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Clinical Trial Enforcement Trends and Best Practices

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Kate Driscoll was a guest on the American Bar Association’s Voices in Health Law podcast, discussing the nature of clinical trials fraud, recent developments in enforcement activity, and the role of lawyers in counseling compliance by clinical research organizations.

Kate Driscoll was a guest on the American Bar Association’s Voices in Health Law podcast, discussing the nature of clinical trials fraud, recent developments in enforcement activity, and the role of lawyers in counseling compliance by clinical research organizations.<a href="https://www.americanbar.org/groups/health_law/voices-in-health-law/clinical-trial-enforcement-trends-and-best-practices/" dir="ltr" target="_blank">Listen to the podcast.</a>

Clinical Trial Enforcement Trends and Best Practices

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Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives. Kate has extensive experience in a wide range of criminal and civil cases, with an emphasis on pharmaceutical and life sciences clients, related to healthcare fraud, the Anti-Kickback Statute (AKS), the False Claims Act (FCA), and the Foreign Corrupt Practices Act. Kate routinely consults with clients on all manner of compliance matters, including providing risk assessments, gap analyses, and maturity evaluations. Kate also recently completed a secondment with a global consulting firm, leading government-facing investigations relating to healthcare matters.Prior to joining Morrison Foerster, Kate served as an Assistant United States Attorney in the U.S. Attorney’s Office for the Eastern District of Pennsylvania. Kate has significant trial experience, obtaining multiple jury and bench trial verdicts. As a federal prosecutor, Kate ran large-scale white-collar investigations, including complex wiretap and forensic financial investigations, involving healthcare fraud, illegal distribution of prescription drugs, money laundering, wire fraud, bank fraud, and tax fraud. Kate conducted parallel investigations with the Civil Division related to potential False Claims Act violations, and the SEC for potential violations of securities laws. Among her experience, Kate led the criminal prosecution of one of the largest theft of trade secrets cases in United States history, involving a leading multinational pharmaceutical company, and also led COVID-19-related government fraud investigations, involving the CARES Act and the Paycheck Protection Program.Kate received the 2019 Inspector General’s Award for Excellence in Fighting Fraud, Waste, and Abuse for the successful prosecution and conviction of healthcare professionals who illegally distributed millions of dollars in prescription drugs. She was also part of the prosecution team that was awarded the Prosecutor of the Year Award for 2021 from the Coalition Against Insurance Fraud regarding work on a significant arson, healthcare fraud, and tax fraud prosecution that impacted hundreds of victims and caused significant damage to the City of Philadelphia. Kate has advised and worked closely with a variety of federal and local law enforcement agencies.Kate is a lecturer at Yale University, teaching a course on white-collar investigations and prosecutions. Earlier in her career, Kate clerked for the Honorable Pamela K. Chen of the U.S. District Court Eastern District of New York. Kate earned her J.D. from the University of Pennsylvania Law School and her A.B. summa cum laude from Bryn Mawr College.<h4 dir="ltr">Representative Experience</h4>Defense Experience<ul><li dir="ltr">Representation of an international consulting firm related to its work for opioid manufacturers, which involves complex, multidimensional work involving state attorneys general, DOJ, and congressional investigations, as well as more than 140 civil lawsuits that are now in a Multi-District Litigation.</li><li dir="ltr">Representation of Anthony Ornato, a former senior career civil servant who recently served as White House Deputy Chief of Staff of Operations, in the January 6 Select Committee investigation and related government investigations.</li><li dir="ltr">Representation of a multinational pharmaceutical and medical device manufacturer in various internal investigations relating to employees’ alleged kickback violations, submission of false claims, bribery, collusion with business partners, and corporate governance issues across North America.</li><li dir="ltr">Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the FCA.</li><li dir="ltr">Advising a pharmaceutical company seeking to mitigate AKS risk in supporting commercially insured patients in the transition to a new biosimilar therapy.</li><li dir="ltr">Representation of a global manufacturing company in reviewing and enhancing their anti-corruption and bribery codes of conduct, third-party due diligence protocols, and procurement policies.</li><li dir="ltr">Internal investigation in the U.S., Europe, and Latin America on behalf of a financial institution, which involved over US$1.3 billion in potential liabilities.</li></ul>Government Experience<ul><li dir="ltr">Matter involving scientists employed by a multinational pharmaceutical company who were criminally charged for conspiracy, theft of trade secrets, wire fraud, and money laundering, all relating to theft of cancer research platforms, valued at more than US$550 million.</li><li dir="ltr">Matter involving a scientist who was extradited from Switzerland after indictment for conspiracy to steal trade secrets related to the theft of research and other confidential information from several multinational pharmaceutical companies.</li><li dir="ltr">Matter involving physicians criminally charged for prescribing more than US$5 million in prescription drugs used to treat opioid addiction outside the course of professional practice and not for legitimate medical purposes.</li><li dir="ltr">Matter involving a financial advisor who was criminally charged for diversion of client funds through bank, mail, and wire fraud, and aggravated identity theft.</li><li dir="ltr">Matter involving arson that displaced hundreds of victims and injured several firefighters. Obtained convictions for all defendants and US$22 million in restitution for the victims. Brought related indictments charging additional criminal conduct, including healthcare fraud, tax fraud, and federal benefits fraud.</li></ul><h4 dir="ltr">Memberships</h4><ul><li dir="ltr">National LGBTQ+ Bar Association</li><li dir="ltr">Philadelphia LGBTQ Bar Association</li><li dir="ltr">Pennsylvania Association Criminal Defense Lawyers (Planning Committee)</li><li dir="ltr">Federal Criminal Law Committee in the Eastern District of Pennsylvania (Executive Committee)</li><li dir="ltr">American Bar Association, Health Law Committee – Healthcare Fraud & Compliance Interest Group Leadership Team (Subject Matter Representative)</li><li dir="ltr">University of Pennsylvania Inn of Court</li><li dir="ltr">The American Health Law Association</li><li dir="ltr">Women’s White Collar Defense Association</li><li dir="ltr">National Association of Criminal Defense Lawyers (2021–22)</li><li dir="ltr">University of Pennsylvania LGBTQ Alumni Association, Steering Committee (2016–19)</li></ul>

Kate Driscoll

Partner

Health Care Fraud