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In Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital v. Alex Azar, Secretary of the United States Department of Health and Human Service, case number 8:18-cv-238, Judge Moody of the United States District Court, Middle District of Florida, Tampa Division, recently held: (1) that 241 documents at issue in a state court action were protected by the patient safety work product; (2) the federal Patient Safety and Quality Improvement Act preempts Article X, section 25 of the Florida Constitution with respect to these 241 documents; and (3) the Secretary of the United States Department of Health and Human Services was enjoined from enforcing the Patient Safety Act in the state court action, which included enjoining the Secretary from imposing the mandatory penalty against the hospital. 

This case was filed in federal court in Tampa, Florida when Tampa General Hospital filed a declaratory judgment to enjoin the Secretary of the United States Department of Health and Human Services from imposing mandatory penalties pursuant to the federal Patient Safety and Quality Improvement Act of 2005, also known as the “Patient Safety Act.” 

For those who are not familiar with The Patient Safety Act, it was enacted to create a system wherein health care providers could voluntarily collect and report medical errors in an attempt to educate themselves on preventable medical errors.  The purpose was to improve the quality of medical care and patient safety. However, to encourage participating it was found it would be necessary that a legal protection of confidentiality was established to promote the free exchange of this information without fear of liability or legal retribution because this information would be shared across state lines. 

Or, as stated by the Department of Health and Human Services, “By establishing strong protections, providers may engage in more detailed discussions about the causes of adverse events without fear of liability from information and analyses generated from those discussions. Greater participation by health care providers will ultimately result in more opportunities to identify and address the causes of adverse events, thereby improving patient safety overall.” HHS, Agency for Healthcare Research and Quality Patient Safety Organization Program Frequently Asked Questions, https://pso.ahrq.gov/faq, accessed September 4, 2019.   

The Department of Health and Human Services also recognized there were potential burdens of maintaining duplicates systems for the federal government and the state governments.  In an effort to resolve this issue, it was decided that healthcare providers would collect all information in one Patient Safety Evaluation System (“PSES”) where the information would remain protected unless and until the healthcare provider determines it must be removed from the PSES for state reporting. As part of the Patient Safety Act, there shall be a civil monetary penalty of not more than $10,000 when a person discloses identifiable patient safety work product in a knowing and reckless violation of this Act.   

This federal case derived from a pending state court medical malpractice action between Lawrence Brawley, the plaintiff, and Tampa General Hospital, the defendant, wherein the plaintiff sought records though a request for production pursuant Amendment 7 seeking record related to “any adverse medical incident” concerning the plaintiff and other patients. Tampa General is a member of a Patient Safety Organization under the Patient Safety Act and there were 241 documents potentially responsive to the request for production.  Tampa General Hospital moved for a protective order, so it did not have to produce any documents in response to this request for production.  The state court judge denied the motion.  Accordingly, the Hospital appealed the state court’s denial of its protective order and requested the state court judge stay the case and its ruling pending the state court appeal and the federal court case.  The state court judge denied this request and held Tampa General Hospital would be fined $100 per day until it produced the 241 documents responsive to the plaintiff’s request for production.

It is important to understand that in Florida, Amendment 7 to the Florida Constitution provides “a right to have access to any record made or received in the course of business by a health care facility or provider relating to any adverse medical incident.”  Amendment 7 gives patients access to any adverse medical incident for any patient.  This contradicts the language of the Patient Safety Act.  This became a significant issue to the Hospital in the state court case because the Patient Safety provides for a civil monetary fine if identifiable patient safety work product documents and information are knowingly or recklessly disclosed.  The fine is not more than $10,000 for each act constituting a violation.  Arguably, disclosure of 241 documents protected by the patient safety work product would amount to 241 separate acts equating to a possible fine of $2.41 million.

This case is significant because Judge Moody held “there is no dispute in this action about whether The Patient Safety Act expressly preempts Amendment 7” when the documents are submitted to a patient safety organization.  It would appear, based on this ruling, that Tampa General Hospital should have the state court’s denial of its motion for protective order reversed and remanded with instructions to enter an order granting it.  However, this is a federal court’s interpretation and application of the Patient Safety Act, and the appeal on the motion for protective order is pending before the Florida Second District Court of Appeal.  Hence, the argument is the federal court ruling is only persuasive authority and not binding.

If the Florida Second District Court of Appeal makes the same finding as the federal court did, then this will provide a beneficial protection to hospitals who are members of patient safety organizations and are submitting documents to them.  It will be imperative for any practitioner representing hospitals in Florida to keep an eye on the state court developments in this case.  The attorneys at Andrews, Crabtree, Knox & Longfellow are keeping an eye on cases like this one, so it can continue to protect the interests and rights of its clients.