forty pills a day with three different types of opioids. Mr. Koon filed suit against the doctor who prescribed the medication, and after years of litigation, he won. The jury awarded Mr. Koon $1.4 million with an additional $1.2 million to his estranged wife. The jury also awarded $15 million in punitive damages against the prescriber and the hospital where he was employed.[7] 

In another case, The Supreme Court of West Virginia held that prescribers could be held liable for their patients’ addiction.[8] Twenty-nine individual patients filed eight separate civil actions alleging that three pharmacies, a physician and other medical providers negligently prescribed and dispensed controlled substances, causing them to become addicted to and abuse the controlled substances. The court decided that, although the patients were responsible for their own addiction and had engaged in illegal acts to obtain controlled substances, the providers also engaged in questionable activities that may have been a factor in causing the addiction. Ultimately, the court allowed the patients to sue providers and allowed juries to apportion fault to both patients and providers for causing the addiction.[9]

Physicians can also be held liable when a patient overdoses on a prescribed medication. In 2015, a California physician was convicted of second-degree murder and sentenced to thirty years in prison. She was accused of ignoring "red flags" about her prescribing habits, including the overdose of a patient in her clinic and receiving nine phone calls in less than three years from authorities informing her that patients had died with drugs in their system. [10]Witnesses told jurors that the physician agreed to give patients powerful opioids without asking follow-up questions even after some – including an undercover agent posing as a patient – told her about their drug addictions.[11]

Strategies for Reducing Risks Related to Opioid Prescribing

In its report, Relieving Pain in America, an IOM task force recommends twelve best practices measures[12]:

  1. Recognize that chronic pain is a disease in its own right.
  2. Promote and enable self-management of pain.
  3. Address gaps in knowledge and competencies related to pain assessment and management.
  4. Avoid negative attitudes about people with pain, and stereotyping and biases that contribute to disparities in care.
  5. Develop educational approaches and materials for people with pain and their families that promote and enable self-management.
  6. Provide consistent and complete pain assessments.
  7. Use opioid therapy for chronic non-cancer pain only when safer and reasonably effective options have failed.
  8. Provide patient education and obtain informed consent when using opioid analgesics.
  9. Monitor during the use of potentially abusable medication.
  10. Avoid excessive reliance on opioids, particularly high-dose opioids for chronic pain management.
  11. Utilize available tools for risk mitigation, such as the state Prescription Drug Monitoring Program.
  12. Utilize a medication use agreement.

Additional Resources

  • American Academy of Family Physicians : Sample Medication Use Agreement
  • The U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion maintains a downloadable copy of the Practitioner’s Manual: An Informational Outline of the Controlled Substances Act.
  • The Opioid Risk Tool (ORT) is a brief, self-report screening tool developed by Lynn R. Webster, MD designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain. Patients categorized as high risk are at increased likelihood of future abusive drug-related behavior. The ORT can be administered and scored in less than one minute and has been validated in both male and female patients, but not in non-pain populations.
  • SOAPP-R is a 24-item questionnaire designed to help providers evaluate the patients’ relative risk for developing problems when placed on long-term opioid therapy. (Butler, Fernandez, Benoit, et. al., 2008)
  • SAMHSA-HRSA Center for Integrated Health Solutions Screening Tools

Sample Medication Use/Treatment Agreements

 

[1] Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. 2018. "Drug and opioid-induced overdose deaths 2013-2017." Morb Mortal Wkly Rep. ePub:.

[2] Ibid.

[3] Wheeler, Lydia. 2019. "Squandered big tobacco money a cautionary tale in opioid cases." Bloomberg Law, June 19. Accessed June 20, 2019. https://biglawbusiness.com/squandered-big-tobacco-money-a-cautionary-tale-in-opioid-cases.

[4] Mann, Brian. 2019. "Purdue Pharma reaches $270 million in opioid settlement with Oklahoma." NPR, March 26. Accessed June 20, 2019. https://www.npr.org/2019/03/26/706969415/purdue-pharma-reaches-270-million-opioid-settlement-with-oklahoma.

[5] Mann, Brian. 2019. "Opioid crackdown could lead to more drug company bankruptcies." NPR, June 10.

[6] Federation of State Medical Board. "Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain." Washington, DC, July 2013.

[7] Brian Koon and Michelle Koon, Respondents, v. Henry D. Walden and Saint Louis University, Appellants. 2017. 539 S.W. 3d 752 (Missouri Court of Appeals, Eastern District, Division One).

[8] n.d. "Tug Valley Pharmacy et al v All Plaintiffs. In: LEXIS, West Virginia Court of Appeals, 2015."

[9] Ibid.

[10] Gerber M, Girion L, Queally J. California doctor convicted of murder in overdose deaths of patients. In: Los Angeles Times, Los Angeles: Los Angeles Times, 2015.

[11] Ibid.

[12]Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research. Washington, DC: Institute of Medicine, 2011.

 

 

 

 

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