From the Tower to the Trenches: Opioids
The United States is in the midst of a drug abuse epidemic fueled by opioid addiction. According to the Center for Disease Control and Prevention, opioid-related fatalities have reached more than 42,000 annually, surpassing deaths from motor vehicle crashes. Georgia ranks 11th among states with the highest number of opioid related fatalities, which increased tenfold in the state between 1999 and 2014.
In February, Georgia State University College of Law hosted “Pain, Profits, Plaintiffs, Prison: A Prescription for Addressing the Opioid Epidemic in Georgia,” which focused on the need for a comprehensive multi-level approach to solving the crisis. The event was part of the college’s popular From the Tower to the Trenches lecture series.
The session was moderated by associate professor Patti Zettler, formerly legal counsel with the Food and Drug Administration. Panelists included Sidney Barrett, chief legal counsel of the Georgia Department of Public Health, now retired; Thomas Griner (J.D. ’96; Ph.D. ‘19) of the Law Office of Thomas E. Griner LLC; Bethany Sherrer (J.D./M.B.A./M.H.A. ’15), legal counsel for the Medical Association of Georgia; and Timothy Lytton, Distinguished University Professor and Professor of Law and associate dean for research and faculty development.
Zettler opened with a brief overview of the scope of the opioid problem and the federal government’s role, including how the FDA regulates approval, labeling, and marketing of prescription drugs. “The FDA alone cannot solve the opioid crisis,” said Zettler who served as a consultant to the National Academies of Sciences, Engineering, and Medicine (NASEM) Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse. “It took decades for the problem to develop, and it will take a sustained and coordinated effort among all stakeholders to effectively address the problem.”
Barrett described Georgia’s recent activities to address the crisis, including the development of a state-wide work group. He outlined a recent update to the law that requires prescribers to check the prescription drug management program before prescribing an opioid to make it more difficult for patients to obtain multiple opioid prescriptions from different doctors. Griner and Sherrer discussed other recent legal innovations including naloxone access, medical amnesty laws, and expanding resources to treat opioid overdoses, as well as the gaps in these laws that need to be addressed.
Lytton explored the opportunities and pitfalls of civil litigation “Like tobacco litigation, most individual plaintiffs have failed at the summary judgment stage, and the most successful lawsuits have been brought by government entities,” said Lytton. However, Lytton noted that the litigation process still serves important functions, including focusing attention on the role of manufacturers in causing opioid addiction through aggressive marketing, distribution, and sales practices; uncovering information through discovery that may not be disclosed to regulators; and prompting media coverage that keeps the issue of opioid addiction on the agendas of legislatures and public officials.