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Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries

Speaker(s): Charlene Keller Fullmer, Geoffrey R. Kaiser, Jacob T Elberg, Judith E. O'Grady, Nathan A. Brown, Odalys Caprisecca, Paul Kaufman, Robin Blaney, Scott D. Danzis, Shireen M Becker, T. Reed Stephens, Thomas F. Felton, Trish Dring
Recorded on: Oct. 5, 2017
PLI Program #: 186821

Nathan A. Brown is a partner in the health care and life sciences practice who focuses on food and drug law, particularly as it relates to medical devices, drugs and biologics.

Practice & Background

Nathan A. Brown advises health industry participants with regard to medical devices, drugs and biologics, as well as cosmetics and food products regulated by the U.S. Food and Drug Administration (FDA). His practice covers regulatory, compliance and policy advice.

Prior to joining the firm, Mr. Brow n served in several prominent roles with the FDA. Most recently, he was detailed by the FDA to serve as health policy advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee to cover FDA issues. On behalf of HELP Committee Chairman Tom Harkin (D-IA), Mr. Brow n played a lead role negotiating and drafting the Drug Quality and Security Act of 2013 (drug compounding and track and trace legislation), and coordinating passage of the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) reauthorizations. He advised committee leadership on a broad range of FDA-related legislative and oversight matters, including device, drug and biologics issues, and met with stakeholders across the FDA-regulated industries.

Before going to the Senate, Mr. Brown served in two roles at FDA. As special assistant to the chief counsel, he counseled FDA leadership on high priority and cross-cutting matters, including emerging public health issues, high-profile enforcement cases and congressional investigations. During his time in the Office of the Chief Counsel, he advised FDA’s Center for Devices and Radiological Health on a wide range of matters, including device review program reform, guidance development, software and health IT regulation, third-party review , laboratory developed tests and administrative appeals. He served as counsel on the medical device user fee reauthorization (MDUFA III) negotiation team, and represented FDA in providing assistance to Congress on device reform and MDUFA III provisions of the FDA Safety and Innovation Act of 2012 (FDASIA).

While at FDA, Mr. Brown also served as senior counselor to the associate commissioner for regulatory affairs (ACRA) in the Office of Regulatory Affairs (ORA), w here he advised the ACRA on compliance, enforcement and policy matters. He represented the ACRA in meetings with industry and in discussions with foreign governments regarding comparability and trade agreements. He also supervised priority matters for ORA, including implementation of FDASIA supply chain and enforcement provisions; coordination with the Office of the Chief Counsel on enforcement matters and litigation; organization of ORA efforts around import policy and implementation of the Food Safety and Modernization Act; and advising the ACRA on enforcement cases and appeals decisions.

Prior to his work at FDA, Mr. Brown was a lawyer in private practice, w here he focused on providing regulatory, legislative and litigation counsel to national associations, public and non-profit hospitals and other health care providers in a wide range of issues relating to Medicaid, Medicare and other health programs. He represented clients before the Centers for Medicare & Medicaid Services, the Department of Health and Human Services Departmental Appeals Board, various state agencies and in litigation in federal and state courts. He also advised clients on election law and lobbying law requirements. 

Public Service

Member, Montgomery County Board of Social Services (2008-2013)

Co-Chair, Maryland Health Benefit Exchange Advisory Committee on Financial Sustainability (2011-2012)

Steering Committee Member, Maryland Women’s Coalition for Health Reform(2006-2011)

Staff Member, Gov. O’Malley’s Transition Work Group/Maryland Department of Health and Mental Hygiene (2006-2007)

Community Involvement

In 2001, Mr. Brown served for six months at Bread for the City Legal Clinic, w here he handled a variety of Social Security disability appeal cases, family law matters and landlord and tenant cases.

Speaking Engagements

“What Hospitals Need to Know about the New Compounding Law ,” July 29, 2014.

Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.

Assistant United States Attorney Charlene Keller Fullmer is the Deputy Chief for Affirmative Litigation in the Civil Division of the United States Attorney’s Office in the Eastern District of Pennsylvania, where she supervises and prosecutes health care and affirmative fraud matters. She led the Philadelphia civil prosecution team that investigated and resolved allegations of off-label promotion of the atypical antipsychotic drug Risperdal by Johnson and Johnson and its subsidiary Janssen Pharmaceuticals, which resulted in a $2.2 billion global settlement with the Department of Justice, the largest paid for a single drug. In 2009, she served on the team that investigated and resolved allegations of off-label promotion and kickbacks by Pfizer, Inc. The $2.3 billion civil and criminal resolution was at the time the largest health care fraud settlement in the history of the Department of Justice. For her efforts in these matters, she was the recipient of the 2014 Attorney General’s Award for Fraud Prevention, an Award of Commendation from the Assistant Attorney General for the Civil Division, Tony West, and the 2014 National Health Care Anti-Fraud Association’s Investigation of the Year. In October 2010, Attorney General Eric Holder presented her with the Attorney General Award for Exceptional Service, the Department of Justice’s highest commendation.

Ms. Fullmer returned to the Justice Department in 2007 after six years in private practice at Duane Morris LLP in Philadelphia, where she litigated defensive matters, including False Claims Act, health care, white collar, antitrust, and insurance coverage litigation. Prior to that time, she served as an Attorney Advisor in Washington, DC and Quantico, VA with the Federal Bureau of Investigation, Office of Professional Responsibility, the Bureau’s Internal Affairs.

She is a 1993 graduate of Lehigh University, cum laude, and a 1996 graduate of Temple University School of Law, cum laude, where she served on the Law Review.

Geoffrey (Jeff) R. Kaiser, who has extensive experience in the healthcare industry, concentrates his legal practice on healthcare fraud and regulatory compliance issues, white collar criminal defense, False Claims Act litigation, integrity monitoring, and internal investigations. Jeff is the head of the Compliance, Investigations and White Collar Practice Group, and is a partner in the Health Services Practice Group. The Health Services Practice Group has been listed in the prestigious Legal 500. The practice is also recognized as “notable” by Chambers USA.

Before joining Rivkin Radler, Jeff served for nearly 10 years in the Criminal Divisions of the U.S. Attorney’s Office for the Eastern District of New York and the U.S. Attorney’s Office for the Southern District of New York. While at the Justice Department, he directed many white collar investigations and prosecutions, including with respect to healthcare fraud, securities fraud, mortgage fraud, mail and wire fraud, and bank fraud.

As Chief of Health Care Fraud Prosecutions and Deputy Chief of Public Integrity in the Eastern District U.S. Attorney’s Office, Jeff directed investigations of fraud allegations against individuals and corporations. He also exercised oversight responsibilities within the Public Integrity Section and overall healthcare fraud cases within the Eastern District of New York. He received many recognitions and honors for his efforts as a federal prosecutor.

After leaving the Justice Department, Jeff served as a managing director with Navigant Consulting, Inc., a global expert services firm, in two of its practice groups: Disputes and Investigations and Healthcare Disputes, Compliance and Investigations. While at Navigant, Jeff led teams performing internal investigations and integrity monitorships of individuals and organizations in the healthcare, construction, and transportation industries, and supervised a major forensic review of mortgage servicing practices by a national mortgage servicer.  He also oversaw the implementation of anti-counterfeiting/brand protection strategies on behalf of global brand owners.

Jeff worked as a civil litigator for more than a decade, handling commercial litigation matters involving an assortment of business disputes.  He developed particular experience in the investigation and prosecution of complex civil frauds under multiple common law and statutory grounds, including the federal Racketeer Influenced and Corrupt Organizations Act (RICO).  In addition, Jeff has acted as advisor to a global conglomerate in the area of anti-counterfeiting and brand protection.

Jeff received his B.A. with Honors from the University of Virginia, where he also graduated Phi Beta Kappa.  He earned a J.D. from New York University School of Law, where he served on the Moot Court Board and received the Advocacy Award.  After graduating from law school, Jeff served for two years as law clerk to the Hon. Fritz W. Alexander II, an associate judge on New York State’s highest court, the New York Court of Appeals.

A frequent writer and speaker on a range of legal topics, particularly in the areas of healthcare fraud and compliance, Jeff was named a Super Lawyer in the Metro New York area, 2012-2017.  Jeff is an adjunct professor of law at St. John’s University School of Law, where he teaches Health Care Fraud.

The Health Services practice has been included in the Chambers USA directory in the Healthcare category.

Jake Elberg is an Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey.  As Chief of the Office’s Health Care & Government Fraud Unit for five years, Mr. Elberg has supervised a team of 15 AUSAs and directed all of the Office’s criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, violations of the Federal Food, Drug & Cosmetic Act, and the improper diversion of prescription drugs, as well as all health care-related actions brought by the Office under the False Claims Act.  In addition, Mr. Elberg has supervised and directed investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs.

In 2013, Mr. Elberg was awarded the Department of Justice’s Executive Office of U.S. Attorneys Director’s Award for Superior Performance as an AUSA for his investigation and prosecution of Maxim Healthcare Services, et al., which resulted in a recovery of $150 Million (the largest ever in a home healthcare case), as well as the felony conviction of nine individuals in six states, including three senior executives of one of the nation’s largest home healthcare companies.

In 2018, Mr. Elberg was awarded the Health & Human Services Office of Inspector General Award for Fighting Fraud, Waste, and Abuse for leading the investigation and prosecution of Biodiagnostic Laboratory Services, which resulted in 53 convictions, including 38 physicians – the largest number of medical professionals ever prosecuted in a bribery case.

Mr. Elberg is also an Adjunct Professor at the Seton Hall University School of Law, where he teaches a course on Health Care Fraud and Corruption.

Mr. Elberg joined the U.S. Attorney’s Office in 2007.  Prior to joining the US Attorney’s Office, Mr. Elberg was an associate at Dwyer & Collora LLP (now Hogan Lovells) in Boston, where his areas of practice included white collar criminal defense, internal corporate investigations, and general commercial litigation.

Mr. Elberg received his JD in 2003 from Harvard Law School, graduating magna cum laude, after having received his BA in 2000 from Dartmouth College, from which he graduated cum laude and with honors.  After graduating law school, Mr. Elberg served as a law clerk to the Honorable Nancy Gertner (District of Massachusetts).

Shireen Becker is a former federal prosecutor who now helps companies conduct internal investigations and build, enhance, and maintain effective corporate compliance programs. Shireen regularly defends clients before a range of government agencies, including the DOJ, HHS-OIG, EPA, and DOD. She has defended a wide variety of white-collar criminal cases involving allegations of bribery of public officials, defense contractor fraud, false claims, and health care fraud.

Prior to joining Jones Day in 2013, Shireen served as the Criminal Health Care Fraud Coordinator for the U.S. Attorney's Office in the Southern District of California. During that time, she prosecuted violations of the Anti-Kickback Statute, criminal false claims, and aggravated identity theft. Her success stories include uncovering a multimillion dollar fraud involving stolen medical equipment from Camp Pendleton, a health care fraud investigation of a hospital CEO, prosecution of wide-ranging contract fraud by a San Diego-based biotech firm, and obtaining one of the largest individual restitution awards for the Social Security trust fund. Shireen also has broad criminal trial experience and has successfully briefed and argued several cases before the Ninth Circuit Court of Appeals.

An engaged community leader, Shireen serves as a Lawyer Representative for the Ninth Circuit Judicial Conference and is on the Board of Directors for the San Diego Chapter of the South Asian Bar Association. She also serves on Jones Day's firmwide Diversity, Inclusion & Advancement Committee and is actively involved in the Firm's pro bono initiative to provide legal assistance to veterans of the U.S. Armed Forces.

Tom is Senior Corporate Counsel, Pricing and Contracting for Celgene Corporation, where he provides general legal support for the Market Access team and supporting functions. Prior to joining Celgene, he worked for AstraZeneca Pharmaceuticals LP. While at AstraZeneca, he worked both directly in the Managed Care business in governance and strategic roles, as well as spending eight years in the Legal Counsel’s office, providing advice and guidance on contracting and government pricing matters, including commercial and government contracting, Medicare and Medicaid, and 340B issues. Mr. Felton began his career at Akin, Gump, Strauss, Hauer & Feld LLP in Washington, DC, providing legal advice to a variety of health care clients, including manufactures, providers, and retail pharmacies, including advice on the implementation of HIPAA, the Medicare Modernization Act, and Medicare Part D.

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector.  His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders.  He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions.  Mr. Blaney writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

T. Reed Stephens, a partner in McDermott Will & Emery’s Washington, D.C. office, practices in the Firm's Health Care Advisory Practice Group. Mr. Stephens’ Litigation and Compliance Advisory practice focuses on health care systems and companies in global industries, such as the pharmaceutical industry. These clients have matters that involve sensitive, complex issues of federal and state regulatory enforcement including ICE, the Depart. of Veterans Affairs, the FDA, the Dept. of Health & Human Services, Congressional Committees, and many State Attorneys General. In his practice, he handles matters for these clients in the following areas: (1) Litigation and Government Investigations; (2) Global Regulatory Compliance including the FCPA; (3) Public Policy -- providing strategic advice to assist clients in navigating various state and federal legislative initiatives; (4) Transactional -- risk assessment and valuation of liabilities as part of the M & A process and intellectual property matters.

Mr. Stephens is a nationally recognized expert in the pharmaceutical fraud and abuse and corporate compliance areas -- speaking frequently to private industry about the federal False Claims Act, the federal and state Anti-kickback laws, the Stark Law, off label drug promotion and the development and implementation of corporate compliance programs. While working for the Department of Justice, he was lead or co-lead counsel in some 60 investigations from 1995 to 2003, the majority involving allegations of health care fraud including more than a dozen multimillion dollar recoveries for the federal government.

While in the government, Mr. Stephens worked closely with the Depart. of Health and Human Services Office of Counsel to the Inspector General to develop various corporate integrity agreements and the Inspector General's Guidance to Pharmaceutical Manufacturers. Mr. Stephens has also been an instructor at the Attorney General’s National Advocacy Center (1998, 2000, and 2002). While with the Department of Justice, Mr. Stephens earned several honors including a Civil Division Special Commendation for Outstanding Service in 2002. Nightengale’s Healthcare News named him one of its “Outstanding Litigators for 2006”, chosen by LMG Life Sciences Guide as a “2013 Life Sciences Star,” and he has been ranked since 2008 in Chambers USA in Health Care. He was recently named one of Washington’s Best Lawyers for Health Care for 2013 by the Washingtonian Magazine.

Mr. Stephens served two three year terms in various capacities on the Board of Trustees of the Norwood School in Bethesda, Maryland. After obtaining degrees from Princeton University and Stanford Law School, where he was a member of the Articles Board of The Law Review, he clerked for the Honorable Clifford Scott Green of the U.S. District Court for the Eastern District of Pennsylvania.

Paul joined Northwell Health as Vice President in the Office of Legal Affairs in September, 2014, where he works on regulatory-related matters.  Prior to that, Paul served for over ten years as the Chief of Civil Health Care Fraud for the U.S. Attorney’s Office for the Eastern District of New York (EDNY), where he worked closely with federal and state law enforcement personnel to develop, investigate and resolve health care fraud cases on behalf of the United States and its agencies.  During Paul’s tenure, the EDNY recovered over $1 billion in settlements of health care fraud cases, and Paul was the recipient of several awards including HHS-OIG’s Integrity Award, the Director’s Award for Superior Performance as an Assistant U.S. Attorney, and the New York City Bar Association’s Stimson Medal for Outstanding Contribution to the Office of the United States Attorney.  Before joining the EDNY, Paul began his legal career as an associate at Proskauer Rose, where he focused on commercial litigation and white collar defensive matters.  Paul graduated from Brooklyn Law School cum laude in 1991, where he served as a Notes Editor for the Brooklyn Law Review.