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Reducing Harm Through Litigation Against Opioid Manufacturers? Lessons From the Tobacco Wars

The opioid epidemic in the United States continues unabated. After increasing every year since 2002, opioid overdose deaths surpassed 33 000 in 2015. Heroin and fentanyl account for an increasing percentage of these deaths, but a substantial number involve prescription opioid pain relievers (OPRs), and many people became addicted to OPRs before transitioning to illicit opioids. In addition to these human costs, the estimated economic burden of OPR disorders exceeded $78 billion in 2013. OPR prescriptions increased by more than 350% from 1999 to 2015, driven predominantly by attempts to reduce the burden of chronic noncancer pain. Although accompanied by a sharp rise in opioid-related morbidity and mortality, increased OPR prescriptions—annual sales of which increased from $1 billion in 1992 to nearly $10 billion in 2015—do not appear to have decreased the population-level prevalence of pain. As the opioid epidemic’s human and economic costs and industry profits accumulate, public scrutiny has turned toward the misleading and, at times, arguably illegal practices of some companies that make and market OPRs. Dozens of state, local, and tribal governments have sued OPR manufacturers for their alleged role in fueling the opioid overdose epidemic, and 41 state attorneys general are investigating potential unlawful sales and marketing practices by OPR manufacturers. The trajectory of these investigations and lawsuits appears similar to those against the tobacco industry during the 1990s, when nearly every state sued tobacco manufacturers over predatory and deceptive practices that led to the death and disability of millions of people. Those lawsuits ended when 46 states and the 4 largest cigarette manufacturers entered into the Master Settlement Agreement (MSA), which provided billions of dollars to state and local governments but did little to foster future reductions in tobacco-related harm. Despite similarities between lawsuits against OPR manufacturers and those leading to the MSA, OPRs and cigarettes differ in important ways. Chief among these differences is that unlike tobacco, which provides no medicinal value and is often deadly when used as intended, OPRs can be used safely and are indispensable for palliative care and treating some cancers, human immunodeficiency virus, and acute pain. The regulatory environment for OPRs and cigarettes also differs in important ways. Nevertheless, the history of tobacco litigation offers important lessons for addressing the role of OPR manufacturers in the opioid overdose epidemic. We examine ongoing litigation against OPR manufacturers within this context, highlighting parallels between lawsuits filed against OPR manufacturers and lawsuits that resulted in the MSA, and discuss why a similar agreement in the OPR context would be unlikely to substantially reduce opioidrelated morbidity and mortality absent contemporaneous comprehensive regulatory reform.