Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.



September 2016: Life Science Compliance Update

Written by , Posted in Home page, September 2016 LSC Update, This Month in Compliance

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July 2016 LSCU Cover

Issue Summary

In this month’s issue of the Update, we literally span the compliance frontier. First, we focus on whether the OIG is giving medical device companies a break when it comes to enforcement. We then move on to transparency and an article by Nick Merryfield and Andrew Wiles comparing the Open Payments data for pharmaceuticals and medical devices. Given that it’s still transparency season, we also have any article by Geert van Gansewinkel of Polaris on European Transparency, and a look at FDA Clinical Investigator disclosures and Open Payments. Finally, Brian Dahl takes a look at the impact of shareholder actions triggered by enforcement actions.



At the Punishment Wheel: Are Medical Device Companies Getting Preferential Treatment?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer for Life Science Compliance Update

The new Cardiovascular Systems, Inc. False Claims Act settlement has some in the industry wondering why CSI settled for such a small amount when we are used to pharmaceutical companies having to dive deep into their pockets to satisfy settlement costs. This article goes through the case background, comparison settlements, and discusses whether medical device companies are treated differently from pharmaceutical companies.



Pharma & Medtech – Like Chalk & Cheese?
Nick Merryfield and Andrew Wiles of WorldDataOnline LLC.

The pharmaceutical and medical technology industries appear to show marked transfer of value variations in this year’s Open Payments data. This study investigates further and asks, is it a case of two sectors using unique commercial models, or a simple case of different reporting methodologies?


State of the European Union – Transparency in Europe 2016 and Beyond
Geert van Gansewinkel, Partner and Managing Director, Polaris Europe

Three years ago, EFPIA adopted the EFPIA transparency code. Now three years later, this article takes the opportunity to look at what has happened so far with transparency reporting in Europe and what the future may hold.


On a Collision Course – FDA Clinical Investigator Disclosure and Open Payments
Dr. Seth B. Whitelaw, Editor, Life Science Compliance Update

FDA’s requirements for clinical investigator disclosure and the Open Payments requirements are at odds in many ways. This article explores those differences and what might be done to remedy the situation.



As If the DOJ Weren’t Enough – Shareholders Are Increasingly Quick to Sue to Recover Lost Value Triggered by Enforcement Actions
Brian A. Dahl

Recent plaintiff wins in lawsuits against life sciences companies seeking to recover lost shareholder value resulting from healthcare fraud investigations and enforcement actions seem to have emboldened more plaintiffs to aggressively pursue this remedy. An effective compliance program is intended to manage the risk of healthcare fraud by putting in place controls designed to help prevent company personnel from paying kickbacks or promoting off label to generate business. Now more the ever, a company that fails to put in place an effective compliance program to manage such risk runs the additional risk of a shareholder lawsuit should a healthcare fraud investigation or enforcement action compromise shareholder value.


AseraCare – Even Courts Seek Second Medical Opinions
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In AseraCare case, the United States Department of Justice (DOJ) sought to show that AseraCare submitted false claims. Relying upon a single medical expert, the DOJ attempted to show patients’ medical records do not contain “clinical information and other documentation that support [this] medical prognosis,” and thus, AseraCare’s claims for those patients were “false.” In rejecting the DOJ’s case and granting Summary Judgment for AseraCare, the Court held that reliance on a single medical expert was insufficient to demonstrate that a company submitted false claims.

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