McDermott Will & Schulte, a global law firm

James A. Cannatti III advises healthcare, technology, and life sciences organizations on complex regulatory, compliance, and enforcement matters at the forefront of the evolving healthcare ecosystem. His practice spans digital health and health information technology (IT) policy, fraud and abuse compliance, and emerging regulatory risk areas, including in the diagnostics, life sciences services, research, pharmacy, and distribution space.

James counsels healthcare providers, diagnostics companies, health IT developers, and life sciences services and research companies on compliance with federal healthcare requirements, including the Anti-Kickback Statute, Stark Law, and EKRA. He also represents clients in internal investigations and enforcement matters, drawing on his deep experience with government expectations and enforcement priorities to provide practical, regulator-informed guidance on navigating enforcement risk and regulatory change.

James’s advisory work frequently addresses cutting-edge regulatory topics and developments, including:

• Fraud and abuse risk and enforcement trends involving healthcare providers, diagnostics, laboratory services, and life sciences companies
• Internal investigations and responses to government inquiries involving the US Department of Justice and the US Department of Health and Human Services’ Office of Inspector General (OIG)
• Compliance with the Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act of 2018 in complex commercial arrangements
• Digital health enforcement and compliance risks, including remote patient monitoring and telehealth
• Information blocking and interoperability requirements under the 21st Century Cures Act
• Health IT certification, APIs, and data-sharing obligations

Before entering private practice, James spent more than a decade at the OIG, where he held a range of roles, including serving as its first Senior Counselor for Health Information Technology. In that role, he worked on the development, interpretation, and enforcement of federal healthcare policy affecting providers, health IT developers, and other industry stakeholders.

While in law school, James served as a managing editor of the Ohio State Journal on Dispute Resolution.

Emily Jane Cook serves as counsel to clients in the healthcare sector from start-ups to established market leaders on a wide range of critical regulatory matters to ensure compliant business operations. Her guidance allows these organizations to prospectively and retrospectively manage the risks associated with operating in a high-complexity and highly-regulated sector.

A national authority on the 340B drug pricing program, Emily also helps clients across the country navigate a wide range of complex federal and state healthcare regulations. Her counsel encompasses issues such as navigating federal and state fraud and abuse laws, development of innovative models for healthcare delivery, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, and federally qualified health centers. This depth of knowledge across many regulatory issues allows her to provide her clients with comprehensive legal advice and guidance, which allows them to fully evaluate risks in their business and clinical operations. She works closely with colleagues in McDermott’s diverse practice areas to deliver fully realized solutions for her clients.

Emily’s deep insights into US healthcare regulation stem from her previous tenure at the US Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). For more than five years, she worked with providers and across government agencies to address regulatory barriers to healthcare delivery. She advised senior HHS leadership on Medicare and Medicaid regulation and reimbursement issues affecting rural communities and providers, and served as senior policy advisor to the National Advisory Committee on Rural Health and Human Services.

Emily is an active member of the American Health Law Association, where she most recently served as the Chair of their Medicare and Medicaid Institute. She is also a member of the firm’s Health/White Collar cross-practice group.

David Quinn (Dave) Gacioch focuses his practice on litigation and enforcement defense, primarily related to the US healthcare sector.  Dave counsels hospitals, health systems, physician practices, and other providers, along with payors, private equity sponsors, pharmaceutical and medical device manufacturers, and others involved in the US healthcare system, on compliance and risk mitigation issues.  He conducts internal investigations for clients, and represents them in government investigations, enforcement actions, and civil and criminal litigation, including class actions.

Dave has deep experience across a number of key substantive issues, including:

• False Claims Act matters pursued by whistleblowers (qui tam cases) or government authorities;
• Fraud and abuse issues arising under the Anti-Kickback Statute, the Stark Law, and other laws governing federal healthcare programs such as Medicare and Medicaid—especially fair market value (business valuation and professional services compensation) issues;
• Federal and state oversight of controlled substance laws, including defending Drug Enforcement Administration (DEA) investigations;
• Information privacy, cybersecurity and data breach response issues arising under the Health Insurance Portability and Accountability Act (HIPAA), 42 C.F.R. Part 2, and other US federal and state laws;
• Website and mobile application user tracking technologies and potential regulatory and litigation challenges to their deployment, including under wiretapping/eavesdropping statutes;
• Conscience and religious freedom-based investigations of providers by the US Department of Health & Human Services, Office for Civil Rights (HHS-OCR);
• Negotiation of, and compliance with, corporate integrity agreements (CIAs) and corrective action plans (CAPs);
• Response to sentinel events, such as allegations of provider staff abuse of patients— including compliance with real-time administrative and criminal reporting obligations while planning for potential investigative, civil litigation, and community relations impacts downstream;
• Compliance with and investigation preparation/defense regarding COVID-19 pandemic relief programs such as the CARES Act Provider Relief Fund and advance/accelerated Medicare payments; and
• Response to civil investigative demands (CIDs) and subpoenas.

Dave works closely with McDermott’s best-in-class Health Industry Advisory team to provide litigation and enforcement defense representation informed by leading-edge thinking on complex healthcare regulatory issues.  As a recent example, Dave co-leads the Firm's Post-Dobbs Resource Center - a joint healthcare, regulatory, privacy and litigation team that counsels clients on how to navigate the challenging legal landscape around abortion and other reproductive health care in the wake of the US Supreme Court's  Dobbs v. Jackson Women’s Health Org. decision in 2022.

Additionally, Dave is working closely with McDermott’s best-in-class Health Information Privacy and Privacy/Cybersecurity teams to provide comprehensive, strategic counseling and representation to clients around website and mobile application user tracking and marketing technologies (AdTech)—including defending multiple class action cases brought against clients under wiretapping/eavesdropping statutes.

Dave is one of the leading lawyers in the United States in the area of responding to HHS-OCR investigations, whether based upon HIPAA or upon conscience and religious freedom laws, and negotiating favorable resolutions when such investigations result in allegations of non-compliance by covered entities or business associates. Notably, Dave served as lead counsel in the successful defense of a health system against the first attempt by the HHS-OCR and the Department of Justice Civil Rights Division to take conscience-based enforcement action against a provider—securing a dismissal of the DOJ lawsuit and a reversal of HHS-OCR’s notice of violation.

As a former advanced emergency medical technician and ambulance service officer, Dave brings a provider’s perspective to the practicalities of healthcare compliance and risk mitigation, which allows him to grasp issues quickly and to communicate them effectively both to and on behalf of providers.

Dave’s practice also includes commercial litigation and dispute resolution on behalf of a variety of clients inside and beyond health care, including a leading alcohol beverages brand.  Additionally, Dave serves as national coordinating counsel for a building products manufacturer in the asbestos product liability litigation.

Dave regularly writes and lectures on the issues referenced above. Dave also has significant trial, hearing, and arbitration experience, and has performed extensive pro bono work.

Previously, Dave served as law clerk to the Honorable Ernest C. Torres, Chief Judge of the US District Court for the District of Rhode Island.

With a practice focused primarily on the development, delivery and implementation of digital health solutions, data and research, Jennifer S. Geetter works closely with both adopters and developers to bring their innovative healthcare solutions to patients and providers. In order to design and deploy digital health technologies effectively, Jenn offers valuable guidance on key issues, like patient on-boarding, provider implementation, privacy and regulatory issues. She advises global life sciences, healthcare and informatics clients on legal issues attendant to digital health, biomedical innovation, research compliance, global privacy and data security laws, and financial relationship management. Jennifer represents a broad range of clients, including the following:

• Mobile app, mHealth, and other digital health technology companies and platform providers
• Informatics, data broker and data aggregator companies
• Pharmaceutical, device and biologics companies
• Health plan, institutional healthcare provider and other enterprises
• Research institutes

Clients seek Jennifer out for her knowledge on the development of data and biospecimen registries and real-world evidence (RWE). She advises healthcare and life sciences stakeholders in considering the complex regulatory and implementation challenges that arise when developing these registries and other digital care solutions, including research, compliance, privacy, interoperability, and data governance, access and curation. Jenn also considers a range of other issues that impact how registries are built, including data governance strategies and application. She has built a strong reputation for counseling clients through registry development, with special emphasis on navigating the unique legal nuances around genetic information, biospecimens, sensitive data and other special use cases. Jennifer assists these clients with a range of projects, including the following:

• Health Insurance Portability and Accountability Act (HIPAA), Federal Trade Commission (FTC), and state and federal privacy, security and breach response preparedness and response
• Development and implementation of data-sharing strategies and platforms to achieve business objectives, particularly in connection with biomedical innovation, healthcare reform, electronic health record implementation and quality assurance requirements
• Data privacy, data mapping and data use strategies for mobile apps and other mHealth and digital technologies
• Research compliance, research program structure, and operational and compliance infrastructure
• Complex research affiliation agreements and arrangements
• Scientific review and research misconduct proceedings and investigations (internal and with government involvement)
• Biobanking and registry development and compliance, including emerging issues in the future, unspecified use of biospecimens and genomic data

In her work with digital health clients on strategic and compliance counseling, Jennifer is especially knowledgeable on interoperable, comprehensive data collaborations and data webs, and human subject research compliance. Her forward-thinking and strategic vision have benefited clients in the development of comprehensive data strategies concerning areas such as privacy, security, data mapping, secondary data use, availability and interoperability.

Highly experienced advocate with 10 US Supreme Court arguments and 100+ appellate and trial court arguments nationwide

Secures major victories across administrative law, intellectual property, immigration, life sciences, securities, transportation, and energy, including landmark Supreme Court cases

Designs and leads high-impact affirmative litigation, often against federal and state agencies to achieve regulatory and policy wins

Handles complex appeals and challenges to government actions

Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. Tony is a practice area leader for the Healthcare Regulatory & Compliance practice.

He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Tony also draws on his background in government investigations to assist clients in evaluating, developing and implementing corporate compliance programs.

Tony previously served as deputy chief of the Administrative and Civil Remedies Branch of the US Department of Health and Human Services (HHS) Office of Inspector General (OIG), where he represented the agency on investigating FCA and civil monetary penalty cases, negotiating and monitoring corporate integrity agreements, and defending exclusion appeals. While serving at HHS, Tony was a principal author of the OIG's current Self-Disclosure Protocol. He also has advised CMS on policy issues, including the Medicare Overpayment Rule and the creation of the Self-Referral Disclosure Protocol.

Tony represents a wide variety of clients, including

• Hospitals and health systems
• Professional services organizations and physician practice management companies, such as anesthesia, dentistry, dermatology, emergency medicine, oncology, primary care, radiology and wellness practices
• Pharmaceutical and medical device manufacturers and distributors
• Long-term care, home health, hospice and other post/sub-acute providers
• Pharmacies and pharmacy benefit managers
• Dialysis providers
• Laboratories
• Ambulance companies
• Health plans
• Electronic health records and revenue cycle management vendors
• Investors and other financial institutions that invest in and/or support the health care and life science industries

Tony writes and speaks frequently on health care regulatory topics and has lectured on health care fraud and abuse issues at Boston University School of Law and American University Washington College of Law.

Prior to his government service, Tony represented hospitals and physician practices on health care regulatory and corporate compliance issues. During law school, Tony was the editor of the 2001 Symposium issues of the American Journal of Law and Medicine.

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,” and a “fierce advocate for her clients” (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).  Her recent experience includes guiding multiple clients through government investigations and related matters arising from the novel issues presented by the Covid-19 pandemic, including issues relating to testing, vaccination and treatment. 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.

Dana McSherry is the Boston lead of McDermott Will & Schulte’s Litigation Practice Group and co-leads the firm’s False Claims Act (FCA) practice. She advises healthcare and life sciences companies in criminal and civil government enforcement matters and in related civil litigation, including civil False Claims Act (FCA) litigation. Dana guides clients through all aspects of civil and criminal investigations relating to Medicare and Medicaid billing and other government contracting issues, including negotiating with the government and managing clients’ responses to civil investigative demands and large-scale investigative subpoenas. She also assists clients in conducting internal investigations and counsels clients across the healthcare industry on compliance and risk management issues.

In late 2018, Dana successfully defended a pharmacist charged with racketeering, mail fraud, and Food, Drug and Cosmetics Act (FDCA) violations. Following a two-month jury trial in the US District Court for the District of Massachusetts, Dana’s client was acquitted of all charges.

In addition to her life sciences practice, Dana also represents individual clients in securities fraud related government enforcement matters, both civil and criminal.

Dana also maintains an extensive pro bono practice. In 2019, Dana successfully represented a parent in a Hague child custody case that involved a week-long trial in the US District Court for the District of Massachusetts. She also successfully represented a civilly committed individual in a civil rights action.

Joseph (Joe) Mulherin focuses his practice on employment class action litigation, with a focus on defending employers against wage-and-hour and employment discrimination lawsuits. Joe has successfully defended clients from a wide variety of industries, including health services, banking, finance, retail, manufacturing, hospitality, staffing, technology, logistics, and construction.

Joe also has deep experience representing employers in federal and state governmental agency matters, including investigations by the US Department of Labor and the Equal Employment Opportunity Commission, as well as their state counterpart agencies.

Leveraging his intricate knowledge of the law and extensive litigation experience, Joe regularly counsels clients on best employment policies and practices and mitigation strategies. His advice takes into account not only the requirements of the law, but clients’ unique business needs and potential exposure.

Joe frequently advises on wage-and-hour policies and practices relating to employee overtime classification, timekeeping, rounding, meal and rest periods, travel time, donning and doffing, on-call time, and handheld devices. He also has considerable experience advising clients on discipline and termination decisions, leave laws, independent-contractor classification, wage payment and vacation laws, commissions and bonuses, and web accessibility for disabled individuals.

Joe is a highly regarded writer and speaker on a broad range of employment law topics.

Jennifer (Jenn) Routh is a trial lawyer who leads high-stakes, complex civil litigation, including matters involving billions of dollars of exposure. She has secured numerous jury verdicts and bench trial wins across a range of disputes, including trade secrets, breach of contract, fraud, breach of fiduciary duty, products liability, negligence, and unfair competition. She won the first jury verdict obtained by any litigant under the Defend Trade Secrets Act, the federal trade secret statute. She is the Partner in Charge of the firm’s Washington, DC, litigation practice.

Jenn represents clients in state and federal courts nationwide, with a particular focus on False Claims Act litigation. Her practice includes qui tam and enforcement actions, including those involving managed care (Medicare Part D and Medicare Advantage), and she represents pharmaceutical companies, payors, and providers in high-stakes healthcare disputes. She also handles disputes for private equity-backed companies, including ownership and control disputes.  Beyond the healthcare space, Jenn represents clients in high-profile, bet-the-company litigation involving novel and highly contested liability issues and significant reputational risk.

Jenn is actively engaged in pro bono representations. She previously clerked for the Honorable Thomas F. Hogan of the US District Court for the District of Columbia.

Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.

Stephen Wu is a nationally recognized antitrust lawyer with more than twenty-five years’ experience defending clients against antitrust litigation and government investigations into mergers and acquisitions and business practices. Stephen is also a trusted strategic advisor who counsels clients on antitrust compliance issues.

Stephen has successfully defended clients in class actions and other complex litigation brought by purchasers, competitors, and employees alleging unlawful price-fixing, wage-fixing, exclusive dealing, group boycott, market allocation, tying, and monopolization claims in federal courts around the country. In addition, Stephen has successfully defended numerous mergers and acquisitions and clients’ business practices from Federal Trade Commission (FTC), Department of Justice, and State Attorneys General investigations. He also regularly advises clients on pricing, distribution, and joint venture matters.

Stephen represents clients in a wide variety of industries, ranging from consumer goods to healthcare to packaging. He is co-head of the Firm’s Health Antitrust Practice Group.

Stephen has been recognized as a leading antitrust lawyer by The Best Lawyers in America, BTI Consulting, Chambers USA, Global Competition Review, Lawyers of Color, The Legal 500 USA, LMG Life Sciences, The National Law Journal, Super Lawyers, and Thomson Reuters Stand-Out Lawyers.

Prior to joining the Firm, Stephen was an attorney for the FTC, where he received its Award for Meritorious Service. At the Firm, Stephen received McDermott’s Pro Bono and Community Service Award for his pro bono efforts.