Expert Witness Profiler

Category: Pharmacology Expert Witness

  • Pharmacology Expert Allowed to Opine on the Clinical Trial

    Pharmacology Expert Allowed to Opine on the Clinical Trial

    Alzamend Neuro, Inc is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer’s disease and other neurodegenerative diseases. To advance the development of a new treatment called ALZN002, Alzamend sought to conduct a phase I/IIA clinical trial to evaluate its safety, tolerability, and preliminary efficacy.

    Biorasi, LLC is a contract research organization or clinical research organization (“CRO”) engaged in the business of providing clinical research services, clinical research professionals, and contract clinical, technical, and other related services.

    Alzamend asserted claims for breach of contract and fraudulent inducement after the ALZN002 Trial was derailed.

    Biorasi filed a motion to exclude the testimony of Plaintiff’s expert witness Dr. Frederick H. Hausheer while Alzamend sought to exclude the testimony of Biorasi’s rebuttal experts, Emily Friedrich and Aimon Iftikhar.

    Pharmacology Expert Witness

    Frederick Herman Hausheer, M.D. is a physician-scientist and biopharmaceutical research executive with over 37 years of experience in clinical drug development, including extensive Phase I–III clinical trial management under FDA and other international regulatory frameworks.

    He earned his M.D. from the University of Missouri-Columbia (completing medical school in three years), completed his internship and residency training there. He has held board certifications in Internal Medicine (since 1985) and Medical Oncology (since 1987). Hausheer completed a fellowship in Medical Oncology (in two years, with promotion to faculty) at the Johns Hopkins Oncology Center and Hospital, concentrating in Pharmacology and Experimental Therapeutics research and development.

    Discover more cases with Frederick Hausheer as an expert witness by ordering his comprehensive Expert Witness Profile report.

    Biomedical Engineering Expert Witnesses

    Emily Friedrich is a licensed Project Management Professional certified in Good Clinical Practices. Friedrich also holds a Bachelor of Science in Molecular Genetics and Biochemistry with a minor in Chemistry from the University of Pittsburgh granted in 2007 as well as a Master of Science and a Doctor of Philosophy in Biomedical Engineering from Carnegie Mellon University.

    She completed postdoctoral training at Northwestern University Feinberg School of Medicine in the Department of Surgery and held a Research Instructor position at the University of Illinois at Chicago in the Department of Pharmacology. Friedrich also served as a Biomedical Research Program Manager at a military treatment facility.

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

    Dr. Aimon Iftikhar specializes in clinical research and development of medical devices with a focus on assessing clinical efficacy and accuracy in real-world settings. She has a Bachelor of Science degree in Biomedical Engineering with minors in Mathematics and Materials Science and Engineering from the University of Connecticut, a Master of Science degree in Biomedical Engineering from Carnegie Mellon University, and a Doctor of Philosophy in Bioengineering with a concentration in Tissue Engineering & Regenerative Medicine from the University of Pittsburgh.

    Gain a comprehensive understanding of Aimon Iftikhar’s qualifications and casework history with her Expert Witness Profile report.

    Discussion by the Court

    A. Biorasi’s Motion to Exclude Frederick Hausheer

    i. Methodology

    Though Biorasi contended that Hausheer relied exclusively on assumptions to form his opinions, Hausheer’s report cited an extensive list of references and supporting documents reviewed including training materials, training logs, resumes, protocol deviation logs, emails, meeting minutes, call notes, as well as various plans regarding protocol deviation, quality management, and risk management.

    Biorasi also contended that Hausheer’s opinions are merely ipse dixit, but Hausheer explained that the conduct of the ALZN002-01 clinical trial “is guided by the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, which are universally recognized as industry standards of practice and are consistent with FDA regulations.” References to Good Clinical Practice guidelines are frequent throughout Hausheer’s report regarding industry standards for qualified personnel and training, trial plans, monitoring, quality management, and blinding and communication controls.

    The Court found that Hausheer’s opinions are not based on mere ipse dixit, but rather the result of reviewing record evidence and measuring the evidence against established industry standards in the context of his own substantial professional experience.

    ii. Helpfulness

    Biorasi argued that Hausheer’s opinions are not helpful for the same reasons it argued they are unreliable. However, the Court already found Hausheer’s opinions to be based on a reliable methodology. Moreover, the Court found Hausheer’s opinions would assist the trier of fact.

    B. Alzamend’s Motion to Exclude Dr. Emily Friedrich and Dr. Aimon Iftikhar

    i. Qualifications

    The Court found that both Friedrich and Iftikhar possess substantial clinical experience and possess certifications in the industry standards relied on by Alzamend’s expert, Hausheer.

    ii. Methodology

    Alzamend argued that because Biorasi’s proposed experts lack experience in double-blinded trials, their methodology is unreliable.

    However, Alzamend cited no case law or statutory authority for its contention that rebuttal experts who possess both clinical experience and certifications in the relevant industry standards should be excluded because they lack adequate double-blinded clinical experience.

    The Court found this methodology to be sufficiently reliable. Alzamend’s
    assertions of lack of experience in double-blinded studies goes to the weight, not the admissibility of the testimony and may be the subject of cross-examination.

    iii. Helpfulness

    Alzamend argued that the rebuttal experts’ opinions are not helpful because they impermissibly usurp the role of the fact finder.

    However, the Court found that the rebuttal experts’ opinions will assist the trier of fact in this case. The rebuttal experts’ assessment of the double-blinded trial, considering their substantial experience and analysis of industry standards, concerned matters that are beyond the understanding of the average lay person.

    As to Alzamend’s categorical objections to credibility determinations, weighing competing evidence, or rendering factual conclusions, Biorasi contended that the rebuttal experts are merely pointing to evidence that contradicts the assumptions relied on by Hausheer. The Court agreed with Biorasi, and it is permissible for an expert to review facts and extrapolate opinions from those facts based on experience and industry standards.

    Held

    • The Court denied Biorasi’s Daubert motion to exclude the testimony of Plaintiff’s expert witness Dr. Frederick Hausheer.
    • The Court denied Alzamend’s Daubert motion to exclude the testimony of rebuttal experts, Emily Friedrich and Aimon Iftikhar.

    Key Takeaway

    The qualification standard for expert testimony is not stringent and so long as the expert is minimally qualified, objections to the level of the expert’s expertise go to credibility and weight, not admissibility.

    Case Details:

    Case Caption: Alzamend Neuro, Inc. V. Biorasi, LLC
    Docket Number: 1:25cv20481
    Court Name: United States District Court, Florida Southern
    Order Date: June 16, 2026
  • Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded

    Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded

    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.

    Jamie Siegel and Washington State’s expert witness, Dr. Adriane J. Fugh-Berman, opined broadly that NNI’s promotional methods and practices caused physicians and patients to use more NovoSeven, including off-label. NNI filed a Daubert motion to exclude the testimony of Fugh-Berman.

    Pharmacology Expert Witness

    Dr. Adriane J. Fugh-Berman, MD is a Professor of Pharmacology and Physiology with a joint appointment in the Department of Family Medicine at Georgetown University Medical Center.

    She has spent her 35-year academic career researching how pharmaceutical companies market to the medical community, and how that marketing affects the prescription practices of that community.

    Get the full story on challenges to Adriane Fugh-Berman’s expert opinions and testimony with an in-depth Challenge Study. 

    Discussion by the Court

    To begin with, NNI did not directly challenge Fugh-Berman’s credentials, and it did not argue that she is not an expert in her field. It did emphasize that she self-identifies as an “activist” advocating for “rational prescribing and promoting public health,” and that her opinions have been excluded as irrelevant in other cases.

    NNI sought to exclude Fugh-Berman’s opinions, arguing that she failed to set out sufficient facts and data to support her unreliable analytical methodologies, and failed to reliably apply her principles and methods.

    Discourse Analysis

    NNI specifically challenged Fugh-Berman’s reliance on “discourse analysis” to support her conclusion that NNI’s promotional activities improperly affected prescribing physicians’ judgment when selecting a pharmaceutical to treat a hemophilia patient. Moreover, NNI argued persuasively that discourse analysis was not even mentioned in her Report. The Court therefore precluded any opinion testimony about applying “discourse analysis” unless raised by the defense.

    Patient A’s Use of NovoSeven

    Fugh-Berman has general knowledge from experience and known studies and is qualified to testify generally about physician behavior in prescribing pharmaceuticals, and what can influence that behavior. However, she will not be permitted to testify that NNI’s promotional methods were responsible for “specific increases in the prescribing behavior” of Patient A’s primary physician, Dr. Ronald Louie, or about the effects of the promotions on Patient A. NNI persuasively argued that Fugh-Berman did not review specific “claims data” and “medical records” associated with Patient A’s use of NovoSeven. Fugh-Berman may summarize what benefits the record demonstrates were provided to Louie and Patient A that may have influenced Louie in the way that studies have shown that these types of benefits influence prescription choices. She will not be permitted to testify that these benefits caused Louie to use NovoSeven. This is an ultimate legal conclusion for the jury.

    NNI also objected to Fugh-Berman’s proposed “factual narrative” testimony. It argued that it would be improper for her to offer a speculative editorial about the alleged nefarious global effects of [NNI’s] marketing practices” and its “sway over the medical community” because it is “neither relevant nor reliable.” The Court agreed.

    Fugh-Berman’s report concluded with two paragraphs opining about the purpose and effect of NNI’s allegedly illegal marketing tactics, and specifically about the consequences of the benefits it provided to Louie, Patient A, and his mother. These ultimate conclusions of law are for the jury, and she will not be permitted to so opine. In other words, she cannot characterize the high dosage or prophylaxis use of NovoSeven as “unproven.” She can testify that, generally, based on her experience, scholarship, and training, promotional campaigns have been shown to affect such behavior.

    Held

    The Court granted in part and denied in part NNI’s Daubert motion to exclude Adriane Fugh-Berman’s testimony.

    Key Takeaway:

    No expert shall testify in a form of an advocate editorializing, or present a conclusory narrative akin to attorney argument, rather than as an expert witness.

    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

    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 16, 2025