Capabilities
Life Sciences and Healthcare Regulatory

Internal Investigations, Audits and Self Disclosure

We have deep experience handling internal investigations and helping life sciences and healthcare clients avoid, and, if necessary, defend government investigations. We have represented companies on-site during extended hostile inspections of multiple facilities, conducted numerous sensitive internal investigations, managed high-profile congressional inquiries, and represented clients in scientific misconduct and disqualification/exclusion matters. Although our goal is to prevail against the government whenever possible, we have also negotiated landmark consent decrees with FDA and settlements and Corporate Integrity Agreements with the Department of Justice, Department of Health and Human Services (HHS) Office of Inspector General (OIG), and state regulators. We routinely assist clients in developing corrective action plans for various types of regulatory noncompliance, and a major aspect of our practice involves proactive compliance reviews and audits intended to reduce risks and avoid enforcement.

Perspectives

Chapter 11: Enforcement and Government Investigations Relating to Medical Devices

PLI's Medical Devices Law and Regulation Answer Book 2014-15. Ed. By Suzan Onel and Karen Becker

Antitrust Investigations: What Counsel for Pharmaceutical Companies and Medical Device Manufacturers Need to Know

Bloomberg BNA

What You Don't Know Can Hurt You

Healio.com

Chapter 11: Enforcement and Government Investigations Relating to Medical Devices

PLI's Medical Devices Law and Regulation Answer Book 2013-14. Ed. By Suzan Onel and Karen Becker

Overview

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