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
- Counsel in collaboration between two multinational pharmaceutical companies to develop and market pharmaceutical products and drug delivery devices to combat leading autoimmune conditions.
- Representation of Boehringer Ingelheim in forming a joint venture with Eli Lilly to develop and market diabetes drugs and therapies worldwide.
- Regular representation of health care facilities in certificate of need matters in Tennessee and Mississippi, including representation of an academic medical center for a new hospital, despite significant opposition from competitors.
- 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.
- Formed and served as counsel for a physician advocacy group that developed and successfully led the effort to pass landmark state legislation to reform the healthcare insurance prior authorization process.
- 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 for a major academic medical center in its successful effort to develop and pass legislation to provide the tools needed to enter into long term joint ventures and other cooperative arrangements with for profit entities, a project that eventually led to the implementation of a number of new healthcare ventures to support the academic mission of the institution.
- 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.
- Representation of a state agency in defense of a federal investigation of alleged HIPAA violations.
- Served as counsel to a clinical research company with sites throughout the United States in connection with its sale to a private equity sponsor for case and equity in a transaction valued at over $300 million.
- Counsel to the owners of a health insurance subrogation and benefits recovery company to a private equity-sponsored buyer for cash and equity in a transaction valued at over $300 million.
- Regular representation of nursing homes, pharmacies and administrative support organizations in Office of Inspector General (OIG) investigations and healthcare provider litigation.
- General representation of ambulatory surgery centers in their formation, development of provider agreements, and defense in regulatory proceedings, including Medicare and Medicaid audits and recoupment demands.
