The U.S. District Court for the Middle District of Florida issued a significant decision on September 5 in a case involving protections for hospital critical self-analysis work product under the federal Patient Safety and Quality Improvement Act (PSQIA). In its ruling, the court found that the PSQIA protects patient safety work product and preempts demands under state laws, such as Florida's Amendment 7, to turn such records over in litigation discovery. This is the first time a Federal Court sitting in Florida has interpreted this Federal Law and its interaction with Florida state constitutional law.

"This is a very significant hospital victory," said Earl E. Googe, Jr., a shareholder with Smith Hulsey & Busey, who submitted an amicus brief in the case on behalf of a group of health systems (AdventHealth, Ascension Health, Baptist Health, Martin Health and The Nemours Foundation) asking the court to uphold PSQIA protections for patient safety work product. "The ruling should be used by every hospital attorney who continues to fight against Amendment 7 document requests and the use of the Charles and/or Edwards cases to persuade state court judges to order hospitals to disclose their patient safety work product."

The case, Tampa General Hospital v. United States Department of Health and Human Services, arose when a state circuit court ordered Tampa General Hospital (TGH) to turn over patient safety work product in discovery in a medical malpractice lawsuit. TGH had submitted those records to its Patient Safety Organization (PSO), as required by the PSQIA. Turning over the documents, as the state court ordered, would constitute a violation of the PSQIA, exposing TGH to thousands of dollars, per document, in fines and penalties. TGH was effectively caught in a Catch-22.

In an effort to escape this dilemma, TGH sought a declaratory judgement in federal court that the documents at issue were protected patient safety work product and the federal PSQIA preempted state laws to the contrary, such as Florida's Amendment 7.

The federal court's ruling, which cited Googe's amicus brief to support its position, found that materials created by a facility and submitted to its PSO meets the definition of patient safety work product and are immune from disclosure under Amendment 7. The court also concluded that, notwithstanding the Charles decision, the PSQIA preempts Amendment 7. Further, the court noted that the discussion of preemption by the Charles court amounted to dicta, writing that preemption was "not directly at issue."

"Since both the Charles and Edwards v. Thomas Florida Supreme Court decisions that declared Amendment 7 meant patient safety records submitted to a PSO were not protected work product, our state's hospitals have been in a very serious situation," said Googe. "Their ability to protect information critical to improving patient safety from discovery in litigation seemed to be gone. With the TGH decision we now have more clarity on how hospitals can protect those records."

While this ruling does not overrule the Charles or Edwards decisions, notes Googe, it should provide authority for attorneys representing hospitals throughout Florida to blunt the effect of the Charles decision; contend that the Charles discussion of preemption was mere dicta; and fight to keep materials provided to a hospital's PSO protected from production and disclosure.

Googe is available for interviews. Copies of the court's opinion are also available, along with the amicus brief submitted by Smith Hulsey & Busey.