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Hogan Lovells
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Healthcare: Pharmaceutical/Medical Products Regulatory

About

Provided by Hogan Lovells

We know how overwhelming it can be trying to effectively navigate today’s regulatory environment and capitalize on strategic opportunities. Many members of our team have previously worked in key positions in both the private and public sectors, including the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Having an in-depth understanding of the relationship between the government and global health care marketplace allows us to counsel you effectively on legal and regulatory issues — and to be your strategic advisor, litigator, and dealmaker, too. 

Our health care transactions team leads the nation in the number of complex hospital, academic medical centers, and health system transactions it has handled. Combining our technical and industry knowledge enables us to understand your objectives, plan for the positions likely to be taken by other parties, and help you develop the best deal structure
and strategy.

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

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What the Team is Known For

Hogan Lovells is a distinguished team with deep expertise across the scope of the healthcare and life sciences industries. The firm handles complex issues including the regulation of new medical devices, biotechnology products and healthcare litigation, government price reporting, privacy and reimbursement issues and digital health. The team's expertise also extends to advising on transactions such as clinical integrations, M&A and contracting.

Work Highlights

Provided by Hogan Lovells

  • Hogan Lovells advised Kaiser on the creation of a new subsidiary, Risant Health.

Strengths

Provided by Chambers

"This is our go-to firm whenever we are addressing complex matters."

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

"Hogan Lovells has the capability to address all of our needs. The team provides incredible support in a timely manner."

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Notable Practitioners

Provided by Chambers

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Helen R Trilling
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Senior Statespeople
Helen Trilling is regulatory and compliance counsel for a range of high-profile medical device companies. She is also well versed in transactional matters, including acquisitions and corporate restructurings.
"She's a talented lawyer."
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Jonathan S Kahan
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Senior Statespeople
Jonathan Kahan has extensive expertise in FDA matters, including marketing compliance and the development of innovative medical devices.
"Jonathon is incredibly experienced, talented and committed to the needs of his clients."
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Robert F Leibenluft
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Robert F Leibenluft
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Senior Statespeople
Robert Leibenluft has notable expertise in representing healthcare networks and academic institutions involved in transactions such as big-ticket mergers. He also counsels on antitrust-related issues.
"Bob is an excellent lawyer."
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David Fox
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David Fox is a leading expert in FDA regulatory work. He represents an array of new and well-established life sciences companies involved in cutting-edge pharmaceutical matters.
"David has a tremendous amount of FDA expertise."
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Beth L Roberts
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Band 2
Beth Roberts is highly regarded for her expertise in reimbursement matters arising from the development of new treatments and diagnostic tools, including devices that use artificial intelligence.
"Beth is a fantastic resource and her specialized knowledge is invaluable."
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Jonathan L. Diesenhaus
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Jonathan L. Diesenhaus
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Band 2
Jonathan Diesenhaus is a strong choice for hospitals facing complex disputes, and regularly takes on sophisticated FCA litigation.
"Jonathan is excellent - he's very responsive and has very strong experience."
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2
Philip Katz
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Band 2
Philip Katz undertakes an array of FDA matters including issues relating to orphan drugs designation and regulatory exclusivity.
"Philip is a strong lawyer."
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2
Sheree R. Kanner
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Band 2
Sheree Kanner offers deep expertise in Medicare and Medicaid litigation and regulatory compliance.
"Sheree is an outstanding attorney."
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Alice Valder Curran
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Alice Valder Curran offers significant strength in pricing issues, including coverage and reimbursement. She also counsels on wider regulatory matters and government investigations.
"Alice is incredibly thoughtful and creative. She also has a practical mindset."
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Clifford D Stromberg
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Band 3
Clifford Stromberg handles M&A for prominent health systems and networks across the country. He counsels on transaction-related regulatory issues and antitrust matters.
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David Horowitz
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Band 3
David Horowitz draws on his extensive experience during his tenure at HHS and FDA. He is renowned for his ability to advise pharmaceutical clients on a range of regulatory issues.
"His guidance is exceptional and extremely valuable."
"David has a great knowledge base and great judgment."
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3
Ken Choe
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Band 3
Ken Choe has particular expertise in advising pharmaceutical manufacturers on pricing matters. He also has strength in governmental investigations and regulatory issues arising from the Affordable Care Act.
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3
Meredith Manning
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Meredith Manning comes highly recommended for her long-standing regulatory expertise, which sees her regularly work with a range of pharmaceuticals. She is equally adept at providing compliance counsel and advising on investigations conducted by entities such as the FDA.
"Meredith is an excellent attorney."
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Michael Heyl
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Michael Heyl advises medical and diagnostic device manufacturers on a broad range of FDA regulation matters. He has expertise in dealing with cross-border issues.
"Mike provides exceptional practical advice."
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Ronald Wisor
Head of Healthcare
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Band 3
Ronald Wisor is the leader of the health practice. He advises an impressive healthcare client base on fraud and abuse, reimbursement and digital health-related issues.
"Ronald is one of the most thorough and highly technical healthcare lawyers."
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John J Smith
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Former clinician John Smith continues to develop a strong regulatory practice assisting pharmaceutical and medical products manufacturers in a wide range of issues, including FDA clearance.
"John is a tremendous partner and I find his guidance invaluable."
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Ranked Lawyers at
Hogan Lovells

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District of Columbia

Healthcare
S
Helen R Trilling
S
Senior Statespeople
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Robert F Leibenluft
S
Robert F Leibenluft
S
Senior Statespeople
View Profile
2
Beth L Roberts
2
Band 2
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Jonathan L. Diesenhaus
2
Jonathan L. Diesenhaus
2
Band 2
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2
Sheree R. Kanner
2
Band 2
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3
Alice Valder Curran
3
Band 3
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3
Clifford D Stromberg
3
Band 3
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3
Ken Choe
3
Band 3
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3
Ronald Wisor
Head of Healthcare
3
Band 3
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Healthcare: Pharmaceutical/Medical Products Regulatory
S
Jonathan S Kahan
S
Senior Statespeople
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1
David Fox
1
Band 1
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2
Philip Katz
2
Band 2
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3
David Horowitz
3
Band 3
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3
Meredith Manning
3
Band 3
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3
Michael Heyl
3
Band 3
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4
John J Smith
4
Band 4
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Industries

Provided by Hogan Lovells

Digital Health