Plaintiff State of Washington alleged that Novo Nordisk Inc. (“NNI”) caused physicians to prescribe its drug, NovoSeven®, to Washington hemophilia patients by: (1) promoting it “off-label” for prophylaxis and “high dose” use; (2) paying kickbacks to physicians; and (3) paying bribes to patients, all of which rendered claims to Medicare and Washington Medicaid false.
The State of Washington has been investigating this case for almost fifteen years, hoping to find evidence of unlawful conduct that allowed its Medicaid program to recoup money it paid for a medically necessary, life-saving drug.
Novo Nordisk’s expert, Dr. Anupam B. Jena, a medical doctor who also has a Ph.D. in economics opined that NNI’s “alleged publication strategy” did not cause the submission of false claims for NovoSeven.
Washington did not challenge Jena’s credentials or expertise, but it did argue that his “causation” opinions were not admissible because (1) they were based on insufficient or mis-stated facts; (2) his methodology was unreliable because though he is not an expert on the independence of medical publications, he makes “assumptions” about the integrity of the publications at issue, while ignoring other evidence particular to the publications and strategies at issue; (3) he opined about areas of medicine and reimbursement that are outside his expertise; and (4) he opined about the law of causation, a matter better left for jury instructions.
Internal Medicine Expert Witness
Dr. Anupam B. Jena, MD, PhD, is the Joseph P. Newhouse Professor of Health Care Policy at Harvard Medical School and a physician in the Department of Medicine at Massachusetts General Hospital. He is also a faculty research associate at the National Bureau of Economic Research. As an economist and physician, Jena’s research involves several areas of health economics and policy including the use of natural experiments in health care, the economics of physician behavior and the physician workforce, medical malpractice, the economics of health care productivity, and the economics of medical innovation.
Jena graduated Phi Beta Kappa from the Massachusetts Institute of Technology. He received his MD and PhD in Economics from the University of Chicago and completed his residency in internal medicine at Massachusetts General Hospital. He is the host of the Freakonomics, MD podcast, which explores the “hidden side of health care.”
Discussion by the Court
The Court concluded that Jena is qualified to opine on the bulk of topics in his Report, including the reliability of peer-reviewed publications. He has sufficient expertise and experience in the field of physician behavior in connection with writing prescriptions to set out the many factors that can influence treating physicians in their selection of pharmaceuticals to prescribe for their patients.
While Jena’s testimony was largely permitted because he is a qualified expert in the fields of medicine and economics and his report is based on sufficient facts or data, Jena was barred from opining on the ultimate legal conclusion that the physicians who prescribed NovoSeven did not do so because of the inducements and benefits NNI extended to them or their patients.
Held
The Court granted in part and denied in part the Plaintiffs Siegel and Washington’s motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Dr. Anupam Jena.
Key Takeaway:
As a general rule, an expert opinion is not objectionable simply because it embraces an ultimate issue to be decided by the trier of fact. However, an expert cannot opine as to a legal conclusion, or to the ultimate issue of law; instructing the jury on the applicable law is the Court’s distinct and exclusive province.
Please refer to the blog previously published about this case:
Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework
Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted
Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded
Case Details:
| Case Caption: | United States ex rel. Siegel V. Novo Nordisk Inc. |
| Docket Number: | 3:23cv5459 |
| Court Name: | United States District Court, Washington Western |
| Order Date: | July 2, 2025 |
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