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The Department of Financial and Professional Regulation v. Walgreen Company

May 29, 2012

THE DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION, PETITIONER-APPELLANT,
v.
WALGREEN COMPANY, RESPONDENT-APPELLEE.



Appeal from the Circuit Court of Lake County. No. 10-MR-1760 Honorable David M. Hall, Judge, Presiding.

The opinion of the court was delivered by: Justice McLAREN

JUSTICE McLAREN delivered the judgment of the court, with opinion. Justices Hutchinson and Birkett concurred in the judgment and opinion.

OPINION

¶ 1 Petitioner, the Department of Financial and Professional Regulation, appeals the circuit court's order granting the motion of respondent, Walgreen Company, to dismiss its petition to enforce its administrative subpoenas. On appeal, petitioner argues that the circuit court erred by granting respondent's motion to dismiss, because: (1) the Patient Safety and Quality Improvement Act of 2005 (the Patient Safety Act) (42 U.S.C. §§ 299b-21 to -26 (2006)) does not prohibit a state regulatory agency from seeking disclosure of any incident reports documenting medication error; (2) the record does not establish that every incident report of medication error maintained by respondent is privileged patient safety work product; and (3) sections 8-2101 to 8-2105 of the Illinois Code of Civil Procedure (Code) pertaining to medical studies (the Medical Studies Act) (735 ILCS 5/8-2101 to 8-2105 (West 2010)) do not apply to pharmacies. Because we determine that the second issue raised by petitioner lacks merit, we affirm.

¶ 2 I. BACKGROUND

¶ 3 On July 1, 2010, petitioner issued three subpoenas to respondent, requesting "All incident reports of medication error involving" three named pharmacists employed by respondent. On October 8, 2010, petitioner filed a petition for enforcement of administrative subpoenas in the circuit court. The petition alleged that respondent filed written objections to the subpoenas with petitioner and failed to comply.

¶ 4 Respondent filed a motion to dismiss petitioner's petition pursuant to section 2-619(a) of the Code (735 ILCS 5/2-619(a)) (West 2010)). Respondent argued that the requested documents were privileged under the Patient Safety Act and the Medical Studies Act.*fn1

¶ 5 In its motion to dismiss and attached memorandum, respondent argued that the documents sought by petitioner constituted "patient safety work product" within the meaning of section 299b-21(7)(a) of the Patient Safety Act, which included reports that "[were] assembled or developed by a provider for reporting to a patient safety organization and [were] reported to a patient safety organization." Respondent asserted that, when a medication error occurs, its pharmacists are required to complete a report in responsent's own "STARS" system.*fn2 STARS is used to generate confidential and privileged quality improvement reports, known as STARS reports. Each STARS report is transmitted to the Patient Safety Research Foundation, Inc. (PSRF), which is a federally certified patient safety organization (PSO).

¶ 6 Respondent attached the affidavit of Suzanne Hansen, vice president of pharmacy services for respondent, who stated upon personal knowledge: "[Respondent] does not create, maintain, or otherwise have in its possession documents which are specifically entitled 'incident reports' pertaining to 'medication error.' " Hansen stated that respondent maintains STARS reports that contain information about an "improperly processed or filled prescription that is dispensed to the customer." A STARS report must be created for each such event. The STARS reports are submitted to the PSRF. "The STARS system is maintained electronically and all reporting through the system is considered strictly confidential."

¶ 7 Petitioner's response argued that "the language in the subpoenas is sufficiently broad to demand all incident reports whether they are maintained in the STARS system or separate from the STARS system." Petitioner also argued that the privilege recognized by the Patient Safety Act applied only to documents created exclusively for the purpose of being transmitted to a PSO, meaning that any document retained for a separate purpose is not privileged. Thus, Hansen's affidavit did not eliminate the possibility that non-privileged documents existed. Further, petitioner argued that the Medical Studies Act did not apply to pharmacies.

¶ 8 In its reply, respondent attached a second affidavit of Hansen stating the following:

"Walgreens does not create, maintain, or otherwise have in its possession incident reports pertaining to medication error other than the STARS reports referenced in my original affidavit. There are no other incident reports pertaining to medication error that are collected or maintained separately from the STARS reporting system."

¶ 9 In petitioner's supplemental response, it disputed Hansen's statements contained in her affidavits. Petitioner attached a counteraffidavit of Scott Golden, a prosecutor for petitioner. Golden stated that he reviewed documents filed by respondent in Lindsey v. Walgreen Co., No. 08 C 3547, 2009 WL 4730953 (N.D. Ill. Dec. 8, 2009), aff'd, 615 F.3d 873 (7th Cir. 2010) (per curiam). Golden stated that, "as of August 18, 2009, the date on which the documents were filed in the Lindsey case, [respondent] maintained and/or collected documents which reference incidents of medication error separate from [respondent's] electronic STARS reporting system." Golden specifically referred to documents that were filed by respondent in Lindsey titled "Pharmacy Manager Performance Review," "Case Inquiry Report[s]," and "Loss Prevention Statements." These documents were attached to petitioner's supplemental response. Golden's affidavit concluded:

"Based on my review of the Documents, I dispute the averment of Suzanne Hansen that '[t]here are no other incident reports pertaining to medication error that are collected or ...


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