Lawsuit challenging protected medical error data dismissed by state appeals court

The Illinois Appellate Court has thrown out a lawsuit brought by the state that challenged the confidentiality of quality control error reports. Doctors were concerned that a ruling for the state would have weakened federal law and made it easier to expose protected health information.

“Illinois physicians are extremely pleased the appellate court affirmed confidentiality in the peer review process,” said William N. Werner, MD, president of Illinois State Medical Society. The medical society, along with the Litigation Center of the American Medical Association and the State Medical Societies, joined a friend-of-the-court brief in support of Walgreens, the defendant in the case. “This decision marks an important step in fostering secure patient safety organization information-sharing processes.”

The case started with an investigation by the Illinois Dept. of Financial and Professional Regulation into alleged medication negligence by three Walgreen Co. pharmacists. In 2010, the agency issued three subpoenas to Walgreens, requesting all incident reports of medication errors linked to the pharmacists. Walgreens refused to produce the reports. The company said the information was prepared as part of its patient safety evaluation system, which is privileged under federal law. The Patient Safety and Quality Improvement Act, enacted in 2005, encourages pharmacies, hospitals and physicians to report medical error information to patient safety organizations, the details of which are shielded from public disclosure.

The department sued Walgreens to enforce the subpoenas. The state said the patient safety law does not block a state regulatory agency from seeking disclosure of medication error reports, and that not every incident report kept by Walgreens was privileged. A trial court ruled in favor of Walgreens. The state appealed.

In its May 29 opinion, the appellate court said the state had “ignored” Walgreens’ position that it kept no incident reports other than those collected for its error reporting program.

“The Patient Safety Act provides that ‘patient safety work product shall be privileged and shall not be subject to discovery in connection with a federal, state or local civil, criminal or administrative proceeding,’ ” the court said. Walgreens “established that the only documents responsive to petitioner’s subpoenas’ narrow scope of incident reports were [such] reports. Accordingly, [Walgreens] established that its reports were privileged pursuant to the Patient Safety Act” (link).

The court granted Walgreens’ motion to dismiss the suit.

At this article’s deadline, it was unclear whether the state planned to appeal to the Illinois Supreme Court. A spokeswoman for the Illinois Dept. of Financial and Professional Regulation said the department is reviewing the case and declined to comment further. A Walgreens spokesman declined to comment on the ruling.

The decision means physicians and others will be more open to reporting errors, thus improving quality of care, said Dr. Werner, of the Illinois State Medical Society.

“Confidentiality is crucial to voluntary PSO reporting,” he said. “If the PSO reports are subject to discovery, voluntary reports from physicians and other health professionals will dry up due to liability fears.”