Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

Posted on July 16, 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, Daniel E. Troy.

Law & Legal Expert Witness

Daniel E. Troy has been an attorney for 40 years, with 23 years of experience in health care regulation, including three years as Chief Legal Counsel to the FDA and many more in the private sector health industry.

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

Discussion by the Court

To begin with, Washington argued that Troy’s opinions were improper legal conclusions about the ultimate issue of law: whether NNI’s marketing practices are protected by the First Amendment or U.S. Food and Drug Administration (“FDA”) regulations. It argued that “can be” is not an opinion at all; it is speculation. Moreover, Washington contended that Troy’s testimony would confuse and mislead the jury about the legality of NNI’s practices, prejudicing it.

NNI responded that there is well-established precedent that a properly qualified expert with expertise in the regulatory framework or landscape of a highly technical and regulated industry or program, such as Medicaid, can help a jury understand the evidence or determine a fact in issue. It argued that far from unduly prejudicing Washington or confusing the jury, Troy’s testimony will assist the jury in understanding the FDA’s enormously complex regulatory structure, in order to evaluate whether NNI’s conduct was improper.

Analysis

The Court agreed with NNI that the bulk of Troy’s testimony will assist the jury and is admissible. This case presents a complexity of issues that requires the jury to understand the regulatory scheme of the government’s oversight of pharmaceuticals through the review of extensive legal briefing spanning the years that this litigation has been pending. However, Troy will not be allowed to testify on how the application of the First Amendment has informed the development of case law in America as it applies to the pharmaceutical industry in its testing and promotion of its drugs.

The Court held that Troy will be permitted to testify about the marketing role that the dissemination of peer-reviewed studies has in the medical industry for the purpose of acquainting practicing physicians with new pharmaceuticals or new treatment applications of established pharmaceuticals, including off-label uses.

Basically, Troy’s testimony should discuss industry and regulatory standards when assessing a specific study or article, including the use of the FDA’s nonbinding Good Reprint Practice guidance, and related recommendations.

Moreover, Troy devoted a significant part of his report to discussing the Konkle Study in the context of the Good Reprint Practice review. This was apparently chosen because Washington cited it as an example of a marketing violation of the AKS.

As a defense expert, the Court reviewed Troy’s report and his expected trial testimony as rebuttal testimony. Troy will be permitted to go through the Good Reprint Practice guidance and review the record by identifying what NNI did factually to meet the Guidance standards. He will not be permitted to testify that NNI’s activities in connection with the Konkle Report rendered NNI in compliance with the AKS “safe harbor” as this would be testimony an ultimate issue of law.

Held

The Court granted in part and denied in part the State of Washington’s Daubert motion to exclude Daniel E. Troy’s testimony.

Key Takeaway:

In the Court’s view, Troy’s testimony is not unlike that of an expert physician specialist explaining to a jury the standard of care for a particular procedure by describing the procedure’s steps and then explaining, through reference to the medical records, what steps the allegedly negligent physician took. The expert would not be permitted to testify that, in his opinion, the reviewed physician was or was not negligent.

Similarly, Troy will be permitted to rebut any evidence produced in Washington’s case in chief regarding its claim that the jury should make a negative inference from the fact NNI rejected the FDA’s request that NNI conduct a Phase III Study. He describes these studies as expensive and explains how other alternatives can be used to demonstrate that NovoSeven is safe and effective, what he calls “real world evidence.”

Troy will also be permitted to rebut any evidence Washington introduces about free drug samples. He can describe how the FDA regulates this activity, and under what conditions free samples can meet the AKS’s safe harbor requirements, and what the record demonstrates about NNI’s distribution of free samples. He, however, may not testify that NNI complied with the regulations relating to free samples.

Washington conceded that, as a general rule, an expert’s opinion is not objectionable simply because it embraces an ultimate issue to be decided by the trier of fact. However, it argued persuasively that an expert cannot offer a legal conclusion or opine on an ultimate issue of law.

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 14, 2025