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.

We begin our May issue with a review of the recent Sun Pharma settlement in the long-running Ranbaxy antitrust litigation.  Although part of the wider enforcement actions against generic manufacturers for alleged anti-competitive behavior, this case focused on the misuse of the FDA’s ANDA process to block competitors.

Turning to litigation and enforcement, we cover three new developments in the ongoing opioid litigation.  However, these three cases have wider implications for life science legal and compliance beyond the narrow scope of opioids.

First, we examine a case involving two physicians charged with running an alleged “pill mill” in Alabama.  Although set in the context of prescription opioids, the case involves the good faith prescribing of pharmaceuticals and is now before the U.S. Supreme Court, which heard oral arguments in March.

Next, we examine the latest developments in Endo’s ongoing discovery woes in Tennessee.   In another state action, the court entered a default judgment against Endo on the question of liability only to have that judgment vacated and the judge disqualified.

Finally, we explore the latest settlement between J&J and West Virginia and its potential implications.  In a marked departure from its previous litigation strategy in Oklahoma, J&J ultimately chose to settle rather than risk a jury verdict.  The case also highlights the challenges of a corporate parent company avoiding liability for action of its subsidiaries when the parent exercises substantial control over the activities of the subsidiary.

Articles

FEATURE

Antitrust, FDA & Sun Pharma – The End of the Line

A Consumer Protection Win & Signal to Generic Drug Manufacturers

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

Summary: In March 2022, Sun Pharma announced a settlement in the long-running Ranbaxy antitrust litigation.  The settlement is a stern warning and reminder to life sciences companies of the substantial risks and costs associated with business efforts to usurp antitrust and generic competition within the industry.   It also sends a message to outside lawyers and consultants that work with industry clients.

Litigation & Enforcement

Alabama Pill Mill Case Gets to the U.S. Supreme Court

Does a “Good Faith” Defense Still Exist for Controlled Substances?

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

Summary: In 2017, two physicians were sentenced to at least 20 years imprisonment for allegedly operating a “pill mill” in Alabama.  In March 2022, the U.S. Supreme Court heard oral arguments on what constitutes “good faith” and acting in accordance with proper medical practice.   The case has broad implications for prescribing controlled substances and for individual physician accountability.

Litigation Shenanigans

Endo’s Opioid Discovery Defiance Results in New Sanctions

By Kirt Kraeuter, Staff Writer

Summary: Even though Endo’s second default judgment in the face of its repeated failures to comply with opioid discovery requests was vacated, it demonstrates the importance of proper discovery.  This article explores the latest rulings as well as the implications for other cases in the face of the cross-notice obligations imposed by the U.S. District Court overseeing the federal opioid multi-district litigation.

Just Another Settlement or Something More

Examining J&J’s West Virginia Opioid Settlement

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

Summary: In April 2022, J&J publicly announced a $99 million settlement with the State of West Virginia to settle allegations that it helped fuel an opioid addiction crisis within the state.  The settlement may signal a change of heart and a renewed propensity by at least J&J to resolve opioid claims without a jury trial.

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.