Policy & Medicine Compliance Update
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May 2021
Issue Summary:
This month our focus is on data and the implications of its use. We start with an article from Helio Health on data analytics and the need for compliance to use those tools to prevent and deter inappropriate conduct. Next, we take a hard look at the implications for companies that fail to comply with discovery orders. Finally, we round out our look at data by exploring the often ignored but critical function of records retention.
In this issue, we look at the Justice Department’s efforts to combat pandemic-fraud. Finally, we explore the recent New Jersey pelvic mesh cases and the issue of whether FDA clearance is appropriate evidence to present to a jury and AdvaMed’s contention that it is.
ARTICLES
YOUR DATA & YOU: WHO WORKS FOR WHOM?
THE BURNING PLATFORM FOR COMPLIANCE DATA ANALYTICS
By Amy Pawloski, Gillian Sutherland, and Benjamin J. Schein
Summary: Almost every life science company today could likely “check the box” when it comes to having some sort of data analytics aspect of their compliance monitoring program. The question regulators will start asking companies, however, is no longer “if” a company has adopted data analyses in support of their programs, but rather, “how and to what extent?” To best safeguard the interests of their organizations, Compliance leaders should be prepared to demonstrate the ways in which their organizations are maximizing the utility of their various data sources to better prevent and deter inappropriate conduct.
ZEALOUS OVER REPRESENTATION
WALMART AND ENDO GO TOO FAR AND ARE SANCTIONED FOR DEFYING DISCOVERY ORDERS
By Dr. Seth B. Whitelaw, Editor
Summary: Two recent situations involving Walmart and Endo illustrate that zealously representing the client has its limits. They also illustrate that there is a role for compliance even during complex litigation. Although both cases involve opioids, the lessons are applicable to all life science companies, their compliance professionals, and their attorneys.
THE DAY OF COVID-19 RECKONING IS HERE
THE JUSTICE DEPARTMENT FOCUSES ON PANDEMIC RELATED FRAUD
By Robert N. Wilkey, Esq., Senior Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: As evidenced by the Justice Department’s announcement on its COVID-19 enforcement efforts, these efforts are critical to the life sciences industry. Enforcement actions for pandemic-related fraud are just getting started, so compliance professionals beware.
GARDEN VARIETY PRODUCTS LIABILITY BECOMES A BATTLEGROUND
THE RELEVANCE OF FDA 510(K) CLEARANCES IN NEW JERSEY PELVIC MESH CASES
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The recent appeal of two New Jersey pelvic mesh cases raised the question of whether evidence of FDA clearance is appropriate evidence for the jury. With limitations, the New Jersey Appellate Division concluded it might be, but questions remain. For life sciences companies, the case is significant because it may set a legal precedent by which Courts will allow juries to consider regulatory compliance as evidence when evaluating a company’s potential liability.
THE HOMELESS FUNCTION
RECORDS RETENTION NEEDS TO COME OF AGE
By Kirt Kraeuter, Staff Writer
Summary: Despite posing known and significant risks, effective records retention remains elusive. In large part, this may be attributed to the multi-disciplinary elements of the work, the complexity of the subject matter, and confusing and inconsistent organizational structures. Life sciences companies would benefit from efficient records retention capabilities, but that will require industry standardization on functional responsibility and core processes that have not yet emerged.
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. And as always, thank you for subscribing and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor
editorial@policymed.com