Purdue Pharma, a pharmaceutical company that manufactures pain medications such as OxyContin, has pleaded guilty to several federal criminal charges and faces $8 billion in penalties for their role in the U.S. opioid epidemic.
The settlement was announced by the Justice Department on Wednesday, Oct. 21. Purdue Pharma is pleading guilty to three charges, including conspiracy to defraud the U.S. and violating federal anti-kickback laws, which prohibit the payment or reward of patient referrals to generate business. The company has agreed to pay a $3.5 billion fine for their actions and forfeit $2 billion of past profit. The company is also responsible for paying $2.8 billion in civil liability.
Purdue, which filed for bankruptcy last year, doesn’t have $8 billion on hand to pay, so as a result of the settlement, the company will be dissolved. Its current assets will be used to create a “public benefit” company governed by a trust, focused on public needs and interests rather than profit, and produce life-saving overdose rescue medications at a more accessible, discounted price. Any money made from this will go towards the $8 billion Purdue has agreed to pay, which will then go towards fighting the opioid epidemic.
“This resolution closes a particularly sad chapter in the ongoing battle against opioid addiction,” said Tim McDermott, assistant administrator for the Drug Enforcement Administration (DEA), in a press release from the U.S. Dept. of Justice. “Purdue Pharma actively thwarted the United States’ efforts to ensure compliance and prevent diversion. The devastating ripple effect of Purdue’s actions left lives lost and others addicted.”
The owners of Purdue, the Sackler family, are also responsible for paying a civil penalty of $225 million, a fraction of the Sackler’s $13 billion net worth that was accumulated mostly from the sale of OxyContin, according to the New York Times.
The opioid epidemic has progressed widely in the U.S. since the 1990s and has impacted millions. According to the Centers for Disease Control and Prevention (CDC), the crisis began with the rise in the prescribing of opioids like OxyContin.
“Opioids were not always widely prescribed for everyday chronic pain,” said Khary Rigg, associate professor in the department of mental health law & policy at the University of South Florida and behavioral health services and policy researcher. Rigg has studied substance abuse disorders for over 15 years. “Fearing the risk of addiction, U.S. physicians largely restricted their opioid prescribing to post-operative pain, cancer-related pain, or pain-related end of life care.”
In 1996, Purdue introduced OxyContin to the market. OxyContin is an extended-release oxycodone product, which Purdue promised would provide continuous and long-term pain relief because of the extended-release formula and being significantly more powerful than other pain medications on the market.
Purdue aggressively marketed the drug to physicians to prescribe OxyContin excessively.
But Purdue also downplayed the drug’s risk of addiction to the general public and the medical community. Purdue paid physicians to make false claims about the risk of addiction and to continue widespread prescription of the drug, according to CNN.
“Purdue’s aggressive and deceptive marketing practices set the stage for widespread opioid prescribing for everything from chronic back pain to migraine headaches to menstrual cramps,” said Rigg. “This spike in OxyContin prescribing soon led to dramatic increases in OxyContin addiction and overdose deaths…Purdue made billions of dollars and hundreds of thousands of people have died.”
Rigg states that Purdue isn’t the only opioid manufacturer that has been accused of malpractice and having a role in advancing the crisis, though they are “the worst offender.” Rigg also points out that in the past, lawsuits against these companies are often dismissed or settled, “and the company is never truly held accountable for their actions.”
The use of prescription opioids for a prolonged period of time or at an excessively high dosage gives an individual a higher chance of opioid addiction, according to the CDC. In fact, the high rates of opioid prescriptions in the 1990s and early 2000s is often considered the first wave of the opioid crisis in the U.S.
CDC data shows that opioid prescription rates began to level off and decline from 2010-2012. But with opioid abuse now more widespread in the U.S., individuals began to turn to stronger, illicit drugs such as heroin. This was the second wave of the crisis: in 2010, drug overdoses from heroin began to rise. In 2013, the third wave hit with the rise in overdose deaths from synthetic opioids such as fentanyl.
Although CDC data shows the rates of opioid prescription have declined, the rate in 2015 was still three times greater than it was in 1999. In 2018, just under 47,000 people died from opioid overdoses, which accounts for roughly 70% of all drug overdoses. Just 10 years prior in 2008, opioid overdoses resulted in 14,800 deaths: an increase of over 200%. Since 1999, roughly 450,000 Americans have died from opioid overdoses, according to the CDC.
As shown by the data, the higher rates of opioid prescriptions in the 1990s will continue to impact the U.S.
Although the Purdue settlement is seen as a success by some in holding the company accountable for its malpractice, others have expressed that the settlement is inadequate. Several attorney generals have come out to express their dissatisfaction with the settlement.
“This settlement provides a mere mirage of justice for the victims of Purdue’s callous misconduct,” said Connecticut Attorney General William Tong in a statement. “The federal government had the power here to put the Sacklers in jail, and they didn’t. Instead, they took fines and penalties that Purdue likely will never fully pay.”
Rigg stated he is also dissatisfied with the outcome of the settlement, noting Purdue’s significant role in the epidemic costing hundreds of thousands of American lives.
“To put it simply, these people are dead because of Purdue’s greed,” said Rigg. “Part of the reason I’m dissatisfied with the settlement is because Purdue only had to pay back about $8 billion when they profited over $30 billion from their unethical practices, which doesn’t seem fair. Also, much of the personal wealth of the Sackler family will remain intact.”
Purdue released a statement on Wednesday, Oct. 21 in which, Steve Miller, the chairman of the board for Purdue stated: “Purdue today is a very different company…we have made significant changes to our leadership, operations, governance, and oversight. Purdue deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice in the agreed statement of facts.”