At least 91 Americans die every day from an opioid overdose. The epidemic has claimed more than 300,000 lives since 2000 and is expected kill another half million over the next decade.
So perhaps it’s time to step up lawsuits against the drug manufacturers that sell the opioids to the tune of $13 billion per year, Stanford Health Policy’s Michelle Mello argues in a commentary in the current issue of The New England Journal of Medicine.
Mello, a professor of law and of health research and policy, and co-author Rebecca L. Haffajee, an assistant professor of health management and policy at University of Michigan School of Public Health, note that although heroin and illicitly manufactured fentanyl account for an increasing proportion of opioid overdoses, the majority of people who are addicted to opioids get hooked on prescribed painkillers.
While clinicians and health-care providers are trying to prescribe fewer opioids, Mello and Haffajee believe litigation is another crucial method to fight the crisis.
“The search for solutions has spread in many directions, and one tentacle is probing the legal accountability of companies that supply opioids to the prescription market,” the authors write.
The final report of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis details decades of aggressive marketing of oxycodone from 1997-2002 that led to a tenfold rise in prescriptions to treat moderate to severe pain. “To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis,” the report said, noting the industry had sponsored some 20,000 conferences for physicians on managing pain with opioids while claiming their potential for addiction was low.
Mello and Haffajee argue that similar to the early cigarette promotions by Big Tobacco, opioid manufacturers have failed to adequately warn patients about addition risks on drug packaging and in their marketing campaigns.
“Some recent claims allege that opioid manufacturers deliberately withheld information about their products’ dangers, misrepresenting them as safer than alternatives,” they write.
Early attempts to bring class-action suits against opioid manufacturers have encountered procedural barriers. Judges typically find that proposed class members lack sufficiently common claims because of different circumstances surrounding opioid use and clinical conditions.
But the tide may be turning. There has been an uptick in litigation against Big Pharma since Purdue Pharma, the maker of the blockbuster painkiller, OxyContin, agreed in 2007 to pay $600 million to settle charges that it misled federal regulators, doctors, and patients about the drug’s risk of addiction and its potential to be abused.
“As the population harmed by opioids grows and more information about the population is documented, it becomes easier to identify subgroups with similar factual circumstances and legal claims — for example, newborns with neonatal abstinence syndrome,” they said.
Perhaps most promising, the authors write, is the “advent of suits brought against drug makers and distributors by the federal government and dozens of states, counties, cities, and Native American tribes.
“Because the government itself is claiming injury and seeking restitution so that it can repair social systems debilitated by opioid addiction, these suits avoid defenses that blame opioid consumers or prescribers,” they said. “They also garner substantial publicity.”
The government is borrowing from the playbooks used to sue tobacco and firearms companies, relying on four strategies:
- Focus on the “public scourge” created by the opioid manufacturers due to their oversaturation of the market, arguing that opioids constitutes a public nuisance;
- Paint the opioid companies’ business practices as deceptive;
- Call out the manufacturers’ lax monitoring of suspicious opioid orders; and
- Ask courts to make companies disgorge the “unjust enrichment” they have reaped at the government’s expense through their unfair business practices.
Two large settlements have occurred in state cases that included unjust enrichment claims, the authors note, although the pharmaceutical companies avoided admitting fault. The Commonwealth of Kentucky settled with Purdue Pharma for $24 million in 2015 over allegations that it had profited while Kentucky was left paying associated medical and drug costs of those who became addicted.
Earlier this year, drug wholesaler Cardinal Health Inc. agreed to pay $20 million to settle a lawsuit brought by West Virginia’s attorney general over accusations that it flooded the market with opioids in a state that now has the highest opioid overdose rate in the nation.
Such lawsuits have garnered a lot of media attention and contributed to pressure on the U.S. government to take action against the abusive practices of drug manufacturers and distributors.
“Win or lose, lawsuits that very publicly paint the opioid industry as contributing to the worst drug crisis in American history put wind in the sails of agencies and legislatures seeking stronger oversight,” Mello and Haffajee write. “Together, litigation and its spillover effects hold real hope for arresting the opioid epidemic.”
Listen to a podcast with Haffajee talking about the opioid crisis.
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Rylan Sekiguchi at the 2017 U.S.-Japan Council conference in Washington, DC
