2021 | VOL. 26 | NO. 1 Health Law Journal A Peer Reviewed Law Journal A publication of the Health Law Section of the New York State Bar Association YOUNG LAWYERS Special Edition Materiality in the Post-Escobar Misbranded Drugs 101: What Era: An Argument for Supreme Mandating the COVID-19 Attorneys Need to Know Court Clarification Vaccination: A Legal Analysis of Materiality CLE All Access Pass Maximize Your Time and Earn CLE Credits with On-Demand Learning Access hundreds of programs online and satisfy your MCLE Special requirement for one low price. Membership > Gain access to all CLE Online video programs and Offer! course materials for one year > New programs added each month $495 for NYSBA Members > Monthly billing option Regular Member Price: $795 For more information visit NYSBA.ORG/ALLACCESSPASS Online only. Does not include live programs, CD or DVD products. All Access Pass requires member login and cannot be transferred. Annual subscription required. HEALTH LAW JOURNAL 2021 Vol. 26, No. 1 THE HEALTH LAW SECTION NEW YORK STATE BAR ASSOCIATION © 2021 New York State Bar Association Contents Regular Features In the New York State Courts 6 Leonard M. Rosenberg In the Legislature 16 James W. Lytle New York State Fraud, Abuse and 19 Compliance Developments Edited by Melissa M. Zambri Cover Art - By Rembrandt - In the Law Journals Mauritshuis online catalogue., Public 33 Cassandra DiNova Domain, https://commons.wikimedia. org/w/index.php?curid=64281722 For Your Information 35 Claudia O. Torrey Young Lawyers Committee Health Law 36 Cassandra DiNova and Brenda Baddam Journal 2021 | Vol. 26 | No. 1 Featured Articles Regulars Legal and Ethical Concerns of Telehealth and 37 Telemedicine Message From Andrew Ko 5 the Chair Karen L. Illuzzi Gallinari Misbranded Drugs 101: What Attorneys 42 Need to Know Welcome New David F. Durso 70 Health Law Section Members General Considerations for Drafting 45 Successful Telehealth Contracts Section Committees Craig W. Anderson 72 and Chairs Chernobyl: Bridging the Gap Between 49 International Nuclear Law and Public Health Melissa Montoni Materiality in the Post-Escobar Era: An 56 Argument for Supreme Court Clarification of Materiality Kyle Madley Mandating the COVID-19 Vaccination: 65 A Legal Analysis Morgan Dowd, JD Publication and Editorial Policy HEALTH LAW JOURNAL Persons interested in writing for this Journal are wel­ Editor comed and encouraged to submit their articles for Brendan S. Parent con sid er ation. Your ideas and comments about the NYU School of Medicine Journal are ap pre ci at ed as are letters to the editor. 227 E 30th St, Ste 721 Publication Policy: New York, NY 10016 All articles should be submitted to: [email protected] Brendan S. Parent, J.D. Email: [email protected] Benjamin Sundholm Devevoise & Plimpton Benjamin Sundholm 919 3rd Ave Email: [email protected] New York, NY 10022-3902 Submitted articles must include a cover letter giv­ [email protected] ing permission for publication in this Journal. We will assume your submission is for the exclusive use of Section Officers this Journal unless you advise to the con trary in your Chair letter. Authors will be notified only if articles are Karen L. Illuzzi Gallinari rejected. Authors are encouraged to include a brief St. John’s Riverside Hospital biography with their sub mis sions. Yonkers, NY 10701-1301 Editorial Policy: The articles in this Journal rep re sent [email protected] the authors’ viewpoints and research and not that of the Journal Editorial Staff or Section Officers. The ac­ Chair-Elect curacy of the sources used and the cases cited in sub­ Anoush K. Scott missions is the re spon si bil i ty of the author. Lippes Mathias Wexler Friedman LLP 54 State St., Fl 10 Subscriptions Albany, NY 12207-2540 [email protected] This Journal is a benefit of membership in the Health Law Section of the New York State Bar Association. Vice-Chair The Journal is available by sub scrip tion to non­attor­ Nathan G. Prystowsky neys, libraries and organizations. The sub scrip tion Axiom rate for 2021 is $160.00. Send your request and check 16 N Broadway, Apt 2N to Member Resource Center, New York State Bar White Plains, NY 10601-2223 Association, One Elk Street, Albany, NY 12207. [email protected] Accommodations for Persons with Disabilities: Treasurer NYSBA welcomes participation by individuals with disabili­ Jane B. Burke ties. NYSBA is committed to complying with all applicable Hodgson Russ LLP laws that prohibit discrimination against individuals on 677 Broadway, St 301 the basis of disability in the full and equal enjoyment of its Albany, NY 12207-2986 goods, services, programs, activities, facilities, privileges, [email protected] advantages, or accommodations. To request auxiliary aids or services or if you have any questions regarding accessibility, Secretary please contact the Bar Center at 518­463­3200. Lisa D. Hayes The Brookdale Hospital Medical Center Publication Date: January 2021 1 Brookdale Plaza Katz 321 Brooklyn, NY 11212-3198 Copyright 2021 by the New York State Bar Association. [email protected] ISSN 1530-3926 ISSN 1933-8406 (online) NYSBA.ORG/HEALTH 4 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Message From the Chair By Karen L. Illuzzi Gallinari Dear Health Law Section Report, the Our committees are listed at Members: latter of which the end of this Journal. Please email our Section Liaison, Catherine Carl I hope this note finds you and all was included at [email protected], indicating the yours well. in our Sum- mer Health Committee/s that interest you. Congratulations for taking a few Law Journal, minutes to enhance your professional are avail- This Health Law Journal Issue education and nurture your profes- able at this In this issue, we are proud to sional development through our link: https:// present scholarly articles contributed Health Law Journal. You are also to be nysba.org/ by some of our youngest Health commended for your membership healthlawsec- Law Section members. The wisdom in the Health Law Section. Through tioncovid19/. and passion they bring to the table, your continued support of our Sec- The NYSBA Government Relations at the beginning of their careers, tion, you are making a difference in team is convening the final Resolu- shines a bright light on the future the lives of countless individuals who tions to appropriate parties within of our industry. The future leaders need assistance during these chal- state leadership. who have contributed to this issue lenging times, even when you are During the November Sections’ address a wide range of important attending to your other priorities. The topics including vaccinations, nuclear Report of our COVID-19 Task Force Caucus and House of Delegates meet- ings, several individuals commented energy, misbranded drugs, telehealth reflects some of the areas where our and how the courts determine mate- members are hard at work making a that the process that evolved over the past many months, during which we riality when evaluating false claims difference. These include advocating allegations. for the protection of health care work- collaborated more than ever before with our colleagues from many other ers and vulnerable populations, such Annual Meeting as the elderly, disabled and communi- Sections, was an example of how ties of color. our Bar Association should function. Your next opportunity to benefit The productive dialogues this effort from local and national expertise on As background, please recall has facilitated will continue through a similarly wide variety of hot health that earlier this year, Immediate the work of our Health Law Section care topics will take place during our Past NYSBA President Hank Green- committees and two Bar-wide Task Annual Meeting, on January 19 and berg charged Hermes Fernandez, Forces, which were created to address January 27, 2020. This rich program our Immediate Health Law Section long-term care issues and ongo- will be available on demand after- Past Chair, with appointing a Task ing issues relating to immunity and wards. I also encourage you to join at Force of the Health Law Section to liability. least one of our committees as well. examine COVID-19 legal issues. The Full participation will ensure you en- Task Force was created and worked Section Committees joy all the benefits of being a member tirelessly over a compressed period of While you are contributing to our of the Health Law Section. time to identify and analyze the key industry and our fellow New York- The chairs of each of our com- legal and related ethical issues, and ers by simply being a member of our it prepared Resolutions recommend- mittees and I are at your service for Section, we encourage each of you any information and assistance you ing action steps to New York State who are not yet members of any of leadership. may need to support your interest our Health Law Section committees and success in health law. You can On November 7, 2020, the to become more actively engaged by reach us by emailing Catherine Carl NYSBA House of Delegates adopted joining the committee most relevant at [email protected], or through the the Health Law Section’s COVID-19 to your practice and your interests. “Contact Us” links on our Section’s Resolutions. They incorporate Through your active involvement, and committees’ web pages. amendments suggested by our col- you can ensure that our efforts and leagues in other Sections. These rec- resources are directed to the topics We look forward to hearing from ommendations address serious issues most important to you. You will also you! impacting the health and livelihoods work directly with and will develop of all New Yorkers. relationships with local health law Karen L. Illuzzi Gallinari experts.