Originally published on Apr 10, 2019.
Demetra Ashley spent three decades at the DEA specialized in the diversion of prescription drugs like OxyContin. Last spring, she left to start a consulting firm called Dashley Consulting, LLC. She has since been engaged by Purdue Pharma, the family-owned maker of OxyContin and there is public outcry against it.
National Consolidation of Opioid Lawsuits
The Opioid Epidemic quickly became front page news starting in 2016 when, nearing the end of President Obama’s tenure in 2016, Congress passed the 21st Century Cures Act. The Act allocated $1 billion over two years to enhance states’ response to the epidemic.
Since then over 1,600 lawsuits were filed against various companies in the pharmaceutical supply chain on misrepresentations of the risks of opioid use and misconduct in regards to distribution. The lawsuits were mostly consolidated by the Federal government, with Judge Dan Aaron Polster of the Northern District of Ohio being tapped as the presiding judge; the trial is set for late October 2019.
The evidence from the DEA records are striking – for example, during 10 months in 2007, McKesson shipped three million prescription opioids to a single pharmacy in a West Virginia town with 400 residents. If the lawsuit continues, even more data will be made public – which will likely be further damaging to these companies’ public reputation. The claims already include that the companies: conspired; committed fraud; were negligent and violated public nuisance laws.
However, there are a few aspects working in favor of manufacturer and distributor defendants. The biggest advantage they have is budget and time. As the trial starts getting into the weeds, legal fees will skyrocket, potentially hurting the plaintiffs. Additionally, with the burden of proof on the plaintiff, the defendants will make onerous discovery requests.
The main goal of the defendants is not dismissal but instead a global settlement covering all outstanding lawsuits. The biggest nightmare of the ordeal is the sheer number of plaintiff parties: if one lawsuit is settled unfavorably, the precedent established can come back to haunt the Defendants in every subsequent lawsuit.
More Lawsuits Are Being Filed
In late March, the Attorney General of the State of New York, Letitia James, filed another massive lawsuit focused on the Opioid Epidemic. Defendants named were the usual suspects: manufacturers, including Purdue, Endo, Allergan; and distributors, including each of the Big 3 and Rochester Drug Cooperative. The facts provided in the case are concise and powerful as it develops a timeline from opioids being classified as “powerful drugs with narrow medical uses that pose dangerously high risks of abuse and dependence;” to a huge number of manufacturer documented misrepresentations and then finally to how distributors failed to prevent diversion. The lawsuits that are currently being filed are benefitting from the 1,600 lawsuits already filed by various cities and countries.
Public Outcry Against DEA Consultants
The engagement of former members of both the DEA and FDA by industry has been common practice for decades because of one simple fact: the insight provided by former DEA diversion agents is extremely valuable in helping companies implement best practices and improve policies on an ongoing basis. Who could be better experts on DEA requirements and expectations than those in charge of enforcement?
Based just outside of Philadelphia, Five Rivers RX provides actionable guidance and excellent administrative services with a focus on client care across Compliance, Commercial, and Quality solutions. Our mission is to improve the health and welfare of the American public by providing solutions and implementing best practices for companies in the pharmaceutical supply chain.