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Patient Safety Act

Carron v. Rosenthal (RI S.Ct.)

Also under Peer review

Issue

The issue in this case is whether the Federal Patient Safety and Quality Improvement Act of 2005 (PSQIA) and the analogous Rhode Island Patient Safety Act of 2008 shield hospital incident reports, which have been prepared solely for the purpose of submission to a Patient Safety Organization (PSO), from discovery in litigation.

AMA interest

The AMA supports the protection of peer review information from litigation discovery.

Case summary

According to her complaint, Katherine Carron was admitted to Newport Hospital for induction of labor on the morning of June 22, 2013. Randall Rosenthal, MD, a hospital employee, was her obstetrician. Dr. Rosenthal prescribed Pitocin to induce the labor, but it did not work. Twelve hours after Mrs. Carron was admitted, Dr. Rosenthal artificially ruptured her amniotic membranes to further the process. She started bleeding, but the membrane rupture did not seem to work either. Dr. Rosenthal went home, leaving a nurse in charge to monitor Mrs. Carron. No obstetricians were left at the hospital after Dr. Rosenthal went home.

Mrs. Carron continued to bleed, but the nurse assured her that the bleeding was normal. Eventually, it became clear that the bleeding was excessive. After a few hours, Dr. Rosenthal was recalled to the hospital. He performed an emergency C-section, but by then the baby had incurred irreversible brain damage.

Two of the hospital nurses, including the nurse who had allegedly assured Mrs. Carron that her bleeding was normal, prepared incident reports on forms entitled “Medical Event Reporting System,” which described what had occurred. These reports were submitted to GE-MERS National Patient Safety Organization, a federally and state certified PSO.  The hospital did not retain copies.

The Carrons sued Dr. Rosenthal and the hospital for medical malpractice. As part of discovery, depositions were taken of the nurses. Apparently, the nurses had trouble recalling what had happened. They did, however, mention the incident reports.

The Carrons asked the hospital for production of the incident reports, but it objected, based on PSQIA and the Rhode Island Patient Safety Act. Following a motion to compel production of the incident reports, the trial judge ordered the hospital to show the incident reports to the nurses in order to refresh their recollections, and the nurses were then to be redeposed. The hospital would not be required to provide the reports directly to the Carrons.

The hospital has asked the Rhode Island Supreme Court for an interlocutory appeal from the order requiring that the reports be shown to the nurses who had prepared them.

Litigation Center involvement

The Litigation Center, along with the Rhode Island Medical Society and numerous other health care organizations, will file an amicus brief in the Rhode Island Supreme Court to urge reversal of the trial court order requiring production of the hospital incident reports.

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.

Southern Baptist Hospital of Florida v. Charles (Fla. Dist.Ct.App., 1st Dist.)

Also under Peer review

Issue

The issue in this case is whether the federal Patient Safety and Quality Improvement Act (PSQIA) privilege against non-disclosure of patient safety information preempts Florida state law, which would otherwise allow a plaintiff in a medical injury lawsuit to discover information voluntarily reported to a Patient Safety Organization (PSO).

AMA interest

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

Case summary

Jean Charles, on behalf of her disabled sister and her sister’s children, sued Southern Baptist Hospital of Florida and several medical personnel, including physicians, for malpractice.  The trial court ruled that the hospital had to produce all documents pertaining to the sister’s care, despite an objection that certain of those documents were privileged from discovery under PSQIA.

Florida law requires the hospital to prepare and maintain the documents in question, but it does not require the hospital to provide them to a state administrative agency unless specifically requested (and no such request had been made).  The claimed privilege depends on a close reading of the PSQIA regulations.  The plaintiffs read those regulations one way (not to create a privilege), but the hospital reads them another (to create a privilege).

The hospital asked the Florida District Court of Appeal to accept jurisdiction in order to decide the discoverability question on an interlocutory, expedited appeal.

On October 28, 2015, the District Court of Appeal accepted jurisdiction and found PSQIA to be “clear and unambiguous such that the language must be given its plain and obvious meaning.”  Under this plain and obvious language, the hospital reports were privileged under the PSQIA.  Moreover, a provision of the Florida Constitution, which would have otherwise made the documents discoverable, was preempted and thus invalid in this case, as it was inconsistent with PSQIA.  The District Court of Appeal therefore quashed the order requiring production of the hospital reports.

Charles has now asked the District Court of Appeal to certify the issue for immediate appealability to the Florida Supreme Court.

Litigation Center involvement

The Litigation Center, through the AMA and the Florida Medical Association, filed an amicus brief in the Florida District Court of Appeal, supporting the hospital and urging acceptance of the appeal.  The brief also urged an expansive reading of the PSQIA privilege. 

District Court of Appeal brief

Tibbs v. Bunnell (S.Ct.)

2014 Ky. LEXIS 599 (Ky. 2014)

Also under Peer review

Issue

The issue in this case is whether the Patient Safety and Quality Improvement Act (PSQIA) 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 PSQIA 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 PSQIA preempted the state law. The Court of Appeals held that the PSQIA 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 petitioned the Kentucky Supreme Court for rehearing.  On December 18, 2014, by a vote of 3 to 3, the petition for rehearing was denied.

The hospital has petitioned the United States Supreme Court for certiorari.  On October 8, 2015, the Court invited the United States Solicitor General to submit a brief on the question whether certiorari should be granted.

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.

The Litigation Center joined an amicus brief in support for the petition for certiorari.

United States Supreme Court brief in support of petition for certiorari

Kentucky Supreme Court brief