The Justice Department plans to intensify its scrutiny on opioid manufacturers’ role in the epidemic plaguing the country with a new task force that will use “all available criminal and civil remedies.” But some experts question the impact the task force will have on ongoing litigation and future legal action taken against drugmakers and distributors.
Experts say the litigation against opioid manufacturers and distributors can help federal and state governments recoup money to cover the costs of the opioid epidemic, but the new unit may run into some barriers in its mission.
“Hopefully we can do some litigation against the opioid companies,” President Trump said at a White House opioid summit last week. “I think that’s very important because a lot of states are doing it, but I keep saying if the states are doing it, why isn’t the federal government doing it?”
The new Prescription Interdiction and Litigation Task Force will examine existing state and local government lawsuits against opioid companies to see what assistance federal law can provide. The Justice Department also announced it would be filing a statement of interest in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors. The DOJ has asked a federal judge to grant the department 30 days to consider whether to participate in the proceedings.
The move drew praise from Democratic Sen. Claire McCaskill of Missouri, who has launched her own investigation into manufacturers and distributors. “Addressing the opioid epidemic requires an all-hands-on-deck response, and Senator McCaskill urges the administration to pair this latest step with additional resources and actions,” McCaskill spokeswoman Laura Epstein said.
Andrew Kolodny, codirector of the Opioid Policy Research Collaborative at Brandeis University, said it makes sense for the DOJ to step in. “The states are dealing with a very expensive problem,” he said. “The damages that the defendants in these cases have done—the manufacturers, the distributors—are in the billions, and so for the federal government to be helping out in some way, for the Department of Justice to be helping in these cases, sounds promising.”
The DOJ assisting state and local cases can send a signal to the public and create an optics nightmare for certain pharmaceutical companies. “It’s a publicity campaign as much as it is a legal contest,” said Richard Ausness, a professor at the University of Kentucky College of Law.
“When the federal government takes a side like they did in the tobacco litigation, too, that sends a signal to the public: ‘These are bad actors over here, and what they’re doing is wrong.’ It certainly creates bad publicity for the drug companies,” Ausness said.
But experts also questioned whether the task force would be effective and whether it would play an appropriate role in the legal battle. In the announcement of the new unit, the DOJ said the federal government must be compensated for the substantial cost caused by the opioid crisis.
“I think it is fine for DOJ to advise other government plaintiffs or to provide them with information (which the defendants will ultimately get as well through discovery),” Ausness wrote in an email to National Journal. “It is also OK for DOJ to bring its own lawsuits against the drug companies under the False Claims Act or [Racketeer Influenced and Corrupt Organizations Act]. However, I don’t think that DOJ should have a seat at the table in the settlement negotiations, nor should they be entitled to claim any part of a global settlement between existing government plaintiffs and the drug companies.”
It is also unclear how the DOJ’s efforts may be affected by a law passed a few years ago that has limited the Drug Enforcement Administration’s ability to go after distributors. The new DOJ task force includes senior officials from the DEA, and lawmakers are seeking insight as to how the DEA and DOJ want to see the statute changed.
The law in question, the Ensuring Patient Access and Effective Drug Enforcement Act, made headlines last fall after a Washington Post/60 Minutes investigation found that the policy made it impossible for the DEA to stop suspicious narcotic shipments from distributors.
The DOJ’s announcement “could be a positive development,” said Regina LaBelle, who was the Office of National Drug Control Policy’s chief of staff during the Obama administration. But “it remains to be seen how this interacts with the new standard for going after drug distributors that passed a couple years ago,” she added.
Attorney General Jeff Sessions said during a press conference last week that DOJ does not think the law will “hamper us in any significant way.” But a day later, the department said in a letter to House members that both the DOJ and DEA supported changes to the statute to make it more in keeping “with the aim of the provision to give DEA a rapid means of protecting the public from imminent danger resulting from the diversion of controlled substances.”
Still, Kolodny said these lawsuits against the opioid companies will accomplish a number of key goals. “We need this litigation so that there’s money to clean up this mess, and we need this litigation so that we can stop the manufacturers and distributors from continuing to make the problem worse, and we need this litigation so that lessons are learned by corporations that if they are going to cause a public health catastrophe in their pursuit of profit, that they are going to be made to pay to clean it up,” he said.
But one advocate said he believes the DOJ’s move was entirely in the wrong direction and could risk patient access to needed medications.
“It’s a mistake, and what it’s trying to do is find a bad guy to blame for what is essentially an ecosystem problem, including industry and physicians and [pharmacy benefit managers] and lack of understanding by consumers,” said Peter Pitts, president of the Center for Medicine in the Public Interest. “You don’t solve a problem by looking for one person to blame. That’s a convenient political tactic, and a thinly, poorly thought-out public-health strategy.”