Policy & Medicine Compliance Update
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September 2023 Issue
September 2023
We begin our coverage this month by thoroughly examining responsible research data sharing. Data-sharing policies require a careful balance between sharing and protecting research data.
Turning to litigation and enforcement, we examine the U.S. Supreme Court’s recent SuperValu decision and its implications for bringing False Claims Act cases. The opinion rejected the “objective reasonableness” standard and resolved an ongoing split among the several U.S. Courts of Appeal.
Next, we highlight new developments in the ongoing litigation over the safety of J&J’s talc-based baby powder products. Although it involves consumer products, the outcomes remain important for drug and device companies seeking to limit their product liability exposure.
Finally, we explore the latest case involving EHR providers. Like previous EHR cases, this case involves false certifications and kickbacks. For compliance professionals, the case provides substantial detail on the mechanics of the false certification scheme.
Articles
FEATURE
Achieving a Delicate Balance
Establishing Responsible Research Data Sharing Policies
By David Vulcano, LCSW, MBA, CIP, RAC, and Dr. Seth B. Whitelaw
Summary: The integrity of the medical research community is built upon a data foundation. A cornerstone of that foundation involves the responsible sharing of healthcare research data, which requires a careful balance between sharing and protecting data. This article discusses some of the complex factors involved.
Tags: Research, Data, Data Sharing, NIH, ICJME, ICH, Transparency, Individual Patient Data, Holdren Memo, Clinical Trials, De-identification, HIPAA, GDPR, EU, Pseudonymization, Anonymization, Re-identification, Reuse, Consent, Data Access, Publication Data Package, Source Data
Litigation & Enforcement
Knowledge is Power
U.S. Supreme Court Rejects FCA ‘Objectively Reasonable’ Standard
By Robert N. Wilkey, Senior Staff Writer
Summary: In June 2023, the U.S. Supreme Court issued an opinion considered by many legal experts as one of the most significant decisions regarding the knowledge requirement under the False Claims Act. The unanimous opinion resolved an ongoing split among the several U.S. Courts of Appeal by rejecting the “objective reasonableness” standard. What is essential is a defendant’s knowledge and subjective beliefs—not what an objectively reasonable person may have known or believed.
Tags: Supreme Court, SuperValu, Safeway, Objective Reasonableness, False Claims, Knowingly, Scienter, State of Mind, Price-Matching, Usual and Customary, Reimbursement, Whistleblower, Safeco, Fair Credit Reporting Act, Grassley, Mens Rea, Falsity, Authoritative Guidance, DOJ
The Best Defense
Johnson & Johnson Continues on the Offensive in the Talc Litigation
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: Given the significant threat posed by U.S. product liability litigation to the viability and success of drug and medical device manufacturers, the efforts by J&J to limit its exposure for the harm allegedly caused by its talc-based consumer products bear watching. As recent developments highlight, the company continues aggressively maneuvering on both the bankruptcy and scientific fronts despite achieving limited success.
Tags: J&J, Bankruptcy, Texas Two-Step, Product Liability, Safe Harbor, Third Circuit, Talc, Asbestos, Baby Powder, J&J Consumer, Inc., LTL, Good Faith, Financial Distress, Verdicts, Settlements, Supreme Court, Uniform Fraudulent Transfer Act
Wash, Rinse, Repeat
NextGen Healthcare is the Latest EHR Provider to Settle FCA Claims
By Kirt Kraeuter, Staff Writer
Summary: NextGen Healthcare became the latest electronic healthcare records provider to settle False Claims Act allegations. The case highlights behaviors showcased in previous EHR providers. It also provides a detailed look into one company’s subversion of the certification process for the EHR systems and customer referral payments.
Tags: EHR, False Claims, Kickbacks, Certification, American Recovery and Reinvestment Act, NextGen, eClinicalWorks, Greenway Health, Athenahealth, DOJ, HHS, Whistleblower, South Carolina Department of Corrections, Referrals, Tone at the Top
About THE Authors[1]
Kirt Kraeuter: Besides being a staff writer for the Policy & Medicine Compliance Update and providing compliance advisory services, Mr. Kraeuter is the former Senior Director of Corporate Compliance at Moderna.
David Vulcano: Mr. Vulcano is the Vice President of Clinical Research Compliance & Integrity for HCA Healthcare. He is also a Policy & Medicine Compliance Update editorial board member.
Dr. Seth B. Whitelaw: Dr. Whitelaw is a Senior Fellow and Adjunct Professor, Life Science Compliance at Mitchell Hamline School of Law, President & CEO of Whitelaw Compliance Group, LLC, and the Editor of the Policy & Medicine Compliance Update.
Robert Wilkey: Mr. Wilkey is the Principal Attorney at Wilkey Legal Consultants, LLC, and focuses on complex civil litigation and legal consultation involving class action matters within the pharmaceutical, medical device, environmental, and consumer protection fields. He is also a senior staff writer with the Policy and Medicine Compliance Update.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy. As always, thank you for subscribing and your continuing support in 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
sbwhitelaw@whitelawcompliance.com
[1] The views expressed in the articles are solely those of the authors and do not reflect those of the authors’ current or former employers and clients.