Expert Witness Profiler

Category: Hematology Expert Witness

  • Medical Expert Cleared to Testify on Treatment in Medicaid Case

    Medical Expert Cleared to Testify on Treatment in Medicaid Case

    The case arose from the use and reimbursement of the drug NovoSeven, which was prescribed to ten Washington Medicaid patients with severe Hemophilia A and inhibitors to Factor VIII. Some used the drug in high doses or for off-label prophylactic treatment. Washington Medicaid reimbursed these prescriptions during the relevant period.

    NNI retained Dr. Michael Tarantino as an expert witness. Tarantino reviewed 65,000 pages of medical records. He found the use of NovoSeven appropriate in eight cases. For the other two, he lacked sufficient data. He also concluded the drug was used safely in the reviewed cases.

    The State of Washington and plaintiff Jamie Siegel moved to exclude his testimony. They argued the case focused on Medicaid reimbursement rules—not medical appropriateness. Washington said Tarantino lacked expertise in state regulations and failed to follow the required hierarchy of evidence.

    Hematology Expert Witness

    Michael Tarantino is a board-certified pediatric hematologist-oncologist with over 30 years of experience in bleeding and clotting disorders. He is the Founder, CEO, and Chief Medical Officer of the Bleeding & Clotting Disorders Institute and Medical Director of the Anticoagulation Consultation Service at St. Francis Medical Center.

    Since 2008, he has served as a tenured Professor of Pediatrics and Medicine at the University of Illinois College of Medicine in Peoria. He earned his M.D. from the University of Wisconsin, followed by a pediatrics residency at the University of Arizona and a fellowship in pediatric hematology-oncology at Wisconsin.

    Tarantino has authored over 125 peer-reviewed publications and 140 abstracts. In 2024, he received the Lifetime Achievement Award from the National Bleeding Disorders Foundation for his contributions to patient care, research, and advocacy.

    Want to know more about the challenges Michael Tarantino has faced? Get the full details with our Challenge Study report.  

    Discussion by the Court

    Expert Qualifications and Scope

    The Court found Dr. Michael Tarantino qualified under Federal Rule of Evidence 702. He had over three decades of clinical and academic experience in hematology. His report reviewed patient records to assess whether NovoSeven use was medically necessary, appropriate, and safe. The Court concluded that his opinions fell within his area of expertise and were relevant to the case.

    Plaintiffs’ Challenge to Relevance

    The State of Washington argued that Tarantino’s testimony failed to address the legal standards for Medicaid reimbursement. Specifically, it said he did not apply the “hierarchy of evidence” required under WAC 182-501-0165(6) or tie his conclusions to regulatory definitions of “medical necessity.” Washington emphasized that the question was not medical appropriateness, but whether the prescriptions met reimbursement criteria.

    Court’s Response: Goes to Weight, Not Admissibility

    The Court held that these arguments affected the weight of the testimony—not its admissibility. Washington had alleged the prescriptions were medically unnecessary and dangerous. Therefore, Tarantino’s analysis of the safety and appropriateness of NovoSeven was directly relevant. The Court ruled that his methodology was reliable and grounded in his clinical experience.

    Context of Medicaid Reimbursement

    The Court noted that Washington Medicaid reimbursed NovoSeven during the relevant time, including after a 2009 internal review by the Hemophilia Working Group. It had already allowed an adverse inference instruction due to the loss of documents related to that review. This instruction permits jurors to infer the documents supported medical necessity. The Court reasoned that expert testimony on medical necessity remained relevant under these circumstances.

    Limits on Testimony Regarding Inducements

    Tarantino also reviewed whether prescriptions were influenced by illegal inducements. The Court allowed him to testify about the medical reasons for using NovoSeven. However, it barred him from opining on whether the prescriptions were free from improper influence. The motion was granted to that limited extent.

    Held

    The Court granted in part and denied in part Plaintiff Washington’s motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Michael Tarantino.

    Key Takeaway:

    An expert’s failure to apply regulatory definitions or cite legal standards may affect the weight of their testimony—but not its admissibility—if their opinions are otherwise relevant, reliable, and within their expertise. Here, the Court allowed Tarantino to testify on the medical necessity, appropriateness, and safety of NovoSeven use, finding that his clinical evaluation was relevant to the claims, even if it did not directly apply Medicaid reimbursement criteria.

    Please refer to the blogs 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

    Internal Medicine Expert’s Testimony Limited Despite His Physician Behavior Experience

    Business Valuation Expert’s Testimony on Physicians’ Compensation Admitted

    Case Details:

    Case Caption: United States v. Novo Nordisk, Inc.
    Docket Number: 3:23cv5459
    Court Name: United States District Court for the Western District of Washington
    Order Date: July 15, 2025
  • Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    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.

    Get the full story on challenges to Marilyn Manco-Johnson’s expert opinions and testimony with an in-depth Challenge Study. 

    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:

    Law & Legal Expert Helps Jury Understand Medicaid’s 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