United States District Court, District of Colorado
DORIS MORRIS; TONY ARMSTRONG; and MELVIN NUNES, as Personal Representative of the ESTATE OF STELLA NUNES, on behalf of all others similarly situated, Plaintiffs,
DAVITA HEALTHCARE PARTNERS, INC., Defendant.
R. BROOKE JACKSON UNITED STATES DISTRICT JUDGE
This order addresses the parties’ respective “Daubert” motions. Defendant moves to exclude the testimony and opinions of plaintiffs’ quality improvement and patient safety expert, Barbara J. Youngberg, R.N., and plaintiffs’ nephrology expert, Steven Borkan, M.D. ECF No. 128. Plaintiffs move to strike portions of the testimony and opinions of defendant’s nephrology expert, Stanley Goldfarb, M.D. ECF No. 130. Following full briefing the Court held an evidentiary hearing on April 29 and 30, 2015, during which all three experts testified. For the reasons discussed in this Order, defendant’s motion is granted in part and denied in part. Plaintiffs’ motion is denied.
The Court has discussed the factual background in this heavily litigated case in two orders addressing DaVita’s motions to dismiss plaintiff’s first and second amended complaints. See Orders issued April 9, 2014 [ECF No. 69] and March 23, 2015 [ECF No. 126]. For present purposes, suffice it to say that plaintiffs received hemodialysis at DaVita clinics. Plaintiffs claim that an ingredient in the dialysate solution used in their treatments caused unsafe increases in their blood pH (alkalosis) that in turn resulted in serious injuries or death. This ingredient, called GranuFlo or NaturaLyte, was not manufactured by DaVita, and the Court has dismissed plaintiffs’ products liability claims. The remaining claims against DaVita concern its monitoring of its patients. Plaintiffs claim that in the process of monitoring and collecting data DaVita either failed to observe changing blood pH levels and therefore acted negligently in administering care, or it observed the problems but kept the information secret, thereby perpetrating a fraud.
Under Rule 702 of the Federal Rules of Evidence, a qualified expert may provide opinion testimony if the evidence is both relevant and reliable. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993). Expert opinions are relevant if they would “help the trier of fact to understand the evidence or to determine a fact in issue.” Rule 702(a); see Daubert, 509 U.S. at 591. They are reliable if the expert is qualified by knowledge, education or experience, and his or her opinions are “scientifically valid” and based on “reasoning or methodology [that] properly can be applied to the facts in issue.” Daubert, 509 U.S. at 593. Reliability generally focuses on the methodology, not the ultimate conclusions of the expert. Ho v. Michelin North America, Inc., 520 F.Appx. 658, 663 (10th Cir. 2013). Factors useful in this analysis include, but are not limited to, the following:
(1) whether the opinion at issue is susceptible to testing and has been subject and has been subjected to such testing; (2) whether the opinion has been subjected to peer review; (3) whether there is a known or potential rate of error associated with the methodology used and whether there are standards controlling the technique’s operation; and (4) whether the theory has been accepted in the scientific community.
Dodge v. Cotter Corp., 328 F.3d 1212, 1222 (10th Cir. 2003) (citing Daubert, 509 U.S. at 593–94).
The proponent of expert testimony has the burden to show that the testimony is admissible. U.S. v. Nacchio, 555 F.3d 1234, 1241 (10th Cir. 2009). The trial court plays a “gatekeeping” role that involves an assessment of the “reasoning and methodology underlying the expert’s opinion” and a determination of “whether it is scientifically valid and applicable to a particular set of facts.” Goebel v. Denver and Rio Grande Western R.R. Co., 215 F.3d 1083, 1087 (10th Cir. 2000). However, the trial court has discretion as to how to perform this gatekeeping function. Id. It is not a role that emphasizes exclusion of expert testimony. I have frequently cited Judge Kane’s description of the purpose of Rule 702:
A key but sometimes forgotten principle of Rule 702 and Daubert is that Rule 702, both before and after Daubert, was intended to relax traditional barriers to admission of expert opinion testimony. Accordingly, courts are in agreement that Rule 702 mandates a liberal standard for the admissibility of expert testimony. As the Advisory Committee to the 2000 amendments to Rule 702 noted with apparent approval, “[a] review of the caselaw after Daubert shows that the rejection of expert testimony is the exception rather than the rule.”
Cook v. Rockwell Intern. Corp., 580 F.Supp.2d 1071, 1082 (D. Colo. 2006) (citations omitted).
With those broad principles in mind, I turn to the task of assessing the relevance, reliability, and, ultimately, the admissibility of the challenged testimony.
BARBARA J. YOUNGBERG
The Court has reviewed Ms. Youngberg’s Declaration of September 2, 2014 [ECF No. 109-1], her Reply Declaration [ECF No. 118-3], and substantial portions of her deposition testimony. Based on those materials and testimony and exhibits admitted at the hearing, the Court makes the following findings:
1. Ms. Youngberg is a licensed attorney and a registered nurse. Although she worked as a critical care nurse before she graduated from law school, her career thereafter has focused on risk management, quality improvement and patient safety in medical care. For 20 years she worked for an alliance of academic medical centers during which she was often charged with designing systems for evaluating new products such as drugs and medical devices so that they could be safely used in patient care. She created a desk reference for risk managers and has written several texts and on-line sources concerning these issues. At the present time she teaches risk management to law students, physicians and health care administrators at the Beazley Institute for Health Law and Policy of the Loyola University College of Law in Chicago. She is a Fellow of the American Board of Health Care Risk Managers and a member of the American Hospital Association’s Patient Safety Fellowship program.
2. In the present case Ms. Youngberg was asked to provide opinions as to whether DaVita’s quality improvement standards and patient safety and risk management programs, as they related to the deployment and use of GranuFlo and NaturaLyte, met the standard of care in the health care industry for such programs. See Hearing Transcript, Day One [ECF No. 151] at 141-42.
3. In her opinion, an effective quality improvement program that meets the applicable standard of care would include the following features: (1) systematic and continuous collection of health-related data relevant to the patient care being provided; (2) analysis and interpretation of that data; (3) modification of existing patient care processes if analysis of the data indicates a need to do so; (4) reassessment of the modifications to confirm that the problems have been remedied; and (5) supplementation of the quality improvement program by review of current literature and best practices in similar institutions. Declaration at ¶¶24–26; Deposition [ECF No. 127-2] at 165–66.
4. Ms. Youngberg acknowledges that DaVita actively collects clinical data from patients, both during treatment and after they leave the treatment center. De-identified data sets generated by the DaVita Quality Index are referenced in many research studies that she has reviewed. This data has revealed an increased incidence of cardiac arrests and sudden cardiac deaths. She read one article that suggests that linkage between alkalosis and cardiac arrest might be related to an increased incidence of cardiac events. Declaration at ¶27.
5. However, Ms. Youngberg states that she found nothing in the documents that were provided to her that indicates that DaVita has systematically reviewed data across its treatment facilities to attempt to determine common causes or similarities of adverse events. She continues, “[i]f done, DaVita could have identified early on the role alkalosis played in patients receiving hemodialysis using GranuFlo and NaturaLyte.” Id. at ¶28.
6. She believes that DaVita would, in turn, have recognized health risks to patients receiving GranuFlo and NaturaLyte:
a. “Had DaVita instituted quality improvement standards, patient safety and risk management programs that met the industry standard of care, DaVita would have recognized that patients receiving dialysates containing excess acetate experienced much greater adverse effects, including but not limited to heart attacks and strokes.” Id. at ¶19.
b. “DaVita would have recognized [that] dialysates containing excess acetate cause elevated blood bicarbonate levels and lowered blood potassium levels.” Id. at ¶20.
c. “It is quite likely that had this active surveillance of cardiac deaths, strokes and myocardial infarctions across all DaVita sites had [sic] been better tracked and more fully investigated DaVita would have identified issues with GranuFlo and NaturaLyte well before the 2012 warning issued by Fresenius and the Class 1 FDA recall.” Id. at ¶29.
7. In her Reply Declaration, Ms. Youngberg states, based upon a Power Point slide provided to DaVita by Fresenius, “it now appears that DaVita actually knew that GranuFlo was increasing bicarbonate levels across the patient population and thereby dramatically increasing the percentage of patients identified as of ‘Alkalosis Concern.’” ECF No. 118-3 at ¶3. When cross-examined about this statement during the hearing, she acknowledged that the Fresenius study referenced in the slide used a serum bicarbonate level above 30 mEq/L (milliequivalents per liter) as an indication of “Alkalosis Concern, ” and that only 28 of the 4, 793 patients (0.6 %) in the Fresenius study rose above 30 mEq/L. Day One Tr. at 162–67. The mean bicarbonate level in the Fresenius patients rose from 22.9 to 23.7 mEq/L, both being within what the study considered to be the desired range. Id. at 167–68.
8. In the Reply Declaration Ms. Youngberg also expresses the opinions that, “given the dangers of alkalosis documented by Dr. Borkan and acknowledged by DaVita, ” under the standard of care DaVita should have taken additional steps “to examine whether the switch to GranuFlo caused an increase in adverse outcomes and/or patient morbidity” and “to reduce bicarbonate in patients with levels that Fresenius’s own study identified as in the range of ‘Alkalosis Concern.’” Id. at ¶¶4–5. However, she has seen no evidence that DaVita has done so.
9. Ms. Youngberg had some experience helping nurses care for end-stage renal disease patients who were receiving peritoneal dialysis or hemodialysis for a few days when she was a student nurse in the mid-1970s. Deposition [ECF No. 127-2] at 35–37. Other than that, she cannot recall receiving any specialized training in nephrology or dialysis. Id. at 41.
10. During her deposition Ms. Youngberg appeared to acknowledge that she did not know (and considered it to beyond the scope of her engagement to know) what measures of clinical outcomes of dialysis patients should be tracked. Id. at 181–82. She either did not know or indicated that she was not asked to comment on such things as the primary cause of death of dialysis patients, risk factors inherent in dialysis treatment, or who writes dialysis prescriptions. Hearing Transcript, Day Two [ECF No. 153] at 153, 172, 238–39. When asked if she had any evidence that DaVita did not look at its own data, she responded, “Only that they continued to use the GranuFlo and NaturaLyte after Fresenius knew that there was a problem.” Id. at 141.
11. The FDA recall issued March 29, 2012 did not prohibit the use of GranuFlo or NaturaLyte. As indicated supra n.2, the notice reported that the manufacturer was cautioning clinicians to be aware of the concentration of acetate or sodium di-acetate contained in the products, and that inappropriate prescription could lead to a high serum bicarbonate level and, in turn, to metabolic alkalosis, which is a significant risk factor for conditions that might culminate in cardiopulmonary arrest and even death. ECF No. 127-4.
12. In her Declaration Ms. Youngberg states that GranuFlo and NaturaLyte contain sodium acetate that a patient’s liver metabolizes into bicarbonate in the hours after dialysis, which causes blood bicarbonate levels to exceed prescribed levels. ECF No. 109-1 at ¶12. When asked whether her statement was a fact or an assumption, Ms. Youngberg responded that she wasn’t asked to comment on the clinical aspect of the case, and that she did not know whether there were differing scientific opinions on that point. ECF No. 127-2 at 131.
13. In its motion DaVita lists a number of examples of what it considers to be Ms. Youngberg’s failure to review pertinent records and her lack of knowledge of things that DaVita does to track patient date, improve quality and keep up with relevant literature. ECF No. 127 at 8–10. I have reviewed the cited portions of Ms. Youngberg’s deposition. See ECF No. 127-2 at 21–24, 142, 178–230. See also Day One Tr. at 180–85. One can quibble about the defendant’s characterization of some of the examples, but overall, I agree that the testimony demonstrates what appears to be little knowledge of many of the quality control and risk management procedures that DaVita has implemented. Id. at 8–10.
14. During her hearing testimony Ms. Youngberg acknowledged that DaVita has written policies and procedures that do address many, if not all, of the quality control, patient safety and risk management practices that she believes a medical institution should have. Her opinions appeared to shift from the absence of appropriate procedures to her opinion that DaVita does not consistently follow (or at least she has not seen evidence that it consistently follows) the written procedures in their manuals. This opinion was based heavily on her interpretation of the deposition testimony of Irina Goykhman, DaVita’s Vice President of Clinical Improvement. See, e.g., Day One Tr. at 151–52, 158, 185, 189–90, 197, 215, 220. The deposition was taken on November 12, 2014, more than two months after Ms. Youngberg completed her declaration. Ex. 33 at 1.
Ms. Youngberg has substantial and impressive credentials in developing, teaching and implementing quality control and risk management procedures in hospitals. She is well-qualified to be able to evaluate quality control policies and procedures in DaVita’s clinics and to express an opinion as to the currency and adequacy of those policies and procedures. Her list of the five features of an effective quality control program could be used to evaluate a particular institution’s program. DaVita does not question the reliability of that methodology. It seems eminently reasonable on its face.
However, Ms. Youngberg apparently did not apply her five-point methodology to DaVita’s program. She does not, other than in conclusory form, state that DaVita’s program lacks those features. To any extent that she did apply her methodology to DaVita, she appears to have missed many policies and procedures documented in DaVita’s records that comprise its program. Moreover, when pressed on cross-examination, she did not seem to fault the written policies and procedures. Rather, based on her interpretation of the deposition of DaVita’s Vice President of Clinical Improvement, her opinion seems to be that DaVita did not always follow its own policies and procedures. That opinion possibly might have some relevance to the specific ...