From Price Strategy to Enforcement Risk – FDA Watch
In this third and final part of our series in collaboration with White & Case and BRG, Wayne chats with Lauren Papenhausen, Partner at White & Case’s Boston office, and Edward Buthusiem, Managing Director at BRG. Together, they discuss pricing-related government enforcement risks and the legal framework; commercialization strategies under heightened enforcement scrutiny; internal investigations and distinguishing isolated issues from systemic compliance failures; board and audit committee oversight of pricing compliance and internal controls; emerging enforcement risks from state-level drug pricing regulation; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Lauren Papenhausen
Lauren Papenhausen is a litigation partner based in the Boston office of White & Case. She focuses her practice on white collar criminal defense and complex commercial litigation. Lauren guides her clients through high-stakes lawsuits, including government and internal investigations, whistleblower lawsuits, class actions and other complex civil litigation.
Lauren has extensive experience handling disputes relating to the Foreign Corrupt Practices Act (FCPA), bribery and kickbacks, the federal False Claims Act, antitrust law, unfair and deceptive trade practices, fraud and contractual performance. She also provides clients with risk management and compliance advice, including assistance with implementing, enhancing and evaluating compliance programs. She is experienced in conducting and assessing due diligence and handling disputes in connection with foreign and domestic investments and mergers and acquisitions. Lauren works with her clients to secure favorable results crucial to their business success.
Recent successes include reversal of all fraud and bribery charges in the “Varsity Blues” college admissions case, declinations by the government in matters involving healthcare diagnostics and laboratory testing, successful representation of a medical device company in a dispute arising out of an acquisition and the dismissal of a civil case alleging unfair and deceptive trade practices at the motion to dismiss stage.
Prior to joining White & Case, Lauren worked as a litigation partner at an international law firm. She also served as a law clerk to the Honorable Algenon L. Marbley, US District Court for the Southern District of Ohio.
Edward Buthusiem
Edward Buthusiem is a managing director in BRG’s Health Analytics practice. He is a leader of the firm’s Corporate Compliance and Risk Management practice and co-leader of its Pharmaceutical Valuation practice.
He has over thirty years of experience advising clients on a variety of business, regulatory, operational, intellectual property, litigation, transactional, and compliance matters, with particular emphasis in pharmaceutical and medical device product and technology licensing transactions, commercial and strategic transactions, business formation and planning, securities, mergers and acquisitions, compliance, and corporate governance. Since joining BRG in 2013, Ed has provided expert testimony and support in litigation matters involving, among other things, the interpretation of licensing and development contracts relating to pharmaceutical and medical device product development, deal structures, valuation, damages calculations and pricing, matters involving fiduciary responsibilities, securities disclosure, adequacy of internal controls, and pharmaceutical pre-clinical and clinical development and commercialization.
Ed has served as a government and court-appointed monitor for entities subject to post-settlement and post-acquisition mandates, including on behalf of the US Department of Justice (DOJ), Securities and Exchange Commission (SEC), and Office of Inspector General (OIG) in connection with civil and criminal actions. He has also served as a court-appointed monitor in connection with the disposition of assets in bankruptcy proceedings and as an independent third party to oversee the implementation of post-closing obligations primarily involving M&A transactions. He has advised healthcare companies and their legal counsel in implementing corporate integrity agreements (CIAs) and negotiating CIA terms with the DOJ, OIG, SEC, and other governmental agencies. Ed has also developed and overseen all aspects of compliance programs, including auditing and monitoring; interactions and engagements with healthcare professionals; determining fair-market value of goods and services provided by and offered to physicians; strategic marketing and sales initiatives; transparency reporting; and clinical, research and development, and post-market surveillance.
Prior to joining BRG, Ed served as general counsel, chief compliance officer, and head of Business Development for a $4 billion global dental and medical device business from 2010 to 2013. His responsibilities included heading the Business Development, Legal, Compliance, Trade Operations, and Environmental Health and Safety Departments and overseeing the provision of these services to global businesses.
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