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Prevent a Clinical Trial from Turning Into a Criminal Trial

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On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the 

<p>We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.</p><p>Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.</p>

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<p><span>On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the Food and Drug Law Institute’s<span> </span></span><strong>Clinical Trials: Deconstructing Challenges and Providing Practical Insights Conference.</strong><span> </span><span>The panel featured a high-ranking attorney from the Department of Justice’s (DOJ) Consumer Protection Branch (CPB) and other regulatory compliance leaders to discuss key trends and issues in clinical trial enforcement that underscored the need to ensure appropriate compliance measures are in place to avoid future investigations.</span></p><p>Read the <a href="https://lifesciences.mofo.com/topics/prevent-a-clinical-trial-from-turning-into-a-criminal-trial" target="_blank">full blog post</a>.</p>

<p>Prevent a Clinical Trial from Turning Into a Criminal Trial</p>

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<p dir="ltr">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.</p><p dir="ltr">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.</p><p dir="ltr">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.</p><p dir="ltr">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.</p><h4 dir="ltr">Representative Experience</h4><p dir="ltr"><strong>Defense Experience</strong></p><ul><li dir="ltr">Represented McKinsey & Company in negotiating a $650 million five-year deferred prosecution agreement and civil False Claims Act settlement with DOJ and Corporate Integrity Agreement with HHS-OIG arising from McKinsey’s past work for opioid manufacturers, including Purdue Pharma.</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><p dir="ltr"><strong>Government Experience</strong></p><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">University of Pennsylvania Inn of Court</li><li dir="ltr">Women’s White Collar Defense Association</li></ul>

Kate Driscoll

Partner

<p>Brian R. Michael is a partner in Morrison Foerster’s Investigations + White Collar Defense Group, and the chair of the firm’s Global Ethics + Compliance practice.</p><p>Recognized as one of the top lawyers in California, Brian draws upon more than 25 years of high-profile experience in private practice, as an in-house leader, and as a federal prosecutor in the Southern District of New York and the Central District of California to represent entities and individuals who turn to him for the most complex, high-stakes white collar criminal cases, internal and government-facing investigations, securities and regulatory enforcement matters, and related litigation and trials. Brian routinely advises clients on a wide range of matters involving corporate and securities fraud, the Foreign Corrupt Practices Act and global anti-corruption laws, workplace misconduct, public corruption, cybersecurity, FinTech and blockchain technologies, trade sanctions, whistleblowing, and human rights and supply chain due diligence, among other areas.</p><p>Brian’s practice also focuses on providing sensitive crisis management and compliance counseling, and he has extensive experience leading the design, enhancement, and implementation of cross-border compliance programs. He regularly leads global risk assessments and provides compliance and crisis preparedness training to companies, boards, and employees.</p><p>In addition to his many years in private practice, Brian served as Deputy General Counsel and Group Chief Compliance Officer at media and entertainment company 21st Century Fox, and as an Assistant United States Attorney in both the Southern District of New York and the Central District of California. At 21st Century Fox, Brian played a critical role in the company’s response to multiple cross-border investigations, including the “UK phone hacking” crisis and the wide-ranging FIFA corruption matter, and oversaw global compliance for Fox broadcast, cable, digital, and sports media businesses, including National Geographic Partners and more than 300 channels in over 180 countries. As a federal prosecutor, Brian tried numerous cases and briefed and argued multiple appeals, as well as led criminal investigations and prosecutions involving complex financial, securities, and healthcare fraud, cybercrime, organized crime and racketeering, money laundering, violent crime, child sexual exploitation, and asset forfeiture, for which he received many commendations and awards. Brian also served as the Violence Against Women Act Coordinator and the Anti-Gang Coordinator for the Central District of California.</p><p>After graduating law school, Brian clerked for former Chief Judge Gilbert S. Merritt of the U.S. Court of Appeals for the Sixth Circuit.</p><p>Brian is a frequent public speaker and commentator on investigations, white collar crime, securities and regulatory enforcement, and compliance topics. He serves on the Board of Advisors for Vanderbilt Law School and on the Executive Committee of the Board of Directors for Teach Democracy, a non-partisan nonprofit dedicated to advancing civics education and engagement among largely underserved youth. He is also a member of the Board of Directors of the Southern California Regional Subcommittee of the ABA’s White Collar Crime Committee and a Fellow of the American Bar Foundation.</p><p>Brian earned his B.A. with distinction in general scholarship from the University of California at Berkeley and earned his J.D. from Vanderbilt Law School, where he was elected Order of the Coif.</p><h4>Representative Experience</h4><h5>Government-Facing Investigations</h5><ul><li>Representation of a national governing body for an Olympic sport in an investigation led by the California Attorney General’s Office into historical allegations of sexual misconduct and abuse by local affiliates, resulting in successful resolution with no adverse findings.</li><li>Representation of a global auto manufacturer in connection with an investigation by the U.S. Attorney’s Office for the Central District of California into alleged foreign bribery and the prosecution of a former employee, successfully resulting in no adverse action against the company.</li><li>Representation of a prominent nonprofit entity in an internal investigation into multiple complaints regarding conflicts of interest, self-dealing, and other significant misconduct committed by top-level executives, resulting in successful separation of the executives on favorable terms for client.</li><li>Representation of a world-leading publisher of online video content in an investigation led by the New York Attorney General’s Office into alleged violations of state law regulating the nature of online content, resulting in successful outcome with no adverse action.</li><li>Representation of prominent private high school in Los Angeles embroiled in the Varsity Blues college admissions scandal, across from the U.S. Department of Justice.</li><li>Representation of a lobbyist in connection with a high-profile and wide-ranging corruption probe of the Los Angeles City Council led by the U.S. Attorney’s Office for the Central District of California, successfully resulting in no criminal action against client.</li><li>Representation of a fund and its three managing members in connection with investigations led by the U.S. Attorney’s Office for the Central District of California and the SEC related to a $500+ million Ponzi scheme and the prosecution of the perpetrator in the largest Hollywood Ponzi scheme ever, successfully resulting in no criminal or civil enforcement actions; featured in a lead story in <em>The New Yorker</em>, CNBC’s <em>America Greed</em>, and multiple documentaries, podcasts, and other publications.</li><li>Representation of senior executives for multiple entities in connection with U.S. Department of Justice criminal and civil enforcement investigations, and related FDA proceedings, related to COVID-19 testing protocols and devices.</li><li>Representation of a high-profile individual in connection with asset forfeiture and related proceedings concerning the 1MDB criminal prosecution in the Eastern District of New York.</li><li>Representation of a former senior research scientist of a multinational life sciences company in an internal investigation and parallel FDA investigation regarding alleged research misconduct by the former CEO in relation to the then-most expensive drug therapy ever, resulting in no enforcement action.</li></ul><h5>Internal and Board Investigations</h5><ul><li>Engaged by the California Department of Justice’s (DOJ) Office of the Attorney General to lead and conduct an independent review of DOJ’s public release of confidential personal information associated with firearms permit holders and applicants, and to prepare and release a public report setting forth detailed factual findings regarding the data release and recommendations for remedial actions.</li><li>Representation of a public multinational media company in multiple highly sensitive internal investigations into manipulation and tampering by third parties of core business activities and information, resulting in successful disruption and cessation of the improper activities and preservation of company’s business integrity.</li><li>Representation of a global auction house in an internal investigation of misconduct by senior executive and advising company leadership and board on mitigation and remediation arising from investigative findings.</li><li>Representation of a global FinTech entity in investigating alleged financial misconduct in Asia-Pacific region that came to light during due diligence for a time-sensitive and significant transaction, resulting in the successful closing of the transaction.</li><li>Representation of CEO and founder of prominent digital media company in board investigation of allegations of misconduct from co-founder, resulting in successful determination that allegations were unfounded.</li><li>Representation of senior public university executive in an investigation arising from whistleblower allegations of misconduct directed towards university’s leadership, resulting in successful finding of no wrongdoing.</li></ul><h5>Compliance Counseling, Crisis Management, and Due Diligence</h5><ul><li>Representation of a global FinTech entity in the design and implementation of a global compliance infrastructure related to the successful roll-out of a new payment tool.</li><li>Led crisis response for prominent investment funds in response to racially charged incidents at real estate developments in the wake of the George Floyd incident, resulting in successful resolution of the conflicts.</li><li>Led due diligence for prominent hedge fund in connection with potential/successful deal activity.</li></ul><h5>Complex Litigation and Trials</h5><ul><li>Representation of high-net-worth individual in dispute over distribution of significant marital estate in litigation across from former spouse, resulting in successful resolution for client.</li><li>Representation of a high-profile professional athlete in mediation and litigation across from former spouse regarding sensitive personal matters.</li><li>Representation of prominent Hollywood executive in connection with termination due to allegations of misconduct and subsequent successful arbitration resulting in finding that termination was unlawful, along with significant financial recovery for client.</li><li>Defense of a global auto manufacturer in consumer fraud litigation across California, including extensive trial preparation for multiple cases the led to successful resolution on favorable terms for client.</li><li>Representation of healthcare executive in complex financial dispute across from multiple insurance carriers, resulting in mediated settlement and dismissal of action.</li></ul>

Brian Michael

Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance