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Empowering Hospitals, Innovators, and Investors Across Every Sector

The DarrowEverett Health Care & Life Sciences Practice advises clients across the heavily regulated and consistently evolving health care and life sciences industry. Service providers including hospitals; facilities; manufacturers; suppliers; lenders; investors; academia; and healthcare technology, biotechnology, food and dietary supplement, insurance, medical device, and pharmaceutical companies turn to us for assistance with the myriad of legal and regulatory issues and challenges that they face day to day in their businesses.

The DE team has extensive experience in healthcare mergers, acquisitions, joint ventures; strategic positioning, restructuring, capital access, private equity investments, divestitures, and bankruptcies. We aid with licensing, tax issues, government investigations, employment matters, governance, regulatory compliance, and Medicare/Medicaid reimbursement disputes and have litigated complex disputes involving commercial transactions and allegations of fraud, anti-kickback, and false claims act violations.

Our clients that manufacture or market products regulated by the US Food and Drug Administration (FDA) must also deal with the constantly changing procedural, regulatory, and legislative matters surrounding compliance, enforcement and product development, approvals, launch, sales, and marketing, reporting obligations, disclosures, and recalls.

The DE Health Care Practice Group regularly advises clients on:

  • Mergers, Acquisitions, & Sales
  • Financing, Restructuring, & Leasing
  • Medicare & Medicaid Reimbursement Disputes
  • Intellectual Property Issues
  • Licensure & Credentialing
  • Heath Insurance Portability & Accountability Act
  • Anti-kickback Laws
  • Corporate Integrity Agreements
  • Corporate, Regulatory, & Security Compliance
  • Employment, Contracting, & Negotiation
  • Stark Law
  • False Claims Act
  • Qui Tam Actions
  • FDA Registration
  • Health Information Technology
  • Litigation, Arbitration, & Administrative Hearings
  • Government Enforcement Actions
  • Federal & State Regulatory Compliance
  • Products Liability
  • Strategic Positioning
  • Senior & Elder Care Services
  • Clinical Investigations
  • Dispute Resolution
  • Labeling, Advertising, & Promotion
  • Product Recalls

Contact Us to Ensure Compliance and Protect Your Business

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Practice Leaders

Dave B. Koo - Partner

Overview

Dave B. Koo, the Chair of our Intellectual Property & Technology Practice Group and a Practice Leader in our Healthcare & Life Sciences Practice Group, brings over two decades of global legal experience representing Fortune 500 companies, major Korean conglomerates, and multinational corporations in complex cross-border litigation, transactional, and regulatory matters. Dave’s practice focuses on high-stakes patent litigation, IP licensing, competition law, and technology transactions, with a deep understanding of both U.S. and international...

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Tel: (401) 453-1200

Kevin Gildea

Kevin P. Gildea - Of Counsel

Overview

Kevin P. Gildea is a member of DarrowEverett’s Corporate & Business Transactions, Healthcare & Life Sciences, Regulatory & Compliance and Data Privacy & Cybersecurity Groups. He has a practice concentrated in the areas of corporate, banking, healthcare and life sciences, renewable energy, nonprofit, and financial services regulation, compliance, litigation and enforcement defense, and transaction and merger-acquisition related structuring, domestically and internationally. He has experience defending companies in civil and criminal government investigations and enforcement actions,...

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Tel: (212) 335-2090