Rebecca A. Delfino
Volume 73, Issue 2, 301-370
We can no longer ignore this—a national crisis resulting in almost one million American deaths, costing hundreds of millions of dollars, ravaging the health care system, and devastating state and local communities. This narrative describes the COVID-19 pandemic and something else: the epidemic of opioid addiction and abuse. In the last twenty years, the opioid epidemic claimed the lives of more than 700,000 people at the cost of more than 500 billion dollars to the economy. The COVID-19 pandemic has made the opioid epidemic worse, causing a staggering increase in opioid-related overdose deaths. Even now, on average, 140 people die every day from an opioid overdose, making it a leading cause of injury-related death in the United States. And 70% of those deaths involve a prescription opioid.
There is a growing sense that those responsible for the opioid epidemic, specifically drug companies and their executives, have escaped responsibility for their dangerous and deceptive practices in manufacturing and marketing opioids. Although they have confronted civil lawsuits, the pharmaceutical industry has faced virtually no criminal scrutiny; only a couple of companies and executives have ever been criminally charged for the devastation that opioids have caused. This raises questions: Given the increasing number of opioid overdose deaths nationally, why are charges and convictions of drug companies and their executives so rare? And why have existing legal mechanisms not worked to punish the improper manufacturing and marketing practices and curb the epidemic? Their misconduct continues because no single federal law exists to prosecute pharmaceutical companies and their executives for causing the epidemic. And existing laws are ineffective; they fail to criminalize the type of conduct that caused the epidemic, contain elements prohibitively difficult to prove, or impose minimal penalties that fail to deter bad actors. Thus, the drug industry has persisted in dubious practices unfettered by civil litigation, government enforcement actions, and fines. This Article seeks to examine these issues and others. It is the first in legal scholarship to offer a concrete and omnibus solution grounded in federal law to address the pharmaceutical industry’s misconduct. The novel 360-degree solution proposed here—the “Controlled Substance Manufacturing and Marketing Accountability Act”—will deter and punish those pharmaceutical companies and their executives who provided misleading information to government regulators and used deceptive practices in marketing opioids to the public. It also recognizes that when properly prescribed, these drugs provide essential relief for pain and suffering. Thus, this Proposal seeks to address prior misconduct and point the way forward to avoid the next drug epidemic.