Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted
Posted on July 17, 2025 by Expert Witness Profiler
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.
The Plaintiffs Jamie Siegel and the State of Washington filed a motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Dr. Marilyn J. Manco-Johnson.
Hematology Expert Witness
Marilyn J. Manco-Johnson is a board-certified hematologist with fifty (50) years of experience treating and managing patients with hemophilia, including those with inhibitors, and other rare blood disorders.
She has treated patients, including those with the inhibitor antibodies, with NovoSeven and alternative hemophilia treatments developed by other pharmaceutical companies.
Discussion by the Court
Manco-Johnson’s report described the history, development, and standard of care applicable to hemophilia treatments. Specifically, she opined that from 2005 to 2015—the period relevant to this case—the prophylactic and high-dose usage of NovoSeven was “safe, effective, and accepted by doctors . . . for certain hemophilia patients with inhibitors.” According to her, NovoSeven was considered “clinically appropriate and an accepted method of treatment.”
However, Washington challenged Manco-Johnson’s report as irrelevant on several grounds. First, it argued that the report did not “mention or analyze the medical necessity” of NovoSeven. Furthermore, it contended that her testimony about the standard of care was also irrelevant, asserting that this “is a case about whether illegal means were used to cause the government to pay for a product that was not medically necessary, as defined by standards particular to the Washington Medicaid program.” Finally, Washington argued that Manco-Johnson should be precluded from testifying about the use of and reference to compendia, since her report does not “mention or evaluate any compendia.”
Analysis
First, the Court agreed that Manco-Johnson’s report failed to mention or evaluate any compendia. Any such testimony will therefore be excluded.
Next, the Court precluded Manco-Johnson from testifying as to whether illegal means caused the off-label use of NovoSeven. Her report does not contain any opinions on this issue.
Finally, the Court concluded that the standard of care applicable to NovoSeven and its medical appropriateness is relevant to this case. Although she does not use the term “medical necessity,” Manco-Johnson opined that NovoSeven was considered safe, effective, and accepted by doctors. Washington raised both medical necessity and acceptance in its briefing. While it suggests the standards for medical acceptance and necessity are distinct, this argument goes to the weight, not admissibility, of Manco-Johnson’s testimony.
Washington has even argued that its claims rest on the alleged unlawful kickbacks, rather than on questions of medical necessity. Nevertheless, there is no dispute that, after several doctors—including Dr. Jeffrey Thompson—and the 2009 Hemophilia Working Group reviewed NovoSeven for medical necessity, Washington Medicaid approved and paid for its use during the relevant period. In fact, Washington has conceded that this payment constitutes evidence of medical necessity.
Moreover, the Court has authorized an adverse inference instruction, allowing the jury to infer that the lost or destroyed Hospital Corporation of America (HCA) records likely showed that reviewers approved NovoSeven because it was medically necessary. Even so, the jury could still conclude that neither Manco-Johnson and Thompson nor the 2009 Hemophilia Working Group followed the regulatory hierarchy of evidence in determining medical necessity. Consequently, Manco-Johnson’s opinion regarding NovoSeven’s medical appropriateness, acceptance, and standard of care became both relevant and admissible.
Held
The Court granted in part and denied in part the State of Washington’s Daubert motion to exclude the testimony of Dr. Marilyn Manco-Johnson.
Key Takeaway:
Manco-Johnson has sufficient expertise and experience treating hemophilia patients with inhibitors with NovoSeven for on- and off-label purposes. Her knowledge, background, and testimonial opinions concerning hemophilia and the evolution of treatment modalities over decades satisfy the requirement in Rule 702 that her testimony will assist the jury in understanding the evidence and determining facts in issue. Her testimony will be largely permitted because she is a qualified expert in the medical field through education, training, experience, knowledge, and skill, her report is based on sufficient facts or data, and her opinions are the product of the reliable application of principles and methods.
Please refer to the blog previously published about this case:
https://expertwitnessprofiler.com/law-legal-expert-helps-jury-understand-medicaids-complex-regulatory-framework
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 15, 2025 |
