Ken Julian Discusses the Future of Opioids and the Law

On July 21st, the Senate Caucus on International Narcotics Control held a hearing entitled “OxyContin Use and Abuse in America.” The hearing was called to address criticism of Purdue Pharma’s aggressive promotion of OxyContin for all types of pain. It was requested by Senators Kelly Ayotte (R-NY), Joe Manchin (D-WV), and Dick Durbin (D-IL).

Senator Durbin took the lead in defending the pharmaceutical industry’s role in marketing opioids. He acknowledged that Purdue had made mistakes but noted, “there are other manufactures out there marketing products for all kinds of pain.” He accused critics of being too quick to blame the pharmaceutical industry and doctors for the opioid crisis.

We reached out to white-collar criminal defense attorney Ken Julian to get his take on these developments.

Q: Purdue Pharma has received a lot of criticism for its role in the opioid crisis. Some have called for criminal liability to be considered, but others wonder if that’s appropriate when other companies are doing similar things. What do you think?

A: There are two elements that suggest some form of liability. The first is the guilty plea of Purdue on criminal charges for misbranding its drug. The second is the Pharmaceutical Research and Manufacturers of America (PhRMA) memo talking about promoting opioids more broadly while denying that there was any risk associated with them.

Q: How significant are these developments?

A: They’re highly significant because, up to this point, the pharmaceutical industry has claimed that they are being unfairly blamed for the opioid crisis. The guilty plea by Purdue changes that argument. In addition, the PhRMA memo clarifies what the strategy was and what the intent of that strategy was.

Q: What should the pharmaceutical companies’ in-house counsel be doing about this?

A: When in-house counsel see red flags, they need to talk to compliance about them. If a company has an R&D budget that is going into opioids — and is very different from the money spent on other drugs — then that should be an issue for compliance.

I’m not saying it would necessarily form the basis of criminal prosecution. But, still, it may be an issue the government is pursuing in grand jury investigations, and it may become known to prosecutors that way.

Q: Is this a new area of risk for pharmaceutical companies? If so, why?

A: The risks had existed since at least 2007 when Purdue pled guilty to criminal charges and paid hundreds of millions in fines. The stakes have been there since 2008 when the first regional case was brought in Eastern Virginia against a doctor who distributed OxyContin.

I think it’s important to remember that criminal liability is a subset of a company’s risk under civil False Claims Act liability. The two areas dovetail with each other. Risks continue until they are eliminated, and sometimes they’re never going to be eliminated.

Q: What do you see as the next significant development in this area?

A: The Department of Justice has been very public about wanting a national discussion on how we should deal with opioids. In my experience, prosecutors are asking for guidance from enforcement agencies about what these companies have done and whether there’s a basis for an investigation.

Q: Is this more than Purdue Pharma?

A: I’m sure that there are other companies out there. It’s not just drug manufacturers — it’s the distributors as well. The issue with the distributors is how much they knew and what they did to alert others or warn of potential opioid diversion and abuse.

Q: Anything else?

A: I think it’s important to understand what the risk involved is. If you’re talking about allegations unique to Purdue or that may affect other pharmaceutical companies, for example, for telling doctors there was no risk associated with opioids while knowing otherwise, then those are unique to certain companies.