Enforcement Outlook | Key takeaways: Healthcare Litigation, Compliance, and Investigation Trends 

Advises companies, boards of directors, and individuals in high-stakes commercial litigation and complex disputes

Represents clients in government investigations, internal investigations, and regulatory enforcement matters

Defends healthcare organizations in False Claims Act (FCA), fraud and abuse, and other healthcare enforcement proceedings

Drew Elizabeth McCormick is a seasoned healthcare regulatory lawyer whose practice spans the full spectrum of federal and state regulatory oversight of the health industry. She is particularly known for her sophisticated command of fraud and abuse laws — including the Anti-Kickback Statute, the Stark Law, the False Claims Act, and state fraud and abuse analogues — as well as Medicare and Medicaid program rules, reimbursement rules and policy, and enrollment, licensing, and certification requirements. She also has extensive experience in various emerging areas of healthcare regulation, including surprise billing regulation and state transaction notice laws.

Drew regularly leverages this deep regulatory knowledge in government audits, civil investigative demands, and internal investigations, helping clients assess exposure, craft defensible responses, and navigate complex interactions with enforcement agencies. Her work also extends to the transactional arena, where she identifies regulatory risks, structures compliant arrangements, and supports diligence and post-closing integration for strategic transactions.

In addition, Drew provides strategic, day-to-day counseling to healthcare providers, payors, and emerging companies, guiding them through operational questions, policy changes, and compliance program design to support both business objectives and regulatory integrity.

Laura McLane co-leads McDermott’s white-collar and government investigations practice as well as the Firm’s False Claims Act (FCA) practice, and is a nationally renowned FCA litigator. For over 25 years, Laura has defended companies touching all aspects of the healthcare and life sciences industries in government investigations, qui tam litigation under the FCA, and related matters. Clients call Laura “an exquisite lawyer, very smart and incisive,” a “fierce advocate for her clients,” and “simply a brilliant attorney with a tremendous ability to navigate difficult circumstances.” (Chambers USA). Laura was named Boston’s Lawyer of Year in Healthcare Litigation by Best Lawyers in America for 2025-2026.

Laura’s experience spans the spectrum of government oversight in healthcare and life sciences. Her clients include healthcare providers of all types as well as laboratories, pharmaceutical and device manufacturers, private equity investors, and an array of other entities that reach the healthcare space. Laura represents clients in FCA matters throughout the country, as well as in federal courts of appeals and the Supreme Court of the United States. She has extensively litigated the myriad issues that typically arise in FCA cases, including representing her client in the landmark Escobar case in the Supreme Court. Clients state that Laura is “fantastic, . . . efficient and able to pull in knowledgeable resources right to the issue” (Legal 500 US) and “Laura is clearly a leader in the FCA space.” (Chambers USA). In addition to her healthcare experience, Laura defends clients facing FCA and other forms of government scrutiny in other industries, such as defense contracting and technology.

Beyond defending clients in investigations and litigation, Laura’s practice includes working closely with clients on FCA risk management and compliance assessments, and counseling buyers and sellers in transactions involving enforcement issues.

Mara Theophila regularly defends healthcare and life sciences clients across the country in high-stakes government investigations and complex commercial litigation. Her clients include pharmaceutical companies, medical device manufacturers, hospitals, ambulatory surgery centers, healthcare networks, physician practices, individual providers, laboratory diagnostic testing companies, insurance brokers, healthcare software companies, and private equity firms.

Mara’s practice focuses on the intersection of government oversight in the healthcare and life sciences space. She has substantial experience with the False Claims Act (FCA), the Food, Drug, and Cosmetic Act (FDCA), the Anti-Kickback Statute (AKS), the Stark Law, and related state laws. Mara has a proven track record of obtaining favorable results for clients in defending against claims being investigated or pursued by the US Department of Justice (DOJ), state attorneys generals, and private litigants. Additionally, Mara works closely with clients to manage their potential FCA and regulatory risks by developing compliance initiatives and other internal measures to minimize exposure moving forward.

Mara also maintains an active pro bono practice, including representation of indigent criminal defendants, non-profit organizations and visa and asylum applicants.

Mara previously served as a law clerk for the Honorable Judge Jane R. Roth of the US Court of Appeals for the Third Circuit and for the Honorable Paul A. Crotty of the US District Court for the Southern District of New York.