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Hyams v. CVS Health Corp.

United States District Court, N.D. California, San Francisco Division

December 11, 2019

RYAN HYAMS, Plaintiff,
v.
CVS HEALTH CORPORATION, et al., Defendants.

          DISCOVERY ORDER REGARDING (1) PATIENT-SAFETY WORK PRODUCT PRIVILEGE AND (2) BURDEN AND PROPORTIONALITY Re: ECF No. 99, 115, 126, 129, 130, 132

          LAUREL BEELER UNITED STATES MAGISTRATE JUDGE

         INTRODUCTION

         The court assumes the reader's familiarity with the subject matter and procedural history of this case. The parties have raised more discovery disputes, regarding (1) patient-safety work product (“PSWP”) under the Patient Safety and Quality Improvement Act, 42 U.S.C. § 299b-21 et seq. (“PSQIA”), [1] and (2) burden and proportionality with respect to the plaintiff's Interrogatories Nos. 1-4 and 19.[2] The court issues this order defining the scope of PSWP protection and directs the defendants to (1) immediately produce all surveillance video and still photographs that they are withholding on the basis of PSWP and (2) reexamine all other withheld documents in light of the court's guidance and produce any non-PSWP documents by December 19, 2019. The court overrules the defendants' burden and proportionality arguments and orders them to respond to the plaintiff's interrogatories.

         ANALYSIS

         1. Patient-Safety Work Product

         The PSQIA defines PSWP with reference to two concepts: “patient safety organization” (often referred to as “PSO”) and “patient safety evaluation system” (often referred to as “PSES”). “The term ‘patient safety organization' means a private or public entity or component thereof that is listed by the Secretary [of Health and Human Services] pursuant to [PSQIA requirements], ” 42 U.S.C. § 299b-21(4), and “[t]he term ‘patient safety evaluation system' means the collection, management, or analysis of information for reporting to or by a patient safety organization, ” 42 U.S.C. § 299b-21(6).

         The PSQIA defines three categories of PSWP:

1. materials[3] “assembled or developed by a provider for reporting to a patient safety organization and [] reported to a patient safety organization; . . . and which could result in improved patient safety, health care quality, or health care outcomes, ” 42 U.S.C. § 299b-21(7)(A)(i)(I) (the “Reporting Prong”)
2. materials “developed by a patient safety organization for the conduct of patient safety activities; and which could result in improved patient safety, health care quality, or health care outcomes, ” 42 U.S.C. § 299b-21(7)(A)(i)(II) (the “PSO-Developed Prong”), and
3. materials that “identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system, ” 42 U.S.C. § 299b-21(7)(A)(ii) (the “Deliberations Prong”).

         Notwithstanding the above, the PSQIA excludes from the definition of PSWP “information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system, ” among other things. 42 U.S.C. § 299b-21(B)(ii).

         The defendants invoke the “constitute the deliberations and analysis” portion of the Deliberations Prong to withhold 71 documents, arguing that the documents contain “[t]he data collected, and the analysis performed concerning the representative patient audit[, which] constitute deliberations and analysis within CVS's PSES.”[4]

         1.1 “Deliberations or Analysis . . .”

         The plain language of the Deliberations Prong extends the definition of PSWP only to “deliberations or analysis.” 42 U.S.C. § 299b-21(7)(A)(ii). It does not extend the definition of PSWP to the underlying facts or documents that might have been the subject of deliberation and analysis.

         This is confirmed by guidance from the Department of Health and Human Services (“HHS”), the agency charged with administering the PSQIA:

We note that the statutory protections for deliberations and analysis in a patient safety evaluation system apply without regard to the status of the underlying information being considered (i.e., it does not matter whether the underlying information being considered is patient safety work product or not). A provider can fully protect internal deliberations in its patient safety evaluation system over whether to report information to a PSO. The deliberations and analysis are protected, whether the provider chooses to report the underlying information to a PSO or not. However, the underlying information, separate and apart from the analysis or deliberation, becomes protected only when reported to a PSO. See section 921(7)(A)(i)(1) of the Public Health Service Act, 42 U.S.C. 299b-21(7)(A)(i)(1).
To illustrate, consider a hospital that is reviewing a list of all near-misses reported within the past 30 days. The purpose of the hospital's review is to analyze whether to report any or part of the list to a PSO. The analyses (or any deliberations the provider undertakes) are fully protected whether the provider reports any near-misses or not. The status of the near-misses list does not change because the deliberations took place. The fact that the provider deliberated over reporting the list does not constitute reporting and does not change the protected status of the list. Separate and apart from the analysis, this list of near misses is not protected unless it is reported. By contrast, this provision fully protects the provider's deliberations and analyses in its patient safety evaluation system regarding the list.

         Patient Safety and Quality Improvement, 73 Fed. Reg. 8112, 8122-23 (Feb. 12, 2008) (proposing rules) (emphasis added); accord Patient Safety and Quality Improvement, 73 Fed. Reg. 70, 732, 70, 743 (Nov. 21, 2018) (adopting final rules) (explaining that “information that constitutes the deliberation or analysis within a patient safety evaluation system is protected, ” as contrasted from “[i]nformation underlying the analysis”) (emphasis added).[5]

         HHS's construction of the Deliberations Prong is consistent with deliberative privileges in other contexts. For example, the government enjoys a deliberative-process privilege over “documents reflecting advisory opinions, recommendations and deliberations comprising part of a process by which government decisions and policies are formulated.” Karnoski v. Trump, 926. F.3d 1180, 1203 (9th Cir. 2019) (quoting Loving v. Dep't of Def., 550 F.3d 32, 38 (D.C. Cir. 2008)). The privilege applies only to materials that are “predecisional” and “deliberative.” Id. at 1204 (quoting Loving, 550 F.3d at 38). Courts have held that “‘[p]urely factual material that does not reflect the deliberative process'” is not “deliberative” for the purposes of privilege. See, e.g., Desert Survivors v. U.S. Dep't of the Interior, 231 F.Supp.3d 368, 379 (N.D. Cal. 2017) (quoting FTC v. Warner Commc'ns Inc., 742 F.2d 1156, 1161 (9th Cir. 1984)). The court does not mean to suggest that the scope of the governmental deliberative-process privilege necessarily controls the scope of the Deliberations Prong of the PSQIA. But it provides a point of comparison and supports that the plain language “deliberations or analysis” used in the Deliberations Prong does not necessarily extend to factual material underlying deliberations or analyses and that HHS's construction of the Deliberations Prong as not extending to such underlying factual material is reasonable.

         The defendants cite an Illinois state court case, Daley v. Tereul, 107 N.E.2d 1028 (Ill. Ct. App. 2018), to suggest that the Deliberations Prong extends to facts underlying their analyses.[6] Daley does not support this argument. First, the documents at issue in Daley “were assembled and prepared by [the defendant] ‘solely' for submission to [its patient-safety organization] and they were reported to [its patient-safety organization].” Id. at 1040; accord Id. at 1042-43 (“[N]othing in the record leads us to believe that the information in the documents was assembled, developed, or prepared for a purpose other than reporting to [the defendant]'s patient safety organization.”). In other words, the documents there were protected as PSWP under the Reporting Prong, as opposed to the Deliberations Prong.[7] Second, the Daley court made a point of holding that “nothing about these documents being privileged renders the facts that underlie the patient safety work product also privileged.” Id. at 1044. Daley does not support the defendants' claim of PSWP over the facts that underlie their analyses - it undermines it.

         The court also observes that plain language of the Deliberations Prong extends the definition of PSWP only to materials that “identify or constitute the deliberations or analysis.” 42 U.S.C. § 299b-21(7)(A)(ii).[8] It does not extend the definition of PSWP to all documents that contain deliberation or analysis. In other words, the fact that a portion of a document may contain protected deliberations or analysis does not transform the document in its entirety into PSWP. Again, by way of analogy, the Ninth Circuit has held in the context of the governmental deliberative-process privilege that “the deliberative process privilege does not protect documents in their entirety; if the government can segregate and disclose non-privileged factual information within a document, it must.” Karnoski, 926. F.3d at 1204 (quoting Loving, 550 F.3d at 38). The defendants do not identify anything in the statutory text of the PSQIA, its implementing regulations, or the case law that suggests that the Deliberations Prong sweeps more broadly. See generally Patient Safety and Quality Improvement Act of 2005, 81 Fed. Reg. 32, 655, 32, 656 n.5 (May 24, 2016) (“‘It is not the intent of [the PSQIA] to establish a legal shield for information that is already currently collected or maintained separate from the new patient safety process, such as a patient's medical record. That is, information which is currently available to plaintiffs' attorneys or others will remain available just as it is today.'”) (quoting 151 Cong. Rec. S8741 (daily ed. July 22, 2005) (statement of Sen. Enzi)).

         1.2 “. . . of . . . a Patient Safety Evaluation System”

         The plain language of the Deliberations Prong extends the definition of PSWP only to deliberations or analysis “of . . . a patient safety evaluation system.” 42 U.S.C. § 299b-21(7)(A)(ii). It does not extend the definition of PSWP to deliberations or analyses outside of a patient-safety-evaluation system.

         The defendants submitted documentation[9] of their patient-safety-evaluation system (“PSES Summary”), which provides in relevant part:

IV. Background, Purpose and Overview of the Retail ...

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