THE FIRM This broad-based group is acclaimed as being a leading force in both the traditional healthcare and FDA regulatory arenas. Its client base highlights the scope of its practice, with medical device companies, pharmaceutical and biotechnology companies, payors and providers on its roster. The group's extensive practice covers False Claims Act litigation and counseling, transactions, and approval matters related to the lifecycle of a product or device. It recently advised Laboratory Corporation of America on the $925 million acquisition of Genzyme Genetics, and also worked with Graceway Pharmaceuticals on FDA matters.
Sources say: "I had a very good experience working with them - they are very confident, pragmatic and very accessible. Their strengths are the quality and immediacy of their responses."
KEY INDIVIDUALS Thomas Bulleit garners praise from commentators as being a first choice in the arena. His widely acclaimed practice has a strong focus on fraud and abuse matters, and his regulatory work with client Stryker has drawn on his reimbursement expertise.
Robert Leibenluft is characterized by sources as "a very fine attorney whose judgment I respect," and he is commended for his antitrust expertise. Recent highlights include representing the State University of New York in acquisitions of Long Island College Hospital and Community General Hospital, two deals with a total value of $450 million.
Ann Morgan Vickery is lauded as a leading name in regulatory matters, noted particularly for her Medicare work relating to drug manufacturers. Her practice incorporates expertise in the impact of healthcare reform on clients from across the industry.
Clients enthuse that David Fox "brings this common-sense solution-driven approach which has been great for us." His product approval practice draws on his experience of working for the FDA and focuses on drugs, combination and biological products. His technical abilities are highly praised, and sources add that "we would never turn to any other person or firm on regulatory matters."
Jonathan Kahan draws on 35 years of experience in FDA law, and is particularly noted for his work with medical device companies. He counsels clients such as Siemens Healthcare on regulatory matters related to clearance and approval of devices. His expertise extends to issues such as the proposed changes to the 510(k) process.
Helen Trilling is applauded as being "just outstanding - she is extremely knowledgeable about healthcare compliance and is an outstanding problem solver." Her practice incorporates compliance and fraud and abuse matters, and she has been increasingly active in health information technology innovations, acting for clients such as GE Healthcare.
Clients applaud Meredith Manning as "fantastic - she is always accessible." She is recognized for her strength in FDA approval and review of drugs and biologics, and her practice also covers enforcement litigation and product promotion.
Robert Brady is praised for his ability to "understand regulatory problems from how the government sees things, and give excellent advice." His long-standing expertise in FDA matters sees him work with a range of clients on product development, approval and promotion.