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October 15, 2019

Long and Winding Road: Federal Court Reasserts Supremacy of PSQIA over Florida Amendment 7 in Medical Malpractice Discovery

By Earl E. Googe, Jr., Esq., Smith Hulsey & Busey, Jacksonville, FL

It is a basic legal construct: federal law trumps state law. And yet, for Florida medical malpractice attorneys, that precept has been challenged in the past several years. Through cases percolating from state trial courts to the Florida Supreme Court, federal laws governing confidential status of patient safety work product have been pitted against state constitutional amendments asserting a patient’s right to know. The U.S. District Court for the Middle District of Florida appears to have recently righted the ship a bit, however, in a decision issued in Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital v. Azar on September 5, 2019.1

The result is a much clearer legal situation for Florida hospitals and other healthcare providers as to when the data they collect to do the important work of improving patient safety is considered privileged and protected from discovery during litigation.

Historical Context:  Florida Amendment 7, the PSQIA, Charles and Edwards

In 1999, the Institute of Medicine (IOM) issued its seminal report, entitled To Err is Human: Building a Safer Health System, in which it estimated that as many as 100,000 Americans were dying annually from medical errors, virtually all of which the IOM asserted were avoidable.

The report received widespread praise 2 from healthcare providers for its conclusion that the solution was to change what the report characterized as a culture of shame and blame that surrounds the identification, reporting and correction of these errors.

Around the same time in Florida, there were some substantial medical malpractice verdicts, especially in cases against physicians in high-risk specialties.3 As a result, many insurers either stopped writing coverage for Florida doctors entirely or instituted substantial premium increases. This drove many physicians out of Florida to friendlier states with some form of cap or other limitation on liability in medical malpractice cases.

In response, then-Governor Jeb Bush created a special task force to travel the state and investigate the crisis, making recommendations to the Florida Legislature for tort reform.4 The Florida Legislature passed legislation,5 and both physician groups and the trial bar introduced constitutional amendments on the ballot. One of those introduced by plaintiffs’ lawyers was Amendment 7, which made all "records of any adverse medical incident" public and gave citizens the right to request such documents, whether in litigation or otherwise. The definition of "adverse medical incident" was quite broad, including any event which did or could have caused loss, injury or damage to any patient. All of the amendments passed,6 including Amendment 7, which is codified in the Florida Constitution at Article X, Section 25.7 It is Amendment 7 that has caused so many headaches for healthcare providers, their counsel and the courts.Amendment 7 has been held to apply without regard to the broadness or burdensomeness of the request for records.8 In particular, the Florida Supreme Court held that the traditional concept of relevance of a discovery request to the issues in the case did not apply to an Amendment 7 request.9 As a result, a person, whether in litigation or not, was given the substantive right to demand that any healthcare facility in Florida produce every record of any adverse medical incident that exists in its possession.

Then, in 2005, the U.S. Congress passed the Patient Safety and Quality Improvement Act (PSQIA), intending to replace the culture of shame and blame with a culture of sharing and learning from medical mistakes.10 The PSQIA authorized healthcare facilities to join federally certified Patient Safety Organizations (PSOs). Information was to be collected by the facility and maintained in a Patient Safety Evaluation System (PSES) before submitting the information and documentation to the PSO to which the facility belonged. In 2009, the U.S. Department of Health and Human Services (HHS) made effective its Patient Safety and Quality Improvement Final Rule implementing the PSQIA and outlining the processes for collection and submission of materials to a PSO.11 HHS designated records collected for submission to the PSO as Patient Safety Work Product (PSWP) and stated they would not be subject to discovery in any legal proceeding "notwithstanding any state, federal or local law" to the contrary.12 In addition, the Final Rule states:

            The Patient Safety [and Quality Improvement] Act upon which the final regulation is based makes patient safety work product confidential and privileged. To the extent this is inconsistent with any state law, including court decisions, the Federal statute preempts such state law or court order.13

Many facilities — particularly those in Florida, that were now learning the profound scope of Amendment 7 and how it would hamper their ability to carry out mandated patient safety efforts without creating evidence to be used against them in future civil actions — rushed to join a PSO.14

It was not long before litigation started to reveal how Amendment 7 and the PSQIA would clash. A 2014 civil medical malpractice lawsuit against Southern Baptist Hospital of Florida, Inc., for example, sought Amendment 7 documents from the facility, which also belonged to a PSO. The documents requested by plaintiff Jean Charles, Jr. included the incident report for the event at issue, along with all other documents involving all other incidents at the hospital since its opening in the 1950s. The trial court ruled that incident reports, including the one involving the plaintiff, had to be produced. The hospital petitioned the state's First District Court of Appeal to quash the ordered production, which was granted.15  Finding that the PSQIA definition of PSWP included the documents the hospital sought to withhold, and that the PSQIA preempted Amendment 7 expressly and implicitly, the First District Court of Appeal quashed the trial court order.

The Charles case then went before the Florida Supreme Court, based on its jurisdiction over any lower court decision finding any part of the state constitution invalid. In its ruling, the Florida Supreme Court found that the documents sought to be protected under the PSQIA were not PSWP entitled to any privileged status.16  In somewhat circular reasoning, the Florida Supreme Court stated that “[s]imply put, adverse medical incident reports are not [PSWP] because Florida statutes and administrative rules require providers to create and maintain these records and Amendment 7 provides patients with a constitutional right to access these records…[t]hus, they fall within the exception of information collected, maintained, or developed separately, or exist[ing] separately, from a patient safety evaluation system.”17

The court further found that Amendment 7 was not preempted by the federal PSQIA. It said the PSQIA created a voluntary program which gave a privilege from discovery to facilities that joined a PSO. This basis for rejecting federal preemption was without any citation to authority. The Florida Supreme Court also suggested that because the PSQIA was adopted after the passage of Amendment 7, there was a lack of intent for the PSQIA to preempt the state law. In light of all of this, the Florida Supreme Court concluded that the PSQIA did not expressly preempt Amendment 7.

The U.S. Supreme Court denied a petition for certiorari for Charles, and it became the law of Florida, apparent preemption interpretation and all. Later that year, the Charles decision was cited by the Florida Supreme Court in Edwards v. Thomas as authority to find that Amendment 7 also expressly eliminated the attorney work product privilege in Florida malpractice cases for "fact work product" — and to imply that Amendment 7 might also have eliminated the privilege for "opinion work product" and for attorney-client communications.18

Reasserting Federal Preemption in TGH v. Azar

It is against this backdrop that the U.S. District Court for the Middle District of Florida confronted a complaint for declaratory judgment by Tampa General Hospital (TGH) against the Secretary of Health and Human Services (HHS), Alex Azar, this year.19 TGH was ordered by a Florida state court in a medical malpractice case to turn over to a plaintiff PSWP materials submitted to the hospital’s PSO. TGH challenged the order in federal court, primarily because the lower court’s ruling left it in a bind. Intentionally producing or disclosing PSWP is punishable under the PSQIA; presently the fine is $11,000 per document disclosed. TGH was between a rock and a hard place: If it produced the documents, the hospital was subject to sanction under the PSQIA; and if it did not, TGH was subject to sanction for contempt in the state court. This was a true Hobson's choice. In fact, as the case was pending in district court, TGH was held in contempt by the state court judge for refusing to turn over the PSWP at issue.20

TGH’s declaratory judgment action was briefed, with The Patient Safety Organization of Florida, Inc. (PSO Florida, the PSO to which TGH belonged) being granted intervenor status. Five Florida health systems — AdventHealth, Ascension Health, Baptist Health, Martin Health and The Nemours Foundation — were also granted the collective status of amici curiae and they submitted a brief in support of TGH. For them, securing federal PSQIA protections for PSWP was a critical issue.

The Middle District of Florida issued its decision on September 5, 2019. The court found that the PSQIA protects documents determined to be PSWP and preempts demands under state laws, such as Florida’s Amendment 7, to turn such records over in medical malpractice litigation discovery. This was the first time a federal court sitting in Florida had interpreted this federal law and its interaction with Florida Amendment 7.

An End to Limbo: Implications of TGH v. Azar for Hospitals and Other Healthcare Providers

The Middle District’s decision in TGH v. Azar amounts to a significant victory for hospitals and health systems in Florida. Until now, they have been in limbo as to whether PSWP confidentiality under the PSQIA takes precedence over Amendment 7 requests, or vice-versa. The decision ends that, and should be used by every hospital and health system attorney who continues to fight against Florida Amendment 7 document requests and the use by plaintiffs of the Charles and Edwards cases to persuade state court judges to order hospitals to disclose their PSWP.

The federal court’s ruling, which cited the health systems’ amicus brief to support its position, found that materials created by a facility and submitted to its PSO meet the definition of PSWP and are immune from disclosure under Florida Amendment 7. Critically, the federal court also concluded that, notwithstanding the Charles decision, the PSQIA expressly preempts Amendment 7. Further, the federal court noted that the discussion of preemption by the Charles court amounted to dicta, stating that preemption was “not directly at issue” in the Charles case.

Since both the Charles and Edwards Florida Supreme Court decisions that declared Amendment 7 meant patient safety records submitted to a PSO were not PSWP, Florida’s  hospitals have been in a very serious situation. Their ability to protect information critical to improving patient safety from discovery in litigation seemed to be gone. With this TGH decision, there now is clarity on how hospitals can protect those records. However, navigating Amendment 7 and the PSQIA is still hazardous territory and requires serious, concerted planning and effort.


While this ruling does not overrule the Charles or Edwards decisions, 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. It also serves as a guidepost for other states confronting similar conflicts between the federal PSQIA and state law.  Courts in other states have been split on the matter of what constitutes PSWP;  some have found that so-called “dual purpose” documents developed to meet both state healthcare laws and for use with PSOs are privileged under the PSQIA, while others have found that such “dual purpose” documents are not privileged.21  The decision in TGH v. Azar can now be cited by healthcare facility defendants in future cases, in jurisdictions where PSQIA protections have been challenged to date. This adds to the growing discourse on the PSQIA, perhaps paving the way for increased consistency between jurisdictions in the future on the matter.  


  1. Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital v. Alex Azar, Secretary of the United States Department of Health and Human Services, Case No. 8:18-CV-238-7-30 CPT.
  2. See for example, Berwick, Don, Five Years After “To Err is Human”:  What Have We Learned?, May 1, 2005, available at (stating the Institute of Medicine’s report “has made a profound impact on attitudes and organizations…[and] has changed the way health care professionals think and talk about medical errors and injury, with few left doubting that preventable medical injuries are a serious problem”).
  3. See Treaster, Joseph B., Malpractice Rates are Rising Sharply: Health Costs Follow, New York Times, September 10, 2001, available at (noting that “[t]he price increases [for malpractice insurance] are highest for obstetricians, gynecologists and surgeons, the doctors who are sued the most frequently…[and in] Florida, these doctors pay more than $100,000 a year for $1 million in coverage”).
  4. Hitt, John C, Shalala, Donna E., et. al., Report and Recommendations of the Governor’s Select Task Force on Healthcare Professional Liability Insurance, January 29, 2003, available at
  5. Florida Senate Bill No. 2-D, 2003 Fla. Laws Ch. 416 (August 14, 2003) (with key provisions of the tort reform legislation including capping non-economic damages awarded in malpractice lawsuits, limiting bad faith actions brought against insurance companies, and enacting measures designed to protect consumers from medical negligence).
  6. There were two other state constitutional amendments on the November 2004 ballot that had an impact on healthcare providers in Florida.  The first was Amendment 3, which provided that an injured claimant entering into a contingency fee agreement with an attorney in a claim for medical liability was entitled to not less than 70% of the first $250,000 in recoveries, and 90% of recoveries in excess of $250,000;  however, the Florida Supreme Court later approved procedures that would allow medical malpractice plaintiffs to waive caps on attorneys’ fees.  The second was Amendment 8 – the so-called ‘three strikes’ amendment – which prohibited medical doctors who have been found to have committed three or more incidents of medical malpractice from being licensed to practice medicine in Florida.
  7. [1] See
  8. Edwards v. Thomas, 229 So.3d 277 (Fla. 2017).
  9. Id.
  10. 42 U.S.C. § 299b-21, et seq.
  11. 73 Fed. Reg. 70732, et. seq. (November 21, 2008), available at
  12. 42 U.S.C. §  299b-22(a)(2).
  13. Id. at 70795.
  14. For a list of federally approved PSOs, see A healthcare facility can only obtain the confidentiality and privilege protections under the PSQIA by working with a federally approved PSO listed at this website.
  15. Southern Baptist Hospital of Florida, Inc. v. Charles, 178 So. 3d 102 (Fla. 1st DCA 2015).
  16. Charles v. Southern Baptist Hospital of Florida, Inc., 209 So.3d 1199 (Fla. 2017).
  17. Id. at 1211.
  18. Edwards v. Thomas, 229 So.3d 277 (Fla. 2017).
  19. Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital v. Alex Azar, Secretary of the United States Department of Health and Human Services, Case No. 8:18-CV-238-7-30 CPT.
  20. Lawrence Brawley v. Donald A. Smith, M.D.,, Case No. 17-CA-000119 (Fla. 13th Cir. Ct.).
  21. See for example, Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014) (Kentucky regulations require healthcare facilities to prepare incident investigation reports, which cannot be privileged from discovery as PSWP; Schlegel v. Kaiser Health Plan, No. CIV 07-0520 MCE KJM, 2008 WL 4570619 (E.D. Cal. Oct. 14, 2008) (finding PSQIA protections are a unique and narrow privilege, not intended to apply to the materials requested);  but contrast, Craig v Ingalls Memorial Hospital, Ill. Cir. Ct., No. 2012-L-008010 (October 28, 2013) (incident reports requested by plaintiff were PSWP and thus privileged and confidential under PSQIA).

About the Author

Earl Googe, Jr. is a medical malpractice defense litigator with Smith Hulsey & Busey in Jacksonville. He authored an amicus brief on behalf of five Florida health systems supporting Tampa General Hospital in TGH v. Azar. Mr. Googe can be reached at [email protected].