In a survey of urologists in the United States, the frequency of malpractice claims was found to be 0.09 claims per physician per year (one claim every 11 years), and this rate was not found to be affected by professional reputation [5]. In effect, the chances of a malpractice suit increase the longer one is in practice, and according to published data, most urologists can expect to be sued twice in their careers [5, 6].

Although older data showed that vasectomy and endourology generated the highest rate of malpractice claims, in multiple recent evaluations of urological claims, oncology (28%) and endourology (12%) have accounted for the majority of malpractice suits, with female urology (10%) following close behind [6, 7]. By 2012, the conditions most likely to result in a closed claim were prostate cancer and kidney cancer [8].

In an analysis of urology malpractice claims associated with indemnity payment, the majority of claims were related to postoperative (31%) and intraoperative events (29%), followed by failure to diagnosis a condition (18%), errors in medication administration (6%), and foreign bodies left at the time of surgery (6%) [9]. Another study of urological claims found that about half of the claims were due to improper performance and diagnostic errors [10]. In terms of severity of injury in closed claims, major and minor temporary injury made up the most amount of claims at 21% each (mean indemnity $244,597 and $205,403, respectively), patient death constituted 17% (mean indemnity $372,071), whereas emotional injury (mean indemnity $15,143) and grave injury (mean indemnity $514,844) made up only 2% each [11].

In an updated analysis of PIAA closed claims data, Sherer et al. found that urology ranks 13th of 26 in the total number of closed claims amongst other medical specialties, with 27% of claims leading to an indemnity payment to the patient [11]. High payouts of greater than $1 million represent less than 8% of payouts since 2008, and although the authors found that these large payouts are occurring more frequently in urology, the overall percentage of high dollar payouts is overall less than for other specialties. Despite the increase in large payouts, it is thought that the driver of overall increased payments recently has been an increase in the average payment amount rather than the increase in large payouts [8]. One survey of urologists found that the mean pretrial settlement for urologists was just under $200,000 (median $70,000), and the mean award to the patient at trial was $214,000 (median $100,000). If the patient was awarded compensation for pain and suffering, this amounted to a mean award of $270,000 (median $85,000) [6].

Tort law, which deals with professional negligence, is the legal process by which medical malpractice claims are handled in the United States. Medical malpractice constitutes any improper, illegal, or negligent act by a healthcare provider that occurs during patient care that causes patient harm and diverges from the accepted standards of medical practice (known as the “reasonable person” standard). In the United States, malpractice law is governed by state, rather than federal, law. The plaintiff, who is typically the patient or a legally designated party acting on behalf of the patient, brings a suit against the defendant, who is the healthcare provider. The allegation must be filed in a timely manner that is determined by the state (“statute of limitation”). Unless malpractice occurs at a government facility or federally funded clinic, the suit is filed in a state court.

Malpractice lawyers involve the plaintiff’s lawyer who is hired by the patient or patient’s representative, and the defense lawyer who is usually appointed by the physician’s insurance company. The plaintiff lawyers are typically hired on a contingency-fee basis, which means that the lawyer only receives payment if a monetary damage is awarded, whether in a settlement or as damages determined by a court. The amount of money taken by the lawyer varies as a percentage (typically 5–50%). The defense attorneys, on the other hand, are paid in legal fees. Physicians can hire their own personal lawyer to additionally provide representation for themselves at their own expense [12].

There are four main elements that constitute medical malpractice, the key of which is determining negligence. (1) A duty was owed: a legal duty is determined to exist when a professional relationship has been established between a patient and a healthcare provider. (2) A duty was breached: the alleged misconduct by the healthcare provider must diverge from the standard of care which a reasonable, similarly situated professional would have administered. Often, expert witness testimony is used to establish this reasonable person standard. (3) The breach caused an injury: there must be a causal relationship established between the alleged misconduct and the resulting injury to the patient. (4) Damages occurred from the injury: damages must be shown to establish medical negligence, and these are typically monetary damages that take into account both actual costs (such as loss of income) and costs of future medical care , and can include noneconomic costs (such as pain and suffering). Damages are rarely punitive and are typically reserved for cases involving egregious and/or deliberate conduct.

After a claim is filed, the defendant will receive a summons, which is a notice that a lawsuit has been filed. At that point, the physician should notify his/her institution and/or insurance company, and the pretrial litigation process of discovery begins. This is typically the most involved and lengthiest portion of the process, and is designed to facilitate cases being settled outside of the courtroom. Discovery involves establishing the facts of the case through sharing information, and will typically comprise a request for medical/billing records, interrogatories (which involves finding out information about the litigants, or those individuals who are involved in the claim), and depositions.

In a deposition, litigants are questioned by lawyers from both sides under oath, and these transcripts are then made available as evidence during a subsequent trial. Typically before litigation, a litigant will engage in extensive preparation with their lawyer, and this may involve study of the medical records and/or other individuals’ depositions, as well as mock deposition with trained specialists. The time and place for the deposition are set by both parties’ lawyers, and a court reporter is present to administer an oath of honesty and take a verbatim transcript which is later made available to both sides. The plaintiff may choose to attend deposition sessions involving the defendant, and a malpractice insurance representative may also be present.

During a deposition, direct examination will occur, with questions from the plaintiff’s attorney directed toward the physician defendant. A cross-examination is allowed by the physician’s attorney, and this can be followed by a redirect and re-cross until all questions have been asked. There are two types of objections that are allowed, and these relate to assertion of privilege and to the form of the question asked.

If a claim does not get settled or dropped, it then moves on to a trial. It is estimated that less than 10% of medical malpractice claims move on to trial, and of those that do go on to trial, about 80% of them are decided in favor of the physician defendant [13]. One survey of AUA members found that nearly 50% of suits were dropped or dismissed without financial settlement, and 36% involved a pretrial financial settlement. Of all claims, only 3.5% of the time did the case go on to trial with the verdict in favor of the patient, compared with 13.2% of all claims that went to trial and were found in favor of the physician [6]. In an analysis of PIAA urology claims, data between 1985 and 2013, 64% of cases were dropped/withdrawn/dismissed, 24% were settled out of court, 7% were found in favor of the physician defendant in court, and 1% were found in favor of the patient plaintiff [11].

At a trial, the information gained during pretrial litigation can be presented, but no new information may be introduced at that time. The burden of proof rests with the plaintiff’s attorney to establish what is known as a “preponderance of evidence.” This is a less rigorous standard of evidence than the “beyond a reasonable doubt” standard used in criminal cases, and means that the jury believes there is a greater than 50% chance that the negligence did occur. After a decision is reached and damages are awarded by a court, either side can appeal the judgment or for a new trial. If the court finds that malpractice has occurred, this is typically reported to state medical licensing boards and/or medical societies, as well as the national practitioner database.

Based on a survey of AUA members , the mean amount of time that a urologist spent defending their first lawsuit was close to 22 days [6]. Costs to defend claims have been rising; from 2007 to 2012, one study found that the average expense to defend a claim increased by 70% (from $29,000 to $50,000); and the average cost to defend a paid claim increased by 77% (from $42,000 to $74,000) [8]. In the last decade, the average cost of defending a claim that went to trial was $104,155 [11].

The best way to survive medical malpractice is to prevent a malpractice claim in the first place. The goal of risk management is to help identify and address cases where a patient care issue may lead to a lawsuit to prevent it in the first place. Risk management may be available to a physician through his/her clinic, hospital, or insurer. Physicians should be in contact with risk management if they have any concerns about the provision of care to a patient or a patient’s outcome that may be perceived as negligence. This means involving risk management in the case of a complication if necessary, even if the physician him/herself does not believe it has resulted from negligence.

In addition, Feld and Moses give some pointers for preventing malpractice claims [14]. These include being knowledgeable about society guidelines and standards of care and careful preoperative assessment of patients including obtaining adequate informed consent. Liability does extend to a physicians’ responsibility to any subordinates; thus, it is important to ensure that office staff and subordinates are well trained and knowledgeable about clinic or hospital policies including how emergency calls are handled. They also caution that emails are discoverable as evidence and one should be knowledgeable about electronic medical record policies regarding timing and completeness of responding to results and communications.

One other strategy for preventing malpractice claims that has garnered recent attention is disclosing medical errors with patients and providing patients with an apology. Studies have shown that one of the biggest factors that leads patients to file a malpractice claim is ineffective communication between physicians and patients which leads to distrust or a perception of a lack of honesty [15–17]. One study that surveyed patients who had filed malpractice claims found that 60% of patients or their family members filed a claim not because of the incident itself but because of how it was handled and poor communication [18].

Thus, the goal of disclosing errors is to restore trust, improve communication, decrease patient anger, and demonstrate accountability and honesty [14]. Ultimately, the end result is to prevent malpractice claims that may have otherwise stemmed from these events. Studies show that when physicians apologize and provide an explanation of a medical error when it occurs and maintain open communication with the patient and family members, they are less likely to be faced with a malpractice suit [8, 19, 20]. The Joint Commission has issued a nationwide disclosure standard that requires patients to be informed about all aspects of care, including unanticipated outcomes; however, no guidance was provided in terms of how to implement this standard [21].

There are several hospital systems that have implemented medical error disclosure programs and have successfully shown their ability to reduce costs while restoring trust and improving patient satisfaction, in addition to decreasing the number of malpractice suits, decreasing litigation costs, and increasing the number of patients who are compensated and the timeline by which they are provided this compensation [22–24]. In one example, the University of Michigan Health System implemented a three-pronged medical error disclosure program, which involved acknowledging cases where patients had an adverse outcome due to an error and compensating those patients expeditiously and equitably, aggressively defending cases that were not believed to constitute neglect, and studying adverse events to improve processes or policies which could prevent future adverse events or improve patient outcomes [22]. They were able to decrease their annual litigation costs by a third (from $3 to $1 million), decrease their average time to resolution of claims from 20.7 to 9.5 months, and more than halve the number of claims (from 262 to 114) after implementation of a three-pronged medical error disclosure program.

Physicians should work with their hospital’s risk management system to understand their own hospital’s policies (as these policies vary widely across institutions) and determine the best method to disclose medical errors. Disclosing a medical error can be a very difficult conversation, and one that physicians have not necessarily been trained how to do. Thus, physicians may require training before a disclosure to learn how to carry out the conversation and what information should be communicated [15, 23]. Gallagher et al. provide some guidelines on the key elements to think about when disclosing unanticipated outcomes to patients, including factual evidence about the event, expressing regret, and providing a formal apology if it was caused by an error or failure of the system [23]. In addition, they advocate for the institution to integrate this into the institutional knowledge through risk-management and patient-safety activities and to establish a “disclosure support system” to ensure that physicians are knowledgeable and all parties receive appropriate emotional support.

Malpractice insurance premiums have been increasing nationwide (8–20% per year in some states), at times outpacing inflation, and the American Medical Association has identified 19 states in “crisis states” [6, 8]. In a survey of urologists, the mean medical malpractice premium in 2003 was $30,665 (median 22,500) [6]. An AUA survey found that 28% of urologists noted having difficulty obtaining coverage, particularly in the Southwestern region [25].

In general, the cost to the healthcare system of medical malpractice is astounding. Costs have been estimated at 2.4% of total healthcare spending in the United States, estimated at $55.6 billion in 2008 dollars [26]. In their 2010 Health Affairs publication, Mello et al. estimated annual indemnity payments to represent $5.72 billion, whereas other costs included administrative expenses (estimated at $4.13 billion) and defensive medicine costs (estimated at $45.59 billion).

The practice of defensive medicine has unfortunately risen because of the malpractice environment. One survey of AUA members found that in light of the current malpractice environment, 58% of urologists considered referring difficult cases to another urologist, 60% considered limiting the scope of their practice, 26% are considering changing the state in which they practice, and 41% are considering leaving the practice of medicine [6]. Another study found that many urologists refer out some types of procedures, with 60% referring laparoscopic surgery, 54% referring urinary diversion, and 20% referring for radical cystectomy [25].

Tort reform has been a hot-button issue in the United States, with advocates seeking to minimize frivolous claims, reducing the costs of malpractice litigation, making malpractice insurance affordable, and ultimately ensuring that patients are protected during this process. There are a variety of the proposed options for tort reform, starting with what has been deemed “conventional” tort reform (including shortened statues of limitations, establishing screening panels, imposing higher standards, damages reform, modification of liability rules, and placing limitations on access to Courts) [27].

One conventional method to try to prevent frivolous claims and decrease the rising premiums of medical malpractice insurance has been to implement caps on noneconomic damages. One study of jury verdicts involving malpractice claims against urologists found that although states with caps had a lower overall median verdict settlement compared with states without caps, this did not seem to influence the number of filed suits and was not thought to be necessarily related to the decreased settlement amounts. Moreover, states with caps on noneconomic damages continued to experience an increase in insurance premiums for urologists [7]. Another study to evaluate caps found that bladder cancer patients with stage III and IV disease were more likely to undergo cystectomy in regions that had malpractice caps, and that the presence of malpractice caps was actually a predictor of disease-specific survival, suggesting that despite whether caps have an effect on insurance premiums or claims, caps may actually influence urologists’ practice patterns when it comes to surgical procedures or patients that they might identify as a potential source of malpractice claims [28].

Some advocate that beyond the costs to the healthcare system, the tort system does not actually serve the patients that it is in place to protect [15]. As a result, alternatives to the tort system have been proposed , including mediation-based models such as mediation or arbitration, and institution of apology and disclosure laws which would foster communication by protecting clinicians who engage in an open and honest discussion of adverse events [29]. Other alternatives include encouraging early settlements, use of “medical courts,” enacting alternatives to the negligence standard, shifting liability to organizations, and predetermining compensable events [27].

Of note, there is no consensus on development and implementation of new technology and techniques in surgery. Randomized controlled trials have long been considered the gold standard for guiding decisions about new treatments, but this technique does not always apply or may not always be feasible when it comes to surgical interventions [30]. For one, there are very few randomized controlled trials in urology, and this is often due to difficulty with feasibility in conducting a randomized controlled trial in a surgical setting—whether because of cost, long timelines, lack of generalizability, or patient accrual [31]. As a result, comparisons of surgical treatments often rely on case–control studies or in incremental changes in surgical techniques. It can be difficult in the surgical setting to determine when a procedure has evolved to become a new or different procedure, and this also raises questions about necessity of informed consent for evolving procedures or regarding requirements for validation of new procedures. Some have advocated that new surgeries require validation before they should be routinely adopted, but as a field, we have neither determined what procedures meet this requirement nor what the concept of “validation” means in the surgical setting [30].

One specific topic to mention with regard to robotic surgery is malpractice and the development of surgical standards specifically in regard to robotic surgery for prostatectomy. The utilization of minimally invasive technology for performing prostatectomy is increasing [32, 33]. However, studies have shown that patients who undergo robotic prostatectomy are less likely to be satisfied and more likely to have regret about their treatment choice compared with patients undergoing open prostatectomy [34]. The authors postulate that this is a result of patients having higher expectations with the more advanced technology offered through robotic prostatectomy.