Medical Device Regulation, Compliance & Policy, Part 3: On False Claims – FDA Watch
In this third part of our series in collaboration with Covington, Wayne chats with Pam Forrest, Partner and Co-Chair of Covington’s Medical Device Industry Group; Michael Granston, Partner and Chair of Covington’s False Claims Act Investigations and Litigation practice; and Krysten Rosen Moller, Partner in Covington’s Life Sciences Enforcement practice. Together, they discuss the government’s current use of the False Claims Act to pursue healthcare fraud; issues that could lead to potential False Claims Act liability for medical device manufacturers; preventive actions device manufacturers can take to reduce enforcement exposure; cases challenging the constitutionality of the act’s whistleblower provisions; developments in the government’s ability to pursue False Claims Act liability for kickbacks; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Pam Forrest
Pamela Forrest has over 25 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements.
Pamela frequently advises medical device manufacturers on responses to FDA enforcement actions, including Form FDA-483 observations and Warning Letters. She has extensive experience working with firms to draft written responses, develop and implement corrective actions, and prepare for re-inspection.
Pamela regularly assists medical device manufacturers, investment banks, and private equity firms with complex due diligence evaluations regarding the FDA compliance status of acquisition targets. She also frequently counsels start-up medical device firms on market entry strategies, and works with firms to identify the appropriate regulatory pathway and shepherd them through the FDA regulatory process.
Pamela has written and spoken extensively on various aspects of FDA regulation of medical devices, and has testified before several State legislative committees regarding medical device legal and regulatory issues.
Michael Granston
Michael Granston, Chair of Covington’s False Claims Act Investigations and Litigation practice, spent nearly three decades at the Department of Justice (“DOJ”) and for the last six years served as Deputy Assistant Attorney General, the highest-ranking career employee in the Civil Division.
Michael advanced through the ranks within the Civil Fraud Section, beginning his DOJ career as a Trial Attorney, and eventually serving as Director from 2013 to 2019. As Director, he oversaw the Department’s pursuit of False Claims Act (“FCA”) investigations and litigation, as well as other actions relating to fraud, kickbacks, and conflicts of interest.
Michael most recently served as Deputy Assistant Attorney General starting in 2019. In this capacity, he managed not only the Civil Fraud Section but also all aspects of the Commercial Litigation Branch, including litigation in areas such as international trade, intellectual property, bankruptcy, and bid protests.
During his tenure at DOJ, Michael supervised many of the most significant FCA matters while playing a primary role in formulating the Department’s FCA priorities and policies. He spearheaded DOJ’s approach to major statutory changes in 2009 and 2010 to the FCA and its qui tam provisions. He also was instrumental in developing various DOJ guidance on the investigation and handling of FCA matters, including most notably a 2018 memorandum that clarified when DOJ should consider dismissing non-intervened whistleblower suits—commonly referred to as the “Granston Memorandum.” Michael helped identify and advance key enforcement priorities under the FCA across multiple administrations, including fraud involving prescription opioids, the Medicare Part C and D programs, the Anti-Kickback and Stark Statutes, government contracts and grants, cybersecurity issues, and trade and customs laws.
Michael also served as the Civil Division’s Chief Ethics Officer and was a member of the State Secrets Review Committee.
Krysten Rosen Moller
Krysten Rosen Moller focuses her practice on representing clients in internal investigations, government investigations, and follow-on civil litigation, with an emphasis on serving clients in the life sciences and healthcare industries.
Krysten assists companies with complex internal and government investigations covering a broad range of issues, including fraud and abuse, advertising and promotion, and bribery and corruption. Krysten has particular experience conducting targeted and efficient internal investigations and representing pharmaceutical and medical device companies against investigations from the Department of Justice or other government regulators. Krysten’s complementary litigation practice focuses on defending life sciences and healthcare companies in related litigation, including cases arising under the False Claims Act and other follow-on litigation arising from government investigations.
Krysten also counsels clients on compliance matters. She regularly represents companies negotiating HHS OIG Corporate Integrity Agreements (CIAs) and advises companies on implementing and operating under CIAs. She has also conducted False Claims Act risk assessments and advised on other fraud and abuse issues.
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