McDermott Will & Schulte, a global law firm

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.

See Less

• Representing a leading global healthcare company in responding to and successfully resolving a four-year multifaceted federal investigation into alleged kickbacks to patient referral sources and false claims for reimbursement, along with parallel civil qui tam action under the False Claims Act
• Helping a leading global healthcare company to negotiate, implement and operate under the terms of a corporate integrity agreement with the Office of Inspector General for the US Department of Health & Human Services (HHS)
• Counseling a major healthcare services company with respect to fair market value and other issues on hundreds of millions of dollars’ worth of mergers and acquisitions (M&A) transactions with potential sources of patient referrals
• Representing multiple healthcare providers facing threats of HIPAA civil monetary penalties from HHS-OCR and negotiating favorable resolutions to such matters
• Securing very favorable (including “no-action” and “technical assistance only”) outcomes for several hospitals and other healthcare providers facing data breach-related investigations by state attorneys general and/or the HHS, Office for Civil Rights
• Successfully prosecuting gross negligence and breach of contract claims on behalf of a Medicare Advantage organization against one of its vendors, resulting in a very favorable resolution after the defendant’s motion to dismiss was denied in full
• Successfully defending a major alcohol beverages brand against a $90 million breach of contract claim by one of its co-packers, and against a separate $16 million breach of contract claim by a supplier
• Serving as trial counsel for an information technology company in a multimillion-dollar breach of contract, fraud and unfair business practices litigation against one of its vendors
• Defending a leading global medical products manufacturer at the London Court of International Arbitration and a Turkish entrepreneur at the International Chamber of Commerce (ICC) International Court of Arbitration in London against multimillion-dollar breach of contract and related claims brought by business partners
• Defending on appeal an order of the US District Court for the District of Massachusetts directing the Massachusetts Department of Corrections to provide inmates with access to weekly religious services (Crawford v. Clarke, 578 F. 3d 39 (1st Cir. 2009))
• Obtaining compensation from the Commonwealth of Massachusetts for an individual who had served a 40-month prison sentence in the mid-1980s for an armed robbery that he did not actually commit
• Securing favorable outcomes for several indigent federal criminal defendants facing charges related to narcotics distribution, gun possession and tax evasion

See Less