Policy & Medicine Compliance Update
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SEPTEMBER 2019 Issue
Issue Summary:
Our focus for September is on Enforcement. To start things off we feature an in-depth review of the Oklahoma public nuisance opioid case against Johnson and Johnson. In October we will follow-up with a review of the recent verdict.
Next we review the latest developments in the New England Compounding Center saga in which the convictions of two former executives were overturned. We then shift to medical devices and start out with an in-depth look at the recent medical device FCA case involving Life Spine, Inc. and its involvement with healthcare professionals. This is followed by a look at the recent ResMed case involving DME device distribution and support services. We also continue our coverage of medical cannabis in the context of the recent FDA Warning Letters.
Rounding out the issue are articles on the impact of the Granston memorandum on qui tam litigation, and updates on the Insys opioid and CareFusion medical device cases.
FEATURE
Opioid Case Tests the Boundaries of Liability – Oklahoma, J&J and the “Mutant Poppy Strain”
By Robert N. Wilkey, Esq.
Summary: The first opioid case to go trial has just concluded in Oklahoma with J&J as the sole defendant. This case is important for all life science companies because of its approach to the concept of public nuisance and the fact that liability may now extend past the final manufacturer to other companies in the product supply chain (e.g., active pharmaceutical ingredient manufacturers). This article provides a detailed review of the case.
TAGS: Opioids, Public Nuisance, Oklahoma, J&J, API
ENFORCEMENT
The Chaos Over Drug Compounding Continues As Judge Throws Out Convictions of NECC Executives
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: A federal judge in Boston recently overturned the convictions of two former NECC executives who had been convicted of defrauding the FDA. In some respects, this case represents a historical anomaly. Thus, while the NECC defendants won on their legal impossibility argument in this instance, going forward, there will be no confusion as to FDA’s authority to regulate such facilities.
TAGS: Compounding, Executives, FDA, NECC, Convictions
Small Companies Are Not Immune from Prosecution – The Case of Life Spine, Inc.
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In July 2019, the Department of Justice announced a False Claims Act suit filed against Life Spine, Inc., for violations of the Act, alleging the company and two of its executives caused hospitals and surgeons to submit false claims to Medicare and Medicaid.
TAGS: Medical Device, FCA, Executives, Speakers’ Programs, Life Spine
DME Suppliers Remain in the Spotlight – ResMed Announces Tentative Settlement Agreement with the Justice Department
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: ResMed recently announced that it reached a tentative settlement agreement with the DOJ in conjunction with an investigation pertaining to ResMed’s business practices involving DME product support services. This case highlights the ongoing enforcement spotlight on DME suppliers, and the challenges of providing product support services in conjunction with DME products.
TAGS: Medical Device, DME, ResMed, Support Services
Cannabis
Cannabidiol Confusion Cannabidiol Confusion Continues as the FDA Weighs In
by Darshan Kulkarni, Pharm.D, MS, Esq.
Summary: The FDA’s regulation of medicinal cannabidiol containing products is an ongoing work in progress. However, the FDA’s recent spate of Warning Letters demonstrates that companies selling CBD products need to exercise caution when making promotional claims.
TAGS: Cannabis, FDA, Warning Letters, Promotion
Qui Tam Litigation
The Granston Memo Applied – Questions Remain
By Gwendolyn Ball, Staff Writer for Policy & Medicine Compliance Update
Summary: First announced in November 2017, the Granston Memorandum appeared to signal a change in the Justice Department’s attitude and policy towards False Claims Act qui tam cases. Now almost two years later, questions remain, and it will likely require the U.S. Supreme Court to resolve them.
TAGS: Qui Tam, Granston, DOU
UPDATES
An Insys Update – Settlement of Civil and Criminal Allegations
by Kaitlin Fallon Wildoner, Senior Staff Writer
Summary: The Insys case is continuing, but in June, the company entered into a global settlement with the Justice Department.
TAGS: Opioids, Settlement, Insys
Medical Device Update – Alleged FDA Violations Lead to a $3.3 Million Settlement for CareFusion
by Kaitlin Fallon Wildoner, Senior Staff Writer
Summary: Recently, CareFusion agreed to settle an FCA case with the Justice Department for $3.3 million while admitting to selling devices not approved or cleared by the FDA. While the full set of facts remains under seal, it appears that CareFusion’s liability stems from faulty representations provided to the company by the original device manufacturer.
TAGS: FCA, Medical Device, Distributor, Third Party
