Healthcare: Pharmaceutical/Medical Products Regulatory
USA Guide 2024 : District of Columbia
Band 2
Email address
[email protected]Contact number
+1 202 737 0500Chambers Review
King & Spalding has strong regulatory and litigation capabilities, frequently advising on high-value Medicare reimbursement appeals for hospitals. The firm also acts on M&A and joint ventures involving providers, as well as health IT concerns. The team is also noted for its experience in the pharmaceutical and biotech space, advising on areas such as clinical trials, marketing and disputes and offering skill in handling drug-pricing issues for pharmaceutical manufacturers.
Work Highlights
- King & Spalding acted on behalf of Adventist to secure federal funding for half of the total cost of constructing a new Howard University Hospital.
Strengths
Provided by Chambers
"King & Spalding's team has a wealth of knowledge and experience."
"The firm's attorneys are consistently quick to respond. We have never been disappointed by the timeliness or thoroughness of their response."
"King & Spalding has expertise and experience in complicated legal and regulatory issues. They have impressive attorneys on numerous topics."
"King & Spalding's team has a wealth of knowledge and experience."
"The firm's attorneys are consistently quick to respond. We have never been disappointed by the timeliness or thoroughness of their response."
"King & Spalding has expertise and experience in complicated legal and regulatory issues. They have impressive attorneys on numerous topics."
Notable Practitioners
Mark Polston is a fine choice of counsel for a diverse client base, including health systems, hospitals and academic institutions involved in significant Medicare challenges.
"Mark has a great practical approach and overall knowledge."
"We depend on Mark for the thoroughness of his understanding of the healthcare industry and the clarity of his guidance."
Christopher Kenny is recognized for his experience in Medicare reimbursement, particularly on behalf of hospitals and hospital systems.
"Chris is extremely responsive and knowledgeable."
Daniel Hettich has an impressive healthcare practice advising hospitals, health systems and medical centers on litigation and investigations.
"Daniel is a great lawyer who manages many complex legal issues."
John Shakow has significant experience in pricing matters including Medicaid price reporting. He also advises pharmaceutical clients on FDA regulatory matters and has expertise in handling internal investigations.
Mark Brown has a strong practice advising on FDA regulations and high-stakes enforcement matters. His clients include pharmaceutical and medical device manufacturers.
"Mark is an outstanding lawyer."
Nikki Reeves is an expert in pharmaceutical-related compliance issues, with a particular focus on FDA matters. She advises on a wide range of issues, including internal and external investigations, joint ventures, corporate integrity agreements and FDA consent decrees.
Seth Lundy focuses on regulatory matters within the pharmaceutical and medical products field. His extensive FDA expertise sees him handling a range of complex fraud and abuse matters.
"He is very knowledgeable."
"Seth is a very good lawyer with a solid practice."