The healthcare industry faces ever-changing business and regulatory demands with a complex array of legal issues. To meet the diverse needs of our clients, Butler Snow has assembled a multi-disciplinary team of attorneys and professionals with a clear understanding of the needs and complexities of the healthcare and life sciences industry, including pharmaceutical and medical device manufacturers and distributors. We are well-versed in all aspects of healthcare, including business, medical and legal matters, enabling us to provide our clients with comprehensive representation.
Our team serves a wide range of for-profit and not-for-profit clients in this area, including:
- Drug and device manufacturers and other life science companies
- Hospitals, academic medical centers and healthcare systems
- Long-term care facilities and home health agencies
- Physicians and physician organizations
- Physician practice management companies
- Ambulatory care centers and diagnostic imaging centers
- Dialysis and disease management companies
In representing clients on a regional and national level, the firm draws on its expertise in product liability, professional liability, commercial litigation, government investigations, health care litigation, Anti-kickback, Stark, False Claims, HIPAA, FCPA and other federal and state regulatory compliance, research and clinical affairs, transactions, finance, intellectual property, real estate, tax, labor and employment and other areas. The depth and variety of our healthcare-related expertise sets our firm apart.
Our practice is actively involved in compliance issues facing healthcare providers today. We specialize in the design, development and implementation of compliance programs for numerous healthcare providers. This includes the training and auditing functions which are mandated for an effective compliance program.
As a part of these compliance efforts, our firm is actively involved in the various healthcare fraud and abuse initiatives, both at the state and federal level. Our attorneys routinely handle Medicare and Medicaid audits. In addition, we are regularly called upon to provide advice in connection with Stark issues, anti-kickback issues and antitrust issues facing healthcare providers.
Our team also regularly counsels both acquirers and targets in negotiation and closing mergers, acquisitions, dispositions and joint ventures and in structuring complex roll-ups and other reorganizations.
We also have extensive experience advising life science clients on a broad range of regulatory compliance and contracting issues relating to research activities, both pre-clinical and clinical. We work hand-in-hand with internal legal teams, clinical teams, and compliance teams with respect to all aspects of both industry sponsored studies and investigator-initiated studies (pre-market and post-market, interventional and observational, and prospective and retrospective) as well as other research activities such as data and materials sharing, advisory boards, grants, sponsorships, and publications. We routinely provide advice regarding compliance with U.S. and international laws and requirements related to medical research performed in the United States and abroad including clinical trial conduct, human subject protection, data privacy, anti-bribery, independent review boards/ethic committees, and product marketing and promotion.
Highlights
- Representation of a chemical/life sciences company in the disposition of its manufacturing assets and operations.
- Counsel in collaboration between two multinational pharmaceutical companies to develop and market pharmaceutical products and drug delivery devices to combat leading autoimmune conditions.
- Counsel in the sale of a healthcare-related technology company to a private equity-backed strategic acquirer.
- Representation of Boehringer Ingelheim in forming a joint venture with Eli Lilly to develop and market diabetes drugs and therapies worldwide.
- Representation of a global pharmaceutical company in connection with the purchase of a privately-held consumer health products company in a transaction valued at $400 Million.
- Representation of healthcare company in numerous transactions involving skilled nursing facilities including (a) $130 million senior credit facility, (b) $55 million senior credit facilities and (c) acquisition, disposition and development transactions of skilled nursing facilities in excess of $100 million.
- Represent developers of ambulatory surgery centers in real estate, syndication and health care regulatory matters
- Establishment of ambulatory surgery center joint venture arrangements across the United States.
- Representation of Bausch & Lomb in connection with its worldwide licensing of contact lens technology and related intellectual property from UltraVision (UK). No deal value was disclosed publicly.
- Counsel in recent sale of healthcare software company to private equity in excess of $150 million.
- Served as legal counsel for dialysis company in its purchase of dialysis facilities requiring FTC approval, including negotiations with the FTC regarding terms of the transaction and continuing monitoring requirements.
- Served as international counsel on behalf of a pharmaceutical client for a project that involved outsourcing of all meeting management in 72 countries, including advice, analysis and negotiation for the project on a broad range of issues, for example, data privacy and global data protection requirements, sunshine and other transparency reporting requirements, and anti-corruption and anti-bribery requirements.
- Daily representation of pharmaceutical and medical device companies in negotiation of clinical trial agreements, investigator initiated study agreements, collaborative research agreements, informed consent documents, and a broad spectrum of sourcing and procurement arrangements covering all aspects of national and international operations.
- Served as on-site secondee for pharmaceutical client for six-months by placing a member of our team at the client’s offices to work alongside in-house counsel and clinical, contracting and regulatory colleagues. By integrating with the client’s teams we were able to appreciate the critical business importance of the clinical programs and calibrate our approach to support those programs, allowing the client’s in-house counsel to focus on strategic and cross functional issues, becoming more effective, proactive business partners with their internal clients.
- Counsel in the development and implementation of a provider-based rural health clinic system for a health system.
- Counsel for an academic medical center in a 340B audit conducted by the Health Resource & Services Administration, including the manufacturer repayment process.
- Counsel for a hospital in opposing penalties arising out of alleged violations of the Emergency Medical Transport and Active Labor Act (EMTALA) and imposition of Immediate Jeopardy process by the Centers for Medicare and Medicaid Services.
