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Patient Safety Act

Illinois Department of Financial and Professional Regulation v. Walgreen Co.

970 N.E.2d 552 (Ill. App. 2012)

Also under Peer review

Outcome:    Very favorable

Issue

The issue in this case was whether the privilege against non-disclosure set forth in the Federal Patient Safety and Quality Improvement Act of 2005 (“Patient Safety Act”) preempts Illinois state laws.

AMA interest

The AMA supports federal legislation that will enhance protection of peer review information.

Case summary

Under the Illinois Pharmacy Act, the Illinois Department of Financial and Professional Regulation (“IDFPR”) is charged with regulating and licensing pharmacists and pharmacies.  It is authorized to conduct investigations and, where appropriate, discipline licensees for the protection of public health.

Following a report that three of its pharmacists may have violated the Pharmacy Practice Act, the IDFPR issued three administrative subpoenas to Walgreens.  The subpoenas required that Walgreens produce “[a]ll incident reports of medication error” involving one of the pharmacists.  In response, Walgreens indicated that the only documents it had which met that description were reports it had prepared under the Patient Safety Act, for purposes of submission to a Patient Safety Organization (“PSO”).  Walgreens objected to production of the incident reports, arguing that they were privileged from discovery under the Patient Safety Act.

The IDFPR sought a court order to compel Walgreens to produce the incident reports, but the trial judge found that the incident reports were, indeed, privileged from discovery under the Patient Safety Act.  It sustained Walgreens’ objection and dismissed the case.  The IDFPR appealed, but the Illinois Appellate Court affirmed.

Litigation Center involvement

The Litigation Center, along with the Illinois State Medical Society joined in an amicus brief in support of the Patient Safety Act privilege.

Illinois Appellate Court brief.

Tibbs v. Bunnell, 2014 Ky. LEXIS 333 (Ky. 2014)

Also under Peer review

Outcome:    Very unfavorable

Issue

The issue in this case was whether the Patient Safety Act privilege against non-disclosure preempts Kentucky state law, which would otherwise allow plaintiffs in medical injury lawsuits to discover information voluntarily reported to Patient Safety Organizations (PSOs).

AMA interest

The AMA supports federal legislation that will enhance protection of peer review information.

Case summary

A patient died while being treated for a medical condition at a University of Kentucky hospital, and the estate for the decedent subsequently sued the hospital for malpractice. The hospital had prepared an incident report and submitted the report to a PSO for the purpose of compiling and analyzing data to improve health care quality. During discovery, the estate asked for production of the incident report. The hospital objected to the production on the basis of the Patient Safety Act privilege, and the trial court ruled the privilege inapplicable.

The hospital then filed an interlocutory appeal with the Kentucky Court of Appeals. It asserted that, even if Kentucky law would otherwise have allowed production of the PSO incident report, the Patient Safety Act preempted the state law. The Court of Appeals held that the Patient Safety Act did preempt Kentucky law. However, the court continued, the privilege would only apply to the extent the incident reports contained a “self-examining analysis.” The hospital appealed to the Kentucky Supreme Court, where it contended that the incident report was fully privileged, regardless of whether it contained a self-examining analysis and regardless of whether it included information beyond such analysis.

On August 21, 2014, by a split decision the Kentucky Supreme Court reversed the Court of Appeals. The Supreme Court held that incident reports may be privileged even if they do not contain a “self-examining analysis.” However, incident reports may be discoverable if they are prepared pursuant to state laws requiring their preparation in connection with the state’s regulation of health care facilities. It remanded for an in camera determination of whether the report in this case was privileged.

The hospital has now petitioned for rehearing.

Litigation Center involvement

The Litigation Center, through the AMA and the Kentucky Medical Association, filed an amicus brief in the Kentucky Supreme Court. The brief urged recognition and an expansive reading of the Patient Safety Act privilege. The Litigation Center also filed an amicus brief in support of the petition for rehearing, but the Court refused to allow it.

Kentucky Supreme Court brief