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When Your Life Sciences Are on the Line: Securities Enforcement

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eighth episode of When Your Life Sciences Are on the Line, where leading practitioners and thought leaders share the insights and advice needed to manage business and legal risk in the life sciences sector.

When Your Life Sciences Are on the Line: Securities Enforcement

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Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. He represents companies, financial institutions, boards, and executives through all phases of investigation and litigation involving allegations of corporate healthcare fraud, securities and other financial fraud, public corruption, criminal intellectual property theft, data breach or disclosure, and international money laundering. Nate leverages his two decades of service in the U.S. Department of Justice to offer clients an invaluable insider perspective on white collar defense, internal investigations, cyber breaches, and government enforcement actions.Prior to joining Morrison Foerster, Nate served as First Assistant U.S. Attorney and Senior Litigation Counsel advising the U.S. Attorney. As Acting U.S. Attorney, Nate led over 135 prosecutors and reported directly to the Attorney General. Before serving as First Assistant, Nate was Chief of the Narcotics and Money Laundering Unit, where he led more than a dozen prosecutors investigating and prosecuting money laundering cases across the United States, Colombia, Europe, and the Middle East. He also contributed to the creation of the District Court’s RISE Program and was an Assistant U.S. Attorney in the Southern District of Florida.Nate earned his B.A., cum laude, from Amherst College and earned his J.D. from Harvard Law School where he served as the Editor in Chief of the Harvard Latino Law Review.<h4>Representative Experience</h4><h5>Defense Experience</h5><ul><li>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 False Claims Act (FCA).</li><li>Advising a pharmaceutical company seeking to mitigate Anti-Kickback Statute (AKS) risk in supporting commercially insured patients in the transition to a new biosimilar therapy. While providing support to commercially insured patients and carving out federally insured patients is not prohibited, such arrangements can draw government scrutiny if they are intended to induce or “pull through” federally insured patients to use medical services or products. We are helping formulate practical parameters for a program that will assist commercially insured patients, meet business goals, and comply with applicable laws and regulations. </li><li>Advising pharmaceutical company whose trade secrets and confidential information were used as the basis for a patent application filed by a competitor and former employees.</li><li>Advising a commercial bank on the acquisition of a medical records company under investigation by DOJ for alleged violations of the FCA.</li><li>Advising an investment management company on the acquisition of a medical device manufacturer under investigation by the DOJ for alleged violations of the FCA.</li><li>Provided training to an online market place regarding the legal framework of the AKS, recent enforcement trends, and compliance best practices.</li></ul><h5>Government Experience</h5><ul><li>Violations of the AKS against a variety of major pharmaceutical companies, which culminated in settlements involving nearly $1,000,000,000 in fines and restitution to resolve the improper use of “patient assistance programs” to subsidize patient co-pays.</li><li>Violations of the CSA against the founder and chief executive officer of a publicly‑traded pharmaceutical company related to the opioids epidemic.</li><li>FCA matters involving improper inducements, insurance pull-through schemes, and improper billing and coding practices.</li><li>Fraud and tax fraud charges against a professor suspected of stealing trade secrets and intellectual property from U.S. interests for a foreign government.</li><li>Conspiracy to obtain unauthorized access to computers and to commit wire fraud and securities fraud charges against a Russian businessman.</li><li>Charges of mail fraud, money laundering, bribery, conspiracy to commit mail and wire fraud, and racketeering conspiracy against coaches, administrators, and parents who fraudulently obtained test scores and college admissions for students related to the Varsity Blues scandal.</li><li>Six-week mail and wire fraud trial against an American businessman involved in a multi-million dollar Ponzi scheme.</li></ul>

Nathaniel R. Mendell

Partner

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

Edward is a former Assistant United States Attorney for the Southern District of New York (SDNY). He represents companies, financial institutions, boards, and executives in internal and government investigations and parallel regulatory and civil litigation. He is experienced in all aspects of white collar crime, including securities and commodities fraud, accounting fraud, insider trading, market manipulation, corporate fraud, digital currency crime, cybercrime, and violations of the Foreign Corrupt Practices Act (FCPA). Edward is frequently recognized by leading industry publications such as Chambers USA where he is ranked as an “Up and Coming” lawyer in the Litigation: White Collar Crime & Government Investigations – New York category, in addition to being recommended by The Legal 500 US for Dispute Resolution: Corporate Investigations And White Collar Criminal Defense, where he is described as, “one of the most experienced FCPA and securities prosecutors to come out of the government.”During his tenure at SDNY, Edward was a senior member of the Securities & Commodities Fraud Task Force and also handled FCPA matters, including three of the largest-ever FCPA criminal resolutions. He is an accomplished trial attorney who tried more than a dozen jury trials to verdict as an Assistant U.S. Attorney. Among his trials were 10 complex, multi-week white collar trials, including six trials in the SDNY’s Securities Fraud Unit, all of which resulted in convictions. He also argued 11 appeals in the U.S. Court of Appeals for the Second Circuit. Edward is a recipient of the Assistant Attorney General’s Exceptional Service Award.Edward is frequently published and quoted by financial publications and media outlets on white collar and securities law developments including The Wall Street Journal, Bloomberg, Law360, New York Law Journal, and Law.com, among others. He is also a member of the Federal Bar Council, Federal Criminal Practice Committee, and the New York City Bar, White Collar Crime Committee.Prior to joining Morrison Foerster and SDNY, Edward served as a law clerk to the Honorable Robert A. Katzmann on the U.S. Court of Appeals for the Second Circuit and the Honorable Lewis A. Kaplan on the U.S. District Court for the SDNY and was a litigation associate at two prominent New York law firms.Edward graduated magna cum laude in the top one percent of his class from Georgetown University Law Center, where he was a senior editor of the Georgetown Law Journal and elected to the Order of the Coif. Edward earned his B.A. magna cum laude with distinction in History from Amherst College.<h4>Representative Experience</h4><h5>Defense Experience</h5><ul dir="ltr"><li>Representation of a technology company in a multi-agency federal criminal investigation involving allegations of illegal gratuities, which included advising the company on remedial actions related to internal controls. The DOJ and SEC took no action against our client.</li><li>Representation of a company in conducting an internal investigation into alleged tax and accounting issues, which included counseling the Audit Committee of the Board of Directors on matters of corporate governance, including internal controls over financial reporting.</li><li>Representation of a multinational consulting firm in a cross-border investigation into allegations of bribery and corruption in South Africa, which involves investigations on multiple continents by DOJ and the National Prosecuting Authority in South Africa, parliamentary inquiries, and a Judicial Commission of Inquiry in South Africa.</li><li>Representation of a multinational, publicly traded global Fortune 500 company before DOJ, SEC, and a multilateral organization in investigations of allegations of foreign bribery and corruption.</li><li>Representation of senior executives of a public company in a DOJ and SEC accounting fraud investigation. The DOJ and SEC took no action against our clients.</li><li>Representation of a senior executive of a public company in a DOJ and SEC insider trading investigation. The DOJ and SEC took no action against our client.</li><li>Representation of a former executive of a global investment bank charged by DOJ with alleged FCPA and money laundering offenses arising from financing transaction in Africa and Europe.</li><li>Representation of senior executive of national bank in multiple investigations by federal and state regulators and law enforcement, including SEC, DOJ, the Federal Deposit Insurance Corporation, and the Financial Industry Regulatory Authority, and in civil class-action lawsuits alleging violations of the federal securities laws. </li></ul><h5>Government Experience</h5>Representative corporate and FCPA investigations include:<ul><li>Secured three of the 10 largest FCPA criminal resolutions, resulting in nearly $3 billion in penalties, including the then-largest FCPA criminal penalty.</li><li>FCPA prosecution of an Uzbekistan official for receiving bribes of $865 million, the largest bribe ever charged against an individual FCPA defendant.</li><li>Secured a $900 million criminal resolution with a major automotive manufacturer to resolve charges relating to an ignition switch defect.</li></ul>Representative white collar investigations and trials include:<ul dir="ltr"><li>One-month accounting fraud trial during the COVID-19 pandemic against the CEO and COO of a public biomedical company for fraudulently inflating revenue.</li><li>Three-week accounting fraud trial against the CFO of a prominent public real estate investment trust for manipulating non-GAAP earnings metrics.</li><li>One-month securities and investment advisor fraud trial against a film producer for a complex scheme involving a New York hedge fund.</li><li>Two-week insider trading and securities offering fraud trial against an investment fund owner.</li><li>Two-week insider trading trial against a Wall Street analyst.</li><li>Six-week securities fraud trial against a law partner for a $2 billion accounting fraud scheme at Refco, a former New York broker of commodities and futures contracts.</li><li>Three-week Racketeer Influenced and Corruption Organizations Act trial against a payday lender for a $220 million fraud.</li><li>Investigation of a prominent antivirus software founder for securities and commodities fraud offenses arising from false and misleading cryptocurrency promotions.</li></ul>