White Collar Criminal Defense Group

DOJ Takes New Steps In Opioid Enforcement

What Happened

In the last few weeks, the Department of Justice has announced new initiatives in the fight against the opioid crisis.  These initiatives included the creation of the Prescription Introduction & Litigation Task Force and a directive that the DEA review regulations regarding production quotas for prescription opioids.

The Rundown

In late February, Attorney General Jeff Sessions announced the creation of the Prescription Introduction & Litigation Task Force – termed the “PIL Task Force” – which will focus DOJ’s civil and criminal enforcement tools on manufacturers, distributors, prescribers and pharmacies.  For manufacturers, the task force will use “all available criminal and civil remedies” to hold them liable for illegal activities, including false or misleading marketing of opioids.  DOJ will also examine pending litigation against manufacturers filed by state and local governments to determine if federal law can assist the litigation.

For prescribers, pharmacies, and distributors, the PIL Task Force will investigate whether DEA regulations are being followed and if the federal False Claims Act can be used to “crack down on pain-management clinics, drug testing facilities and physicians that make opioid prescriptions.”

The PIL Task Force will also partner with HHS to (1) improve coordination and data sharing against the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; and (3) recommend changes in laws.

Additionally, on March 1, the Attorney General issued a memo directing the DEA to evaluate its regulations concerning production quotas for prescription opioids.  As readers may know, the DEA is charged with regulating the amount of opioids that manufacturers are allowed to produce as set forth in DEA regulations establishing these production and manufacturing quotas.  However, as the Attorney General’s memo notes, “the United States is an outlier in the number of opioid prescriptions issued each year.”  The Attorney General directed the DEA to revisit the quotas and accompanying regulations to determine if they are appropriate in light of the opioid crisis

For the Record

Remarks by Attorney General Sessions

PIL Task Force:  “The PIL Task Force will aggressively deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses in the United States, with a particular focus on opioid manufacturers and distributors.”  (February 27, 2018).

Opioid production quotas:  “Time is of the essence.  Given the urgency of this crisis, with an estimated 175 Americans dying per day, we need DEA to act quickly to determine if changes are needed in the quotas.”  (March 1, 2018).

If you become the subject of a PIL investigation, please do not hesitate to contact one of our Attorneys today.

DOJ Expands FCPA Declination Policy To Other Criminal Matters

What Happened

The Department of Justice suggested last month that it will decline prosecution in corporate criminal matters in which the corporation engages in voluntarily disclosure.

The Rundown

On February 28, 2018, DOJ sent a letter declining to prosecute Barclays in connection with crimes involving a foreign exchange front running scheme.  Though several Barclays executives were charged, DOJ declined to prosecute the corporation.  Barclays had agreed to pay back $13.9 million in profits after cooperating with DOJ in an extensive investigation of the alleged wrongdoing.

The declination signals a policy shift toward presuming declination in cases where the corporation voluntarily discloses, which is DOJ’s default position in all FCPA matters.  John Cronan, the acting head of DOJ’s Criminal Division and Benjamin Singer, chief of the securities and financial fraud unit confirmed the move, telling attendees at the ABA’s white collar conference in the beginning of the month that DOJ will use the FCPA Corporate Enforcement Policy as nonbinding guidance in other criminal cases.  Pursuant to that policy, unless certain aggravating factors are present, DOJ will decline to prosecute corporations who cooperate and proactively disclose and remedy FCPA issues.

For the Record 

In the declination letter to Barclays, Deputy Attorney General Rod Rosenstein wrote that one aspect of DOJ’s commitment to “finding effective ways to ensure that individual wrongdoers are held accountable for corporate criminal behavior . . . is to punish the people who make or knowingly participate in decisions that violate the law” but the Department also wants “to avoid imposing penalties that disproportionately punish innocent employees, shareholder, customers and other stakeholders.”