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.

For our first issue of 2022, we begin with an exploration of the paradoxically view of qui tam whistleblowers and the continuing skepticism of their motives for bringing False Claim Act (“FCA”) cases.  Next, we provide an update on the proposed amendments to the involving labor market collusion and no-poach agreements.  It seems this issue is making a resurgence under the Biden administration.

We also examine the recent decision by the Oklahoma Supreme Court overturning the verdict against J&J for opioid marketing.  The case highlights the continuing struggle to hold manufacturers, distributors, and pharmacies responsible for their alleged role in creating the current epidemic.  Finally, we also review California’s recent attempt to hold opioid manufacturers accountable that suffered a similar setback.

Feature

A Tale of Two Whistleblowers

Understanding the Paradox of Hero Versus Rogue

By Dr. Seth B. Whitelaw, Editor

Summary:  Even with the current whistleblower protections, deciding whether to come forward is complex and challenging.  Despite the demonstrable contributions whistleblowers make to combatting fraud and misconduct, skepticism about their motivations by Government regulators, attorneys, and compliance professionals remains an ongoing barrier.

TAGS: Whistleblower, False Claims, Qui Tam, Retailation, Materiality, Data Analytics, fraud

Litigation & Enforcement

The Long and Winding Road

The FCA Amendments of 2021 Continues Its Journey Through Congress

By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer

Summary:  In July 2021, a bipartisan group of senators introduced the False Claims Amendment Act of 2021 to revise the Federal False Claims Act.  Since then, the legislation has undergone some changes, which this article highlights.  However, the proposal faces an uphill battle to become law.

Tags: False claims, Amendments, Grassley, Qui Tam, Escobar, Implied False Certification, Materiality, Dismissal, DOJ, Granston Memo, Discovery, S. 2428

The Dangers of Not Poaching (And We Don’t Mean Eggs)

Efforts to Keep Talented Employees and Reduce Wages Raise Antitrust Risks

By Gwendolyn A. Ball, J.D. Ph.D., Staff Writer

Summary:  Labor market collusion in the form of wage-fixing and no-poaching agreements is a per se violation of the Sherman Antitrust Act.  While such collusion is not a new risk, given the recent attention from the White House, the FTC, and the DOJ, together with the current labor shortages, it is a more pressing priority.

Tags:  Antitrust, Collusion, Labor Market, No-Poach, DOJ, FTC, White House, Executive Order, Sherman Act, Wage-Fixing, Price-Fixing, DaVita, Surgical Care Affiliates, Advantage On Call, Nurses, Labor Shortage, Non-solicitation

Opioids and the Ongoing Struggle for Accountability

The Oklahoma Supreme Court Reverses the J&J Opioid Decision

By Robert N. Wilkey, Esq., Senior Staff Writer

Summary:  On November 9, 2021, the Oklahoma Supreme Court, in a 5-1 decision, reversed the lower court’s previous 2019 decision that determined Johnson & Johnson, along with several other Defendants, had engaged in a widespread illicit marketing scheme to market prescription opioids causing the current epidemic.  The Court determined that the state’s public nuisance law does not extend to manufacturing, selling, and distributing prescription opioids.  This article reviews the decision and its potential impacts on other opioid lawsuits.

Tags: opioids, api, J&J, Oklahoma, Washington, public nuisance, nuisance, J&J, Oklahoma Supreme court, marketing, first amendment, commercial speech, Abatement

California State Superior Court Refuses to Extend Public Nuisance Liability

By Robert N. Wilkey, Esq., Senior Staff Writer

Summary:  On November 1, 2021, the California State Superior Court determined that several opioid manufacturers were not liable for the opioid crisis within the State.  Specifically, Judge Peter J. Wilson determined that the State failed to make its case for public nuisance, false advertising, or unfair competition.  While it is the second case to reject the public nuisance theory, efforts to hold manufacturers, at least partially responsible for the opioid crisis, likely will continue in 2022.

Tags: Opioids, California, Public Nuisance, Nuisance, Marketing, Unfair Competition, False Advertising

From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times.   We encourage you to subscribe  and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals