Written By Liz Lehmann
On January 23, 2018, Onondaga County (the “County”) joined many cities and counties across the nation in suing pharmaceutical companies and drug distributors over their role in the opioid crisis.
Background
Opioids killed more than 42,000 people in 2016 nationwide, 142 of which were in Onondaga County. Forty percent of all opioid overdose deaths involved a prescription opioid. The amount of prescription opioids sold to pharmacies, hospitals and doctors’ offices has quadrupled in the last decade, where the overall change in the amount of pain that Americans reported has been unchanged. Studies indicate that many users begin with pills but shift to injecting heroin due to its cheaper cost.
In response, individuals, as well as municipal and county governments, are filing lawsuits against the leading opioid manufacturers and distributors, alleging that the opioid addition stems from the manufacturers’ over-promotion and sales of prescription opioid medications, such as OxyCotin, Percocet, Vicodin, and numerous generics.
The Complaint
The County’s Complaint names over two-dozen defendants, including Purdue Pharma (manufacturers of OxyCotin), Teva Pharma and its subsidiary Cephalon (manufacturers and distributors of fentanyl, a synthetic opioid), Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, and Endo Health Solutions (manufacturers of oxymorphone and hydrocodone products).
The causes of action consist of negligence, fraud, deceptive acts and practices, false advertising, and the Racketeer Influenced and Corrupt Organizations Act (“RICO”). The Complaint alleges that defendants disseminated false and misleading messages, downplaying the seriousness of prescription opioids and creating false perceptions that they were safe and effective for the long-term treatment of pain.
The County’s claim for relief include costs for providing medical care; treatment, counseling, and rehabilitation services; treatment of infants born from opioid-related medical conditions; care for children whose parents suffer from opioid-related disability; and costs associated with law enforcement and public safety relating to the opioid epidemic.
Another Big Tobacco Moment?
The growing number of lawsuits against drug manufacturers and distributors has led some to wonder whether the opioid crisis will deal Big Pharma its Big Tobacco moment. In the 1990s, several states—including New York—sued the major cigarette manufacturers to recover Medicaid and other costs associated with treating sick and dying cigarette smokers. In 1998, the cigarette manufacturers and 46 states entered into a Master Settlement Agreement, imposing prohibitions and restrictions on tobacco advertising and practices that sought to hide negative information about smoking, in addition to the requirement that a tobacco prevention foundation be created. The Agreement also had a $248 billion civil payout, from which hundreds of millions of dollars went to New York State.
Experts and attorneys distinguish the present litigation from the tobacco settlement, however. The big difference? The current cases involve causes of action against companies who appear to be fully compliant with the law. Unlike tobacco, where cigarettes are bought directly from the manufacturer to the consumer and can harm smokers and nonsmokers alike, prescription opioids are individually taken upon the recommendation and advice of a doctor. Addictions arise from the misuse of the prescription opioid. Should the drug manufacturer be responsible for such misuse?
Another shortcoming may be the plaintiffs’ failure to demonstrate specific instances where drug companies misled doctors or consumers. A recent lawsuit filed by the City of Chicago against Big Pharma had four out of five of its defendant manufacturers dismissed for such lack of specificity. The remaining defendant—Purdue—had already added clear warnings of the risks of addiction to its OxyCotin labels after pleading guilty to criminal misbranding in 2007. Also as a result from the 2007 charges, Purdue changed its manufacturing process to include “abuse-deterrent technology,” making the drugs nearly impossible to crush, snort, or inject.
Overall, as a general matter, it may be difficult for the courts to assign blame when it comes to the opioid epidemic, where pain medications are lawful, approved, and regulated by the FDA, in addition to including many intermediaries.
Big Pharma’s Response
Some of the named defendants have issued public release statements. Regarding this Complaint, Purdue stated:
We maintain that the allegations made in these lawsuits against our company are baseless and unsubstantiated. Our actions in the marketing and promotion of our opioid pain medicines were appropriate and responsible. At the same time we recognize that opioid abuse and addiction are serious public health issues that must be addressed. Finding those solutions will require collaboration among many stakeholders across the country. We look forward to being a part of the ongoing dialogue and finding ways to address the crisis.
Despite Big Pharma’s denial of wrongdoing, settlements have been reached in other lawsuits involving opioid manufacturers and distributors. In late 2015, Purdue paid $24 million in a settlement agreement to the state of Kentucky on the claim that Purdue had marketed their OxyCotin drug as safe. In 2017, Mallinckrodt PLC—a defendant in the County’s present lawsuit—paid $35 million to resolve an investigation into their monitoring and reporting methods for suspicious orders of opioids. Costco paid $11.75 million in 2017 based on an investigation indicating that they had irresponsibly filled improper or incomplete prescriptions.
What’s Next?
Settlement discussions are underway in jurisdictions across the nation. Some manufacturers, such as Purdue, have proposed a global settlement in an attempt to cease investigations and lawsuits. However, lengthy litigation will likely ensue and it is expected that more cities and counties will join in the legal onslaught.
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Sources Cited
Andrew Donovan, Onondaga County Blames Opioid Manufacturers and Distributors for Heroin Crisis, Files Lawsuit, LocalSYR.com (Jan. 23, 2018),
Complaint and Jury Demand, County of Onondaga v. Purdue Pharma, L.P. et al. (N.D.N.Y. 2018).
Eric Heisig, Federal Judge Presiding Over Opioid Litigation Will hold Jan. 31 Conference for Settlement Talks, Cleveland.com (Jan. 12, 2018).
Erika Fry, Big Pharma Is Getting Hit With a Huge Wave of Opioid Suits, Fortune (Sept. 27, 2017).
Jef Feeley and Jared S. Hopkins, Purdue Approaches States in Bid to Settle Opioid Claims, Bloomberg (Nov. 17, 2017).
Lindsey Pasieka, Opioid Lawsuits, ConsumerSafety.org (2018).
The Master Settlement Agreement: An Overview, Tobacco Control Legal Consortium (2015).
Sanja Gupta, Unintended Consequences: Why Pain Killer Addicts Turn to Heroin, CNN (Jun. 2, 2016).
Understanding the Epidemic, Centers for Disease Control and Prevention (Aug. 30, 2017).
Zachary A. Siegel, Suing Big Pharma for the Opioid Epidemic Is Too Little, Too Late, Medium (Oct. 11, 2017).
Photo courtesy of TLI.