Siegel v. Novo Nordisk Inc

Opinion

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5 UNITED STATES DISTRICT COURT 6 WESTERN DISTRICT OF WASHINGTON AT TACOMA 7 UNITED STATES OF AMERICA, et CASE NO. C23-5459 BHS 8 al., ORDER 9 Plaintiffs,

10 Ex rel., 11 JAMIE SIEGEL, M.D., 12 Plaintiff-Relator, 13 v. 14 NOVO NORDISK, INC., 15 Defendant. 16

17 THIS MATTER is before the Court on plaintiffs Siegel and Washington’s motion 18 to exclude the testimony of defendant Novo Nordisk Inc. (NNI)’s expert witness, Mr. 19 Joshua Slen, Dkt. 417. 20 Slen is a healthcare consultant with a Masters in Public Administration. He has 21 had decades of experience in the administration and consultation of healthcare programs, 22 1 has extensive knowledge about state administered Medicaid programs, and is 2 knowledgeable about the governing and regulatory frameworks of several states. He has

3 expertise in utilization management, and understands how states (including Washington) 4 approve drugs generally and for off-label uses. Slen’s expert report, titled “Preliminary 5 Report on Medicaid Drug Utilization Tools,” describes state Medicaid programs’ 6 practices relating to the on- and off-label utilization of prescription drugs. Dkt. 409 at 31. 7 Washington argues Slen’s testimony improperly consists of legal conclusions and 8 is irrelevant because it relates to pre-authorization utilization management tools that

9 Washington could have used. Dkt. 417 at 3–5. It also contends Slen is not an expert on 10 Medicaid fraud and kickback schemes. Id. at 2. 11 A qualified expert may testify in the form of an opinion or otherwise only if the 12 proffered testimony is both relevant and reliable. Fed. R. Evid. 702; Teradata Corp. v. 13 SAP SE, 124 F.4th 555, 566 (9th Cir. 2024) (citing Daubert v. Merrell Dow

14 Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993)). Rule 702 and Daubert impose on the 15 district court a “gatekeeping” duty to ensure that opinion testimony is relevant and 16 reliable, and an expert’s opinion should be excluded if it does not have a reliable 17 foundation or if it is not based in the knowledge and experience of the relevant discipline. 18 Sonneveldt v. Mazda Motor of Am., Inc., 2024 U.S. App. Lexis 32836, *3 (9th Cir. Oct.

19 21, 2024) (citing Primiano v. Cook, 598 F.3d 558, 564-65 (9th Cir. 2010)). “Expert 20 opinion testimony is relevant if the knowledge underlying it has a valid connection to the 21 pertinent inquiry. And it is reliable if the knowledge underlying it has a reliable basis in 22 the knowledge and experience of the relevant discipline.” Surgical Instrument Serv. Co. 1 v. Intuitive Surgical, Inc., 2024 U.S. Dist. Lexis 81690, *5 (N.D. Cal. March 31, 2024) 2 (quoting Alaska Rent-A-Car, Inc. v. Avis Budget Grp., Inc., 739 F.3d 960, 969 (9th Cir.

3 2013). When an expert meets the Rule 702 threshold, “the expert may testify and the jury 4 decides how much weight to give that testimony.” Primiano, 598 F.3d 558 at 565. 5 Slen has sufficient expertise and experience in the field of Medicaid 6 reimbursement for drugs used for on- and off-label purposes and the regulatory 7 framework surrounding their approval. His testimony will be largely permitted because 8 he is a qualified expert in the field of healthcare administration through education,

9 training, experience, knowledge, and skill, his report is based on sufficient facts or data, 10 and his opinions are the product of the reliable application of principles and methods. 11 The jury may find Slen’s extensive knowledge and experience helpful. His 12 explanations of the regulatory environment may assist the jury in understanding the 13 complexity and technicalities of Medicaid utilization management. However, the Court

14 concludes that any testimony regarding utilization management tools that could have 15 been, but were not, used by the State of Washington’s Health Care Authority has no 16 relevance and could confuse the jury. Any such testimony is therefore unfairly prejudicial 17 to the plaintiffs. Fed. R. Evid. 403. Slen’s testimony shall be limited to describing the 18 regulatory framework to what is applicable to the plaintiffs’ case. The Court will

19 carefully assess the extent to which Slen’s testimony adds information irrelevant to this 20 case. The Court expects Slen’s testimony on these matters will take less than one hour, 21 followed by a short cross-examination. 22 1 Washington’s motion to exclude Slen’s opinion, Dkt. 417, is to this extent 2 GRANTED. It is otherwise DENIED.

3 IT IS SO ORDERED. 4 5 Dated this 9th day of July, 2025. A 6 7 BENJAMIN H. SETTLE 8 United States District Judge 9 10 11

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