The following is an excerpt from Practice Perspectives: Vault’s Guide to Legal Practice Areas.
Elizabeth Kolbe and Neil Nandi, Associates—Health Care
Elizabeth (“Beth”) Kolbe is an associate in Sidley’s Health Care group in Washington, DC. She was a summer associate at Sidley in 2011 and has been at Sidley for more than six years. Her practice involves representing clients from a range of stakeholders in the health care industry (e.g., pharmaceutical, device, and durable medical equipment manufacturers; insurers; provider groups; health care technology companies; and many others) and focuses on health care regulatory and compliance matters, including federal health care coverage, coding, and reimbursement issues; government price reporting; health care compliance; health information privacy; government and congressional investigations; and health care fraud and abuse. Beth’s work involves engagement with government agencies and lobbying in Congress. She is also active in Sidley‘s Summer, Diversity, and Women’s Committees, among others. Beth received her undergraduate degree from Harvard and her law degree from Stanford.
Neil Nandi is a litigator in Sidley’s Health Care group in Chicago. He has represented pharmaceutical and medical device manufacturers, medtech companies, pharmacies, and large health care providers in investigations, False Claims Act cases, and antitrust class actions, among other matters. His most memorable experiences include taking depositions and drafting motions and appellate briefs. He highly values his pro bono work, including representing a nonprofit in an arbitration and helping an asylee obtain her green card. Neil attended the University of Pennsylvania for college and Harvard for law school, after which he clerked for Judge James B. Loken of the U.S. Court of Appeals for the Eighth Circuit.
Describe your practice area and what it entails.
Sidley’s health care practice counsels clients in the heavily regulated health care industry. Sidley’s health care lawyers defend clients in government investigations; try civil cases; counsel clients on pricing, reimbursement, fraud and abuse, compliance, HIPAA/HITECH privacy, transparency, and antitrust issues; advocate on behalf of clients before the Department of Justice, FDA, HHS, the FTC, Congress, and other state and federal regulatory agencies; and help assess regulatory risk in transactions.
What types of clients do you represent?
Sidley’s health care practice advises clients throughout the health care industry, including pharmaceutical, device, biotech, and durable medical equipment manufacturers; hospitals and other large institutional health care providers; research institutions; health information technology companies; pharmacies; skilled nursing facilities; physician practices and other service providers; insurance companies; diagnostic laboratories; wholesalers; trade groups; and private equity funds that invest in health care companies.
What types of cases/deals do you work on?
Beth: I work with clients on a wide range of regulatory and enforcement matters. These matters involve, for example, counseling clients on drug product launches and the complicated interplay of pricing, coding, coverage, and reimbursement issues. I also regularly advise clients on government program and price reporting obligations, as well as on compliance program best practices. My practice also includes responding to internal and government investigations relating to, for example, patient assistance programs. This work regularly involves meeting with government agencies, such as the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and the Office of Inspector General, as well as engagement with congressional offices. In light of my passion for disability rights, I have focused my pro bono work on disability-related cases and projects.
Neil: I represent clients in high-stakes, bet-the-company litigation and white collar criminal and civil investigation and enforcement matters. Matters I’m handling now include representing a pharmaceutical manufacturer in civil litigation in federal court, assisting a medical technology company in an internal investigation, representing a national pharmacy chain in an investigation by the Department of Justice and state governments, and representing a physician association in class action antitrust litigation. I also maintain an active pro bono practice, through which I recently assisted a family with an adoption and litigated a lease dispute on behalf of a local nonprofit.
How did you choose this practice area?
Beth: I have always had an interest in health care issues. As an undergrad, I majored in health care policy, and while in law school, I knew I wanted to bring that interest into my legal career. When looking at firms, I was drawn to Sidley because of its incredibly strong and diverse health care practice that included policy and regulatory work, allowing me to dive into the coverage and pricing issues I have long had an interest in.
Neil: I interned in the Civil Frauds Section of the Department of Justice after my first year in law school. That section oversees many of the investigations which clients retain Sidley to defend. The complex and ambiguous issues that I saw during the internship led me to seek out opportunities to learn more about the health care industry and to advocate on behalf of parties litigating often-unclear legal requirements. In addition to the subject matter of the practice area, I was also drawn to the Health Care group’s diverse work: on any given day, associates may be drafting a dispositive motion in a fraud case, researching antitrust law, analyzing recent settlements to advise a client on litigation risk, or preparing a presentation to defend a client before the government in a closed-door meeting.
What is a typical day like and/or what are some common tasks you perform?
Beth: Every day is different, and that’s one aspect of the practice I love. As a regulatory lawyer, many of my matters are relatively discrete, which means that in a day, I can jump around on as many as 15 different matters. The work varies from researching—and even drafting—new legislation, drafting comment letters addressing new government rules, advising clients, fact gathering for investigations through witness interviews, or meeting with the government, to name just a few daily tasks. Through my six years at Sidley, I have handled a wide array of cases and matters resulting in a deep understanding of the health care industry. I think such broad health care experience is unique at a law firm.
Neil: Each day varies significantly based on the status of different matters. For example, sometimes I may spend a half or full day conducting interviews at a client site, appearing in court, or presenting to the government. Other days might be a mix of motion drafting, phone calls with clients, correspondence with experts, and legal research. In addition to those tasks, other common tasks include managing document productions, drafting factual summaries based on our investigation, and analyzing recent filings in our cases.
What training, classes, experience, or skills development would you recommend to someone who wishes to enter your practice area?
For students interested in regulatory work, taking administrative law can be beneficial. For those interested in litigation, civil procedure and evidence are the most helpful courses. To the extent offered, seminars in health care or food and drug law and antitrust can also be helpful.
What misconceptions exist about your practice area?
Lawyers in Sidley’s health care practice do not handle medical malpractice cases, which some people think of when they hear “health care law.” Instead, the group’s work focuses on the industry’s interactions with the government, including advocating for policy change, complying with regulatory requirements, and addressing allegations of illegal conduct for large corporate health care clients. While not malpractice-related, on the regulatory side, we also have experience with some patient-facing issues, such as advising on patient outreach and patient education, as well as coverage denials, which can be very interesting.
What is unique about this practice area at your firm?
Sidley is uniquely positioned among major health care practices to advise on the full range of issues facing companies in the industry. From compliance issues and regulatory issues that are deep in the weeds of agency guidance to investigations and active litigation, Sidley has expertise in all areas. As a junior associate, you typically get immediate experience on complicated regulatory issues, which position you to better advise clients on enforcement and litigation work. Sidley has more than 100 lawyers who have held senior positions within key regulatory agencies in the U.S. and around the globe.
What are some typical tasks that a junior lawyer would perform in this practice area?
Junior lawyers perform a wide variety of tasks. For example, on the litigation side, a junior lawyer may be the only associate working on a small investigation, in which case that associate will need to balance researching law, managing document production, assisting with witness interviews, and drafting memos and presentations. On a larger matter, the same associate may have a more narrow focus, but will still be responsible for developing a mastery of key facts and proactively identifying ways to put the client in the best position for a successful result. On the regulatory side, junior associates work directly with partners on client questions, which may range from how to implement a new rule, legal issues with a new business initiative, or questions on how to seek coverage for a new product. Junior associates get immediate client contact through calls and in-person meetings, as well as exposure to government agencies through government meetings.
What kinds of experience can summer associates gain in this practice area at your firm?
Attorneys in the health care practice often ask summer associates to sit in on calls with clients, the government, experts, and opposing counsel. Additionally, summer associates regularly assist with researching law and drafting analytical memos for clients and often have the opportunity to attend and present at client meetings.