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5 UNITED STATES DISTRICT COURT 6 WESTERN DISTRICT OF WASHINGTON AT TACOMA 7 UNITED STATES OF AMERICA, et CASE NO. D23-5459 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 Jamie Siegel and the State of 18 Washington’s1 Daubert motion to exclude the opinion testimony of defendant Novo 19 Nordisk’s (NNI’s) expert witness, Michael Tarantino, M.D. Dkt. 419. 20 21 1 This Order refers to plaintiff relator Siegel and intervenor plaintiff Washington State 22 together as “Washington” for clarity, ease of reference, and consistency. Siegel filed the motion. 1 Dr. Tarantino is a board-certified hematologist and is qualified as an expert in his 2 field of treating hemophilia patients. His Report, Dkt. 420-1, contends he has reviewed
3 65,000 pages of medical records of ten Washington Medicaid patients who used 4 NovoSeven for “severe Hemophilia A with inhibitors to FVIII,” including the off-label 5 use for prophylaxis and high doses, to evaluate whether their use of NovoSeven was 6 medically necessary, appropriate and accepted. He opines that the use of NovoSeven was 7 appropriate for eight of the patients; for the other two, he did not have enough data to 8 draw a conclusion. Dkt. 420-1.
9 Washington seeks to exclude Tarantino’s testimony under Federal Rule of 10 Evidence 702 and Daubert. Dkt. 419. It asserts that the issue in the case is not whether a 11 patient “appears to have been prescribed medically appropriate doses of NovoSeven,” but 12 instead whether Washington law governing reimbursement allows for payment. Id. at 1. 13 It argues that Tarantino has no expertise on this issue; he struggles to define the terms he
14 uses and does not tie them to any definition in a Washington law or regulation. It 15 contends he does not even mention the “compendia of drug information,” upon which 16 NNI’s summary judgment motion, Dkt. 386, in part relies. 17 Washington specifically contends that Tarantino’s Report “curiously” omits the 18 phrase “medically necessary” when opining that the use of NovoSeven was “appropriate”
19 and “safe.” Id. It contends that because Tarantino does not mention the “hierarchy of 20 evidence” required under Washington law to determine if a treatment is medically 21 necessary and thus reimbursable, and that his opinion does not address whether 22 1 Washington Medicaid regulations would or should have covered any “off label” uses of 2 NovoSeven under those regulations’ “medical necessity” standard. Id. at 2–5.
3 NNI responds that Washington’s theory of the case is that patients’ use of 4 NovoSeven was medically unnecessary and dangerous. It therefore asked Tarantino to 5 review the records and determine whether the NovoSeven prescriptions written for them 6 were medically necessary, appropriate and accepted, and whether the use was safe. Dkt. 7 443 at 4. It argues that Tarantino is qualified, and that based on his review of the medical 8 records, he opines that the prescriptions were medically necessary, appropriate, and
9 accepted, and that the use of NovoSeven was safe. Id. (citing Dkt. 420-1 at 6). It contends 10 these opinions are relevant, reliable, and admissible. Id. at 5. 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 at 565. 5 Washington emphasizes that, despite his assignment and his conclusion, most of 6 Tarantino’s Report does not address the “medical necessity” of the prescriptions he 7 reviewed and does not address the WAC 182-501-0165(6) “hierarchy of evidence” 8 required to establish medical necessity for a NovoSeven prescription. Washington argues
9 that Tarantino’s opinion might be relevant in a medical malpractice case, but it is not 10 relevant to as to whether the NovoSeven prescriptions were reimbursable under 11 Washington Medicaid regulations. 12 As was the case with the Daubert motion to exclude the testimony of Dr. Manco- 13 Johnson, this argument goes to the weight, not the admissibility of the opinion testimony.
14 There is no dispute that Washington Medicaid paid for the use of NovoSeven during the 15 relevant period—including after Dr. Jeffrey Thompson and the 2009 Hemophilia 16 Working Group reviewed the use of NovoSeven for medical necessity, and authorized 17 payment for its use. The Court has agreed that the loss of documents reflecting that 18 review warrants an adverse inference instruction permitting the jury to infer that the
19 documents would have shown that Washington Medicaid viewed the use of NovoSeven 20 as medically necessary. Dkt. 480. Implicit in such an instruction is the possibility that a 21 jury could find that while Tarantino and Manco-Johnson did not faithfully follow the 22 hierarchy of evidence in concluding the use was medically necessary, there is similarly 1 no evidence that Dr. Thompson and the 2009 Hemophilia Working Group did so either, 2 though Washington Medicaid continued reimbursement for high dose and prophylactic
3 use of NovoSeven. Their opinions about this issue are relevant and admissible, and they 4 are subject to rigorous cross examination about WAC 182-501-0165(6)’s hierarchy of 5 evidence. 6 Tarantino’s opinion testimony about the safety of NovoSeven in the cases he 7 reviewed is also reliable, and relevant, and admissible. See Dkt. 420-1 at 6, ¶ 11. 8 Tarantino will also be permitted opine as to why NovoSeven was used in the cases
9 he reviewed, to rebut Washington’s contention that the NovoSeven prescriptions were the 10 result of illegal inducements. He will not be permitted to testify that the prescriptions 11 were not the result of the inducements, and Washington’s motion is to this limited extent 12 GRANTED. 13 Taratino is a qualified expert in his field, his review of the patients’ medical
14 records used a reliable methodology based on sufficient facts and data and which will be 15 helpful to the jury on the “acceptable” and “safe” nature of the NovoSeven prescriptions 16 at issue.
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5 UNITED STATES DISTRICT COURT 6 WESTERN DISTRICT OF WASHINGTON AT TACOMA 7 UNITED STATES OF AMERICA, et CASE NO. D23-5459 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 Jamie Siegel and the State of 18 Washington’s1 Daubert motion to exclude the opinion testimony of defendant Novo 19 Nordisk’s (NNI’s) expert witness, Michael Tarantino, M.D. Dkt. 419. 20 21 1 This Order refers to plaintiff relator Siegel and intervenor plaintiff Washington State 22 together as “Washington” for clarity, ease of reference, and consistency. Siegel filed the motion. 1 Dr. Tarantino is a board-certified hematologist and is qualified as an expert in his 2 field of treating hemophilia patients. His Report, Dkt. 420-1, contends he has reviewed
3 65,000 pages of medical records of ten Washington Medicaid patients who used 4 NovoSeven for “severe Hemophilia A with inhibitors to FVIII,” including the off-label 5 use for prophylaxis and high doses, to evaluate whether their use of NovoSeven was 6 medically necessary, appropriate and accepted. He opines that the use of NovoSeven was 7 appropriate for eight of the patients; for the other two, he did not have enough data to 8 draw a conclusion. Dkt. 420-1.
9 Washington seeks to exclude Tarantino’s testimony under Federal Rule of 10 Evidence 702 and Daubert. Dkt. 419. It asserts that the issue in the case is not whether a 11 patient “appears to have been prescribed medically appropriate doses of NovoSeven,” but 12 instead whether Washington law governing reimbursement allows for payment. Id. at 1. 13 It argues that Tarantino has no expertise on this issue; he struggles to define the terms he
14 uses and does not tie them to any definition in a Washington law or regulation. It 15 contends he does not even mention the “compendia of drug information,” upon which 16 NNI’s summary judgment motion, Dkt. 386, in part relies. 17 Washington specifically contends that Tarantino’s Report “curiously” omits the 18 phrase “medically necessary” when opining that the use of NovoSeven was “appropriate”
19 and “safe.” Id. It contends that because Tarantino does not mention the “hierarchy of 20 evidence” required under Washington law to determine if a treatment is medically 21 necessary and thus reimbursable, and that his opinion does not address whether 22 1 Washington Medicaid regulations would or should have covered any “off label” uses of 2 NovoSeven under those regulations’ “medical necessity” standard. Id. at 2–5.
3 NNI responds that Washington’s theory of the case is that patients’ use of 4 NovoSeven was medically unnecessary and dangerous. It therefore asked Tarantino to 5 review the records and determine whether the NovoSeven prescriptions written for them 6 were medically necessary, appropriate and accepted, and whether the use was safe. Dkt. 7 443 at 4. It argues that Tarantino is qualified, and that based on his review of the medical 8 records, he opines that the prescriptions were medically necessary, appropriate, and
9 accepted, and that the use of NovoSeven was safe. Id. (citing Dkt. 420-1 at 6). It contends 10 these opinions are relevant, reliable, and admissible. Id. at 5. 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 at 565. 5 Washington emphasizes that, despite his assignment and his conclusion, most of 6 Tarantino’s Report does not address the “medical necessity” of the prescriptions he 7 reviewed and does not address the WAC 182-501-0165(6) “hierarchy of evidence” 8 required to establish medical necessity for a NovoSeven prescription. Washington argues
9 that Tarantino’s opinion might be relevant in a medical malpractice case, but it is not 10 relevant to as to whether the NovoSeven prescriptions were reimbursable under 11 Washington Medicaid regulations. 12 As was the case with the Daubert motion to exclude the testimony of Dr. Manco- 13 Johnson, this argument goes to the weight, not the admissibility of the opinion testimony.
14 There is no dispute that Washington Medicaid paid for the use of NovoSeven during the 15 relevant period—including after Dr. Jeffrey Thompson and the 2009 Hemophilia 16 Working Group reviewed the use of NovoSeven for medical necessity, and authorized 17 payment for its use. The Court has agreed that the loss of documents reflecting that 18 review warrants an adverse inference instruction permitting the jury to infer that the
19 documents would have shown that Washington Medicaid viewed the use of NovoSeven 20 as medically necessary. Dkt. 480. Implicit in such an instruction is the possibility that a 21 jury could find that while Tarantino and Manco-Johnson did not faithfully follow the 22 hierarchy of evidence in concluding the use was medically necessary, there is similarly 1 no evidence that Dr. Thompson and the 2009 Hemophilia Working Group did so either, 2 though Washington Medicaid continued reimbursement for high dose and prophylactic
3 use of NovoSeven. Their opinions about this issue are relevant and admissible, and they 4 are subject to rigorous cross examination about WAC 182-501-0165(6)’s hierarchy of 5 evidence. 6 Tarantino’s opinion testimony about the safety of NovoSeven in the cases he 7 reviewed is also reliable, and relevant, and admissible. See Dkt. 420-1 at 6, ¶ 11. 8 Tarantino will also be permitted opine as to why NovoSeven was used in the cases
9 he reviewed, to rebut Washington’s contention that the NovoSeven prescriptions were the 10 result of illegal inducements. He will not be permitted to testify that the prescriptions 11 were not the result of the inducements, and Washington’s motion is to this limited extent 12 GRANTED. 13 Taratino is a qualified expert in his field, his review of the patients’ medical
14 records used a reliable methodology based on sufficient facts and data and which will be 15 helpful to the jury on the “acceptable” and “safe” nature of the NovoSeven prescriptions 16 at issue. Tarantino’s opinions are relevant, and they satisfy Rule 702’s requirement they 17 assist the jury in understanding the evidence and determining facts in issue. 18 Washington’s Daubert motion to exclude Dr. Tarantino’s expert opinions, Dkt.
19 419, is otherwise DENIED. 20 IT IS SO ORDERED. 21 \\ 22 1 Dated this 15th day of July, 2025. A 2 3 BENJAMIN H. SETTLE 4 United States District Judge 5 6 7 8 9 10 11 12 13 14 15 16 17 18
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