Illinois case poses risk of peer review data going public

An upcoming decision by the Illinois Appellate Court is raising concerns nationwide that doctors' peer review information could be exposed during lawsuits.

The legal challenge is the first significant attack on the Patient Safety and Quality Improvement Act and the scope of its confidentiality protections for medical professionals, legal experts say. The federal law, 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.

"If that [information] becomes public and used for discipline, people are going to be very reluctant to participate in that system," said Wayne Polek, MD, president of the Illinois State Medical Society. "We don't think the state should be intervening in these types of legislative mechanisms."

The case stems from an investigation by the Illinois Dept. of Professional and Financial Regulation into alleged medication negligence by three Walgreen Co. pharmacists. The agency in 2010 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 the law.

The state sued Walgreens to enforce the subpoenas. A trial court ruled in favor of Walgreens. The state appealed. Oral arguments are expected by January 2012.

The Illinois attorney general's office, which is representing the state, declined to comment. In court filings, attorneys for the agency said state law provides the authority to "subpoena and compel the production of documents, papers, files, books and records in connection with any hearing or investigation regarding a potential" law violation.

The Patient Safety Act is being applied too broadly in this case, the state said. Attorneys also question whether all error information collected by Walgreens is protected under the federal law.

"Dismissal of the department's subpoena without affording the department the opportunity to issue interrogatories and potentially depose relevant witnesses permits the overbroad application of the patient safety work product privilege," the state said.

Peer review at risk?

The Patient Safety Act was designed so that errors could be analyzed by PSOs and recommendations made on how to improve health care services, said Ed Rickert, an attorney for Walgreens. Federal protections for doctors and others participating in these programs trumps state law, he said.

"The whole purpose of the [federal law] is to allow a free flow of information where providers voluntarily disclose information about errors in an environment that's protected," he said. "If a court were to rule the Patient Safety Act doesn't really protect this type of data, the whole purpose of the federal law ends up going out the window."

On the other hand, a ruling for Walgreens would reaffirm the federal protections and provide a stronger barrier against legal challenges, he said.

Either way, the ruling will impact more than just Illinois doctors and patient safety organizations, legal experts say. Other courts will cite the ruling in future challenges against the law.

"It's the first case in the country that is going to really look at the federal Patient Safety Act and the protections under that act. It could create a chain effect all across the country," Rickert said.

Some PSOs have voiced support for Walgreens. A joint friend-of-the-court brief was filed by such organizations in California, Illinois, Michigan and North Carolina. The Litigation Center of the American Medical Association and the State Medical Societies, along with the Illinois State Medical Society, have joined the court brief. The Litigation Center wanted to express its support for Walgreens.

"The privilege and confidentiality components of the Patient Safety Act are critical to the PSOs and participating providers in their respective efforts to improve patient care, and are extensions of similar state statutes which for years have protected the confidentiality of peer review information gathered to address medical errors and improve patient outcomes," the Litigation Center said. "A ruling by this court which either does not recognize that the Patient Safety Act preempts conflicting state law, or which limits the broad scope of the confidentiality provided by the act, will have a serious and detrimental impact on the continued efforts of PSOs and their provider members to improve the quality of patient care and reduce escalating health care costs."

"A chilling effect"

Court rulings in similar peer review-related cases have been mixed.

In August, the Kentucky Jefferson Circuit Court, Division Two, denied a patient's request for medical error information from a hospital. The motion was made as part of an ongoing medical negligence lawsuit involving a neurosurgeon. Among other reasons, the court cited the Patient Safety Act as grounds for its denial.

"The possibility that information given regarding a sentinel event could then be discovered in a civil proceeding could have a chilling effect on accurate reporting of such events," Judge James M. Shake wrote.

In 1996, the California Supreme Court granted the Medical Board of California the right to obtain otherwise-protected peer information from a hospital. In that case, the board requested the information as part of an investigation concerning a physician accused of drug use.

The California ruling causes some physicians to think twice about releasing information during peer reviews, said Gregory Abrams, a partner at Pacific West Law Group in Oakland and former California Medical Assn. legal counsel.

"I can tell you when doctors are made aware that the medical board can get peer review information, they tend to be very skittish," he said. "It certainly has influenced how doctors look at their task. I think there is always a nagging concern in the back of their minds" about peer information being released.

The Walgreens case probably would bring similar effects if judges rule for the state, Abrams said.

A decision for the state also would negatively impact patient safety and ongoing improvements to health care, said Nancy Schanz, RN, director of the North Carolina Quality Center Patient Safety Organization.

"What the Patient Safety Act has done is create for us a safe place to be able to report serious events and to have the opportunity within your organization to have some very frank, very candid conversations about the findings," she said. "If you pierce that veil, we won't have that candor. We won't have the ability for providers to come forward and really open their hearts and minds as to what can be done better within the system."