Introduction

All surgeons are ethically concerned about limiting surgical complications. In the United States, surgical complications are also associated with the potential for malpractice litigation. In many countries, legal risks are not limited to civil proceedings as in the United States, but may actually involve criminal prosecution.

Even the most experienced, meticulous surgeon occasionally may have complications; some of these complications can result in permanent injury to patients. Although technical errors in the operating room may result in complications, the fact that a complication has occurred is not evidence that a medical error has been made. Interestingly, technical errors often involve routine operations performed by experienced surgeons performing operations within their area of expertise.¹ With regard to thyroid and parathyroid surgery, malpractice suits most frequently are related to recurrent nerve injury or hypoxic brain damage because of airway obstruction resulting from bilateral nerve injury or hematoma.² The most common nontechnical cause for malpractice suits related to the thyroid is the delayed diagnosis of cancer.² Although most malpractice cases list lack of informed consent in the bill of particulars, informed consent, in and of itself, is rarely the cause of action.

It is difficult to develop a rational strategy to protect a surgeon in the event of a malpractice suit that is based on data rather than anecdotes and personal opinion. In this chapter, we will explore the available data regarding malpractice suit risk in thyroid and parathyroid surgery. We will focus primarily on this issue in the United States, where the risk of malpractice lawsuits is greatest.

Determining the actual number of malpractice lawsuits related to thyroid and parathyroid surgery that are filed in the United States is virtually impossible. Many lawsuits are either dropped completely or settled out of court, and frequently the terms of the settlement are sealed and thus not available as public record. However, a review of the literature on the topic shows that there are several different approaches that make it possible to estimate the scope of the problem.

One method of identifying malpractice lawsuits is to study the number of jury verdict awards, as these are matters of public record. Kern examined jury verdict reports from U.S. civil court cases between 1985 and 1991 and found that there were a total of 62 cases related to endocrine diseases.³ Of these cases, 32 jury awards were related to complications of thyroid surgery and only two related to complications of parathyroid surgery. In 22 of the 62 cases analyzed, a delay in the diagnosis was the basis of the verdict of which 11 cases were related to thyroid cancer whereas only two were related to hyperparathyroidism.

More recently, in 2003, Lydiatt reported on jury verdicts related to cases involving thyroid surgery between 1987 and 2000 by searching the WESTLAW (West Publishing Co., St. Paul, Minnesota) computerized legal database.² He found 33 cases total, of which 10 (30%) were related to surgical complications, all but 1 of which was due to recurrent laryngeal nerve injury. In a third of these cases of recurrent laryngeal nerve (RLN) injury, bilateral nerve injuries had occurred.

In 2010, Abadin and colleagues utilized a different computerized legal database (Lexis/Nexis Academic) to study United States cases between 1989 and 2009 related to thyroid disease.⁴ These authors identified 143 cases; however, individual case review revealed that only 33 cases involved alleged negligence following thyroid surgery. Of these 33 cases, 15 cases (46%) involved RLN injury, 3 cases (9%) claimed inadequate surgery, and the same number alleged unnecessary surgery. Of the 15 cases related to RLN injury, seven cases were decided in favor of the patient, while eight favored the surgeon. The jury awards ranged from $150,000 to $3.7 million.

In 2009, Shaw and Pierce used a different method to study malpractice claims.⁵ By studying closed claims involving vocal cord paralysis that were reported by 16 of the largest malpractice insurers between 1986 and 2007, these authors were able to identify 112 claims of which only 28 (25%) actually went to trial. Of the 112 claims reviewed, 39 (35%) were related to thyroid or parathyroid surgery. A full 60% of the 112 closed claims were settled before trial. Overall, in 15% of the 112 filed cases, no settlement or jury trial was ever pursued. In their analysis, of the 28 cases that went to trial, only 2 (7%) were found in favor of the plaintiff. In contrast to the high jury awards seen in the Abadin study, Shaw and Pierce noted the largest payment to be $875,000 (although adjusted for inflation the number would be $1,575,000).

The numbers of cases noted by all of these authors is really quite small when one considers that the number of thyroidectomies performed in the United States was approximately 61,500 in 2003.⁶ Although there is no way to quantify exactly how many malpractice claims involving thyroidectomy are filed, informal discussions with many experienced thyroid and parathyroid surgeons who have reviewed medical records as expert witnesses suggest that many more than the few cases noted per year in the previous studies are actually considered or filed in the United States annually. It appears that the malpractice cases reported in the studies above are only the tip of the iceberg of malpractice cases related to thyroid and parathyroid surgery.

Legal Basis of Malpractice

The legal basis of a malpractice suit rests on four components. The surgeon has entered into a relationship obligating provision of care to the patient. The surgeon violated the relevant “standard of care.” The “substandard care” resulted in injury to the patient. This resulted in compensable damages to the patient.⁷ The essence of the case is usually the question “Did the surgeon deviate from the standard of care?”

The “standard of care” is not an absolute algorithm or set of guidelines. In legal terms, it is the level at which the average, prudent provider in a given community would practice. It is how similarly qualified practitioners would have managed the patient’s care under the same or similar circumstances. The standard of care is essentially redefined in each case based on the testimony of expert witnesses. It does not imply the highest standard of care and may simply represent “a course of treatment advocated by a considerable number of recognized and respected professionals”.⁸

Of note, the legal doctrine that is most commonly used by plaintiffs in malpractice cases involving RLN injury is res ipsa loquitur, which translated from Latin means “the thing speaks for itself.” According to this view, the proof of negligence is in the actual complication itself. For example, if a patient is found to have an infection secondary to a retained sponge, no proof of negligence is required as the event itself is the proof. Many malpractice attorneys make a similar argument about RLN injuries following thyroid or parathyroid surgery. However, surgeons and defense attorneys will uniformly disagree with this concept. They maintain that an RLN injury is a known complication of surgery that can occur regardless of the care taken by the surgeon. As such, the occurrence of an RLN injury is an unfortunate, but known, complication of surgery, but not necessarily a result of negligence.⁴

The Standard of Care

Numerous professional organizations have published guidelines that are relevant to the surgical treatment of patients with thyroid and parathyroid diseases. Perhaps the most commonly discussed in the United States are those developed by the American Thyroid Association.⁹ These guidelines were developed using the principles of evidence-based medicine. Guidelines are not absolute rules, and the authors of the ATA Guidelines state “it is not the intent of these guidelines to replace individual decision making, the wishes of the patient or family, or clinical judgment.”⁹

Although guidelines are not synonymous with the legal concept of standard of care they can be used to help establish the standard of care, and their use in litigation is increasing.¹⁰ Most often, they are used to demonstrate that there was a deviation from the standard of care, but they also can help exculpate a physician rendering care consistent with recognized guidelines. To protect oneself in the event of a malpractice suit, and potentially to avoid suits, the surgeon should provide care consistent with published guidelines when it is in the best interest of the patient. When unique situations or the patient’s informed wishes require substantial deviation from these guidelines, the reason for these deviations should be carefully documented in the medical record.

Many available studies investigating rates of permanent injury to the recurrent laryngeal nerve report rates of approximately 1% of patients undergoing thyroidectomy¹¹ and less often during parathyroidectomy,¹² though theses rates may be underestimated in series without routine postoperative laryngoscopy. Actual transection of the nerve during surgery is less common.¹³ Some data suggest that exposure of the entire nerve is less likely to result in nerve injury than simple identification of a portion of the nerve.¹⁴ It is our opinion that identification of the nerve during thyroidectomy represents the standard of care in the United States today. There may be situations where the nerve cannot be identified, such as during operations on advanced cancers or very large thyroid glands, or when performing reoperations. The standard of care cannot mandate that the nerve actually be identified but rather that every attempt should be made to do so and that these attempts should be documented in the operative report. If the nerve cannot be identified, the reasons for this and whatever other strategies were employed to minimize the risk of nerve injury should be similarly documented. Many surgeons do not routinely identify the recurrent nerve during parathyroid surgery, particularly during focused, minimally invasive, single-gland exploration. This can be acceptable as long as appropriate care is taken and documented to avoid the nerve in such a focused operation.

Preoperative laryngoscopy obviously does not influence the incidence of nerve injury during surgery but represents important physical exam information. Preoperative laryngoscopy could possibly protect a surgeon from litigation if a paralyzed vocal cord had been identified preoperatively. Some experts believe that every patient undergoing thyroidectomy should have preoperative laryngoscopy to help plan the operation, appropriately counsel the patient about the risks of surgery, and protect the surgeon from litigation.^15,16 There are situations where such information may be valuable for operative decision making. However, its utility in asymptomatic patients without malignancy has been questioned.¹⁷ Patients undergoing thyroidectomy, particularly those with cancer, who have symptoms suggesting vocal cord paralysis or invasion of the larynx, hypopharynx, trachea, or esophagus should be appropriately evaluated by whatever techniques or imaging studies are necessary including fiberoptic laryngoscopy. Based on these considerations, it is difficult to broadly define a standard of care for this investigation at this time (see Chapter 15, Pre- and Postoperative Laryngeal Exam in Thyroid and Parathyroid Surgery).

Intraoperative recurrent laryngeal nerve monitoring is being used with increasing frequency¹⁸ and is discussed in detail elsewhere in this book (see Chapter 33, Surgical Anatomy and Monitoring of the Recurrent Laryngeal Nerve). Several studies do not demonstrate a decrease in recurrent laryngeal nerve injury when this technique is used.¹⁹ There is at least a suggestion that the incidence of nerve injury may be less in reoperations when nerve monitoring is used²⁰ and that temporary nerve injury rates are lower when a nerve monitor is used.²¹ We feel surgeons should be aware that this technique is gaining greater acceptance and appears to be used with greater frequency among younger as well as higher volume thyroid surgeons.¹⁸ In addition, it may be true that the use of nerve monitoring could potentially help in the defense of a surgeon sued for injuring a nerve during thyroidectomy by demonstrating that he or she used every possible precaution to avoid nerve injury. Given the conflicting evidence on rates of vocal cord paralysis and the difficulty in quantification of benefit of neural monitoring, we feel it is difficult to broadly define standard of care relative to neural monitoring at this time.

Malpractice Claims and the Parathyroid Glands

Permanent hypoparathyroidism is a recognized complication of thyroidectomy.²² It alone is rarely a reason for a malpractice suit.⁴ The risk of parathyroid injury can be decreased by identifying the glands during surgery, avoiding injury to their blood supply, and autotransplanting glands that cannot otherwise be preserved. As mentioned previously, the occurrence of this complication does not mean that there has been a deviation from the standard of care. The operative report should carefully detail whatever techniques the surgeon employed to avoid parathyroid injury. Failure to mention the parathyroids and maneuvers to preserve them in the operative report of a patient who ends up with permanent hypoparathyroidism is a difficult case to defend.

Malpractice suits resulting from parathyroidectomy are less common than following thyroidectomy.³ Causes for action are similar to those during thyroidectomy including recurrent nerve injury and airway obstruction. Issues unique to parathyroid surgery include the role of preoperative imaging and intraoperative parathyroid hormone (IOPTH) measurement. Preoperative imaging can identify the abnormal parathyroid in most cases of primary hyperparathyroidism²³ and is discussed extensively elsewhere in this book (see Chapters 63, Intraoperative PTH Monitoring during Parathyroid Surgery and 57, Guide to Preoperative Parathyroid Localization Testing). Although preoperative imaging may be helpful when conventional bilateral exploration is performed, there is little evidence that the success rate is improved when imaging is performed. Some sort of preoperative imaging must be performed if limited, single-gland exploration is considered. Preoperative imaging, frequently with more than one modality, is mandatory if reexploration for recurrent or persistent hyperparathyroidism after previous exploration is planned.²⁴ Although there may be situations where parathyroid exploration without preoperative imaging is not a deviation from the standard of care, the authors believe that a failed parathyroid exploration would be easier to defend in court if imaging had been performed.

IOPTH measurement to assure the adequacy of parathyroidectomy is being employed with increasing frequency, particularly when limited, single-gland exploration is planned.²⁵ Although radioguided surgery may be used to guide single-gland exploration instead of IOPTH measurement,²⁶ it is considered less sensitive.²⁷ Strategies have been also been proposed to minimize the risk of persistent hyperparathyroidism without the use of IOPTH or radioguidance.²⁸ In most cases, either IOPTH measurement or radioguidance should be used if limited, single-gland exploration is planned. If neither modality is available and after careful explanation of the risks and benefits of limited exploration compared to bilateral exploration including the increased risk of persistent hyperparathyroidism, performance of a more limited operation may be defensible in the event of malpractice suit. Also in certain circumstances of lower preoperative PTH levels, or especially if there is preoperative localizing study concordance many surgeons may not find utility in IOPTH. As with so many special circumstances in the care of individual patients, this discussion with the patient must be carefully documented. Referral to an institution where these techniques are available might also be considered if the surgeon cannot offer the appropriate modalities. Although measurement of IOPTH in conventional bilateral exploration may be helpful, particularly if all four parathyroids cannot be identified, we do not believe that failure to use this technique is a deviation from the standard of care.