Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded
Posted on July 21, 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.
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.
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 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
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 |
