Jones Day, Partner
Yaakov Roth's goal is to strategically develop and effectively present the key legal arguments that will secure victory for clients through appellate advocacy and dispositive motions. He has represented clients in high-profile Supreme Court cases, argued appeals in the federal Courts of Appeals, and prepared motions to dismiss and for summary judgment across a range of substantive areas.
Yaakov's most recent Supreme Court experience includes vindicating former Virginia Gov. Bob McDonnell from political corruption charges, narrowing the geographic scope of private civil RICO lawsuits, and pursuing a major challenge to the Affordable Care Act from inception through high court review. At the appellate level, Yaakov's oral advocacy has included pressing a First Amendment challenge to an Ohio law prohibiting "false" campaign statements, seeking disclosure of a Justice Department policy manual concerning criminal discovery, and protecting the religious freedom rights of Death Row inmates. He has successfully defended his clients against defamation, antitrust, Title VII, and ERISA claims — including nationwide class actions — and pursued a host of challenges to federal, state, and local regulations. His ERISA experience also includes a series of withdrawal liability arbitrations and related litigation.
Yaakov speaks and writes about the Supreme Court and First Amendment issues and maintains an active pro bono practice centered around religious freedom and criminal justice.
Jones Day, Partner
Yaakov Roth's goal is to strategically develop and effectively present the key legal arguments that will secure victory for clients through appellate advocacy and dispositive motions. He has represented clients in high-profile Supreme Court cases, argued appeals in the federal Courts of Appeals, and prepared motions to dismiss and for summary judgment across a range of substantive areas.
Yaakov's most recent Supreme Court experience includes vindicating former Virginia Gov. Bob McDonnell from political corruption charges, narrowing the geographic scope of private civil RICO lawsuits, and pursuing a major challenge to the Affordable Care Act from inception through high court review. At the appellate level, Yaakov's oral advocacy has included pressing a First Amendment challenge to an Ohio law prohibiting "false" campaign statements, seeking disclosure of a Justice Department policy manual concerning criminal discovery, and protecting the religious freedom rights of Death Row inmates. He has successfully defended his clients against defamation, antitrust, Title VII, and ERISA claims — including nationwide class actions — and pursued a host of challenges to federal, state, and local regulations. His ERISA experience also includes a series of withdrawal liability arbitrations and related litigation.
Yaakov speaks and writes about the Supreme Court and First Amendment issues and maintains an active pro bono practice centered around religious freedom and criminal justice.
Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).
Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history. She holds a master’s degree in history from UCLA and a law degree with high honors from Duke Law School.
Partner, Hollingsworth LLP, Washington, DC.
Mr. Lasker litigates a wide variety of complex civil matters, with a current focus on toxic torts, environmental litigation, Alien Tort Statute litigation, and pharmaceutical products liability. Mr. Lasker has also represented clients in a variety of civil and criminal government investigation-related matters involving bank regulatory compliance, False Claims Act claims, and alleged price fixing, and he served as lead counsel in successfully defending a foreign client against a Foreign Corrupt Practices claim in a jury trial that was featured in the Legal Times. He represents clients in jury and bench trials, before arbitral panels and administrative courts, and both at trial and on appeal.
Mr. Lasker has significant experience defending against all matter of legal claims involving FDA- and EPA-regulated products and alleged toxins and environmental contaminants. He has represented clients in pharmaceutical products liability claims involving antipsychotic medications, obstetrical drugs, antifungals, antiepileptics, and cough/cold medicines, and in toxics/environmental matters involving herbicides, asbestos, lead paint, nonionizing radiation, and chemical solvents. He has represented clients in matters arising both in the United States and abroad, and in matters arising under both domestic and international law. Mr. Lasker's practice also includes matters involving sensitive national security issues, and he has represented his clients’ interests in meetings with both U.S. and foreign government officials. He has extensive expertise in developing and implementing sophisticated medical causation and science-based defenses, and he has successfully litigated issues involving Daubert, the federal preemption defense, and natural resource damages claims. He also assists clients in due diligence investigations as relates to environmental and toxics liabilities and through amicus briefing on key legal issues.
Mr. Lasker played a prominent role in helping to establish asbestos defendants’ rights to insurance non-products coverage through a successful amicus effort that secured one of the seminal judicial opinions recognizing the existence of such coverage, litigation efforts resulting in securing several hundreds of millions of dollars in asbestos non-products insurance recoveries, and oral presentations and publications on issues involving non-products coverage. He has also defended personal injury claims in asbestos litigation, advancing medical causation defenses as the asbestos litigation has extended to tertiary and even more remotely-situated corporate defendants.
Mr. Lasker is frequently requested to speak and publish on issues of interest to his clients, and he has been interviewed on such topics in numerous fora, including the AMA's American Medical News, Bloomberg News, the National Law Journal, and thePhiladelphia Inquirer. Mr. Lasker serves on the Board of Editors of LJN's Product Liability Law & Strategy newsletter and he is the Chair of the Toxics & Hazardous Substances Committee of the International Association of Defense Counsel (IADC), an invitation-only professional association for corporate and insurance defense attorneys around the world. He also serves as a member of the Defense Research Institute (DRI).
Partner, Hollingsworth LLP, Washington, DC.
Ms. Womeldorf joined the Hollingsworth LLP following clerkships with the Honorable Lewis F. Powell, Jr. and the Honorable Anthony M. Kennedy of the United States Supreme Court. She previously served as a law clerk to the Honorable Robert R. Merhige, Jr. of the United States District Court for the Eastern District of Virginia.
Ms. Womeldorf concentrates her practice on complex civil litigation. She has substantial experience in the defense of high-stakes mass torts, including serving as a member of the defense steering committee in the substantial welding fume Multidistrict Litigation (“MDL”) pending in Cleveland. She also represents pharmaceutical manufacturers in the defense of personal injury claims involving prescription drugs.
Ms. Womeldorf counsels clients on a wide range of issues designed to minimize potential liability, including issues related to workplace practices, Sunshine in Litigation legislation and class action treatment of medical monitoring claims. She is a member of the Sedona Conference Working Group on Protective Orders, Confidentiality and Public Access, and she actively participates with Lawyers for Civil Justice (“LCJ”). Her practice extends into general complex commercial litigation and employment law issues, and she previously served as counsel in the Office of the Senate Chief Counsel for Employment of the United States Senate.
Ms. Womeldorf participates in the Georgetown University Law Center’s Supreme Court Institute, which conducts moot courts for approximately 50 percent of the cases argued before the United States Supreme Court in any given term. She served as Lead Articles Editor for the Washington & Lee Law Review, and is a member of the Defense Research Institute (DRI).
Ms. Womeldorf is recognized in the Washington, DC edition of Super Lawyers for 2013 as she was in 2012.
Secretary, Galen Institute
John Hoff, founding board member of the Galen Institute, has a unique background that combines both health care policy and legal expertise. He served as the Health Attaché of the United States Mission to the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the U.S. Mission to the Organization for Economic Cooperation and Development (OECD) from 2005-2009. While stationed in Paris, Mr. Hoff represented the U.S. Government on a broad range of issues of health and science policy on the international level, including intellectual property rights, health information technology, medical innovation, and comparative health systems data.
Prior to his work with UNESCO and the OECD, Mr. Hoff served as a Deputy Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services. He was in charge of the Office of Disability, Aging, and Long Term Care Policy. He led the Office’s research on these issues, and also worked on additional policy initiatives such as reform of the medical malpractice litigation system, improvements in patient safety, and reform of the health care financing system.
Before joining the Government, Mr. Hoff practiced law for more than 30 years, specializing in health law and policy. He has published a number of articles and drafted legislation on health care issues, including the first bill introduced in Congress for market-based health care reform.
Mr. Hoff received his B.A. and LL.B. degrees from Harvard University. He is a member of the Bar of the District of Columbia and of the Supreme Court of the United States.
Scott K. Ginsburg Professor of Health Law & Policy, Georgetown University
David A. Hyman, M.D., J.D., is the Scott K. Ginsburg Professor of Health Law & Policy at Georgetown University. Professor Hyman focuses his research and writing on the regulation and financing of health care. He teaches or has taught health care regulation, civil procedure, insurance, medical malpractice, law & economics, professional responsibility, and tax policy.
While serving as Special Counsel to the Federal Trade Commission, Professor Hyman was principal author and project leader for the first joint report ever issued by the Federal Trade Commission and Department of Justice, “Improving Health Care: A Dose of Competition” (2004). He is also the author of Medicare Meets Mephistopheles, which was selected by the U.S. Chamber of Commerce/National Chamber Foundation as one of the top ten books of 2007, and the co-author (with Charles Silver) of Overcharged: Why Americans Pay Too Much for Health Care (2018). He has published widely in student-edited law reviews and peer-reviewed medical, health policy, law, and economics journals.
Robert L. Willett Family Professor of Law, Washington and Lee University School of Law
Timothy Stoltzfus Jost, J.D., holds the Robert L. Willett Family Professorship of Law at the Washington and Lee University School of Law. He is a coauthor of a casebook, Health Law, used widely throughout the United States in teaching health law and now in its sixth edition. He is also the author of Health Care at Risk, A Critique of the Consumer-Driven Movement, Health Care Coverage Determinations: An International Comparative Study, Readings in Comparative Health Law and Bioethics, and many articles and book chapters on health care regulation and comparative health law and policy. He has written numerous monographs on legal issues in health care reform for national organizations and blogs regularly for Health Affairs on regulatory issues. He is a consumer representative to the National Association of Insurance Commissioners and a member of the Institute of Medicine.
James R. Dougherty Chair for Faculty Excellence, University of Texas School of Law
Bill Sage, both a medical doctor and a lawyer, and a leading expert in health law and policy, joined the UT Law faculty at the beginning of the fall semester in 2006. Sage holds the James R. Dougherty Chair for Faculty Excellence and teaches courses in health law and in regulation and public policy. Sage is also the vice provost for health affairs at UT-Austin.
Sage has edited two books, including Medical Malpractice and the U.S. Health Care System (Cambridge University Press, 2006), and has written approximately 75 articles in legal, health policy, and medical publications. From 2002 through 2005, he was the principal investigator for the Project on Medical Liability in Pennsylvania funded by The Pew Charitable Trusts. In 2002, Sage served on the Institute of Medicine’s Committee on Rapid Advances in Health Care. In 1998, he received an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation. In 1993, he headed four working groups for the White House Task Force on Health Care Reform. He is an elected fellow of the Hastings Center on bioethics, and is a member of the editorial board of Health Affairs.
In 2002, Sage served on the Institute of Medicine’s Committee on Rapid Advances in Health Care. In 1998, he received an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation. In 1993, he headed four working groups for the White House Task Force on Health Care Reform. He is an elected fellow of the Hastings Center on bioethics, and is a member of the editorial board of Health Affairs.
Paula Stannard is a former deputy general counsel and acting general counsel of the U.S. Department of Health and Human Services (HHS), where she oversaw the Food and Drug, Civil Rights and Legislation divisions of the 450-attorney HHS Office of the General Counsel and provided legal advice and counsel to senior HHS officials, including the Secretary of the department, on the issues arising in their respective areas.
At Alston & Bird, Paula advises clients on regulatory questions that arise out of the on-going health care reform effort and focuses her practice on HIPAA and health information technology (including certified EHR and meaningful use issues), food and drug and other regulatory issues in the health care sector. Her HHS experience provides clients substantive knowledge of, and experience in, FDA, HIPAA, e-health and health IT, federal health insurance regulation, patient safety, and public health preparedness and emergency response issues.
Paula received her J.D. from Stanford Law School in 1990, where she was an executive editor of the Stanford Law Review, and her B.A., magna cum laude, in political science and Latin from Amherst College, where she was elected to Phi Beta Kappa. She clerked for the Honorable J.L. Edmondson of the United States Court of Appeals for the Eleventh Circuit.
Stanford University
(J.D., 1990)
Amherst College
(B.A., 1987)
Managing Director, Alvarez & Marsal Healthcare Industry Group
With prior service as Deputy General Counsel of the U.S. Department of Health and Human Services and as Executive Vice President and General Counsel of Tenet Healthcare, he brings more than 20 years of experience in addressing challenging healthcare issues in government and private industry.
Mr. Urbanowicz regularly advises boards of directors, senior management, investors and lenders of health care organizations facing significant regulatory, compliance, financial or operating challenges. His clients include healthcare providers, payors and suppliers.
Recent engagements include: serving as a federally-appointed hospital restructuring and safety monitor; compliance and operational improvements for publicly-traded and not-for-profit Medicare Advantage plans, Medicare Prescription Drug Plans (PDP) and Medicaid managed care companies; renegotiating of government debt for a major hospital system; restructuring advisory services to the Medicaid program of a large state; numerous internal and government investigations involving healthcare providers including: academic health systems, medical device companies, pharmaceutical manufacturers, long term care hospital companies, hospice providers, dental services companies and disease management companies.
Mr. Urbanowicz also serves on the board of directors of Maxim Healthcare Services, one of the nation’s largest home health services companies, and chairs the company’s compliance committee.
As Deputy General Counsel of HHS, from 2001 to 2003, Mr. Urbanowicz served as the senior legal adviser to the Secretary of Health and Human Services on significant federal healthcare policy issues including Medicare and Medicaid provider payment and fraud and abuse enforcement policy. He was part of the team that drafted the historic Medicare Prescription Drug Act of 2003.
During his tenure at Tenet, Mr. Urbanowicz was responsible for successfully resolving several major federal criminal investigations and civil lawsuits facing Tenet by the U.S. Department of Justice, the Securities and Exchange Commission, and the HHS Office of Inspector General. Prior to his government service, he was a partner in the law firm of Locke, Liddell & Sapp.
Mr. Urbanowicz earned a bachelor of arts’ degree and a Juris Doctor degree from Tulane University. He is admitted to the bars of the District of Columbia, the U.S. Supreme Court and the Louisiana Supreme Court, and is a member of the American Law Institute.
Director of Litigation and Senior Attorney, Hamilton Lincoln Law Institute
Theodore H. Frank is director at the Hamilton Lincoln Law Institute and the Center for Class Action Fairness. Frank founded and ran CCAF as a non-profit, public interest law firm in 2009.
Frank has won several landmark appeals and tens of millions of dollars for consumers and other plaintiffs through his class action work. Adam Liptak of The New York Times calls Frank “the leading critic of abusive class action settlements” and the American Lawyer Litigation Daily referred to him as “the indefatigable scourge of underwhelming class action settlements.”
Previously, Frank clerked for the Honorable Frank H. Easterbrook on the Seventh Circuit Court of Appeals, and was a litigator at firms in Washington and Los Angeles and a resident fellow at the American Enterprise Institute. Frank is a frequent public speaker and has testified before Congress multiple times on legal issues. He has been profiled by The Wall Street Journal, Forbes, GQ, and the ABA Journal, among other publications.
In 2008, Frank was elected to membership in the American Law Institute. He also serves on the Executive Committee of the Federalist Society Litigation Practice Group. Frank graduated from The University of Chicago Law School in 1994 with high honors and as a member of the Order of the Coif and the Law Review. He is a member of the District of Columbia Bar and the state bars of California and Illinois.
Jones Day, Partner
Yaakov Roth's goal is to strategically develop and effectively present the key legal arguments that will secure victory for clients through appellate advocacy and dispositive motions. He has represented clients in high-profile Supreme Court cases, argued appeals in the federal Courts of Appeals, and prepared motions to dismiss and for summary judgment across a range of substantive areas.
Yaakov's most recent Supreme Court experience includes vindicating former Virginia Gov. Bob McDonnell from political corruption charges, narrowing the geographic scope of private civil RICO lawsuits, and pursuing a major challenge to the Affordable Care Act from inception through high court review. At the appellate level, Yaakov's oral advocacy has included pressing a First Amendment challenge to an Ohio law prohibiting "false" campaign statements, seeking disclosure of a Justice Department policy manual concerning criminal discovery, and protecting the religious freedom rights of Death Row inmates. He has successfully defended his clients against defamation, antitrust, Title VII, and ERISA claims — including nationwide class actions — and pursued a host of challenges to federal, state, and local regulations. His ERISA experience also includes a series of withdrawal liability arbitrations and related litigation.
Yaakov speaks and writes about the Supreme Court and First Amendment issues and maintains an active pro bono practice centered around religious freedom and criminal justice.
Litigation Update: Merck et al. v. Becerra et al.
Yaakov M. Roth
Pharmaceutical company Merck & Co., Inc. (Merck) filed a lawsuit against the U.S. Department of...
Litigation Update: Merck et al. v. Becerra et al.
Yaakov M. Roth
Pharmaceutical company Merck & Co., Inc. (Merck) filed a lawsuit against the U.S. Department of...
Litigation Update: Merck et al. v. Becerra et al.
A Second Look at the CREATES Act: What’s Not Being Said
Erika Lietzan
Note from the Editor: This article critically discusses the CREATES Act, which is currently pending...
Preemption of Punitive Damages in Prescription Drug Litigation
Eric Lasker, Rebecca A. Womeldorf
Over the past 16 years, the United States Supreme Court has repeatedly addressed the question...
Health Care Reform
John S. Hoff, David Hyman, Timothy S. Jost, William M. Sage, Paula M. Stannard, Peter Urbanowicz
Last Updated at 11:00 AM, Friday, October 27, 2009 The current debate about health care reform...
Vioxx Settlement: State AGs’ New Rights to Enforce Food & Drug Law
Jennifer Wolsing
In May 2008, Merck entered into a $58 million, 29-state Vioxx settlement. Payouts begin in...
Oklahoma: The Inverted Federalism of Grider v. Compaq
Theodore "Ted" Frank
In Phillips Petroleum Co. v. Shutts, the U.S. Supreme Court held that due process prohibits...
The Vioxx Settlement
Washington, District of ColumbiaIGWG: Beyond its Mandate?
John S. Gardner
Letter from the Editor . . . The Federalist Society takes seriously its responsibility as...