Opinion
18-cv-06972-JST
01-29-2024
ADRIAN HOLLEY, et al., Plaintiffs, v. GILEAD SCIENCES, INC., et al., Defendants.
ORDER GRANTING MOTIONS TO EXCLUDE TESTIMONY REGARDING FIRST EARLY TRIAL PLAINTIFF DERRICK JONES
RE: ECF NOS. 1324, 1328
JON S. TIGAR, UNITED STATES DISTRICT JUDGE
Before the Court are the parties' motions to exclude testimony regarding First Early Trial Plaintiff Derrick Jones. Defendant Gilead Sciences, Inc. seeks to exclude the testimony of Dr. Derek Fine. ECF No. 1324. Plaintiffs seek to exclude portions of the testimony of Dr. Jessica Ridgway. ECF No. 1328. The Court will grant both motions.
I. MOTION TO EXCLUDE TESTIMONY OF DR. DEREK FINE
The proponent of expert testimony “has the burden of proving admissibility.” Lust ex rel. Lust v. Merrell Dow Pharms., Inc., 89 F.3d 594, 598 (9th Cir. 1996). Under Rule 702 of the Federal Rules of Evidence:
A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert's opinion reflects a reliable application of the principles and methods to the facts of the case.
Following Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), trial courts serve a “gatekeeping” role “to ensure the reliability and relevancy of expert testimony.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).
“Expert opinion testimony is relevant if the knowledge underlying it has a valid connection to the pertinent inquiry. And it is reliable if the knowledge underlying it has a reliable basis in the knowledge and experience of the relevant discipline.” Alaska Rent-A-Car, Inc. v. Avis Budget Grp., Inc., 738 F.3d 960, 969 (9th Cir. 2013) (quoting Primiano v. Cook, 598 F.3d 558, 565 (9th Cir. 2010)). The question “is not the correctness of the expert's conclusions but the soundness of his methodology.” Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1318 (9th Cir. 1995). Thus, courts should “screen the jury from unreliable nonsense opinions, but not exclude opinions merely because they are impeachable.” Alaska Rent-A-Car, 738 F.3d at 969. “Shaky but admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the burden of proof, not exclusion.” Primiano, 598 F.3d at 564.
Gilead challenges the admissibility of Fine's testimony that Jones has chronic kidney disease (“CKD”). For the reasons that follow, the Court agrees that such testimony is inadmissible because it is unreliable. In Fine's own common-issue expert report, he opined that:
Fine's case-specific report uses the phrase “chronic kidney damage,” ECF No. 1323-10 at 7, which Fine considers to be synonymous with CKD, ECF No. 1323-11 at 7.
Chronic kidney disease has been defined as a GFR < 60 ml/min or evidence of kidney damage (e.g., anatomical abnormalities, proteinuria) for > 3 months. Identification of chronic kidney disease through GFR [glomerular filtration rate] estimation and urine protein assessment allows for staging of disease and stage appropriate management strategies according to published guidelines. These stages/categories based on level of estimated GFR (“eGFR”) and albuminuria also provide important prognostic information regarding CKD.ECF No. 1323-10 at 47 (footnotes omitted). He cited the National Kidney Foundation K/DOQI (Kidney Disease Outcomes Quality Initiative) clinical practice guidelines for chronic kidney disease and the KDIGO (Kidney Disease-Improving Global Outcomes) 2012 clinical practice guideline for the evaluation and management of chronic kidney disease, and he also relied on the KDIGO guidelines to define the categories of CKD. Id.; Id. at 140. The KDIGO guidelines define CKD as follows:
1.1: DEFINITION OF CKD
1.1.1: CKD is defined as abnormalities of kidney structure or function, present for > 3 months, with implications for health. (Not Graded)
Criteria for CKD (either of the following present for >3 months)
Markers of kidney damage (one or more)
Albuminuria (AER >30mg/24 hours; ACR >30mg/g [>3mg/mmol]) Urine sediment abnormalities Electrolyte and other abnormalities due to tubular disorders Abnormalities detected by histology Structural abnormalities detected by imaging History of kidney transplantation
Decreased GFR
GFR <60ml/min/1.73 m2 (GFR categories G3a-G5)
Abbreviations: CKD, chronic kidney disease; GFR, glomerular filtration rate.
ECF No. 1324-10 at 19. The K/DOQI guidelines similarly define CKD “as either kidney damage or GFR <60 mL/min/1.73 m2 for >3 months. Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies.” ECF No. 1344-2 at 2. Thus, as Plaintiffs observe in their opposition brief, citing Fine's common-issue report, “CKD is defined by GFR below 60 ml/min or evidence of kidney damage (e.g., anatomical abnormalities) for more than three months.” ECF No. 1343-3 at 7.
Fine acknowledges that Jones's GFR never dropped below 60, and he agrees “that in the absence of evidence of kidney damage, a patient would not qualify for CKD if their eGFR is above 60.” ECF No. 1323-11 at 13-15. Consequently, based on Fine's own testimony, the only way for Jones to be diagnosed with CKD would be if he had kidney damage for more than three months.
However, Fine testified that the only data on which he was basing his CKD diagnosis was Jones's “declined GFR above 60 that fluctuates.” Id. at 13. As to the markers for kidney damage, Fine testified that Jones's urinalyses were always normal, as were his serum phosphorous levels. Id. at 9, 23. And he agreed that Jones did not have albuminuria or protein in the urine, urine sediment abnormalities, electrolyte or other abnormalities due to tubular disorders, or structural abnormalities deterred by imaging, and that Jones has not had a kidney transplant. Id. at 5, 11. Fine also agreed that there is no histology to analyze because Jones has never had a kidney biopsy. Id. at 12. Instead, he testified that he was “assuming with a degree of medical certainty” that a biopsy, had one been done, would have shown some abnormalities because “a loss of GFR is an indicator of abnormalities in the kidney.” Id. at 12-13.
Plaintiffs have not demonstrated that this is a reliable methodology for determining whether a person has CKD. Fine assumes that Jones has kidney damage because he speculates as to what a biopsy might show. However, he could not point to “any publication or medical literature that says a patient should be diagnosed with CKD based on a declining GFR above 60 where kidney damage is assumed without a biopsy.” Id. at 14. And while Fine opined in his common-issue report that, “[t]hough kidney biopsy provides definitive diagnosis, clinical diagnoses are frequently made without a kidney biopsy,” ECF No. 1323-10 at 40, this stops short of suggesting that CKD can be reliably diagnosed without a kidney biopsy where the patient's GFR never falls below 60 and there are no other markers of kidney damage present. Plaintiffs present no evidence-aside from Fine's own case-specific testimony-that a fluctuating GFR that remains above 60 is, standing alone, a reliable basis for concluding that a patient has CKD. This is not sufficient under Rule 702. Fine may well believe that Jones has CKD, but expert testimony must be based on “more than subjective belief or unsupported speculation.” Daubert, 509 U.S. at 590. “[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). The Court excludes as unreliable Fine's testimony that Jones has CKD.
Plaintiffs point to no other evidence that Jones has CKD. To the contrary, Plaintiffs acknowledge “that Mr. Jones' healthcare providers did not diagnose him with CKD.” ECF No. 1343-4 at 12. And Plaintiffs' own expert, Dr. Michael Harbour, whom Plaintiffs have now withdrawn, testified that he “did not see any evidence of bone or acute kidney injury or chronic kidney disease,” in Jones's records, and he agreed that Jones “does not actually have a renal injury.” ECF No. 1323-7 at 3, 4. Accordingly, Fine's remaining opinions-that Jones's CKD is permanent and has long-term implications, that his CKD was caused by TDF, and that his CKD “would have been prevented or lessened had TAF been available and used in the treatment of his HIV infection,” ECF No. 1323-10 at 12-are excluded as not relevant. Such testimony would not “help the trier of fact to understand the evidence or to determine a fact in issue” when there is no basis for concluding that Jones has CKD. Fed.R.Evid. 702(a).
II. MOTION TO EXCLUDE TESTIMONY OF DR. JESSICA RIDGWAY
Expert discovery in this case was bifurcated into common-issue and case-specific discovery. Gilead disclosed Ridgway only as a case-specific expert, and Plaintiffs seek to exclude portions of Ridgway's testimony as improper common-issue testimony. In particular, Plaintiffs challenge Section III of Ridgway's report, which seeks “to provide a basic overview of the HIV epidemic and the evolution of HIV treatment.” ECF No. 1327-4 ¶ 10.
Plaintiffs acknowledge that “courts may allow new common-issue testimony when it is necessary foundation for case-specific opinions,” but they argue that the challenged testimony does not meet this standard. ECF No. 1328 at 4. Although parties “are entitled to a certain amount of leeway regarding the scope of case-specific experts' testimony,” such “leeway is not unlimited” and does not extend “beyond the limited general [common-issue] opinions necessary to make [their] testimony clear and coherent.” Heath v. C.R. Bard Inc., No. 3:19-cv-0803, 2021 WL 2869282, at *4 (M.D. Tenn. July 8, 2021). Case-specific experts may rely on common-issue “opinions proffered by experts who are properly designated to offer such opinions when forming [their] case-specific opinions relating to particular plaintiffs,” but they “may not exceed the bounds of [their] designation[s] by offering these opinions [themselves].” In re Bos. Sci. Corp. Pelvic Repair Sys. Prods. Liab. Litig., No. MDL 2326, 2018 WL 8054249, at *2 (S.D. W.Va. May 30, 2018)
Ridgway's challenged common-issue testimony does not meet the standard for admissibility. Gilead argues that “[e]ach statement in Dr. Ridgway's background section lays the necessary foundation for-and will help the members of the jury to understand-her opinions about Jones's specific medical history,” ECF No. 1346-3 at 10, but it relies on only three examples that the Court discusses in the next paragraph. Gilead does not, for example, attempt to argue that Ridgway's statement that “HIV was first observed in the United States in 1981 in five young men who had been diagnosed with the deadly disease Pneumocystis carinii pneumonia (‘PCP'), which the CDC detailed in a published report” would have any impact on the jury's understanding of her opinions in this case. ECF No. 1327-4 ¶ 11. Nor does it appear that Gilead could make such a connection.
Gilead argues that some of the challenged testimony is necessary to understand the impact of Ridgway's statement that Jones's “CD4 count was 346 cells/uL,” but that sentence continues to explain that Jones's count “is below the normal range of above 500 cells/uL,” and the Court is unconvinced that the jury requires additional context. Id. ¶ 20. Gilead also argues that background information regarding viral mutations is necessary to provide context for Ridgway's description of Jones's treating physician ordering a genotype test, but Ridgway goes on to conclude that the test performed on Jones “showed several minor mutations,” none of which “had a major impact on the efficacy of ART [antiretroviral therapy] treatment regimens for Mr. Jones.” Id. ¶ 21. The Court cannot conclude that Ridgway's earlier history of ART treatment, including descriptions of drugs that Jones never took and for which there is no evidence that any physicians considered prescribing to him, Id. ¶¶ 12-13, “forms a vital basis for” Ridgway's case-specific opinions. Heatherman v. Ethicon, Inc., No. 1:20-cv-01932-RBJ, 2020 WL 5798533, at *6 (D. Colo. Sept. 29, 2020). Ridgway does not, for example, tie any of her discussion about the earlier treatments for HIV to her opinions about Jones's treatment. Finally, Gilead suggests that the history of HIV treatment, including that earlier treatments involved multi-pill treatments, is necessary for the jury to understand “the enormous benefits of Atripla®, including being a single table regimen with proven efficacy and a strong safety profile,” to Jones. ECF No. 1327-4 ¶ 22. But, in a subsequent paragraph not challenged by Plaintiffs, Ridgway explains:
At the time it was first prescribed to Mr. Jones, Atripla® was one of the preferred initial treatment regimens for HIV recommended in the DHHS [Department of Health and Human Services] guidelines for management of HIV. It was also the only available once-daily single tablet ART regimen on the market, allowing the patient to only take one pill once a day to treat HIV. Single tablet regimens are generally preferred by patients and healthcare providers and have been associated with improved ART adherence. ART adherence is crucial because it improves patient health outcomes, decreases the risk of developing resistance to HIV medications, and decreases the risk of transmitting HIV to others. Atripla® was effective in treating Mr. Jones's HIV. While taking Atripla®, Mr. Jones's viral load became undetectable, and his CD4 count increased to normal levels.Id. ¶ 32 (footnotes omitted). The Court agrees with Plaintiffs that this is sufficient to place Ridgway's case-specific opinions about Atripla in context, and that any additional common-issue information in Section III of her report is unnecessary.
Gilead argues that even if the challenged testimony does not provide necessary foundation for Ridgway's case-specific opinions, it should nonetheless be admitted based on the five-factor test that some courts have considered when determining whether to bar testimony that has not been timely disclosed: “(1) the surprise to the party against whom the evidence would be offered; (2) the ability of that party to cure the surprise; (3) the extent to which allowing the evidence would disrupt the trial; (4) the importance of the evidence; and (5) the nondisclosing party's explanation for its failure to disclose the evidence.” ECF No. 1346-3 at 15 (quoting San Francisco Baykeeper v. W. Bay Sanitary Dist., 791 F.Supp.2d 719, 733 (N.D. Cal. 2011)). However, Gilead fails to cite any case where a court has applied this test when considering whether to bar common-issue testimony that was not disclosed until a case-specific expert report. As Plaintiffs correctly observe, courts that have considered this question have excluded common-issue evidence that did not lay a foundation for case-specific opinions without considering any other factors. E.g., Davis v. Johnson & Johnson, No. 2:20-cv-02635-HLT, 2022 WL 2116230, at *1 (D. Kan. June 9, 2022); Heath, 2021 WL 2869282, at *4-5; Fitzsimmons v. Biomet Orthopedics, Inc., No. 2:19-cv-182-FtM-29NPM, 2020 WL 6784236, at *5 (M.D. Fla. Nov. 18, 2020); Marlin v. Bos. Sci. Corp., No. 8:20-CV-181, 2020 WL 5993789, at *4 (D. Neb. Oct. 9, 2020); Heatherman, 2020 WL 5798533, at *5-6; Simpson v. Johnson & Johnson, No. 5:20-cv-1237, 2020 WL 5630036, at *2 (N.D. Ohio Sept. 21, 2020); Bayes v. Biomet, Inc., No. 4:13-cv-00800-SRC, 2020 WL 5594059, at *4 (E.D. Mo. Sept. 18, 2020); In re Bos. Sci. Corp. Pelvic Repair Sys. Prods. Liab. Litig., 2018 WL 8054249, at *2. Moreover, in one case, the court relied on the expert's deposition testimony in reaching its conclusion that some testimony should be excluded because it was common-issue and not case-specific testimony, thus indicating that the fact that the opposing party had an opportunity to depose the witness without disrupting the trial schedule did not save the common-issue testimony from exclusion. Fitzsimmons, 2020 WL 6784236, at *5. This Court will follow the same approach.
Ridgway is not precluded from providing context for her case-specific opinions regarding Jones. What she may not do is provide general common-issue testimony that is unnecessary for understanding her case-specific opinions. Section III of her expert report falls into the second category and is therefore excluded.
Gilead argues that Plaintiffs' expert, Dr. Harbour, also included common-issue opinions in his case-specific reports. However, Plaintiffs have withdrawn Harbour's testimony in Jones's case, and the Court expresses no opinion on whether it would have admitted what Gilead contends is common-issue testimony by Harbour had Gilead moved to exclude it.
CONCLUSION
For the above reasons, the Court grants both Gilead's motion to exclude Fine's testimony and Plaintiffs' motion to exclude portions of Ridgway's testimony.
IT IS SO ORDERED.