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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; Norton Hospitals v. Cunningham (Ky. S.Ct.)

Also under Peer review

Issue

The issue in these cases is 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

In each of the present cases, a patient died while being treated for a medical condition at a Kentucky hospital, and the respective estate for the decedent subsequently sued various health care providers for malpractice.  Also in each case, the hospital had prepared an incident report and submitted the report to a PSO for the purpose of compiling and analyzing the data to improve health care quality.  During discovery, the estate asked for production of these incident reports.  The defendants objected to the production on the basis of the Patient Safety Act privilege, and the trial court ruled the privilege inapplicable.

The respective defendants then filed an interlocutory appeal with the Kentucky Court of Appeals.  They 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 defendants in these cases have appealed to the Kentucky Supreme Court, where they contend that the incident reports are fully privileged, regardless of whether they contain a self-examining analysis and regardless of whether they include information beyond such analysis.

Notwithstanding the appeal of this discovery-related issue, the underlying cases continued in due course. Ultimately, the Cunningham v. Norton Hospitals case was tried to a jury, which held in favor of Norton Hospitals. Cunningham elected not to appeal, and on September 26, 2013, the Kentucky Supreme Court dismissed the Norton Hospital appeal as moot. However, the Tibbs v. Bunnell appeal continues.

Litigation Center involvement

The Litigation Center, through the AMA and the Kentucky Medical Association, filed amicus briefs in the Kentucky Supreme Court in each of these cases.  The briefs urged recognition and an expansive reading of the Patient Safety Act privilege.

Kentucky Supreme Court brief in Tibbs case

Kentucky Supreme Court brief in Norton case