King & Spalding LLP represents clients in a range of complex disputes, including drug pricing issues under the federal 340B program, and is also a name to note for advice concerning the FDA’s regulatory procedures governing biologics and biosimilars. A number of investors in life sciences entities also regularly come to the firm for assistance in transactional matters. Leading the team is a three-person group of FDA regulatory specialists, with Mark Brown advising on both compliance and enforcement action, Nikki Reeves handling Form 483s and product recalls, and Seth Lundy, who assists medical device manufacturers design compliance programs and handle government investigations. Brian Bohnenkamp is also noted for his expertise in creating compliance programs, which he handles for both emerging and established players in the sector, while Lisa Dwyer specializes in the burgeoning digital health space, in addition to pre-market strategies. John Shakow is the name to note for issues of drug pricing, where he offers significant litigious experience. The practice was strengthened in August 2023 by the arrival from Hyman Phelps & McNamara, P.C. of Jeffrey Shapiro, an expert on the FDA’s approach to medical device regulation.
Testimonials
Collated independently by Legal 500 research team.
- 'The life sciences practice at King & Spalding is a highly experienced, business-savvy team of delightfully genuine and personable attorneys.'
- 'Seth Lundy is a consummate all-around life sciences commercialization and compliance leader and partner.'
- 'This team is very strong and plays off each other to advise its clients for solutions that work for the business. They clearly lay out risks and levels of risk so that you can make well-advised decisions as a business.'
- 'Brian Bohnenkamp is very knowledgeable in and practical for the pharmaceutical space, including rare diseases, pricing, patient support, and other intricate areas. He lays out risk levels well while getting right to the point.'
- 'Nikki Reeves is very knowledgeable in the pharmaceutical space. She provides information that helps you to make informed decisions for the business. She brings in the appropriate people, as necessary, to move decision-making along quickly.'
Key clients
- AbbVie
- Acadia Pharmaceuticals
- Allergan, Inc.
- Amarin Corporation
- Amgen
- Baxter International
- BioMarin
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Coloplast Corporation
- Daiichi Pharmaceuticals
- Eli Lilly
- EMD Serono
- Exact Sciences
- Garmin International, Inc.
- GSK
- HeartFlow, Inc.
- Henry Schein
- Hope Medical Enterprises, Inc. (Hope Pharmaceuticals)
- Imperative Care
- Integra LifeSciences
- Invacare Corporation
- Kiyatec
- LEO Pharma, Inc.
- LivePerson
- Medtronic
- Novo Nordisk
- PhRMA
- Takeda Pharmaceuticals
- Teleflex, Inc.
- Urogen
- Zimmer Biomet
Work highlights
- Advised HeartFlow Holding, Inc. on its $215m Series F and Series F-1 preferred stock financing, which was led by Bain Capital Life Sciences.
- Represented Eisai in connection with a restructuring of its collaboration with US-based Biogen.
- Represented Novo Nordisk before the Third Circuit concerning manufacturers' obligations to sell drugs to hospitals at a discount under the federal 340B pricing program.
Lawyers
Practice head
The lawyer(s) leading their teams.
Mark Brown, Nikki Reeves, Seth Lundy