By Aara Ramesh
The nation’s continued struggle with the opioid epidemic and its fallout entered a new phase on Tuesday, June 29, when a dozen companies faced in court, for the first time, a six-member jury in a case brought by the state of New York, and its Nassau and Suffolk counties, against pharmaceutical manufacturers and distributors for the role they allegedly played in exacerbating the opioid crisis.
Announced in March 2019, the lawsuit filed by the state is the nation’s “most comprehensive suit against opioid distributors and manufacturers” to date, and includes charges against the Sackler family (the owners of Purdue Pharma), Teva Pharmaceutical Industries, Endo International, McKesson, Cardinal Health, and various distributors.
The suit alleges that the manufacturers and distributors of opioid pain-killing medications engaged in “false, deceptive marketing practices,” misrepresenting the true dangers of opioids, and “egregiously failed their duties to avoid [the] unlawful diversion” of the drugs. The jury will assess whether the marketing and distribution practices so described actually led to widespread opioid addiction and abuse.
Pharma giant Johnson & Johnson was also named in the suit, but on June 27, the Attorney General of New York Letitia James announced that the company had struck a deal with the state. The parties agreed to a settlement of $230 million to be paid out over nine years, which will go to funding the treatment and mitigation of opioid addictions in New York. The company also said it would stop selling all opioid products nationwide.
Purdue Pharma has pleaded guilty to federal crimes twice in relation to the manufacture, sale, and advertising of opioids. Meanwhile, the Sackler family, many of whom were involved with the company, have not faced any criminal charges. They admit no wrongdoing and say they “acted legally and ethically.” More than 400 civil cases have already been filed against the family for their alleged misconduct. An attorney for the company said, “The Sacklers are paying $4.275 billion, and they very much plan and expect to be done with this chapter.”
The nation’s first trial in this matter was in Oklahoma, wherein the state won a $465 million judgement. Similar trials have also already occurred in California and West Virginia. Experts say a verdict in favor of New York could inspire other counties within the state and many across the countries to file their own claims.
The nation is just starting to examine under a microscope who is liable for the the hundreds of thousands of deaths caused by the opioid epidemic. According to some estimates, the economic loss associated with prescription opioid abuse in the U.S. is around $78.5 billion a year, in healthcare costs, lost productivity, addiction treatments, and criminal justice procedures.
America’s history with using opioids for pain relief stretches back to the Civil War, when morphine was used by medics as “a battlefield anesthetic,” leading many to become dependent on it after the war. In 1898, heroin was produced commercially for the first time by the Bayer Company. It was believed to be less addictive than morphine, so was prescribed to those suffering from morphine addictions.
According to the U.S. Food and Drug Administration (FDA), for the majority of the twentieth century, opioid-based medications were used mostly for pain relief in cancer patients. Researchers began to explore how to treat acute pain in chronic, non-cancer illnesses, suggesting that the existing treatments at that time were inadequate.
In 1995, the FDA approved Purdue Pharma’s OxyContin (a controlled-release oxycodone pill) for use by the public. The National Institute on Drug Abuse says that towards the end of the 1990s, before the general public became aware of the dangerous and addictive nature of prescription opioid pills, pharmaceutical companies began spreading messaging in the medical community indicating that the pills would not cause addictions. This urged practitioners to increasingly recommend them to those dealing with pain. This marked the first wave of the opioid epidemic, according to the Centers for Disease Control (CDC).
By the early 2000s, the government began to note an alarming rise in the number of reports of overdoses, deaths, and ER visits linked to prescription pain-relieving drugs, especially OxyContin. According to the FDA, from 1999 to 2003, the number of people who said they used OxyContin for non-medical reasons rose from 400,000 to 2.8 million. Between 2004 and 2009, there was a 98% increase in the number of ER visits related to the abuse or misuse of pharmaceuticals, with the biggest culprit being opioid pain relievers such as OxyContin.
The FDA says it issued a warning letter to Purdue Pharma in 2003 for their allegedly “misleading advertisements.” In 2007, the federal government leveled criminal charges against Purdue Pharma for those very same advertisements. The company and its executives pleaded guilty and were ordered to pay $634.5 million in criminal and civil damages.
The second wave of the epidemic began in 2010, when officials started noting a rise in heroin-related overdose deaths. Researchers say that around 4–6% of those who abuse prescription opioids move into using heroin, and up to 80% of those who use heroin started their addictions after being exposed to prescription painkillers.
The CDC says the third wave began in 2013, when the predominant drug involved in overdose deaths shifted from heroin to synthetic opioids, and illicitly manufactured fentanyl, in particular. In 2016, synthetic opioids were responsible for nearly half (46%) of all opioid deaths. In 2010, that figure was only at about 14%.
According to the Drug Enforcement Authority (DEA), fentanyl is 80-100 times stronger than morphine, and 50 times more potent than heroin. Just 1 kg (2.2 lbs) of fentanyl can potentially kill half a million people. In December 2018, CDC data revealed fentanyl to be the narcotic most commonly involved in overdoses, with its rate of involvement increasing 113% every year between 2013 and 2016.
Worryingly, the third wave shows no signs of abating. Border officials have noticed a sharp surge in the amount of fentanyl being smuggled in through ports of entry and other locations as well. Federal agents in El Paso, Texas, have reported a 4,000% increase in the amount of fentanyl they have seized over the last three years at locations other than ports of entry. The amount seized was up 719% at ports of entry in 2020.
Experts say drug cartels are importing cheap raw materials from China and then manufacturing the fentanyl themselves. It is the preferred narcotic for cartels due to its profitability, potency, and compact size making it easier to smuggle into the U.S.
Today, a significant portion of opioid-related overdose deaths involve a dangerous cocktail of drugs that mix depressants like fentanyl with stimulants like cocaine and methamphetamine. Some say this marks the emergence of a fourth wave of the crisis.
Meanwhile, efforts to tackle the incidence of opioid addictions in the country continue. On Monday, June 28, the DEA announced a new initiative to improve access to medications such as methadone that are used to treat opioid addictions, which will benefit a swathe of people largely in underserved rural areas and Tribal communities.