All businesses that manufacture, distribute, or dispense controlled substances should pay close attention: Last month, the U.S. Department of Justice (DOJ) took an unusual step—it obtained court orders barring two Ohio doctors from selling controlled substances. Prior to a conviction or any finding of a legal violation, the DOJ employed rarely used statutory provisions of the Controlled Substances Act (CSA) that allow it to seek declaratory and injunctive relief relating to violations of the CSA. This step, small though it may appear at first blush, is more akin to a giant leap. The statutory provisions are broadly worded, and if past use of analogous provisions is truly prologue, the DOJ could be getting ready to use the CSA to demand big changes from any entity that is a part of the supply chain for opioids or any other controlled substances.
First, the facts. According to the DOJ, defendant Michael Tricaso ran clinics at gyms in northeast Ohio. In the course of his work, Dr. Tricaso met a gym-goer who turned out to be a confidential informant. Soon, Tricaso was selling that informant controlled substances in a hotel parking lot, without a prescription. Defendant Gregory Gerber was a bit more subtle, at least according to the DOJ. Dr. Gerber prescribed controlled substances to patients of his medical offices. The problem was that the patients simply did not need the powerful opioids he was supplying them.
Now, the lawsuits. To stop these alleged unlawful acts, the DOJ brought two civil lawsuits in an Ohio federal court—United States v. Tricaso and United States v. Gerber. The lawsuits seek a variety of remedies, including monetary penalties. But the most interesting—and most important—remedy that they seek is injunctive relief. In fact, in each case, the DOJ sought—and obtained—temporary restraining orders immediately prohibiting the doctors from selling controlled substances. The DOJ did make clear, in a press release, that the investigations of the doctors were ongoing, which suggests that prosecutors are also considering criminal charges.
All of this seems somewhat routine: law enforcement shutting down what it believes to be unlawful activity while it conducts a criminal investigation. It isn't. The statutory provisions that the DOJ used to obtain equitable relief against the doctors—21 U.S.C. § 843(f) and 21 U.S.C. § 882(a)—are not the typical stuff of press conferences. Yet, the DOJ brought out the U.S. Attorney General himself to announce the cases, and to tout the claim that its temporary restraining order effort was a "first-of-its-kind."
Dusting off and prominently displaying obscure, seldom-considered statutory provisions may be noteworthy in itself. But there is even more to the story. For at least two reasons, the DOJ's fanfare surrounding these cases merits close attention by anyone who touches opioids or other controlled substances.
First, § 843(f) and § 882(a) are broadly worded. Section 843(f) allows the government to seek equitable relief "relating to violations" of certain parts of the CSA. Such language, at least on its face, sweeps in lots of conduct and may not even be limited to the person or entity that actually committed the violation. The only limitation is that any court order be "tailored to restrain violations" of the act. Section 882(a) is even less restrictive; it allows the government "to enjoin" violations of the CSA.
Put simply, these provisions are not just about putting the bad guys out of business, so to speak. They might also provide the DOJ a great deal of flexibility in imposing obligations on any person or entity associated with opioids, unconstrained by existing regulations or the notice-and-comment process required for new regulations. And they might even support a DOJ effort to stop a company from distributing product until a regulator—the U.S. Drug Enforcement Agency (DEA) or the U.S. Food and Drug Administration—can be sure that the company complies with its obligations.
Second, the DOJ has a history of exploring—if not pushing—the boundaries of analogous provisions when it is confronting a crisis. The best example of its doing so is its use of the Injunctions against Fraud Act to address conduct associated with the financial crisis.
The Injunctions against Fraud Act, 18 U.S.C. § 1345, is a civil remedy tucked into the criminal code. The provisions of § 1345 allow the DOJ, among other things, "to enjoin" banking law violations and to "take such other action, as is warranted to prevent" injury to anyone for whose protection the action is brought. The DOJ used those provisions in myriad ways—to shut down mortgage brokers, to force financial institutions to improve their compliance programs, and to provide consumer relief for individuals who suffered during the downturn, for example—that went beyond specific regulatory requirements.
What might this mean for you? If you are at all connected to the opioid business, or otherwise regulated by the DEA, it may mean a great deal:
- The DOJ has rediscovered a potentially powerful tool, and has now shown that it is willing to use it;
- In other contexts, the DOJ has used such a tool to shut a company down until it can satisfy the government that it is operating lawfully, even without proving the violation in court;
- The DOJ has also used similar tools to force changes in the way that companies of all types and sizes do business, notwithstanding existing regulatory regimes; and
- There is every reason to believe that the DOJ will do the same here, given the oft-made pledge by DOJ officials to use all the tools at their disposal to confront the opioid crisis.
Of course, it remains to be seen how the DOJ will actually use the injunctive authority of the Controlled Substances Act. But with all of the resources focused on opioids, expect that such use will be creative and aggressive.