United States, et al., ex rel. Jaime Siegel v. Novo Nordisk, Inc.

Analysis Group was retained by Sidley Austin on behalf of Novo Nordisk in a whistleblower lawsuit alleging that the company promoted its hemophilia drug, NovoSeven, for off-label use and provided kickbacks to physicians and patients, in violation of the False Claims Act and Anti-Kickback Statute. The plaintiffs – the State of Washington and Dr. Jamie Siegel, Novo Nordisk’s former director of hematology – alleged that Novo Nordisk promoted NovoSeven for unapproved uses, including at higher doses and for prophylactic treatment, and that these practices, along with improper payments and benefits provided to physicians and patients through patient assistance programs and sponsored events, caused the submission of false claims to Medicaid and Medicare.  

An Analysis Group team led by Managing Principal Andrée-Anne Fournier and Vice President Atang Gilika supported affiliated expert Dr. Anupam B. Jena, Professor of Health Care Policy and Medicine at Harvard Medical School. Dr. Jena submitted expert reports and provided deposition and trial testimony on issues of causation and pharmaceutical industry practices, including the factors that influence physicians’ prescribing decisions, the role of patient assistance programs in supporting care, and common interactions between drug manufacturers and physicians. He opined that there was no evidence that health care providers had prescribed NovoSeven more frequently than they otherwise would have.

Following a trial in the US District Court for the Western District of Washington, a jury cleared Novo Nordisk on all claims, rejecting allegations of Medicaid and Medicare fraud. The verdict concluded a decade-long legal dispute and confirmed that the plaintiffs had failed to establish any causal connection between Novo Nordisk’s actions and the submission of false claims.