There was an explosion in the number of medical malpractice lawsuits filed in the early part of this century, and general surgeons experienced the effects of this boom in and out of the operating room. While medical negligence lawsuits have been recognized for over two centuries, the modern-day impact of this type of litigation in the United States has been simmering for decades. With litigation reaching crisis proportions in the mid-1980s and again in the last decade, medical risk management has become an integral part of every surgical practice [8].

The legal theory behind medical malpractice claims originates in English jurisprudence dating back to the eighteenth century; however, lawsuits alleging medical malpractice were filed sparingly in the United States until the middle of the nineteenth century [9]. By 1850, medical malpractice litigation as we know it today was entrenched in the American legal landscape. Historians have attributed the precipitous increase in professional negligence actions in the United States to the cultural decline in fatalist philosophical thought and the marked increase in religious perfectionism, both concepts having grown out of the Christian revivals of the 1820s and 1830s [10]. The increase in the number of suits filed in later decades of the nineteenth century has been attributed to the birth of what has been called “marketplace professionalism” [11]. The concept of marketplace professionalism, unique to the United States during this stage in the country’s development, illustrates the most dramatic American divergence from traditional European models of professional evolution [11]. Historically, the learned professions of Western Europe were granted authority by the ruling class. In the United States, however, this sanction was not embraced by American society and became most evident in the 1830s when concepts of social status, economic class, monopoly, and elitism garnered great public criticism [11]. The professions, including law and medicine, were thrust into the marketplace to fend for themselves in an environment of Darwinian competition. Consequently, the medical profession expanded to include those who were trained and untrained, alternative, and traditional, with little quality control. At the same time, lawyers found themselves in an equally hostile culture of competition, and medical malpractice became an area of growth for the legal profession [11].

The result of this fight for professional survival was an unprecedented increase in the number of medical malpractice suits filed in the United States. Between 1840 and 1860, the number of lawsuits alleging medical negligence grew by 950 % [11]. Although medical malpractice litigation exploded onto the scene in the middle of the nineteenth century as a result of a cultural shift, the phenomenon has perpetuated in response to both scientific innovation and the call for professional regulation. Historically, with every new era of medical innovation or expansion came an increase in claims for negligence. Once the innovation became passé, the wave of litigation abated but it never fell back to zero [12].

Despite the recognition that medicine is not perfection and physicians are fallible, our culture demanded a standard by which mistakes could be measured. Accordingly, the mid-nineteenth century saw the advent of various professional organizations, including the American Medical Association. As a result of this self-regulation, unqualified physicians were identified and driven from the profession. However, the impact on those who remained was the creation of uniform standards by which medical professionals would be judged. In the wake of these new licensing requirements and standards of care, the profession was exposed to more litigation as lawyers now judged physicians by the profession’s own standards [12].

Finally, the introduction of professional liability insurance in the late nineteenth century proved to be both a champion and an enemy of the physician. Insurance virtually erased risk to the financial survival of the individual practitioner, but at the same time it guaranteed resources to the malpractice plaintiff [13]. As a result, the introduction of insurance to the profession effectively guaranteed the survival of medical malpractice litigation into the twentieth century and beyond [13]. Today, medical malpractice litigation is pervasive. One economic study by the Joint Economic Committee of the US Congress suggests that the current state of the medical malpractice litigation system has had a negative impact on the access to and the cost of professional liability insurance, the quality of health care, and the cost of and access to health care in this country [14]. While the future of the current medical liability system in the United States is unknown, the prudent bariatric surgeon must be able to identify potential risks associated with litigation and how best to avoid it.

Despite having preconceived ideas of how they will be perceived, physicians should be reassured to learn that juries usually “get it right.” Over 30 years of data show us that outcomes in medical malpractice litigation are remarkably consistent with the quality of care provided to a patient as critiqued by physician peers [15]. In general, physicians win 80–90 % of those cases where other physicians conclude there is weak evidence of medical negligence, 70 % of the borderline cases, and 50 % of cases where other physicians believe that the plaintiff should prevail [15]. In fact, one study suggested that favorable physician outcomes in the face of no documented evidence of negligence have improved and that the perception of a broken American tort system is misplaced [16].

After the litigation crises of the mid-1980s and early 2000s, a 2006 study by Aon, a global provider of risk management and insurance and reinsurance brokerage, revealed that claims against hospitals and physicians began to stabilize. In its seventh annual Hospital Professional Liability and Physician Liability Benchmark Analysis, Aon attributed the decrease in frequency and increase in severity to claims management, tort reform, and patient safety and quality assurance efforts [17]. This stabilization in frequency of claims remained true for several years until the economy took a turn for the worse [18]. A new study suggests that by the end of 2012, claim severity for hospitals and physicians nationwide had increased by 2.5 % with claim frequency increasing by 1 %. In its 2012 Benchmark study, Aon and the American Society for Healthcare Risk Management concluded that we should expect to see a sharp increase in medical malpractice claims and warn that loss rates for both hospitals and physicians are projected to grow by 3.5 % by 2013 [19].

What is medical malpractice? How does a plaintiff prove medical malpractice? Why the surge in medical malpractice claims involving bariatric surgery? Why do people sue their physician? What is the impact of a medical malpractice lawsuit on the physician’s career? What is the impact on the physician’s job satisfaction and personal happiness? These are the questions that cause the medical profession angst, despair, and insomnia. For some, the topic inspires only ire and frustration.

The word malpractice has been defined as “any professional misconduct, unreasonable lack of skill or fidelity in the profession or fiduciary duties, evil practice or illegal or immoral conduct” [20]. The term medical malpractice is derived from the Latin mala praxis—bad practice—and was first applied to the profession of medicine by Sir William Blackstone in 1768 [21]. To prevail in a medical negligence suit, the plaintiff must prove by the greater weight of the evidence all four elements of the cause of action. That is, to prove a prima facie case of medical negligence, the plaintiff must establish:

Once the physician–patient relationship is established, the physician owes his or her patient the duty of due care. “Due care” is defined as the care required of a reasonably prudent physician in the same field of practice under the same or similar circumstances [24]. In most cases, the duty of due care—or the standard of care—must be proved through expert testimony. Likewise, any alleged breach of the standard of care and proximate causation must be proved through the introduction of expert testimony. The plaintiff often uses documents such as medical records, medical literature, and demonstrative aids such as models, charts, medical chronologies, and diagrams at trial as well.

Physicians are sued for myriad reasons, from the sublime to the ridiculous. That said, most suits for malpractice allege the following:

In recent years, there has been a focus on finding data to support why plaintiffs choose to sue healthcare practitioners. One recent survey reveals that the number of years in practice dictates the likelihood of being named in litigation. A 2011 survey sent out by the ASMBS Patient Safety Committee determined that the probability of reporting at least one lawsuit independently increased with the number of years a surgeon was in practice [25]. Another study revealed that only about 5 % of physicians are sued annually but that 42.2 % of physicians have had medical malpractice claims filed against them during their career [26]. Pediatricians and psychiatrists were sued least often with their colleagues in surgery and obstetrics/gynecology having higher frequency data [26]. That said, a subsequent American Medical Association study revealed that 55 % of all cases filed against physicians are dismissed, with less than 5 % of cases making it to trial [27]. Of those cases tried to a judge or jury, 79.6 % of cases resulted in verdicts in favor of the physician [27]. The study involved claims closed between 2002 and 2005 and outcomes varied across specialties, with medicine-based specialties enjoying the highest rate of dismissal (61.5 %) and pathologists suffering the lowest (36.5 %) [27].

So why do surgeons get sued? Anecdotally, we know that bad clinical outcomes are at the heart of most litigation. The data shows that those bad clinical outcomes can be tied to injury to adjacent organ or anatomic structure. In a 2008 survey of 91 lawsuits against general surgeons, 30 % of those suits involved iatrogenic injury to adjacent structures, 37 % of which involved nerve injury [28]. However, patients and their families also sue because they are angry, offended, or grieving. As well, experience tells us that plaintiffs often use the litigation process to apportion blame, shift accountability, manage guilt or grief, and seek closure.

Bariatric surgeons see claims of malpractice for similar reasons, although weight-loss procedures and morbidly obese patients are unique in the medical litigation mise-en-scéne. Cases against bariatric surgeons include many of those claims delineated above but also may include the following allegations:

Today, the lion’s share of litigation involving weight-loss procedures concentrates on allegations of negligence during the postoperative period, immediate postoperative inpatient care, and follow-up once the patient is discharged to home [29]. Specifically, postoperative leaks and delayed diagnosis of recognized complications of the procedure are the most common cause for a subsequent medical negligence claim [30]. Regardless of the theory of liability against the bariatric surgeon, the suits continue to be filed across the nation.

Informed consent is a process, not a piece of paper. It is a common misconception that one proves informed consent with a signed “consent for treatment” form. To the contrary, the signed consent form is merely one piece of evidence that the attending physician completed the informed consent process. The doctrine of informed consent is based on the premise that people have a right to decide what happens to their own bodies and minds. It is based on the concept of autonomy—a concept firmly grounded in philosophy, not law. Autonomy—or self-determination—embraces the notion that people have the right to choose the course of their own medical treatment in accordance with their own values, mores, religious beliefs, and life goals. The principle is also grounded on the premise that no other person, institution, or other entity should be permitted to intervene to overrule an individual’s wishes, whether or not those wishes are “right,” as long as the decision does not negatively affect another individual [31]. That choice, however, must be based on information regarding diagnosis, prognosis, risks, and benefits of the procedure or course of therapy, as well as the consequences of refusing treatment.

The doctrine of informed consent is composed of two discrete components: permission and knowledge. A patient is entitled to give express permission for any touching by another and that permission is to be based on information that is deemed to be important by the patient’s physician. That is, it is incumbent on the medical practitioner to impart all information necessary for the patient to make a well-reasoned, educated choice regarding treatment. Informed consent is of paramount importance when dealing with elective procedures, as consent is implied in the case of an emergency. As bariatric surgery is a high-risk elective procedure by its very nature, the informed consent process must be well planned and well executed.

Causes of action involving issues of informed consent fall into two categories: the tort of battery (no consent) or negligence (inadequate consent). Battery—or unauthorized touching—occurs when the physician fails to obtain informed consent or if the touching exceeds the scope of the informed consent. Negligent informed consent is consent that is based on inadequate information. In most jurisdictions, informed consent is based on the “reasonable” man standard; that is, consent is informed when it is based on the information that a reasonably prudent surgeon would convey to his or her patient during the informed consent process. Suits alleging negligent informed consent usually require expert testimony on the subject; cases alleging battery do not.

Generally, the informed consent process should include the following:

It is important to be sensitive to false or unrealistic expectations in the patient population and to dispel any misconceptions about the procedures of anticipated outcome. It is reasonable to assume that any representation about obesity surgery made on a Web site, in promotional materials, or in informational pamphlets or videotapes will be relied upon by patients and their families. Surgeons should be wary of making promises and predictions.

The most credible piece of evidence in litigation is medical record documentation. Accordingly, the medical record must be complete, concise, accurate, legible, timely, and authentic. While this may seem a daunting task, physicians may be asked to interpret or rely upon a medical record several years after the provided care and treatment to a patient. In the busy practice, particularly one in the academic milieu, it is of paramount importance to maintain an accurate and comprehensive medical record.

Why document in the medical record? Is the documentation strictly used to defend the surgeon who finds himself embroiled in litigation? No. The medical record memorializes care and treatment contemporaneously in an effort to promote continuity of care, accurate communication among the care team members, and data for retrospective review and analysis and to defend surgeons who find themselves embroiled in litigation.

Accurate and complete documentation may prove to be the most important tool in the management of the bariatric patient. In this highly specialized practice of surgery, both the pre- and postsurgical phases of treatment require effective communication among various disciplines (i.e., medicine, surgery, nutrition, psychology, and occupational and physical therapy) and adequate data to provide comprehensive, timely, and safe treatment to this unique patient population. In general, effective inpatient documentation describes in an objective manner all noteworthy data regarding a patient’s presentation, history and physical, recommendations for treatment, actual ongoing care and treatment, and follow-up. It is important to include the most current information available, which will ensure that the patient’s chart will be the most reliable resource for ongoing patient care and the best evidence that appropriate and timely care was provided. As the medical record is the primary conduit for continuing care and communication among a patient’s care providers, it should include all pertinent clinical information, including the physician’s assessment and reaction to laboratory reports, radiology, and other studies. Surgeons often fail to include their rationale for clinical decisions, including data to support the differential diagnosis; however, this information is critical. Physicians should be sure to document a differential diagnosis when the facts permit a reasonable inference that something other than the primary diagnosis may be valid. It is far more difficult to allege that a surgeon failed to consider all of the options when faced with clinically pertinent data if it is documented in the medical record, especially in an area of medicine where potential complications are many, are potentially lethal, and often occur quickly.

Regardless of the procedure, the operative note should be dictated expeditiously—ideally on the same day—and should include all findings and complications encountered and the related management of those findings. Operative notes dictated weeks or months after the procedure are a “red flag” in litigation, particularly in situations where complications were encountered by the surgical team. Despite the routine nature of some surgical procedures, the prudent surgeon should avoid using “boilerplate” language, rather endeavoring to personalize the operative note to the individual patient. Furthermore, all dictation should be reviewed, corrected, and signed promptly and include the results of the sponge and instrument counts. Likewise, postoperative orders should be legible and signed by the operating surgeon, and follow-up and discharge instructions should be signed by the patient or his or her responsible party.

In the bariatric clinic setting, it is important to document all preoperative patient encounters, referrals, and consultations. Preoperative screening should be comprehensive and noted in the patient’s chart, as well as all relevant discussions with the patient and family and any consultants. All consultation reports should be contained in the record, as well as preoperative laboratory results, radiology, and other screening exams pertinent to the bariatric patient headed for surgery. When documenting the informed consent process, include the risks, benefits, and alternatives discussed, as well as whether additional information was provided to the patient and family (e.g., videotape, brochure, pamphlets, referral to support groups, or other forms of patient education). In most cases, the informed consent process for bariatric procedures is lengthy, is candid, and may be included in the patient screening mechanism. That being said, it should be well documented to protect the care team from claims alleging inadequate consent after a bad outcome.