Food, Drug & Cosmetic Law Section

 

Larissa C. Bergin, Esq.

Jones Day

Washington, D.C. 

Larissa Bergin’s practice addresses the antitrust concerns arising from M&A matters, joint ventures, federal investigations, and commercial practices. She has overseen the antitrust aspects of corporate M&A, including due diligence, risk-shift negotiations, Hart-Scott-Rodino (HSR) filings, Second Requests, investigational hearings, integration planning, and consent decrees with federal agencies. She works with clients in a variety of industries, including the technology, health care, retail, and pharmaceutical sectors. Many of Larissa’s clients have international reach, and she has been involved in matters that require advocacy before governments throughout Asia, the EU, and North America.

Larissa also advises clients on corporate contracting and operational practices that can run afoul of the antitrust laws, including supplier agreements, information sharing, competitive benchmarking, and Robinson-Patman Act pricing matters.

At the start of her career, Larissa clerked at the U.S. Court of Federal Claims, where she addressed intellectual property, tax, and government contract issues, including Serco, Inc. v. United States (also referred to as the Alliant protest), a bid-protest case involving a $50 billion procurement for government-wide information technology and services.

Larissa is a member of the Antitrust Section of the American Bar Association and is secretary of the New York State Bar Association, Food, Drug, and Cosmetics Law Section. She is admitted in the New York, Connecticut, and District of Columbia bars.

Larissa has been quoted on MSNBC regarding how Obamacare has affected M&A activity and in Getting the Deal Through on generic drug approval.

 

Jorge Contreras, J.D.

University of Utah

Jorge Contreras (Harvard (JD), Rice Univ. (BSEE, BA)) is a Presidential Scholar and Professor of Law at the University of Utah with an adjunct appointment in the Department of Human Genetics.  His research focuses on intellectual property, technical standardization, antitrust law and science policy. He is the author of more than 100 scholarly articles and book chapters and the editor or author of ten books. IN 2020, he helped to co-found the Open COVID Pledge, a framework enabling institutions and companies to commit their patents and copyrights to the COVID-19 response at no charge.

 

Daniel Fabricant, Ph.D.

CEO & President, Natural Products Association (NPA)

Daniel Fabricant, Ph.D. is CEO and President of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, foods, personal care products and more. Most recently, Dr. Fabricant served as the Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA), where he directed agency policy, public affairs and regulatory action regarding regulation of the dietary supplement industry for more than three years. While with the agency, he successfully navigated the large, heavily-matrixed government organizational structure to bring life to a regulatory function that was non-existent for almost 20 years.  Dr. Fabricant carried his interest in natural products into the classroom, earning a Ph.D. in Pharmacognosy from the University of Illinois at Chicago, where he has served as an adjunct professor in the Department of Medicinal Chemistry and Pharmacognosy since 2009. He has also published extensively and is internationally recognized for his regulatory and governmental public health expertise and natural products research.

 

Laura R. Hammargren, Esq.

Senior Counsel, 3M Litigation

St. Paul, MN

Laura Hammargren is Senior Counsel with 3M Litigation in St. Paul, Minnesota, where she manages product liability and PFAS litigation, commercial litigation, and certain investigations.  She belongs to the 3M Legal Affairs Diversity & Inclusion Committee and chairs the external outreach subcommittee.

Prior to joining 3M, Laura was a partner in Mayer Brown’s litigation group in Chicago, Illinois, where she focused on product liability matters, government investigations, and complex commercial and employment litigation.  Laura also worked at Dorsey & Whitney in Minneapolis, Minnesota, and clerked for the Minnesota Supreme Court.

J.D., University of St. Thomas School of Law, Minneapolis, MN

Bachelor of Journalism, University of Missouri, Columbia, MO

 

Kristie Kuhl, J.D.

Finn Partners

Kristie Kuhl, J.D., managing partner, is head of New York Health, Chicago Health and US health product communications for Finn Partners. PRovoke named Finn Partners Healthcare Agency of the Year for 2018, finalist for Global Healthcare Agency of the Year in 2020, and while at Makovsky, it was named Healthcare Agency of the Year for 2014. She was honored as a Top Woman in PR in 2020.

Her legal and communications skills provide keen insight in bringing together communities with diverse interests and creating focus on one patient-driven goal. Clients have tapped her to lead numerous agency brand communications efforts.

Kristie was named a Top Woman in PR by PRNews in 2020, a “Rising Star” in 2002 by the Healthcare Business Women’s Association, and a PR Team Leader Finalist and Honorable Mention in the 2009 PR News PR People of the Year. She holds a Juris Doctorate from Quinnipiac University School of Law in Hamden, Connecticut, where she was the recipient of the school’s highest honor, the Dean’s Award.

 

Ron Lanton, Esq.

Principal, Lanton Law; President, Lanton Strategies

New York, NY

Ron Lanton has over 25 years of experience focused on government affairs and legal including activities on the municipal, state, and federal government levels with 15 years dedicated to the healthcare sector. He is currently Principal of Lanton Law and President of Lanton Strategies.

Ron has been an Executive Director & Senior Counsel for a national boutique healthcare law firm. Prior to his law experience Ron founded the healthcare government affairs and lobbying firm True North Political Solutions. At True North, Ron lobbied and provided strategic consulting for retail/specialty pharmacies, HME, compounders, home infusion and device stakeholders throughout the country. Ron ran this company for 5 years.

Prior to creating True North, Ron created a government affairs department for wholesale-distributor H. D. Smith and served as the company’s exclusive lobbyist.

Ron has also worked at Stateside Associates, a greater Washington D.C. area government affairs consulting firm, clerked for a federal magistrate and was appointed as a municipal commissioner on beautification and environmental issues. He frequently consults Wall Street firms on financial issues related to the healthcare sector.

Ron is Chair of the Biologics Committee for the New York Bar Assocation and is admitted to practice in Illinois, District of Columbia and New York. He frequently consults Wall Street firms on financial issues related to the healthcare sector.

 

Janet B. Linn, Esq.

Tarter Krinsky & Drogin LLP

New York, NY

Janet B. Linn is an intellectual property litigator at Tarter Krinsky & Drogin, with more than 30 years’ experience litigating patent, trademark, and other intellectual property cases, advising on patent prosecution, and providing patent validity and infringement opinions. She has litigated cases in a broad range of technologies including pharmaceuticals, medical devices, consumer products and mechanical devices.
Active in the profession, Ms. Linn is a former Chair and a current member of the Patents Committee of Association of the Bar of the City of New York, a member at large of the ABCNY Council on Intellectual Property, the current Vice Chair of the Food Drug & Cosmetic Section of the New York State Bar Association, and a member of Women in Licensing. She is a frequent author and lecturer on intellectual property issues.

 

Brian J. Malkin, Esq.

McDermott Will & Emery LLP

Washington, D.C. 

Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA-regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.

 

Robert B. McCray, J.D. 

Robert B. McCray has served the health care industry as a lawyer, CEO, investor and investment banker.  Mr. McCray is a member of the HIMSS Enterprise Board of Directors and member of the Boards of Directors of MacroHealth, Alliance Healthcare Foundation (AHF) (past Board Chair) and Consuli which he cofounded.  He serves on the Board of Advisors of PCHAlliance and is President of the Wireless-Life Sciences Alliance (WLSA), which he co-founded in 2005.  Mr. McCray Chairs the MacroHealth Compensation Committee and serves on the HIMSS Platform Committee and the AHF Finance and Investment Committees.

Previously, Mr. McCray served as Managing Partner of Triple Tree, LLC, a merchant bank focused on the healthcare sector; Chairman, President and CEO of HealthCap, Inc., a venture capital-backed physician practice management company; as President, COO and early investor in Digital On-Demand, Inc., a technology company operating the RedDotNet music distribution system in major retail chains; as Managing Director of Caremark Physician Resources, a division of Baxter; and co-founder and Chairman of OnCall Medicine, Inc., a medical house calls company.  Prior to his business career, Rob practiced healthcare regulatory and transactional law for 15 years and created a focused inter-disciplinary healthcare law firm and consultancy with a national client base (Weissburg & Aronson; Hunter McCray Richey & Brewer).

Some previous appointments include: Member of the Board of Directors and Chairman, Governance Committee at Midmark Corporation; Chairman of the Sacramento (County) Environmental Commission; Chairman of the Sacramento City Toxic Substances Commission; President of the Environmental Council of Sacramento; board member of the American Lung Association – Sacramento Emigrant Trails.

Mr. McCray holds a Bachelor of Science Degree from the University of California, San Diego and a Juris Doctor degree from the University of California, Davis School of Law.

 

Dr. Prasun Mishra, PhD

Dr. Mishra (Ex-Genentech, Ex-NCI, Ex-NIH) is the founding president and CEO of American Association for Precision Medicine (AAPM) and chair of ACT –AAPM’s Coronavirus Taskforce. He is leading research efforts focused on preventing & curing chronic diseases; not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives.

He is also founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery & development through technology, big data, robotics, and artificial intelligence. He is a serial entrepreneur who founded his first company after graduating high school, and second company during his PhD. Since then, he has accumulated a wealth of experienced by building, investing and advising numerous other companies. He is an investor, co-founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data-analytics, robotics, mental health, and digital health.

Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr. Mishra has keynoted, chaired, curated and organized numerous successful international conferences. Prior to Agility Pharma, Dr. Mishra served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche. Where he participated in several drug discovery project teams. He also lead the efforts to establish robotic automation (robotization) driven mammalian cell based phenotypic screening capabilities and hit to lead identification efforts within Genentech. Moreover, his passion for drug development and precision medicine has led to identification of new drug targets, biomarkers, companion diagnostics and several drugs/ combinations in the clinic.

His research work has been recognized globally by over 40 prestigious awards and honors. Due to his unique perspective & selfless service, he is highly respected & sought-after mentor to many. The companies that he has advised have raised multimillion dollars. Notably, he serves as a mentor and advisor to startup accelerators such as IndieBio, Health2.0’s Project Zygote (digital health accelerator) and California Life Sciences Institute’s FAST program, to help grow California’s life sciences innovation ecosystem.

 

Mary Beth Morrissey, Esq., MD, PhD

Fordham Ravazzin Center on Aging

Mary Beth Morrissey, a practicing attorney in White Plains who has joined the Alcott Law Group, has over 20 years’ experience in health law and not-for- profit governance practice.

Morrissey brings a wealth of experience in past general counsel and legal counsel roles to her current practice. She served as General Counsel to the Terence Cardinal Cooke Health Care Center, NYC, a 700-bed, multi-program health care facility with a nursing home, specialty hospital for children and an intermediate care facility, as well as other units of care. She also served as Legal Counsel to Catholic Charities, and Health Law Counsel to Bleakley Platt and Schmidt in White Plains, NY, before launching her own practice.

She is well versed in the full range of issues that concern non-profit health care organizations and human service agencies, especially the challenges presented by systems reform and transformation. In addition to traditional areas of health and not-for profit practice such as corporate governance, regulatory compliance and preventing fraud and abuse through policy and procedure development and staff education and training, she is also well-equipped to provide guidance on promoting innovation, designing programs, evaluating programs and outcomes, and managing and interpreting data.

Morrissey has written extensively on complex issues related to health care decision making, including the role of family systems and caregivers and ethics committees. Morrissey is the founder and president of the Collaborative for Palliative Care, a consortium of professionals and health care providers dedicated to research, education and advocacy to advance palliative care. She earned her PhD in Social Work at the Fordham University Graduate School of Social Service (2011), where she was a recipient of the Langenfeld Research Award for her doctoral research; her MPH at the New York Medical College School of Health Sciences and Practice (2005); and her JD at Fordham Law School (1982).

She is currently a Research Fellow at the Fordham University Global Healthcare Innovation Management Center, and Program Director of the Fordham University’s Post- Masters Health Care Management Certificate Program in Public Health, Palliative and Long-Term Care, an interdisciplinary education and training program she designed and launched in Spring 2013 for health and social service professionals as well as attorneys, health care and business managers.

Morrissey currently holds numerous leadership roles nationally and regionally – Treasurer of the Society for Theoretical and Philosophical Psychology of the American Psychological Association, Co-Chair of the American Public Health Association (APHA) Aging Policy Committee and member of APHA’s Action Board, hair of the New York City Bar Association Bioethical Issues Committee, and Co-Chair of the Health Law Committee and a Director of the Westchester County Bar Association. She is the immediate past chair of the Westchester Public Private Partnership for Aging Services, past president of the Public Health Association of New York City and the State Society on Aging of New York, and past co-chair of the Westchester Women’s Bar Association Elder/Health Law Committee and the Women’s Bar Association of the State of New York Health Law Committee.

She was the recipient of the Above the Bar Award for Most Socially Conscious Attorney in 2014, the Pace Women’s Justice Center Creative Vision for Elder Justice Award in October 2013, and the Mental Health Association On the Move Award in October 2012, as well as the 2012 Aging Services Golden Harvest Corporate Leadership Award in her role as founder and President of the Collaborative for Palliative Care.

 

Chris Palermo, Esq.

Harris Beach, PLLC

New York, NY

Chris Palermo is a partner at Harris Beach, PLLC, where he is a member of the firm’s Medical and Life Sciences, Mass Torts and Industry-Wide Litigation and Business and Commercial Litigation practice groups. Chris has extensive experience defending complex commercial and regulatory disputes, including mass tort and product liability actions, federal and state government enforcement actions and consumer class actions. He has regularly represented clients in civil litigation and government investigations brought by the U.S. Department of Justice, state Attorneys General and whistleblowers under the federal False Claims Act, state false claims acts and consumer protection statutes involving pharmaceutical manufacturer marketing, sales and pricing practices.

Chris serves on the Executive Committee of the Food, Drug & Cosmetic Law Section of the New York State Bar Association and is a member of NYSBA’s House of Delegates.

Chris is a cum laude graduate of Georgetown University Law Center and Princeton University.

 

Jennifer Piatt, Esq.

Network for Public Health Law

Edina, MN

Jennifer Piatt, JD, (“Jen”) is a Senior Attorney with the Network for Public Health Law. She also serves as a Research Scholar with the Center for Public Health Law and Policy at the Sandra Day O’Connor College of Law. She earned her JD at the Sandra Day O’Connor College of Law at Arizona State University in the spring of 2018.

As a law student, Jen worked with the Center for Public Health Law and Policy and the Network for Public Health Law as a student research assistant. In these roles, Jen provided drafting assistance and co-authored articles on a range of topics in the public health law sphere. Post-graduation, Jen served as a law clerk to Vice Chief Justice Ann A. Scott Timmer of the Arizona Supreme Court. In this position, Jen provided research and drafting assistance and prepared bench memos for cases granted review. Following her clerkship, Jen worked in private practice as a pharmacy regulatory attorney at Quarles & Brady LLP, in the firm’s Phoenix, Arizona office. In this role, Jen advised multiple clients on pharmacy and drug wholesale compliance and regulatory issues, provided contract drafting assistance, assisted with state pharmacy and wholesale licensing, and assisted clients going before state boards of pharmacy.

 

Steven Shapiro, Esq.

Of Counsel, Rivkin Radler LLP

New York, NY

Steven Shapiro has over 30 years of experience in food and drug regulatory matters and regularly counsels clients in the areas of food and drug law relating to the manufacture and marketing of foods, dietary supplements, over-the-counter drugs, and cosmetics. Among other services, he reviews product labels, claims and ingredients and assists companies with bringing new products into the market.

A part of the Firm’s Health Services Practice Group, Steven concentrates on areas of interest to the natural products industry and spends much of his time advising companies on the intricacies of the Dietary Supplement Health and Education Act of 1994 (DSHEA), as they concern the marketing of dietary supplements.

Steven has also assisted clients in matters relating to enforcement by the Food and Drug Administration (FDA), including handling FDA inspections, responding to Warning Letters, and injunctions and seizure actions. He is a contributor to many natural product industry trade magazines and a frequent lecturer on topics of concern to the natural products industry at various trade shows and for the Food and Drug Law Institute.

In addition, Steven has extensive experience in reviewing advertising and marketing materials, as well as representing companies in investigations initiated by the Federal Trade Commission (FTC) and the various state Attorneys General. He has also represented companies in matters arising from the Drug Enforcement Administration’s control of List I chemicals, and the U.S. Customs Service’s control of imports into the United States.

His litigation practice includes involvement in several cases concerning interpretations of the Food and Drug Act, which have resulted in judicial precedents. He also handles general litigation matters for a number of the firm’s clients.

Steven has been appointed to the SCNM Master of Science in Nutrition Business Leadership Advisory Council, where he advises on the course content for the Southwest College of Naturopathic Medicine’s M.S. program.

The Health Services Practice Group has been listed in the prestigious Legal 500. The practice also has been included in the Chambers USA directory in the Healthcare category.

 

Julia C. Tierney, J.D.

Chief of Staff, Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Julia (Julie) Tierney is the Chief of Staff for FDA’s Center for Biologics Evaluation and Research (CBER). In that capacity, she serves as the principal advisor to the CBER Center Director and facilitates planning and implementation of Center priorities. She joined CBER in early 2017 as a Senior Policy Advisor for Strategic Planning & Legislation. During her tenure in CBER, she has advanced a wide range of significant policy and outreach initiatives, as well as serving as the lead on legislative strategy for the Center.

From 2015 to 2016, Ms. Tierney served as FDA’s detailee to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee as a Senior Health Policy Advisor, negotiating many of the FDA-related provisions of the 21^st Century Cures Act and handling other FDA-related legislative issues. Prior to that, in her capacity as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, between 2008 through 2015, she provided ongoing legal counsel to FDA leadership and program staff on drug and biologic-related legal issues.

 Prior to working at FDA, Ms. Tierney practiced food and drug law at private law firms. She received her J.D. from Georgetown University Law Center and her undergraduate degree in Biology and History from Johns Hopkins University.

 

Marc S. Ullman , Esq.

Of Counsel, Rivkin Radler LLP

New York, NY

Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration regulatory issues with a focus on the Dietary Supplement/Natural Products Industry; Federal Trade Commission proceedings and litigation concerning consumer protection compliance and response to enforcement actions, concerning advertising practices, privacy and cyber security. Previously, he practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

Marc’s practice as part of the Firm’s Health Services Practice Group includes representation of clients on issues relating to FDA compliance, including labels, labeling, claims, and good manufacturing practices. He has also represented clients in a number of complex adversarial proceedings with the FDA relating to the scope of the agency’s powers under the Dietary Supplement Health and Education Act of 1994 and its ability to seek remedies such as consumer restitution as well as, counseling clients on general litigation related issues and most recently on complex legal issues of concern to the emerging hemp trade in the United States. He has represented clients in adversarial proceedings involving the FTC, including the negotiation of consent decrees and litigation regarding the adequacy of substantiation of advertising claims. Marc has appeared/testified on behalf of clients before the Food and Drug Administration’s Food Advisory Committee and at the FDA’s 2000 hearing concerning the impact of the First Amendment to the United States Constitution on FDA’s regulation of health claims concerning diseases. He has also counseled clients in connection with matters under investigation by the United States Congress.

Marc’s expertise includes guiding clients through FDA’s New Dietary Ingredient Notification (NDI) Process and counseling on issues involved in achieving status as Generally Recognized as Safe (GRAS) as a prerequisite for ingredient use in food products. His work in these areas includes counseling on the first GRAS assessment for Stevia leading to the first legal importation of this ingredient as a sweetener. He also provides counsel to clients dealing with serious recall situations. His work has included representation of clients at the heart of the pet food/melamine, StarCaps and pistachio recalls providing advice in dealing with the FDA, insurance companies, potential consumer claims, media contacts and general crisis management.

In addition, Marc speaks frequently on these and other matters at various events, including the Natural Products Industry SupplySide East and SupplyWest Trade Shows and the Natural Products Expo East and Expo West Trade Shows. He has also presented and moderated a panel discussion entitled, “Crisis Management and Risk Reduction” on several occasions, including at the Metropolitan Association for Food Protection’s annual meeting. Marc is an instructor at a well-known training seminar on Good Manufacturing Practices for Dietary Supplements offered several times a year across the country and has spoken at a number of the Annual Meetings of the New York State Bar Association.

Marc is on the Board of Directors of the Natural Products Association (NPA) East, a nonprofit trade organization serving the natural and organic foods, vitamins, supplements and cosmetics industries and a Member of the Southwest College of Naturopathic Medicine Master of Science in Nutrition Business Leadership Advisory Council.

The Health Services Practice Group has been listed in the prestigious Legal 500. The practice also has been included in the Chambers USA directory in the Healthcare category.