Summary of Key Cases: Protections Under the Patient Safety and Quality Improvement Act of 2005 (PSQIA)

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1 Summary of Key Cases: Protections Under the Patient Safety and Quality Improvement Act of 2005 (PSQIA) Kathryn K. Wire JD, Project Manager Center for Patient Safety February 25, 2015 Illinois Decisions Illinois Department of Financial and Professional Regulation v. Walgreens (Illinois, 4/7/11) On July 1, 2010, Walgreens was served with subpoenas requesting all incident reports of medication errors from 10/31/07 through 7/1/10 involving three of its pharmacists, as part of an investigation by the Illinois Department of Professional Regulation ( IDFPR ) and the Pharmacy Board. Walgreens, which had created The Patient Safety Research Foundation, Inc. ( PSRF ), a PSO, collected the reports as part of its PSES and reported to the PSO. Walgreens declined to produce the reports because they were PSWP and therefore not subject to discovery under the PSQIA. IDFPR acknowledged that the PSQIA preempts conflicting state law, but argued that Walgreens arrangement wouldn t justify the protections. Walgreens affidavits demonstrated that it collected the reports in and electronic system that reported to its PSO and that it did not create, maintain or otherwise have in its possession any other incident reports. The Trial court ruled in favor of Walgreens, finding that: Walgreens STARS reports are incident reports of medication errors sought by the Department in its subpoenas and are patient safety 1

2 work product and are confidential, privileged and protected from discovery under The Federal Patient Safety and Quality Act. Walgreens Appellate Court Decision 2012 IL App. (2d) ( On May 29, 2012, the Appellate Court affirmed the trial court s decision to dismiss the IDFPR lawsuit. The matter was not appealed. The court rejected the IDFPR s arguments that the requested reports could have been used for a purpose other than reporting to a PSO or that other incident reports were prepared by Walgreens which were responsive to the subpoenas because both claims were sufficiently rebutted by the two affidavits submitted by Walgreens. Craig v. Ingalls Memorial Hospital, Ill. Circuit Court, No L (10/28/2013) A medical malpractice action filed against the hospital and physicians. The hospital contracted with Clarity PSO on January 1, Plaintiff served a discovery request seeking: Two patient incident reports Morbidity and mortality case review worksheets prepared pursuant to the University of Chicago Medical Center Network Perinatal Affiliation Agreement Minutes of the Executive & Clinical Review Committee and Department of Pediatrics The hospital argued that the incident reports and M&M worksheets were created, proposed and generated within Ingalls for submission to the Clarity PSO and thus were patient safety work product under the Patient Safety Act and therefore privileged and confidential and not subject to discovery. 2

3 The hospital further argued that the Committee minutes were protected under Illinois Medical Studies Act. On October 28, 2013, after an in camera inspection, trial court denied plaintiff s motion to compel. Kentucky Decisions Tibbs, et al. v. Bunnell (2012 SC MR) The opinion is available at SC MR.pdf. Plaintiffs in two medical malpractice actions sought to discover incident reports, patient safety and quality improvement reports and peer review information. One case was tried to verdict and resolved before the appeal was complete. The defendants argued that the material had been collected as part of their respective PSES s for the purpose of reporting to a PSO. The trial court in each case ordered the production of the requested documents. The defendants filed for writs of prohibition with the Kentucky Court of Appeals. The Appeals Court, in nearly identical decisions, ruled that: o o The PSQIA pre empted Kentucky state law. BUT, the scope of protection under the PSQIA extended only to documents that contain self examining analysis. In other words, only those materials prepared by the actual treatment provider would be protected. An appeal to the Supreme Court of Kentucky followed, where the court rejected the selfexamining analysis approach. However, it allowed discovery of the documents based on the 3

4 PSQIA exception to the federal protection for information that has to be reported under state law. o KY has an administrative regulation that requires the preparation of incident investigation reports and peer review and credentialing records. The information need not be reported. o The Court ruled that the PSQIA could not protect information developed pursuant to a state requirement, even if it did not need to be reported to the state, under an exception to the definition of Patient Safety Work Product (PSWP) for information that needs to be reported to a state agency. (42 U.S.C.A. 299b 21 (7)(B) ) The hospital, backed by the PSO community, has attempted to have the case re heard, without success. Tinal v. Norton Healthcare (W.D. KY), No. 3:11 CV 596 S, May 8, 2014 (link) The court reviewed the law and its history comprehensively. Lawyers defending PSO participants should read it for guidance on how to approach PSWP protections. The plaintiff s claim was for employment discrimination under the federal civil rights statutes, and she claimed that the PSQIA should only apply in medical malpractice cases. The court disagreed, finding that the statute established a broad privilege and stating, [w]e have no authority to go behind the plain meaning of the statute. Norton s privilege log listed the documents for which it claimed the privilege, and the court held that it need not describe the content of each one, other than to describe its preparation and sourcing as PSWP. The court reviewed the documents in camera, and litigants should be prepared for that step. 4

5 The case relied on a finding that the provider had (1) defined a PSES, (2) performed its analysis and generated the documents as part of the PSES, and (3) reported to the PSO per hospital policy. Fancher v. Shields, et al. (No. 10 CI 4219, Jefferson, Div. 2, August 16, 2011) Defendant Norton Hospital sought a protective order for sentinel event records and root cause analysis. In addition to claiming protection under the PSQIA, it alleged that the information was protected under the attorney/client privilege. The court rejected the notion that the documents were attorney/client communication, as they were not prepared for the purpose of seeking legal advice, nor were they prepared to support litigation or for use at trial. The court held that the PSQIA protected the documents. Note: The Kentucky Supreme Court has struck down three legislative attempts to provide confidentiality protection for peer review activity in malpractice cases. In noting that no Kentucky court had addressed either the issue of PSQIA protections or the issue of pre emption, it found pre emption, under the doctrine that a state law that conflicts with federal law is without effect citing K.D. ex rel Dieffebach v. U.S. (715 F Supp 2d 587) (D. Del. 2010). Florida Decisions Horvath v. Iasis Healthcare Holdings, Inc. (Florida, 10/16/2012) Medical malpractice plaintiff filed a motion to compel the discovery of records related to adverse medical incidents occurring in the care and treatment of the plaintiff. 5

6 Defendant stated in an affidavit that the only report relating to the plaintiff was protected patient safety work product (PSWP). Defendant further argued that the PSA pre empts state law, including Florida Amendment 7, which otherwise would permit discovery of this report. The court concluded that the report was collected as part of the hospital s PSES and reported to a PSO or a PSO type organization. Relying in part on the Walgreens case, the trial court ruled that the report was PSWP. The court further ruled that the PSA expressly pre empts Amendment 7 where the adverse medical incident record in question is determined to be PSWP. Charles v. Southern Baptist Hosp. et al., Duyal County, Case No CA A (July 30, 2014) This trial court order expresses a very restrictive view of PSWP (more below), and the hospital is appealing the order with support from the PSO community. Florida has very specific requirements for hospital risk management, including staff licensure and submission of certain incident reports to the state. The statute also requires the hospital to gather information via incident reports that may not be reported to the state, but which is necessary to carry out the mandated activities. The discovery request specifically asked for reports prepared pursuant to the state law. The court accepted the pre emption of the Patient Safety Act and acknowledged that (1) the hospital had a PSES, (2) that the information was utilized appropriately in that context, and (3) therefore would be protected PSWP except for the state risk management and reporting requirements. 6

7 The court found that the need to gather the information under state law and to report some of it precluded any of it from being protected PSWP, stating [i]t is the collection and maintenance of information and records for a regulatory purpose, not the actual provision of that information to the government, that takes information out of the ambit of the PSQIA. Cases from other states Morgan v. Community Medical Center Healthcare System (Pennsylvania, 6/15/2011) Case involves a malpractice suit filed against a hospital claiming that it negligently discharged the plaintiff from the emergency room. Plaintiff walked out of the ED but fell, struck his head on concrete and was readmitted with a subdural hematoma. Plaintiff obtained a trial court order for the hospital to produce an incident report regarding the event. The hospital appealed, arguing that the incident report was privileged and not subject to discovery under both its state confidentiality statute and the PSQIA. The Pennsylvania protection only applies if the hospital establishes that the report was solely prepared for the purpose of complying with the Pennsylvania Safety Act. Plaintiff argued, and the court agreed, that the report could have been prepared principally for other purposes such as for insurance, police reports, risk management, etc. and therefore the report was subject to discovery even if later submitted to a patient safety committee on the board of directors. With respect to the PSQIA, the court applied a similar analysis was the incident report collected, maintained or developed separately or does it exist separately from a PSES? If so, even if reported to a PSO, it is not protected. 7

8 The court determined that hospital had not met its burden of establishing that the report was prepared solely for reporting to a patient safety organization and not also for another purpose. Note: The PSQIA does not support this analysis. Gooden v. CVS Caremark Corp, No. 11CVA (Nov. 20, 2012) A Franklin Ohio County court upheld the protection provided for patient safety work product (PSWP). The plaintiff s attorney requested an incident report from a CVS Pharmacy, arguing that the protection did not apply as the defendants had admitted liability. The defendants argued that Congress intended to improve the quality of patient care by creating a culture of safety through a non punitive voluntary reporting system. This broader interpretation of the Act requires that the privilege be extended even if liability has been admitted. The court ruled that the PSO protection applied. Townsend v. CVS Pharmacy et al., 438 th Dist. Ct., Bexar County, TX, No CI (March 26, 2014) Trial court order denied motion by plaintiff to obtain incident reports and error history information in professional liability case against pharmacy company. The court had reviewed the documents in camera and provided only its conclusion that they were protected. 8