In July, the Swinomish Indian Tribal Community filed a lawsuit against multiple pharmaceutical companies in the U.S. District Court in Seattle, Washington. They join a growing number of state, federal, and sovereign tribal government organizations that are attempting to hold the industry responsible for its contributions to the opioid crisis. Named in this lawsuit are many familiar “big pharma” giants: Purdue Pharma, Endo Pharmaceuticals, and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
In California, similar efforts are underway. Thirty counties across the state have joined forces to sue both the manufacturers and distributors of prescription opioids. The lawsuits, filed in an Ohio federal court, claim that drug manufacturers deliberately misinformed doctors and patients alike of the addictiveness of their products. They also assert that the distributors of the product failed to properly control shipments of opioids in violation of the federal Controlled Substances Act.
Opioids are a class of painkillers that have been heavily prescribed by doctors across the United States to patients experiencing “chronic pain.” The most commonly prescribed opioids are OxyContin and Percocet (trade names for oxycodone), Vicodin (hydrocodone), and Fentanyl (a painkiller synthesized to resemble opium-derived morphine and heroin). The opioid crisis reached a new peak in 2016, with overdoses killing 64,000 Americans that year.
Liability in these lawsuits hinges on accusations of false advertising, and the failure of distributors to adequately monitor and control the supply. There exists plenty of evidence and research that supports these claims. From an outside perspective, Big Pharma is tied inextricably to the ongoing opioid crisis. But the lawsuits face considerable legal headwinds, and the pharmaceutical industry is braced to take advantage of them.
The argument for false advertising may potentially be the most difficult for the industry to fend off.
Opioid manufacturers have long advertised their products as both a safe and effective alternative to other forms of pain treatments. This has persisted even in the face of evidence that directly suggests the opposite.
In 1980, a letter to the New England Journal of Medicine was published by a pair of doctors. They claimed that addiction to opioids was a very rare occurrence among hospitalized patients. It concluded that for patients subjected to opioids with no prior history of addiction, the risks were minimal. The letter, lasting all of five sentences, contained little in the way of substantive evidence. However, it was cited over 600 times by various pharmaceutical companies in their marketing efforts aimed at doctors wary of the addiction risks.
Among the manufacturers aggressively citing the letter was Purdue Pharma.
Between 1996 to 2002, Purdue funded over 20,000 pain-related education programs. Among their initiatives included financial support for the American Pain Society, the American Academy of Pain Medicine, and many other organizations focused on the diagnosis and treatment of pain. These groups advocated for more aggressive diagnosis of chronic pain, and increased recommendations to use opioids in treating it. Their efforts intensified as the company introduced OxyContin in the mid-1990s.
Similar marketing campaigns continue to this day. The Pain & Policy Studies Group offers one of the starkest examples of efforts to discount the addiction risks of opioids. Their glossary contains an entry for “opiophobia,” describing a “phenomenon” of exaggerated concern over addiction to opioids that prevents the appropriate use of the drugs.
Some of the lawsuits focus on the role that drug distributors played in the opioid crisis
Many of the lawsuits, including those from California, claim that major drug distributors failed their responsibility to control and monitor the products they shipped. Pharmacies serving small communities often received shipments of opioids that far exceeded their needs.
West Virginia, one of the states hardest hit by the epidemic, saw over 780 million pills delivered to pharmacies serving a total of 1.8 million residents between 2007 and 2012 — 433 pills for every resident.
Investigative reporting by the Charleston Gazette-Mail suggests that distributors ignored state and federal laws, allowing shipments to proceed unfettered for years even in the face of potentially suspicious order amounts. Additionally, the state Board of Pharmacy failed to enforce regulations that existed since 2001. The board even provided doctored inspections and reviews to small-town pharmacies that were consistently ordering far more pills than necessary.
Another major warning sign of the developing opioid crisis was the increase in orders for higher doses per pill. In the Gazette-Mail’s investigation, official order counts for OxyContin tablets show a marked increase in orders for higher dosage pills, from 5 milligrams to 15 milligrams. As resistance to opioids grows with regular use, addicts often sought the higher dose pills. If they could not get the prescriptions, they would steal the pills; ample supply to draw from was never in question. And if they could not buy or steal them, heroin was potent alternative with oftentimes lethal consequences.
The lawsuits contend that the distributors had not performed their due diligence. They were in the best position to call attention to excessive shipments and limit them while investigations into the orders proceeded.
While the lawsuits cite ample evidence about false advertising or negligence throughout the pharmaceutical industry, potential legal obstacles may affect the outcomes.
When the FDA approved of oxycodone in the 1970s, it was classified as a Schedule II drug. This meant that the drug, available since 1939, was formally recognized for having a high potential of addiction and abuse.
Purdue Pharma introduced OxyContin as an abuse-resistant alternative to other forms of oxycodone. The FDA approved of the labeling, and the drug maker has used the FDA’s own approvals to deflect from its marketing efforts. Other drug makers have pointed fingers at the distributors, and distributors responded by pointing back to the manufacturers, or further down the supply chain towards the pharmacies and doctors writing the prescriptions.
Further complicating the issue is that prescription opioids are hardly the only source of concern in the overall epidemic. Heroin, cocaine, and other recreational street drugs continue to kill tens of thousands every year. Fentanyl, one of the most powerful opioids available, killed over 20,000 individuals in 2016 alone. The argument potentially to be made is that the overall opioid epidemic, and all the deaths it claims, cannot be centered on the pharmaceutical companies alone. Attacking them would not resolve the other routes these drugs can take to get to the streets.
Some industry experts place the blame on doctors, many of whom were influenced by industry marketing and educational initiatives. Before the epidemic truly began, opioids were viewed with distrust among medical professionals in the United States. But after the introduction of OxyContin, companies like Purdue Pharma spent considerable sums to reverse their “perceptions” of opioids. The industry has argued that if doctors were aware of risks, why would they continue filling out prescriptions?
Pill mills and foreign sellers are being used to further deflect attention away from the role of manufacturers and distributors in the crisis.
The industry claims that holding it liable for selling its products ignores another very real problem at the opposite end of the opioid chain: pill mills. A pill mill allows addicts to easily acquire their drugs with minimal fuss and no insurance, so long as they can pay the prices being asked.
These operations can consist of individual doctors or pharmacy workers, to full-blown businesses operating under the guise of a legitimate pharmacy. The cash can come easy and fast, so long as people are willing to part with the ample supply “off the record.”
Of additional concern is the role transnational crime organizations have had in distributing opioids. The Sinaloa Cartel has been flooding the U.S. with supplies of fentanyl, sourced from Chinese factories. Additionally, shipments of heroin have similarly increased to take advantage of users in search of a high. Pharmaceutical manufacturers and distributors are pointing to these illicit providers as a more critical concern, in hopes of deflecting attention away from themselves.
Ultimately, any legal action taken against Purdue Pharma and other industry giants will be the first of many steps to bring the opioid crisis to an end. However, the industry’s war chest grows by billions of dollars every year. Any lawsuit, no matter how successful, may not be enough to put an end to the crisis.
This blog is not meant to dispense legal advice and is not a comprehensive review of the facts, the law, this topic or cases related to the topic.