In his March 2018 confirmation hearing, President Trump’s nominee to head DOJ’s Civil Division, Joseph “Jody” Hunt, signaled that DOJ would continue with its aggressive enforcement of the FCA. In fact, Hunt said that he and the Trump administration are focused on “vigorously enforcing the [FCA]” and “aggressively” combating the opioid epidemic by using the FCA as one of its enforcement tools. Mr. Hunt commented that the Civil Division will focus on holding accountable “opioid manufactures, distributors, and others in the distribution and prescription chain.”  Mr. Hunt signaled that he will deploy all civil and criminal remedies to accomplish these enforcement goals. [1]

Mr. Hunt’s comments follow DOJ’s announcement of the Prescription Interdiction and Litigation (PIL) Task Force on February 27, 2018. [2] In a speech by Attorney General Jeff Sessions, DOJ announced that the Task Force “will use criminal and civil actions to ensure that distributors and pharmacies” are obeying federal regulations created to prevent the improper prescribing of medications.[3] The Task Force plans to use the FCA as one of a number of enforcement tools to “crack down on pain-management clinics, drug testing facilities, and physicians that make opioid prescriptions.” [4] The Task Force will look at every level of the opioid distribution system, from manufacturer to distributor, and will coordinate with multiple agencies, including the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA). It will also consider a wide array of enforcement approaches, including the FCA, among other civil, criminal and regulatory enforcement measures.

In a separate speech before the Federal Bar Association’s Qui Tam Conference on February 28, 2018, Deputy Associate Attorney General Stephen Cox echoed the Attorney General’s statements, emphasizing the power of the FCA to reach all levels of the opioid distribution chain. [5] Cox highlighted DOJ’s September 2017 settlement with Galena Biopharma, in which the company paid $7.55 million to settle claims that it paid kickbacks to physicians for prescribing a fentanyl-based opioid. [6] At the time, the Acting United States Attorney for the district where the charges were brought also characterized the prosecution as part of the battle against opioids. Cox noted that two of the physicians involved in the Galena case were tried, convicted, and sentenced to prison for, among other things, prescribing opioids outside the usual course of professional practice.

On February 27, 2018, Attorney General Sessions also announced that DOJ intended to file a statement of interest in multidistrict litigation currently pending in the United States District Court for the Northern District of Ohio (17-MD-2804). In early March, DOJ filed a statement identifying several potential recovery statutes and other legal considerations, and sought 30 days to decide whether to participate in the proceedings. DOJ followed up on April 2, 2018, filing a motion seeking to “(1) to participate in forthcoming settlement discussions . . . and (2) to participate as friend of the Court by providing information to the Court and the parties to facilitate effective non-monetary remedies to address problems arising from the national opioid crisis.”

It is also important to note that state and local governments are likely to pursue a similar approach to combatting the opioid crisis through enforcement actions under state false claims acts. In November, the St. Louis County Minnesota Board of Commissioners authorized a lawsuit on its behalf in state court. On March 14, the county filed a 10-count complaint alleging, among other things, violations of the state’s FCA. [7]

Practice Note: The national opioid crisis is a public health emergency that will be a top law enforcement priority for the foreseeable future. DOJ has steadily increased its public statements about the crisis and, with the establishment of the PIL Task Force, has indicated that it intends to investigate every level of the opioid distribution system. DOJ’s insertion into the Ohio MDL may be a harbinger of what is to come—greater involvement from DOJ in existing cases and increased volume of government investigations and litigation.