The Overturning of Roe v. Wade

David Quinn (Dave) Gacioch focuses his practice on healthcare litigation and enforcement defense. 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. 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; 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 is partnering with an expert healthcare regulatory team to counsel clients on how to prepare for the possibility of major changes to the legality of abortion across the US if the Supreme Court’s forthcoming decision in Dobbs v. Jackson Women’s Health Org. overturns Roe v. Wade. 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.

Stacey Callaghan counsels healthcare entities, healthcare technology companies, data companies, and private equity entities as they navigate transactional, regulatory, and compliance issues. She focuses on assisting clients on matters including data privacy and protection requirements under HIPAA and other privacy laws, data breach investigations and compliance, and data sharing, licensing, and de-identification arrangements. Stacey also assists clients in developing telemedicine strategies and documenting agreements given the evolving digital health regulatory landscape. Stacey is experienced in executing healthcare transactions, and routinely guides clients through joint ventures, mergers and acquisitions and strategic collaborations. She counsels on governance matters and regulatory issues, including compliance with federal and state fraud and abuse laws. Prior to joining McDermott, Stacey was a healthcare associate at a large US-based law firm. She is a frequent author on a variety of healthcare legal issues, primarily those issues impacting providers in the digital health space. During law school, Stacey served as the executive notes editor for the Journal of Legislation.

Dana McSherry advises healthcare and life sciences companies in criminal and civil government enforcement matters and in related civil litigation, including civil False Claims Act litigation. She advises clients concerning 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. Dana 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. Dana serves as the hiring partner for the Boston office.

Caroline Reignley provides valuable counsel on healthcare regulatory and reimbursement law to her clients, including for-profit and nonprofit hospitals, health systems and physician groups. She is particularly focused on advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding, licensure, accreditation and healthcare compliance matters. Caroline also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statue. Her experience navigating civil and criminal investigations within the healthcare space informs her strategic approach to risk management in transactions and the development of robust compliance programs. Her background as a health law fellow for a regional nonprofit health system and as a law clerk at the US Department of Health and Human Services provides a unique understanding of legal issues from both the regulator and provider perspectives.

Paul M. Thompson represents clients in complex criminal and civil matters. He has extensive experience in internal investigations, voluntary disclosures, grand jury investigations, appellate practice and congressional investigations, with a particular focus on clients in the healthcare industry. Paul served on McDermott’s Executive and Management Committees. From 2011 to 2015, he also served as Managing Partner of the Washington, DC office. Complex Criminal and Civil Healthcare Matters: Paul represents healthcare clients that are the subject of criminal investigations and civil enforcement proceedings. A significant part of Paul’s practice is devoted to representing clients in matters involving allegations under the False Claims Act, the Anti-Kickback Statute and the Stark Law. In addition, Paul helps clients conduct internal investigations, file self-disclosures, update compliance programs and litigate cases under Administrative Procedure Act. Complex Criminal and Civil Antitrust Matters: Paul also represents clients in criminal antitrust investigations conducted by the Department of Justice (DOJ), and civil antitrust investigations conducted by State Attorneys General. Paul represents these same clients in parallel civil antitrust class actions. Additionally, he regularly trains clients on antitrust compliance issues, assisting them in revise their antitrust compliance programs. Congressional Investigations: Paul represents clients in high-profile congressional investigations, including before the Senate Judiciary Committee, the Senate Permanent Subcommittee on Investigations, the House Energy and Commerce Committee, and the House Committee on Oversight and Government Reform. Appellate: Paul has served as lead appellate counsel in more than 100 cases in nearly all of the US courts of appeals and before the US Supreme Court, including handling cases at the certiorari and merits stages. Among other significant matters, Paul represented Arthur Andersen before the US Supreme Court in a case involving the interpretation of the Federal Arbitration Act. From 2002 to 2005, Paul served as an Assistant United States Attorney in the Appellate Section of the United States Attorney’s Office in the Western District of Pennsylvania. From 2005 to 2007, he worked as counsel to the US Senate Judiciary Committee, where he worked on the Senate confirmation hearings for Chief Justice John Roberts and Justice Samuel Alito. Paul has also served as a law clerk to the Honorable D. Brooks Smith, former Chief Judge of the US District Court for the Western District of Pennsylvania and current Chief Judge on the US Court of Appeals for the Third Circuit. Paul has published articles in the National Law Journal, Roll Call, Executive Counsel, Corporate Counsel, the Yale Law Journal Pocket Part and the Vanderbilt Law Review. He has been quoted in top legal and business publications such as the Washington Business Journal, The Hill, Roll Call and Am Law Daily, and has served as a panelist at the National Press Club.

Sarah G. Raaii focuses her practice on employee benefits and matters related to health care reform, data privacy and HIPAA compliance, executive compensation, and health and welfare, cafeteria, 401(k), 403(b) and pension plans. Sarah has experience counseling clients on regulatory compliance with the Affordable Care Act (ACA), Health Insurance Portability and Accountability Act (HIPAA), Employee Retirement Income Security Act (ERISA), Consolidated Omnibus Budget Reconciliation Act (COBRA), Internal Revenue Code and related state and federal laws affecting employee benefit plans. She assists clients with drafting employee benefit plan documents and amendments and represents clients before the Internal Revenue Service (IRS), US Department of Labor (DOL) and Pension Benefit Guaranty Corporation with respect to plan qualification issues. Sarah also advises clients on employee benefits diligence, design, implementation and transition matters arising from corporate and private equity mergers and acquisitions. Prior to joining McDermott, Sarah worked for the National Economic Council at the White House, where she implemented the Affordable Care Act and developed the DOL fiduciary rule with leaders from the Executive Office of the President, the Department of Labor, the Department of Health and Human Services and the Department of the Treasury. Sarah previously worked with in-house attorneys and federal and state government relations professionals in the Leadership Development Program of a Fortune 500 global insurance and financial services corporation. During law school, Sarah served as a contributing editor for and was published in the Iowa Law Review.