After Luvetta Goff died of complications during an elective spinal surgery at University of Kentucky HealthCare, her estate sued her doctors and asked for any documents related to hospital investigations into the matter.
The doctors, however, argued that a post-incident report generated for the purpose of improving and evaluating overall safety was protected by federal law from being used in a malpractice lawsuit.
It's a dispute that may wind up before the U.S. Supreme Court and has potential implications for the effectiveness of patient-safety organizations nationwide.
Providers say the federal Patient Safety and Quality Improvement Act bars information gathered for patient-safety organizations from being used in medical malpractice lawsuits. Such protection, they say, is vital if providers are to continue submitting information to patient-safety organizations, which analyze reports of errors and near-errors in order to make recommendations to improve safety.
In an amicus brief filed with the Supreme Court, the Joint Commission calls the consequences of the case “potentially dire."
The Joint Commission says that a lower court's decision that the records may not be protected, if not reversed, “will reverberate nationwide as healthcare organizations will almost certainly operate based on the least generous interpretation of the patient-safety work product privilege for fear that patient-safety work product will later be used against them in litigation.”
The American Hospital Association, the Federation of American Hospitals and the Alliance for Quality Improvement have also filed amicus briefs supporting the doctors in the case.
“The Patient Safety Act's success depends on voluntary participation by providers, and providers will participate only if they can rely on the act's confidentiality guarantee,” the American Hospital Association and the Federation of American Hospitals argued in their brief.
Attempts to reach Michael Lucas, an attorney for the Goff estate, were unsuccessful Thursday and Friday. But he argued in a brief filed with the Kentucky Supreme Court that the federal law does not protect the record because it was generated because of other regulations and state laws. He also argued that rules about what types of documents may be requested in court cases, or discovered, should be interpreted broadly to allow “maximum discovery because discovery is an important tool in litigation which should be a search for the truth.”
Attempts to reach several prominent medical malpractice plaintiffs lawyers for comment on the case were unsuccessful.
The Kentucky Supreme Court said in divided ruling in August that the incident report might not be protected if it was also prepared in accordance with state laws related to state regulation of healthcare facilities. The court concluded that the federal law was not meant to protect records required by state law just because those records may also be tied to in-house patient-safety evaluation systems and patient-safety organizations.
“Congress never intended the act to deprive the states of state-mandated information relevant to their regulatory duties,” according to the Kentucky Supreme Court opinion.
That ruling led the three doctors to petition the U.S. Supreme Court in March to hear the case. It's possible the justices may decide by the end of the current term this summer whether to take on the matter.
Provider and patient-safety organization groups say it's vital the U.S. Supreme Court take the case so the outcome in Kentucky doesn't undermine the federal law protecting data intended to inform safety efforts.
The law, signed in 2005, followed the Institute of Medicine's landmark report on medical errors, To Err is Human: Building a Safer Health System. The law was meant to encourage providers to voluntarily communicate otherwise privileged information with one another and with patient-safety organizations in hopes of learning from mistakes.
“What this law was intended to do was to break the silos, to get all that information out of the hospitals in a very protected way so hospitals could be transparent with one another on how to improve patients' safety,” said Peggy Binzer, executive director of the Alliance for Quality Improvement and Patient Safety, a national professional organization for patient-safety organizations and providers who work with them.
Binzer said if the Kentucky Supreme Court decision stands, “We would expect Kentucky not to report this information so … providers in Kentucky are not going to learn from providers in other states and patients are going to be harmed.”
There's also a risk, if the Kentucky decision stands, that courts in other states might start adopting the Kentucky Supreme Court's reasoning, said William Thro, general counsel for the University of Kentucky, who is representing the doctors in the case.
“It will have disastrous consequences on the working of this statute not only in Kentucky but potentially nationwide if courts in other states choose to follow this decision,” Thro said.
The fundamental aim of the federal law and patient-safety organizations is to encourage providers to speak candidly to one another so they can learn from others.
“If the contents of that conversation become available in medical malpractice trials, none of the participants will speak up, none of the participants will write anything down," Thro said. "And as a result we won't learn from their mistakes—it will happen again."