Paul E. Kalb, M.D.
PAUL KALB, who heads the firm’s national Healthcare practice and serves as a co-leader of its Life Sciences practice, brings an uncommon clinical perspective, grounded in his experience as an attending physician at the Memorial Sloan-Kettering Cancer Center, to bear in his work for a wide range of healthcare clients. He has successfully represented many of the world’s leading drug, biotech and device manufacturers as well as hospitals and other providers in criminal, civil, and administrative enforcement actions involving healthcare fraud and abuse and off-label promotion. He has led teams that defended numerous matters and negotiated ground-breaking settlement agreements and Corporate Integrity Agreements.
In addition to his work on enforcement matters, Paul counsels both boards of directors and companies on compliance issues, including compliance program effectiveness and CIA implementation and management. 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.
Representative matters that are public include:
Represented Genentech in connection with a lengthy criminal and civil investigation regarding Rituxan
Represented DaVita in connection with an investigation of the company’s joint venturing practices
Represented GlaxoSmithKline in Corporate Integrity Agreement negotiation
Favorably resolved a case brought against client Novo Nordisk regarding allegations of illegal promotional activity
Represented GE Healthcare in connection with an investigation of the company’s pricing and promotion of a radiopharmaceutical product
Defended Eli Lilly and Company in two investigations by federal and state prosecutors
Paul's work defending clients has earned him acknowledgement 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 JD/MD, Kalb is lauded for his tremendous, nuanced appreciation of critical enforcement matters.” Chambers also described him as a leader in the fraud and abuse arena, saying he is “widely acclaimed for his work representing device and drug manufacturers in government investigations,” and that “sources praise his ‘fantastic practice.’” The 2013 edition commended Paul as a “client-focused, results-oriented and pragmatic" attorney, and an ‘extremely good strategic thinker.’" Paul has also 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 named as a leading lawyer in PLC’s worldwide Dispute Resolution survey. In 2013, he was named by Ethisphere Magazine as one of two “Attorneys Who Matter” in the healthcare/pharma sector and he was featured as a “Life Sciences Star” for outstanding Fraud and Abuse work in the inaugural edition of EuroMoney’s LMG Life Sciences 2012. He has also been named by Super Lawyers magazine as one of the Top 100 lawyers in Washington based on a vote of peers, and recognized by Washingtonian magazine as one of the “Top Lawyers in Washington,” and by The Best Lawyers in America in Healthcare Law.
On four occasions, BTI Consulting, on the basis of a survey of general counsels 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 an 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 and completed his residency in Internal Medicine at the New York Hospital-Cornell Medical Center.
Paul is an author, along with Robert Fabrikant, Mark Hopson and Pamela Bucy, of Health Care Fraud: Enforcement and Compliance and has written numerous articles in legal, medical, and industry publications.
- “Second Circuit Rejects Regulation of Off-Label Promotion as Misbranding,” International Law Office, December 19, 2012 (co-authored with Coleen Klasmeier and Jeffrey M. Senger).
- “OIG's Continued Focus on Corporate Executives,” Bloomberg Corporate Accountability Report, December 7, 2012 (co-authored with Hae-Won Min Liao and Greg B. Sherman).
Paul is a member of the firm’s Executive Committee. He speaks regularly at industry conferences and has also lectured on fraud and abuse issues at the Justice Department’s National Training Center. He also was a visiting lecturer at Yale College in Medicine, Law and Public Policy.
- Panelist, “Developments in the Regulation and Enforcement of Off Label Promotion,” Life Sciences College: U.S. Pharmaceutical, Biotechnology and Medical Device Update (New York, NY, May, 2015).
- Panelist, –“FDA and the First Amendment,” FDA/CMS Summit for Biopharmaceutical Executives 2014, Panel regarding promotion/commercial speech (December 12, 2014).
- Presenter, “Off-Label Communications and the Constitution: Will FDA Finally Change its Policies?” 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum (November 4, 2014).
- Presenter, “Evolution of Government Enforcement,” 2014 PhRMA Law Section (April 9, 2014).