Perspective

Quality health care and patient safety have emerged as major concerns in society. The Institute of Medicine's report entitled To Err is Human: Building a Safer Health System led to considerable discussion in both the public and private sectors on the need to align the current medico-legal systems to meet these growing concerns.(1) Recent headline news featured horrific patient safety problems in some of the most prestigious institutions in the United States. Examples included deadly and costly misdiagnoses, sloppy surgeries, and failed robotic ventures that led to major malpractice payouts. Last year, following multiple contentious special sessions, Florida passed Senate Bill 2D to address the medical malpractice insurance "crisis" in the state.(2) Patients started suing doctors in escalating conflict that led to higher malpractice premiums, driving out many of the commercial insurance companies, and dissuading physicians from practicing medicine in the state.

In Florida, $1 million coverage will cost in liability premiums up to $250,000 per year for neurosurgeons and obstetricians, for those who can get coverage. Large academic health care centers like the University of Miami paid more than $40 million in 2004 on legal premiums and legal payouts. The health care crisis in Florida has led to reduced access of care for patients and has exacerbated the already limited health care coverage to more than 1 million uninsured people. This has reduced both quality of care and patient satisfaction in an already overburdened health care system.

Why has this crisis developed? A 2003 General Accounting Office report noted that, although multiple factors contribute to increased premium rates, losses on medical malpractice claims—which make up the largest part of insurers' cost—appear to be the primary driver of rate increases.(3) Medical malpractice costs totaled nearly $25 billion in 2002, or $85 per person, compared with $5 per person in 1975. Surprisingly, only 7% of malpractice cases end with a jury verdict, and 80% of those result in a favorable verdict for the physician. But the 600% rise in mega-verdict awards in the last 15 years, the average of which reached an astonishing $3.5 million in 2000, has helped whet the appetite of lawyers and clients. An example of this trend was a recent verdict in Palm Beach County for $75 million awarded due to a neurologically impaired infant.

Florida responded by placing itself on the nation's cutting edge of the medical malpractice resolve by recognizing the link between patient safety, medical errors, and medical malpractice.(4) Unique 2004 legislation created the Florida Patient Safety Corporation, which set up the first voluntary state-wide near miss reporting program, modeled after the successful system used in commercial aviation.(5) The 2004 legislation also required that patients be notified if they were involved in an adverse event that caused significant harm. Finally, the legislation mandated patient safety education for all health care providers. Unfortunately, along with these reasonable requirements, the Florida Trial Attorneys (in response to an aggressive tort reform campaign by the Florida Medical Association to cap non-economic damages at $250,000) promoted two extreme constitutional amendments greatly limiting patient care and reversing many of the patient safety gains of the 2004 legislation. Efforts to reconcile the two opposing viewpoints have, to date, failed.

In November 2004, the citizens of Florida passed two constitutional amendments (7 and 8) by a large majority.(6) Amendment 7, the "Patients' Right-To-Know About Adverse Medical Incidents Act," allows full access to all patient records related to adverse medical events, turning back 20 years of quality assurance (QA) and peer review protection. The broad definition of the new law allowed patients, families, and their attorneys access to all records kept by a facility, including all meetings, morbidity and mortality conferences, root cause analyses, and any other professional exchange of information related to a patient's injury or death. In April 2005, the Florida legislature partly narrowed the application and interpretation of the new law, but damage to the health care system had been done. Reporting of events started to decline, and the fear of weakened peer review and QA protection had permeated the state. Anecdotal evidence suggests that morbidity and mortality conferences have either stopped or been greatly sanitized; many now use fictitious data during case presentations.

Pursuant to the new law signed by Governor Jeb Bush on June 20, 2005, patients who have been harmed may obtain all records of their care, including all documentation of provider deliberation. They may also request all records of similar adverse events that occurred to other patients. The health care facilities or providers subject to these requirements include hospitals, ambulatory surgery centers, mobile surgical facilities, and all physicians. After extensive political debate, the law was modified to limit civil or administrative actions against health care providers or facilities, but the information obtained under the law can still be used in medical liability actions. Amendment 8, the "Three Strikes and You Are Out" Act, calls on the Florida Board of Medicine to revoke medical licenses from providers who have had three adjudicated malpractice incidents (or "strikes"). A strike is considered any malpractice judgment, findings from disciplinary cases, decisions of binding arbitration finding malpractice, and malpractice judgments from any other state.(7) This has had the effect of increasing the number of unjustified and premature settlements in trivial cases, since litigation-alert physicians fear they might lose a lawsuit.

Despite the groundbreaking 2004 patient safety legislation, Amendments 7 and 8—although ostensibly created to improve patient care—have had the exact opposite effect on health care facilities and their providers. They have put a chill on the reporting of all patient events and have put a damper on patient safety and sensitive quality improvement research. Amendments 7 and 8 have led to an alarming wave of paranoia among health care providers and administration in discussing patient safety initiatives. In many health care organizations in Florida, physicians and nurses are being told not to discuss among themselves any adverse patient event without the presence of legal counsel. They are instructed not to document any information that could be used to sue the health care facilities. Without these vital conversations, there is no learning from mistakes and near misses, increasing the chances that adverse events will happen again. The education of medical students and housestaff is also being weakened because of the atmosphere that inhibits free discussion or documentation of errors. In many teaching hospitals, medical students are restricted from participating in meetings in which adverse patient data are shared due to fear of discoverability.

The present medico-legal climate in Florida, clearly illustrated by the Terry Schiavo case, has polarized the debate about tort reform. This debate has marginalized moderates and favored extreme political and legal measures. These conditions have, undoubtedly, created the most hostile professional and clinical conditions observed in the US, while fomenting a major social and political crisis in Florida.

I believe that it is time to stand down from the invective and rock throwing among physicians, attorneys, insurers, and regulators. The recent events in Florida have poisoned the ability to sustain patient safety efforts, while offering less access to and reduced accountability for care to consumers. It is altering the practice of medicine in Florida significantly, thus blocking efforts to make health care more transparent and evidence based—the cornerstones of patient safety. We must create more opportunities to focus on healing the roots of medical malpractice, clinically and legally, to ensure that safe patient care and thoughtful, creative research can proceed.

It has been said "where California goes, the US goes." The events of the last several years coupled with the severe health care and liability crises suggest that Florida might be overtaking California in this role. Measures placed on the ballot by citizen initiatives are by their very nature missing the devil of the details. Clearly, in Florida, Amendments 7 and 8 were misleading and confusing. Perhaps we need to incorporate a Plan-Do-Study-Act (PDSA) cycle for public policy.(8) In any case, the recently passed Patient Safety and Quality Improvement Act of 2005 protecting the reporting of adverse events might perhaps offer state preemption, but only time will tell its full impact.(9)

As other states work through the societal-political issues of redesigning health care systems to make them safer while making them more transparent and accountable, it is key to examine closely and carefully what has occurred in Florida. It is tempting to view the situation in Florida as a stand-alone crisis, but in fact it should be viewed as a harbinger—the canary within the medico-legal mines—of a wider culture of dysfunction in the US health care system. The untoward consequences of well-intentioned Florida legislation have crippled the health care system and left patients, payors, and providers considerably worse off than before. If these issues are not addressed soon, many other states facing similar dire circumstances will see patient care suffer and access reduced by providers fleeing, and important research and learning to make patient care safer come to a halt. The ethical, political, and economic case for health care medico-legal reform is overwhelming. Now is the time for change.

Paul Barach, MD, MPHAssociate Professor, Department of Anesthesiology and MedicineAssociate Dean for Patient SafetyUniversity of Miami Medical School

References

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1.Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.

2.Medical Incidents. The Florida Senate. S0002 (2003 D). Available at: https://www.flsenate.gov/Session/Bill/2003D/2D. Accessed November 15, 2005.

3.Medical Malpractice Insurance: Multiple Factors Have Contributed to Increased Premium Rates. Washington, DC: United States General Accounting Office; June 2003. GAO-03-702. Available at: http://www.gao.gov/cgi-bin/getrpt?GAO-03-702 Accessed November 15, 2005.

4.Florida Legislative Bill SB 2-D, Sections 35 and 36 Reports. Miami Center for Patient Safety Web site. Available at: http://anesthesiology.med.miami.edu/Library/MPSC%20docs/MPSC%20docs/Reports.html. Accessed November 15, 2005.

5.Aviation Safety Reporting System Web site. Available at: http://asrs.arc.nasa.gov. Accessed November 15, 2005.

6.A look at the trend in ballot initiatives. Vote Smart Florida Web site. Accessed November 15, 2005.

7.Rosen HD, Donlevy-Rosen P. Amendment 8—How to Protect Yourself. Advanced Asset Protection Planning Web site. Accessed November 15, 2005.

8.The Deming Cycle PDSA. Value Based Management Web site. Available at: http://www.valuebasedmanagement.net/methods_demingcycle.html. Accessed November 15, 2005.

9.President Signs Patient Safety and Quality Improvement Act of 2005 [news release]. Washington, DC: Office of the Press Secretary; July 29, 2005. Available at: http://www.whitehouse.gov/news/releases/2005/07/20050729.html. Accessed November 15, 2005.