Former Novo Nordisk General Counsel James C. Shehan Joins the firm

Hyman, Phelps & McNamara, P.C. is pleased to announce that James C. Shehan has joined the firm as Of Counsel. Previously, Mr. Shehan served for 19 years as Novo Nordisk Inc.’s General Counsel and Corporate Vice President of Legal, Government and Quality. His extensive experience will bolster the firms already deep expertise in, and inside knowledge of, the drug industry. Specifically, Mr. Shehan’s work at the firm will focus on:

• Internal investigations and strategic handling of federal enforcement actions;
• Corporate compliance and GMPs;
• Hatch-Waxman and advertising litigation;
• Private and public transaction due diligence; and
• Drug development, biosimilars, and other areas essential to the drug industry.

At Novo Nordisk, Mr. Shehan was a part of an executive team that led one of the most successful healthcare companies in the United States. During his years there, Novo Nordisk became the US market leader in diabetes, established other thriving therapeutic areas, went from ~ 200 employees to more than 5000, and grew sales from ~$100 million to more than $5.5 billion while achieving over 40 consecutive quarters of double-digit sales growth.

Mr. Shehan began as the sole member of the legal department and eventually managed a staff of 100. His tenure included the approval of four blockbuster drugs, a multi-year GMP investigation, a Supreme Court Hatch-Waxman case, the successful defense of a Lanham Act false advertising challenge to the launch of a new biotech product, the partial spin-off of ZymoGenetics Inc. in what was at that time the largest private equity placement in history, and patent litigations related to human growth hormone, medical devices, and inhaled and injectable insulins.

Mr. Shehan also established Novo Nordisk’s compliance program and government affairs function. In the latter role, he led Novo Nordisk’s efforts to shape the passage and implementation of the Affordable Care Act, particularly the provisions that allow for the first time in the US the approval of biosimilar drugs and the Sunshine provisions that require pharmaceutical and medical device companies to publicly report certain payments to physicians. In the former role, he obtained extensive experience in the areas of health care fraud, off-label promotion and government drug price reporting and discounting.

Mr. Shehan has served on the boards of the Healthcare Institute of New Jersey, the National Association of Manufacturers and the Healthcare Leadership Council. He was also for many years a member of the Law Section Executive Committee of the Pharmaceutical Research and Manufacturers of America and the General Counsel Committee of the Biotechnology Industry Organization. He is Chairman of the Board of the American Friends of the Statens Museum for Kunst (Denmarks national art gallery).

Prior to Novo Nordisk, Mr. Shehan spent five years as a regulatory attorney at Pfizer, where he worked on matters such as the approval and launch of Zithromax, Zoloft, and Procardia XL and the product liability litigation and regulatory issues stemming from the Bjork-Shiley heart valve. Mr. Shehan began his career as a Regulatory Counsel in the Office of the Associate Commissioner of Health at FDA. He is a recipient of FDAs Award of Merit for his work on the implementation of the Hatch-Waxman Amendments.

Mr. Shehan is a graduate of Georgetown Law School and the Columbia University. He is admitted to practice law in New York State.