New DOJ Task Force to Take on Opioid Crisis Using the FCA and Other Enforcement Tools

Earlier this week, the US Department of Justice (DOJ) launched a new front in its effort to combat the opioid crisis and explicitly stated that it will deploy the False Claims Act (FCA) as part of its offensive. In a press release and parallel speech delivered by Attorney General Jeff Sessions on February 28, 2018, DOJ announced the creation of the Prescription Interdiction & Litigation (PIL) Task Force.

According to DOJ, the PIL Task Force will combat the opioid crisis at every level of the distribution system, from manufacturers to distributors (including pharmacies, pain management clinics, drug testing facilities and individual physicians). DOJ will use all available civil and criminal remedies to hold manufacturers accountable, building on its existing coordination with the US Food and Drug Administration (FDA) to ensure proper labeling and marketing.  Likewise, DOJ will use civil and criminal actions to ensure that distributors and pharmacies are following US Drug Enforcement Administration (DEA) rules implemented to prevent diversion and improper prescribing. Finally, DOJ will use the FCA and other enforcement tools to pursue pain-management clinics, drug testing facilities and physicians that make opioid prescriptions.

The task force will include senior officials from the Offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, as well as senior officials from the Executive Office for US Attorneys, the Civil Division, the Criminal Division and the Drug Enforcement Administration. The attorney general has also directed the PIL Task Force to establish a working group to improve coordination across the federal government, evaluate possible regulatory changes and recommend changes to federal law. Sessions emphasized that the task force will work closely with the Department of Health and Human Services and all levels of law enforcement to address the diversion and over-prescription of opioid painkillers.

Sessions also ordered the task force to examine existing state and federal lawsuits to identify instances where the DOJ can provide assistance. He noted that the DOJ is already involved in several such lawsuits, and announced that it would soon file a statement of interest in multidistrict litigation currently pending in the Northern District of Ohio.  In that case, US District Court Judge Dan Polster recently urged the parties to work towards a settlement that will not only resolve the monetary issues in the case, but that will also address the underlying crisis by reducing the quantity of pills in circulation and helping to ensure that the pills that are manufactured are used for legitimate purposes.

DOJ sees the FCA as a natural fit for fighting opioid abuse. As Attorney General Sessions outlined in his speech, the Medicare prescription drug program spent more than $4 billion on opioids in 2016 alone. Last year, the government settled FCA cases against a number of entities over opioid sales, including two pharmacies for combined total of nearly $14 million.

DOJ’s announcement follows the trend that we identified last month that the government is “expanding focus on prescribers and health care providers who submit claims to federal health care programs for opioid prescriptions, as well as drug treatment and drug testing services.” In addition to creating the Opioid Fraud and Abuse Detection Unit—a data analytics program to identify evidence of overprescribing and opioid-related health care fraud—DOJ has engaged in extensive enforcement activity over the past year, including prosecutions against several individuals (including physicians). The creation of the PIL Task Force further reinforces the importance of organizations ensuring that their compliance programs’ risk assessment, auditing and monitoring functions take into account the organizations’ opioid prescription issues and practices.

Amandeep S. Sidhu
Amandeep (Aman) S. Sidhu focuses his practice on complex commercial disputes with an emphasis on regulated industries, including health care-related investigations and litigation. He represents hospitals and health care companies in investigations and defense of qui tam whistleblower litigation involving federal False Claims Act (FCA), Stark Laws and Anti-Kickback Statute in federal district courts throughout the United States. Aman regularly supports settlement negotiations with the US Department of Justice for clients in multiple jurisdictions, including negotiation of corporate integrity agreements with the US Department of Health and Human Services Office of Inspector General. Aman also represents health care and life sciences companies in the navigation of state and federal investigations, including responding to congressional inquiries. Aman serves on the Firm's Diversity/Inclusion Committee, Pro Bono and Community Service Committee and Associate Development Committee. Read Amandeep Sidhu's full bio.

Matthew M. Girgenti
Matthew M. Girgenti focuses his practice on complex civil litigation and government investigations. He has experience in a broad range of litigation matters, including Fifth Amendment takings claims against the federal government Contract and tort disputes between commercial entities Americans with Disabilities Act claims defense False Claims Act litigation Administrative, state and federal motion and appellate practice Read Matthew Girgenti's full bio.

Paul M. Thompson
Paul M. Thompson focuses his practice on white-collar criminal defense, congressional investigations and appellate matters. He is a current member of the Firm-wide Management Committee and a former member of the Firm’s Executive Committee. From 2011 to 2015, Paul served as partner-in-charge of the Washington, DC office. Read Paul M. Thompson's full bio.