Patient Safety in Plastic Surgery (eBook)

Chapter 2

Legal Considerations

Hunter S. Allen, Jr. ■ Michael T. Sumner

More than ever before, plastic surgeons and other health care providers are focusing on patient safety. The practice of plastic surgery is growing, and the changes are vast. The American Society of Plastic Surgeons (ASPS) reports that there were 1.8 million cosmetic surgery procedures performed in 2007, 10 million minimally invasive cosmetic procedures, and 5.2 million reconstructive procedures were also performed.1 These numbers represent both a 59% increase in total cosmetic procedures and a 17% decrease in total reconstructive procedures performed since 2000. Directly related to these changes, more plastic surgeons are now performing procedures in office-based surgery centers or other nonhospital sites. Such surgery centers are widely considered to be advantageous, because they provide the surgeons greater control over their schedules, allow for increased efficiency and consistency in staffing, and can offer patients more privacy and convenience.2 However, because of a number of possible disadvantages, these office-based surgery centers can potentially threaten patient safety and the quality of care provided. Compared with hospitals, these centers often are given less regulatory oversight, employ less-trained and less-experienced physicians and staff, use poorer quality equipment, complete fewer documented procedures and protocols, maintain less thorough records, and have increased anesthesia risks.3

At the same time, there has been a patient safety movement in health care over the past two decades that has sought higher quality and safer health care.4 Some studies, such as the National Health-care Quality Report from 2007, have reported that the safety and quality of health care have improved over the past few years. However, other studies, such as those performed by Altman et al5 and Leape and Berwick,6 demonstrated the opposite. Nevertheless, the patient safety movement has resulted in harsher consequences for those physicians and health care providers who allegedly offer substandard care. Some argue that patient safety and malpractice are interconnected.7 Thus improving patient safety will lead to safer and higher-quality health care; in addition, it will also help to assuage the concerns of plastic surgeons and other health care providers by reducing the likelihood of adverse events or outcomes and minimizing the often-negative consequences that result.

With the ultimate goal of providing quality health care and adhering to Hippocrates’ admonition to “First, do no harm,” plastic surgeons and other health care providers should strive to prevent potential adverse events and outcomes; they should also always be prepared for the unexpected. Furthermore, adverse events, when they occur, should be investigated thoroughly, disclosed properly, and ultimately used as learning tools to ensure that similar events or outcomes do not recur. Written from the perspective of medical malpractice defense attorneys, this chapter provides a comprehensive, seven-part framework that discusses how plastic surgeons and other health care providers can improve patient safety—and why it is increasingly important that they do so.

BACKGROUND

Traditionally, physicians and physicians’ practices were accountable to state licensing laws, hospital medical staff groups and credentialing, and professional organizations. However, the patient safety movement over the past two decades has dramatically altered health care. Legislation seeking to enhance the quality of care and codify patients’ rights has been passed on all levels. The Health-care Quality Improvement Act of 1986, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Stark Amendments, and the Patient Safety and Quality Improvement Act of 2005 are a few examples. With the advent of these laws, the federal government has taken a more active role in controlling and regulating physicians and their practices by establishing administrative agencies and reporting clearinghouses, and by promoting safer practices for patients. Medical boards in every state have also been vested with broader authority to investigate and regulate the practice of medicine within their states. Many of these bodies have, in turn, promulgated a vast array of regulations with the stated goal of improving patient care.

In addition to the government’s role in the patient safety movement, numerous patient safety groups have been created, including the National Patient Safety Foundation, the National Quality Forum, the Leapfrog Group, the Institute for Health-care Improvement, and the Anesthesia Patient Safety Foundation. These groups often have their own policies, procedures, best-practice guidelines, and, arguably, their own agendas. In the field of plastic surgery, ASPS and the American Society for Aesthetic Plastic Surgery (ASAPS) have recently enacted patient safety guidelines.8,9

In 1999, the Institute of Medicine (IOM) published its landmark study To Err is Human.10 Though the exact figures have subsequently been disputed,11,12 the study reported that approximately 44,000 to 98,000 people die in hospitals each year from medical errors that could have been prevented.10 A poll conducted by the Kaiser Family Foundation shortly after the release of the report found that 41% of Americans were closely following the error stories in the newspaper; 42% believed that the report identified medical errors as a “serious problem” that resulted in a large number of preventable deaths.13 A 2004 public opinion survey found that 34% of Americans believed that they or a family member had been the victim of a medical error at some point in their life, and 21% percent reported that the error had caused serious health consequences.14

Furthermore, the last two decades have also seen what many have called a malpractice liability crisis.15,16 Including both jury awards and settlements, median malpractice awards per paid claim doubled between 1990 and 2001.15 Liability insurance premiums have risen virtually across the board, with insurance premiums for some specialties increasing 15% to 30% or more.15 These increases have led many physicians to go on strike, change specialties, move to different states, or change careers altogether.15 At the same time, there has been a corresponding reduction in the number of companies providing liability insurance.16 The St. Paul Company—the largest writer of professional liability insurance throughout the 1990s—ceased writing new policies in 2002.16 That same year, the American Medical Association (AMA) reported that 12 states were in a medical malpractice crisis and another 30 had troubling signs of crisis.17 In the 1970s, a similar crisis occurred in the field of anesthesiology; many concurrent efforts and approaches addressed the issue by improving safety.18 In fact, safety measures increased so much that insurance premiums for anesthesiologists are currently among the lowest of all specialties.

A 2005 study by Dr. David Studdert et al19 found that defensive medicine, the deviation from sound medical practice that is induced primarily by the threat of liability, is extremely common in the United States, with 93% of physicians in high-risk specialties reporting that they practice some form of it. Many physicians involved in the study reported providing care that they thought was unnecessary or not medically indicated. This care included ordering diagnostic tests (59%), invasive procedures (32%), medications (33%), and specialist referrals (52%); in addition, many physicians reported that they avoided performing high-risk procedures (29%) and treating high-risk patients (39%). As an example, many plastic surgeons prescribe antibiotics for 5 to 7 days after elective clean cases, which is contrary to antibiotic guidelines (see Chapter 11). It appears that the main motivation for this is the fear of being sued. However, such a practice is clearly not ideal for either the patient or society as a whole. Lengthy courses of antibiotics have not been shown to decrease the risk of infection; instead, they increase the patient’s risk of having an adverse drug reaction and contribute to the growing problem of microorganisms becoming resistant to drugs. Following the correct guidelines is legally defensible. The administration of antibiotics for 5 to 7 days after elective clean cases is not the standard of care, and this practice should cease.

This crisis has led many states to pass broad tort reform legislation; more than half of the states have enacted such legislation, including placing caps on noneconomic damages in medical malpractice lawsuits, establishing stricter standards for expert testimonies, and limiting immunity for physicians in certain high-risk specialties. Many organizations have also developed guidelines of how to proceed after an adverse outcome (Box 2-1).

Some of these reforms have been found to be constitutional, whereas others have not withstood constitutional challenges or have not yet been reviewed by the appellate courts. However,...