Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you to subscribe to our monthly publication Policy and Medicine Compliance Update.
This month we begin our issue of Policy and Medicine Compliance Update with an examination of the opioid crisis as a case study. Although the crisis and the ensuing litigation are far from over, the crisis already provides universal compliance and corporate governance lessons.
Sticking with the opioid crisis, we next examine the upcoming trial of Laurence Doud, III. Doud is the former CEO of Rochester Drug Co-Operative, and his case is the first criminal trial of an opioid distributor executive.
Moving to litigation and enforcement developments, we begin with coverage of new amendments to the federal False Claims Act, by a group of senators led by Sen. Charles Grassley. The bill would increase the ability of relators to bring qui tam actions, limit the government’s ability to dismiss qui tam cases, but protect the government from high discovery costs in suits in which it does not intervene but which the court feels have little probability for success.
From there, we next examine the recent case involving Avanos Medical, Inc. The DOJ charged Avanos with felony misbranding for defective PPE, resulting in a sizeable monetary penalty and a Deferred Prosecution Agreement.
Lastly, we examine the ongoing developments surrounding Medicare co-pays and independent charities. Recently, Teva lost its bid to get the DOJ’s case involving Copaxone dismissed lending further credence to the DOJ’s and HHS OIG’s position on this topic.
Finally, we end with our two new columns featuring a noted life science compliance professional discussing how they became involved in compliance and our “Shifting Sands” column highlighting recent job and roles changes within the profession. If you have items that you want include in our “Shifting Sands” columns such as new hires, promotions, or other recognition, please send them to me at editorial@policymed.com.
Articles
FEATURE
The Opioid Crisis is a Teachable Nightmare
A Case Study in Compliance & Corporate Governance
By Dr. Seth B. Whitelaw, Michael J. Hercz, and Stephen D. Lerner
Summary: The opioid crisis and its ensuing litigation are far from over. However, the crisis and litigation already provide universal compliance and corporate governance lessons for all life science companies seeking to avoid a similar fate that befallen the companies involved in the crisis.
Litigation & Enforcement
Opioids, Distributors & Individual Accountability
Former Rochester Drug Co-Operative CEO Prepares for Trial
By Morgan Valentish
Summary: Now scheduled for January 2022, the impending trial of Laurence F. Doud, III is the first criminal trial of an opioid distributor executive. It bears watching by all life science company executives as the Justice Department continues expanding its drive to hold responsible corporate officers accountable for company misdeeds, especially where there is a clear impact on public health.
Modernizing Lincoln’s Law
Congress Proposes New Amendments to the Federal False Claims Act
By Gwendolyn A. Ball, Staff Writer
Summary: Senator Grassley and a bipartisan group of senators are proposing new amendments to the False Claims Act that would increase the ability of relators to bring qui tam actions. The bill also would limit the government’s ability to dismiss qui tam cases but protect the government from high discovery costs in suits in which it does not intervene but which the court feels have little probability for success.
You Can’t Cloak Misrepresentation
Avanos Settles Charges It Misbranded Its Surgical Gowns
By Gwendolyn A. Ball, Staff Writer
Summary: Because of the current pandemic, the Justice Department has increased its pursuit of fraudulent PPE purveyors. However, while heightened, this focus is not new, as Avanos Medical, Inc. recently discovered. As a result, the DOJ and Avanos settled felony misbranding charges with a Deferred Prosecution Agreement and a sizable monetary penalty.
Kickbacks Disguised as Charity
Teva Loses Bid to Dismiss the Copaxone Co-pay Charity Case
By Robert N. Wilkey, Esq., Staff Writer
Summary: In September 2021, Teva lost its bid to dismiss the Justice Department’s case against it for improper use of independent charitable foundations to cover Medicare beneficiary co-pays. The denial of Teva’s motion further strengthens the government’s theory about the improper use of such charities and highlights the DOJ’s continuing efforts to root out the allegedly unlawful activities.
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