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Overview

Health law is an incredibly diverse area of practice which does not focus on a singular type of legal work. Attorneys in this field focus on the health industry in general, but the types of work available vary widely. Some lawyers counsel health care entities on a range of transactional and regulatory matters, including mergers and acquisitions and joint ventures. Others handle any litigation-related matters that arise for their health care industry clients. Some lawyers focus on compliance issues, ensuring clients are adhering to regulations and laws and conducting internal investigations for clients, while others work on the government side, enforcing regulations. This area is an exciting one because it is constantly evolving and changing, especially when it comes to digital health. Lawyers focusing on digital health may work on IP-related matters, privacy and data security, regulatory issues, policy research, and more. On the nonprofit side, lawyers may work for an organization that promotes public health, access to health care, advocacy for a specific health issue, etc. Clients in the health law arena range from hospitals and medical centers to insurance companies and pharmaceutical entities to laboratories and private equity funds—plus many more.

Featured Q&A's
Get an insider's view on working in Health Law from real lawyers in the practice area.
Sandra M. DiVarco, Partner • Anisa Mohanty, Counsel
McDermott Will & Emery

Describe your practice area and what it entails.

Sandy: I represent hospitals and health care systems in all aspects of their operations, advising on both transactions and regulatory matters. My background as a registered nurse and risk manager gives me a unique perspective on clinical care and quality/safety matters as well. In 2020, I took on a leadership role in the firm’s comprehensive COVID-19 response efforts. That means that not only do I advise health care industry clients on their changing operations and the rapidly evolving pandemic regulatory environment, I’m also engaged as part of the cross-practice, firmwide team of attorneys tasked with providing COVID-related guidance to clients across every other industry—everything from cruise lines to national event organizers and media companies.

Anisa: The bulk of my practice falls into three areas: 1) advising traditional FDA clients related to advertising and promotion, pre-market pathways, and traditional compliance and enforcement matters; 2) providing FDA guidance in connection with life sciences transactions of all types across product areas; and 3) regulatory issues that arise as part of research collaborations, joint ventures, and clinical trial agreements.

What types of clients do you represent?

Sandy: I primarily advise nonprofit hospitals and health care systems, ranging from small, independent community hospitals to the largest national and international systems. Given the depth of McDermott’s Healthcare group, and the breadth of our firm’s clients, I also routinely assist a broad range of other health care providers as well.

Anisa: I primarily work with medical device and drug manufacturers, innovative technology companies entering the digital health space, and companies investing in these spaces.

We both also regularly advise on the regulatory aspects of private equity transactions and platform company operations after acquisitions.

What types of cases/deals do you work on?

Sandy: Traditionally, my practice has centered upon health care transactions of all types and regulatory advice on mission-critical health care operations and complex patient care matters. In 2020 in particular, much of my day-to-day (and sometimes late-night!) work focused on advising clients on pandemic-related regulatory and patient care matters, including establishment of alternate care sites and, now, vaccination protocol compliance.

Anisa: Our FDA practice focuses heavily on medical devices and digital health products, and we also have expertise in pharmaceuticals and related patent and Hatch-Waxman Act matters. We work on transactions involving everything from traditional FDA-regulated product manufacturing to food products to dietary supplements and more.

How did you choose this practice area?

Sandy: I practiced as a registered nurse at a large academic medical center before attending law school, so health law was a natural focus for me. But having a health care background is not a prerequisite to being a health care lawyer. There are a lot of ways to become a health lawyer, and successful health care lawyers may have experience in health care administration or public health or even no health background at all. 

Anisa: I served as Regulatory Counsel at FDA for about six years. When I decided to make the move to private practice, I reached out to McDermott based on the firm’s solid health law reputation. Luckily, the firm happened to be in the process of building out its FDA practice. The timing was perfect.

What is a typical day like and/or what are some common tasks you perform?

Sandy: It’s interesting to contemplate what a typical day has looked like since March 2020. Regulatory guidance early on changed literally multiple times a day. We issued client alerts on every new development and responded to questions from clients in every industry.  I spend a lot of time providing real-time advice and counsel to clients. No two days are the same—but that’s part of what makes practice in this area so dynamic.

Anisa: The best thing I can say about my practice is that there is no such thing as typical. On any given day, I may be engaged on 15 completely unique matters. Today, I worked on a co-development agreement, provided advice around marketing claims, assessed the regulatory status of a new COVID test, and coordinated the audit parameters for the target company as part of an acquisition. The variety and the pace keep every day interesting.

What training, classes, experience, or skills development would you recommend to someone who wishes to enter your practice area?

Sandy: While not required by any means, exposure to health care operations/businesses or health law courses can be helpful in hitting the ground running in advising hospitals and health systems. Early participation in the Health Law Bar through the American Health Law Association and/or local state associations is also a great way to get exposure to timely subject matter and get to know future colleagues practicing in this area.

Anisa: People ask me if you need to serve at the FDA before entering private practice as an FDA lawyer. It’s certainly not a prerequisite, but having career experience on the FDA side makes it easier to understand the regulator’s perspective, better assess where they might place their priorities, and more accurately benchmark risk. I’d say FDA service is a more efficient way to gain that insight than, perhaps, working for 20 or 30 years in the field. Either way, I’d absolutely recommend getting involved with the Food & Drug Law Institute and its New to Food and Drug Law (NFDL) group in particular. Their conferences and other educational opportunities are great. But perhaps even more importantly, the Food and Drug Bar is a relatively small ecosystem, and it helps to get to know practitioners in the same space with whom you will likely work with down the road.

You’ll have to forgive the self-promotion, but we also have to say that the entire calendar of McDermott health care conferences and webinars provides some of the best industry education in the field.

What misconceptions exist about your practice area?

Sandy: It’s not uncommon for people to equate health law with medical malpractice or personal injury. But in fact that’s a tiny fraction of health-related legal practice. We joke that health care is the most highly regulated industry next to nuclear energy—and if that’s not the truth, we have to be close! That’s what’s really at the core of not just my practice, but health care law as a field—the industry’s amazingly complex regulatory scheme.

Anisa: Many people don’t understand what an FDA lawyer does. They don’t realize how much the FDA regulates. In fact, 20 cents of every dollar spent in the U.S. is on FDA-regulated products. The agency is responsible for the oversight of more than $2.8 trillion in consumption of food, medical products, and tobacco. That means that there are all kinds of companies who are impacted by FDA regulations and need guidance to navigate them. [*Source: https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance]

What is unique about your practice area at your firm?

Sandy: McDermott’s Healthcare practice is one of the firm’s marquee practice areas, which means that every client benefits from one of the broadest possible bases of knowledge and experience, capable of providing total life cycle counseling on any issue our clients might encounter. That’s what’s most unique about the Hospital and Health System practice area at the firm—that in virtually every instance, the counsel I provide is one piece of a multifaceted legal strategy that holistically benefits every aspect of our clients’ operations.

Anisa: A lot of other FDA practices are hyper-specialized, which means they lack access to other important specialty expertise and can’t provide counsel on non-FDA issues. Because our practice sits within the Healthcare practice—which is somewhat unusual—we’re able to serve all of our clients’ needs beyond strictly FDA counseling, including pricing and reimbursement, fraud and abuse issues, and deal-making.

What are some typical career paths for lawyers in this practice area?

Sandy: You can be a very junior lawyer and still play a meaningful role on a hospital or health system deal. That’s part of the McDermott Healthcare advantage: You’ll be working on a team with a diversity of experience and exposure to health care at different levels and in many parts of health care operations. One of the keys to success, I’d say, is a mind for solving puzzles. Our challenge is to fit our clients’ business objectives within regulatory frameworks that don’t always keep pace with current operations or current thinking from a clinical standpoint. It’s often our job to fit a square peg into a round hole.

Anisa: The most exciting thing about an FDA practice career path at McDermott is that you are encouraged to take ownership of a particular sub-specialty area and carve out your niche. There is a virtually endless slate of FDA-related subjects and products, and each is highly complex and technical.

How has the digital health market affected your practice?

Sandy: Digital health is an ancillary to my core practice, providing guidance on licensing and accreditation. We’re applying long-time health regulatory constructs in whole new ways. For example, how does provider licensing work in the context of telemedicine? How and where does a provider need to be licensed if he or she is delivering care in-person as well as via telemedicine?

Anisa: FDA’s framework for traditional medical devices is what is applied to digital health products, and it’s definitely an imperfect fit. And as is true with most other regulators, FDA often isn’t moving nearly as quickly as industry. It’s very challenging to advise clients on how evolving regulations might impact the long-term viability of their products and solutions. But at the same time, we have an exciting opportunity to proactively engage with FDA and other regulators and help them think strategically about digital health product categories as they formulate new guidance. We’re actively partnering every day with both the industry and the regulators to help shape the future.

Sandra M. DiVarco, Partner—Hospitals & Health Systems; Anisa Mohanty, Counsel—FDA Practice Group within the Health Industry Advisory Practice Group

Sandra (“Sandy”) M. DiVarco counsels hospitals and health systems regarding all aspects of health law transactions and health system restructurings. A significant component of her practice also involves assisting health care providers with regulatory, licensure, and accreditation issues, including state-level and Centers for Medicare and Medicaid Services (CMS) survey responses, formulation of successful plans of correction, Joint Commission complaint responses, and Emergency Medical Treatment and Active Labor Act (EMTALA)/regulatory investigations. Drawing on her experience as a registered nurse who holds a current license in the state of Illinois, Sandy brings a pragmatic, firsthand perspective to her clients’ complex and mission-critical matters.

Anisa Mohanty is a former Regulatory Counsel at the U.S. Food and Drug Administration (FDA). Anisa advises medical device, biotech, and pharmaceutical companies on FDA premarket strategy and post-market compliance issues, from advertising and promotion to disclosure and periodic reporting. She offers guidance to her clients in connection with premarket pathways; Good Laboratory Practice and Good Clinical Practice and Good Manufacturing Practice; Quality System requirements; and the development, creation, and review of advertising and promotional materials for FDA-regulated products. Anisa also supports investors and companies engaged in transactions and investments involving FDA-regulated drugs, medical devices, and other products.

Eric Klein, Partner • Jeralin Cardoso, Partner
Sheppard Mullin

Describe your practice area and what it entails.

Eric: My practice focuses on health care mergers and acquisitions and joint ventures to create economies of scale and growth strategies. I also work with clients to evolve from traditional fee-for-service reimbursement systems to next-
generation value-based and risk-based reimbursement structures.

The health care team at Sheppard Mullin works with industry leaders and rising stars in today’s health care industry. We have a very broad, multi-sector practice, which includes clients that are health insurance companies, hospital systems, physician organizations, post-acute care providers, large and emerging health care technology companies, and private equity and other investors. Our practice includes transactions (mergers and acquisitions, joint ventures, strategic alliances, and complex contracts), health care regulatory (licensing, compliance, privacy, and other areas), health care employment law, health care antitrust, and health care finance. We also have launched a health care artificial intelligence (AI) initiative, with partners and associates advising both AI companies and users of health care AI.

Jeralin: My practice focuses on health care mergers and acquisitions, representing both buyers and sellers. I assist clients in strategizing about the future of their organizations and helping them execute on those visions. This not only includes negotiating deal-specific transaction documents, but also developing what the relationship between the parties will look like beyond the closing of a specific transaction. I work with clients on physician compensation systems, corporate governance, management arrangements, and the equity components of transactions.

What types of clients do you represent?

We represent both leading and emerging health care companies. On the health plan side, our clients include Cigna, Centene, Molina, Aetna, and many of the Blue Cross and Blue Shield health plans.

In the physician services sector, we have worked on some of the most complex and largest transactions, including the second-largest physician services transaction of 2019 with the merger of Summit Medical Group and CityMD and the earlier $4.4 billion purchase by DaVita Inc. of HealthCare Partners. We work with many of the leading next-generation physician organizations across the country, including Landmark, ChenMed, Aledade, VillageMD, CareMore, Iora Health, and Agilon Health.

On the hospital side, we represent many of the leading hospital systems in the country, including CommonSpirit, Bon Secours Mercy Health, Providence, Montefiore, and University of California Health System.

In private equity, we represent many of the largest and most successful health-care-focused private equity funds, including Welsh Carson, General Atlantic, TPG Capital, and H.I.G. Capital. We also work with many of the middle-market private equity funds that help to grow new regional and national health care companies, such as Varsity Healthcare Partners, Amulet Capital Partners, Cobepa, Bison Capital, and Arlington Capital.

What types of cases/deals do you work on?

Eric: As previously mentioned, my practice focuses on mergers and acquisitions, joint ventures, and other growth strategies. A recent transaction I worked on was the strategic alliance between Cigna and Oscar Insurance Company, which brought Cigna’s provider networks and experience together with Oscar’s next-generation technology to create new insurance products for small group employers with 1-50 employees.

Jeralin: As previously mentioned, my practice focuses on mergers and acquisitions. I represent physician groups and private equity firms that are focused on investing in physician organizations (whether single-specialty, multi-specialty, or primary care physician organizations).

How did you choose this practice area?

Eric: Although I come from a health care family, my entrance into health care was more one of serendipity in that I joined a health care firm to grow their general transactional practice and found that they had a few health care regulatory partners who were not able to do the type of transactions I could. Right at that time we started to see one of the waves of consolidation in the health care industry, and so I jumped in using my general corporate transactional skills and have stayed in the health care industry ever since. It’s been an exciting and challenging area with much change and evolution that keeps me engaged every day.

Jeralin: I always knew I wanted to do corporate transactional work, and as a junior associate, I had the opportunity to work with Eric Klein and his team. I was impressed by the complexity and type of transactions they were working on. It piqued my interest, and I have enjoyed working in this space ever since.

What is a typical day like and/or what are some common tasks you perform?

Eric: I am constantly on the phone and in meetings with clients, advising them, negotiating deals, and trying to fix problems. Every day is a mix between working with existing clients and being introduced to new opportunities. I also look to combine the new changes in health care with my past experience to help clients navigate this incredibly complex health care universe that exists today.

Jeralin: Similarly, a large majority of my time during the business day is spent on the phone or in meetings with clients. Otherwise, I am working on transaction-related documents.

What training, classes, experience, or skills development would you recommend to someone who wishes to enter your practice area?

Jeralin: It’s important to have a general understanding of health care law as well as the inner workings of a business generally. I would advise anyone interested in a health care transactional practice to become familiar with the various rules and regulations governing the health care industry and to take advantage of any business, finance, and accounting classes to understand business strategy. We spend a great amount of time working with clients beyond drafting documents, helping them think through strategy and how the laws impact their business operations, and being able to have those discussions will bring additional value to your clients.

What is the most challenging aspect of practicing in this area?

Eric: Health care is an ever-changing environment in that we have new regulations, new interpretations, and new business arrangements every week. Additionally, there is a large amount of money in the health care industry right now, which is driving change. If you put that together with the changing technology, such as machine learning and other artificial intelligence, we see tremendous evolution. It is both a challenge and a joy to keep up with all of it.

Jeralin: The most challenging aspect is the ever-changing health care landscape and working with your clients to meet their business objectives while also maintaining compliance with the rules and regulations of the industry.

What do you like best about your practice area?

Eric: I like that I am able to be helpful to my clients, to have the ability to work with amazing colleagues, and to work in one of the best and most vibrant health care teams across the country. We are all working together to improve a very fractured and difficult health care system. Our team does a great job of combining legal and business strategy to improve how health care is delivered by our clients. Additionally, the health care team is the firm’s most successful industry team to date, which has given us tremendous support and visibility within the firm. This support has allowed us to be innovative and entrepreneurial and to be one of the most rapidly growing areas within the firm.

Jeralin: Health care law is a very interesting and complex area. Our health care team works collaboratively to help our clients think of innovative ways to meet their business goals and continue to navigate the complex health care landscape. I like being able to help clients find a way to achieve their goals and assist them in putting those plans in place.

What are some typical tasks that a junior lawyer would perform in this practice area?

Eric: A junior lawyer could be expected to work with clients on day-to-day operating matters, supporting transactions by learning about health care companies and identifying problems, drafting agreements and documents to reflect business arrangements, and developing one or more areas of specific expertise. For example, one of our first-year lawyers recently came to me wanting to launch an initiative for a health care blockchain technology. At most other firms, a first year might not be listened to for that suggestion. At our firm, we gave him support, paired him with more experienced attorneys, and helped launch this initiative.

Jeralin: Our junior associates are given meaningful responsibility early on in their careers. A junior associate is likely to participate in client meetings and conference calls to gain experience on how transactions are structured and negotiated. As we do with our junior associates, we also get our summer associates involved in understanding regulatory aspects and integrating them into transactions so they have a realistic expectation of what it will be like when they return as a junior associate.

How do you see this practice area evolving in the future?

Eric: Health care law will continue to grow with the health care industry. If you said 20 years ago that health care law would have to think about issues like technology, artificial intelligence, or telemedicine, no one would have ever believed you. We think that the application of technology to health care will continue to refashion the delivery of health care services and create opportunities for both better care and for cures. Health care law will have to keep up with all of that and help us achieve that as a society.

Jeralin: As Eric said, we will continue to see technology change how patients view and receive health care, which may have an impact in how health care is defined moving forward. We are already seeing a change with things like telehealth and other technologies being introduced to measure various aspects of people’s health. It will be interesting to see how technology continues to change how we practice law in this area.

Eric Klein, Partner, and Jeralin Cardoso, Partner—Corporate & Securities

Eric Klein has grown Sheppard Mullin’s 165-plus attorney health care practice from two attorneys in 2008 to a national leading health care law firm today. Eric has focused on growing a diverse, exciting multi-sector health care practice and has mentored eight associates (50 percent female/50 percent male) to partner status in the past eight years. Eric works with many of the leading national health insurance companies, hospital systems, physician organizations, and health care private equity funds on mergers and acquisitions, strategic alliances and joint ventures, and growth strategies. His practice includes working on multi-billion-dollar transactions and advising new health care technology-enabled startup companies. He received his J.D. from Boston University School of Law and his A.B. from Princeton University.

Jeralin Cardoso is co-leader of the firm’s Corporate & Securities practice group. She has worked with a broad range of health care clients, including physician groups, hospitals, ancillary service providers, and private equity and strategic investors. Jeralin has a deep understanding of the business and strategic needs of medical groups and health care organizations. She was a summer associate and has been with Sheppard Mullin since graduating law school in 2007. She received her J.D. from Pepperdine School of Law and her B.A. from University of California San Diego.

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