
Paul E. Kalb, M.D.
Healthcare and FDA
Life Sciences
Food, Drug and Medical Device
In addition to his work on enforcement matters, Paul counsels private equity firms on life sciences investments and advises both boards of directors and companies on compliance issues. He is also a co-founder of the Medical Information Working Group, a coalition of life sciences companies dedicated to rationalizing the rules governing the exchange of scientific information.
Paul served on Sidley’s Executive Committee from 2007–2022 and, in that capacity, helped lead the firm’s strategic planning process. He co-founded Sidley’s Global Life Sciences practice, served as Global Practice Leader for the firm’s Healthcare and FDA Group from 2018–2022, and headed the firm’s Health Care Group from 2004–2018. He currently leads the firm’s Covid-19 Task Force and coordinates the firm’s healthcare and life sciences transactional initiatives.
Paul’s work representing clients has earned him acknowledgment in numerous industry publications. Naming Paul a “Health Care MVP,” Law360 noted that “his track record shimmers with borderline-historic achievements for life sciences clients” and that he “has repeatedly helped save the day when drugmakers faced steep fines and exclusion from government health programs.”
According to Chambers USA, from which he received a “Tier 1” ranking: “A J.D./M.D., Kalb is lauded for his tremendous, nuanced appreciation of critical enforcement matters.” Chambers also described him as “wickedly smart” and “widely acclaimed for his work representing device and drug manufacturers in government investigations,” and said that “when you bring him in and he’s talking, people listen.’” Chambers also described Paul as a “client-focused, results-oriented and pragmatic” lawyer; an “extremely good strategic thinker”; and a “strategist who is very analytical, very responsive, and easy to work with.”
Paul has received the highest ranking among U.S. lawyers in the “Government Enforcement and Investigations” category in PLC’s surveys of leading Life Science lawyers worldwide since 2006, and he has been recognized as a leading lawyer in PLC’s worldwide Dispute Resolution survey. He has been named by Super Lawyers magazine as one of the Top 100 lawyers in Washington based on a vote of peers; and he has been recognized by Washingtonian magazine as one of the “Top Lawyers in Washington” and by The Best Lawyers in America in Healthcare Law. Additionally, Paul was named a “Life Sciences Star” by LMG Life Sciences (2019–2023). Benchmark Litigation has honored Paul as a “Litigation Star” (2022–2024).
On five occasions, BTI Consulting, on the basis of a survey of general counsel of Fortune 1000 companies, has named Paul as a member of the BTI Client Service All-Star Team for law firms.
Paul is a graduate of Yale Law School, where he was a senior editor of the Yale Law Journal. Prior to attending law school, he received his M.D. degree, magna cum laude, from the Boston University School of Medicine where he was elected to the Alpha Omega Alpha Honor Medical Society. He completed his residency in Internal Medicine at the New York Hospital-Cornell Medical Center, and subsequently worked at both Memorial Sloan-Kettering Cancer Center and Yale-New Haven Hospital.
Paul has written numerous articles in legal, medical, and industry publications. He has focused, in particular, on the fiduciary obligations of directors to oversee “mission critical” risks. He speaks regularly at industry conferences and has also lectured on fraud and abuse issues at the Justice Department’s National Training Center. He was a visiting lecturer at Yale College in Medicine, Law, and Public Policy.
経験
- 代表案件
- メンバーシップ&アクティビティ
Representative matters that are public include:
- Represented Millennium Pharmaceuticals in its successful defense of a qui tam action involving allegations of improper promotion of one of the company’s drugs
- Represented GE Healthcare in connection with an investigation of the company’s pricing and promotion of a radiopharmaceutical product
- Represented Bausch & Lomb in connection with a criminal investigation of ISTA Corporation, an acquired asset
- Represented Genentech in connection with criminal and civil investigations regarding Rituxan and Tarceva
- Represented DaVita in connection with an investigation of the company’s joint venturing practices and an investigation of its Healthcare Partners Medicare Advantage business
- Represented GlaxoSmithKline in Corporate Integrity Agreement negotiation
- Favorably resolved cases brought against Novo Nordisk regarding allegations of illegal promotional activity
- Defended Eli Lilly and Company in two investigations by federal and state prosecutors
得意分野
- Crisis Management and Strategic Response
- 食品・医薬品・医療機器関連の規制業務
- ライフサイエンス
- Healthcare
- バイオテクノロジー
- Cell and Gene Therapy
- 臨床試験
- コンプライアンス カウンセリング - FDA
- コンプライアンス カウンセリング - ホワイト カラー
- 虚偽権利主張法
- 海外腐敗行為防止法/汚職禁止
- 米国食品医薬品局による執行
- グローバル薬価
- 大陪審による調査
- 医療分野強制執行
- 医療訴訟
- Healthcare Payment, Delivery, and Management Services
- Healthcare Providers
- Healthcare Providers Crisis Management and Strategic Response
- 医療政策と政府問題委員会
- 医療規制当局
- Healthcare Transactions
- 内部調査
- Life Sciences Transactions
- 医療機器
- 製薬
- Pre-Commercial Life Sciences Companies
- Public Companies
- ライフサイエンス業界へのM&Aと投資におけるリスク評価と緩和
- リスク緩和:米国販売マーケティング
ニュース&インサイト
資格
弁護士資格・登録
- U.S. Supreme Court
- U.S. Court of Appeals, 5th Circuit
- U.S. Court of Appeals, 8th Circuit
- U.S. Court of Appeals, 9th Circuit
- U.S. Court of Appeals, 10th Circuit
- U.S. Court of Appeals, 11th Circuit
- U.S. Court of Appeals, D.C. Circuit
- U.S. Court of Appeals, Federal Circuit
- U.S. District Court, District of Columbia
- District of Columbia
- ニューヨーク
学歴
- Yale Law School, J.D., 1990
- Boston University School of Medicine, M.D., 1983 (magna cum laude, Alpha Omega Alpha)
- Boston University, B.A., 1979 (summa cum laude, Phi Beta Kappa)