Michigan, like the rest of the country, suffers from an opioid epidemic. Every day, more than 100 Americans die from an opioid overdose1. Some economists estimate that the opioid crisis has cost the U.S. economy more than $1 trillion since 2001 and is on pace to cost an additional $500 billion through 20202.
The profligate use of opioid pain relievers has contributed mightily to the epidemic. A few data points tell the story:
- About a quarter of patients prescribed opioids for chronic pain do not use them as directed3.
- Roughly 4 out of 5 heroin users first abused prescription opioids4.
- United States citizens consume about 80% of the world supply of oxycodone and almost all of the supply of hydrocodone.
Predictably, lawyers and their clients have engaged the legal system to assign responsibility for the opioid epidemic. The wave of opioid litigation has reached Michigan. Opioid litigation, modeled largely on the tobacco lawsuits of the 1990’s, has grown exponentially over the last few years. State and local governments initially targeted pharmaceutical manufacturers. Now, distributors such as McKesson and Cardinal have been sued. In 2017, more than 250 state and local governments sued organizations throughout the opioid supply chain, including manufacturers, wholesalers and distributors. Michigan has joined the cause. The number of Michigan cities and counties that have sued opioid manufacturers and distributers is growing. The list includes Detroit, Oakland County and Wayne County. Healthcare providers have reason to fear the opioid litigation wave. Plaintiffs’ attorneys will continue to look down the opioid distribution chain for new targets.
Michigan physicians and hospitals may well be next. Indeed, the next wave of opioid litigation is already building. A growing number of lawsuits against hospitals and physicians allege negligent opioid prescribing practices. The suits typically allege that a physician was negligent by overprescribing opioids or that hospitals failed to effectively monitor their physicians’ prescribing practices, thereby contributing to addiction and all of its dire consequences.
This trend will continue. The United States Department of Justice targets physicians believed to overprescribe opioids. DOJ has hired new federal prosecutors who focus exclusively on investigating and prosecuting healthcare providers who improperly prescribe opioids.
Physicians and hospitals should, of course, strive to improve prescribing practices because it is the right thing to do for patients. Moreover, providers should take concrete steps to protect themselves from the building wave of opioid litigation. Physician groups and hospitals should:
- Require specialized training for all opioid prescribers on the medical staff. Hospitals should assure adherence to Michigan’s new standards for prescribers.
- Ensure that monitoring and testing for appropriate opioid prescribing practices is an integral component of every compliance program.
- Develop a comprehensive screening tool to identify patients who may have a genetic or social predisposition for opioid addiction, or who have struggled with such issues in the past.
- Develop quality metrics related to opioid prescribing practices. Mine the data to identify and counsel outliers. Assume that the government is mining your data to find outliers among opioid prescribers.
- Adopt an effective patient education program related to opioids and the potential for addiction.
- Implement a protocol for patient intervention for those suspected of developing dependency or addiction.
Hospitals and physician groups should adopt evidence-based best practices for the prescription and management of opioids. While a number of tools are available, the Center for Disease Control and Prevention (“CDC”) Guidelines for Prescribing Opioids for Chronic Pain is an excellent resource. The guidelines are summarized as follows:
1. OPIOIDS ARE NOT FIRST-LINE THERAPY. Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain.
2. ESTABLISH GOALS FOR PAIN AND FUNCTION. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.
3. DISCUSS RISKS AND BENEFITS.
4. USE IMMEDIATE-RELEASE OPIOIDS WHEN STARTING.
5. USE THE LOWEST EFFECTIVE DOSE. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to more than 50 morphine milligram equivalents per day, and should avoid increasing dosage to 90 morphine milligram equivalents per day, or carefully justify a decision to titrate dosage to more than 90 morphine milligram equivalents per day.
6. PRESCRIBE SHORT DURATIONS FOR ACUTE PAIN.
7. EVALUATE BENEFITS AND HARMS FREQUENTLY.
8. USE STRATEGIES TO MITIGATE RISK. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.
9. REVIEW PDMP DATA. Clinicians should review the patient’s history of controlled substance prescriptions using state Prescription Drug Monitoring Programs (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him/her at high risk for overdose.
10. USE URINE DRUG TESTING.
11. AVOID CONCURRENT OPIOID AND BENZODIAZEPINE PRESCRIBING.
12. OFFER TREATMENT FOR OPIOID USE DISORDER.
There is no assurance that opioid prescribing physicians and hospitals won’t be sued in today’s rapidly developing litigation environment. They can, however, through the rigorous implementation of common sense policies ensure that they have a defense.
1CDC/NCHS, National Vital Statistics System, mortality. U.S. Department of Health and Human Services, CDC; 2017.
2Altarum; economic toll of opioid crisis in U.S. exceeded $1 trillion since 2001. February 13, 2018.
3Vowles, K.E., McEntee, M.L., Jones, P.S., Forhe, T., May, J.P., Vangoes, D.N. Rates of opioid misuse, abuse, and addiction and chronic pain: a systematic review and data synthesis. Pain. 2015.
4Muhuri, P.K., Gfroerer, J.C., Davies, M.C. Associations of non-medical pain reliever use and initiation of heroin use in the United States. CBHSQ data review, August 2013.
About the Authors:
Kerry Harvey is a Member in Dickinson Wright’s Litigation Practice group. Kerry’s private practice experience includes representation of healthcare providers, financial institutions and public officials. As U. S. Attorney for the Eastern District of Kentucky, Kerry placed special emphasis on financial fraud, healthcare fraud, and public corruption. In addition to extensive litigation experience, Kerry advised a number of businesses as outside general counsel concerning compliance, governance, and regulatory issues. Kerry can be reached at 859-899-8739 or firstname.lastname@example.org and you can visit his bio here.
Andrew Sparks is an Of Counsel in the firms Litigation Practice group. Andrew practices in the area of litigation with a particular emphasis on government enforcement, white collar criminal defense, internal and government investigations, health care and false claims act matters, and complex business disputes. Andrew can be reached at 859-899-8734 or email@example.com and you can visit his bio here.