This article explores why the national court system has seen a steady influx of claims alleging practitioners’ failure properly to perform vasectomy or ensure sterilization and the manner in which that influx has caused physicians to reassess their methods of practicing medicine in an increasingly litigious environment and make the appropriate and necessary accommodations. Through their experiences as medical malpractice litigators and through the analysis of reported cases, national jury verdicts, and insurance claims made and paid in lawsuits arising from claims regarding the performance of vasectomy, the authors enlighten the reader as to the legal theories and hurdles applicable to such claims and the medical theories most often elucidated and litigated by the patients who bring them. Also offered are suggestions as to the manner in which the practitioner may be proactive in both preventing and defending exposure to malpractice litigation.
According to the last annual report of the National Practitioner Data Bank, the central repository of information regarding malpractice payments made on behalf of physicians nationally, during calendar year 2006, 79% of the new reports concerning malpractice payments were physician related, with the median and mean malpractice payment amounts for surgeons totaling $175,000 and $311,965, respectively. Significantly, 3218 malpractice-related payments were made by surgeons in 2006, with the median and mean payouts $145,000 and $252,476, respectively. From 1990 to 2006, almost 64,000 malpractice payouts on behalf of surgeons were reported to the National Practitioner Data Bank.
More pointedly, according to PIAA’s 2008 Risk Management Review of Urologic Surgery, urologic surgery ranks twelfth in the number of claims reported from 1985 through 2007, among the 26 specialty groups included in the database. The total indemnity paid on behalf of urologists during that time period was $285 million, and also ranked twelfth among the 26 specialty groups reported. In calendar year 2007, over $9 million in indemnity payments for 42 claims in urologic surgery were reported, with an average indemnity payment of $227,838. In all, however, urologic surgery claims, at 2.5%, were a small percentage of claims reported to PIAA in 2007.
Improper performance was the most prevalent medical misadventure claimed in urologic surgery suits. Within that heading, male sterilization procedures ranked fifth among the procedures alleged to have been improperly performed. Of the five most common misadventures resulting in lawsuits (operative procedures on the prostate and seminal vesicles, the bladder, the kidney, the penis, and male sterilization), sterilization was the only one with an average indemnity of less than six figures ($42,143; from 1985–2007). Diagnostic interview, evaluation, and consultation were the “procedures” that resulted in the most claims against urologic surgeons, emphasizing the importance of the information imparted and recorded during the initial patient interaction. Not surprisingly, sterilization procedures ranked first among urologic surgery claims in which the primary injury claimed was emotional.
Medical professionals are certainly familiar with a wide variety of stressors, uncertainties, and hurdles inherent to the practice of medicine, and the practitioner has learned and developed methods and algorithms to deal with them. When physicians are named as defendants in a lawsuit, however, it is akin to entering a foreign land without a passport or an appreciation of the language. It drags practitioners outside of the medical arena and subjects them to forces over which they have little, if any, control and even less knowledge.
Patients who bring such suits, particularly in the realm of “wrongful conception” as a result of a failed or recanalized vasectomy, have their own significant stressors and anxieties. Both sides going forward must understand this fact. It serves no one to engage in characterizations of those who sue, or those who are sued.
This article raises questions and suggests answers as to why the national court system has seen a steady influx of claims alleging practitioners’ failure properly to perform vasectomy or ensure sterilization and the manner in which that influx has caused physicians to reassess their methods of practicing medicine in an increasingly litigious environment and make the appropriate and necessary accommodations. Through their experiences as medical malpractice litigators and through the analysis of reported cases, national jury verdicts, and insurance claims made and paid in lawsuits arising from claims regarding the performance of vasectomy, the authors hope to enlighten the reader as to the legal theories and hurdles applicable to such claims and the medical theories most often elucidated and litigated by the patients who bring them. At the conclusion of this article the authors offer suggestions as to the manner in which the practitioner may be proactive in both preventing and defending exposure to malpractice litigation.
What is malpractice?
The authors have always found it instructive, whether discussing the matter with physicians or laypersons, to educate the listener as to the charge delivered by the Court to the average jury member sitting in judgment in a medical malpractice action, just before commencing deliberation. Malpractice, as defined by the Pattern Jury Instructions , from whence the Court derives its ultimate charge to the jury, reads as follows ( Box 1 ):
Malpractice is professional negligence and medical malpractice is the negligence of a doctor. Negligence is the failure to use reasonable care under the circumstances, doing something that a reasonably prudent doctor would not do under the circumstances, or failing to do something that a reasonably prudent doctor would do under the circumstances. It is a deviation or departure from accepted practice.
A doctor who renders medical service to a patient is obligated to have that reasonable degree of knowledge and skill that is expected of an average specialist who (performs, provides) that (operation, treatment, medical service) in the medical community in which the doctor practices.
The law recognizes that there are differences in the abilities of doctors, just as there are differences in the abilities of people engaged in other activities. To practice medicine a doctor is not required to have the extraordinary knowledge and ability that belongs to a few doctors of exceptional ability. However every doctor is required to keep reasonably informed of new developments in (his, her) field and to practice (medicine, surgery) in accordance with approved methods and means of treatment in general use. A doctor must also use his or her best judgment and whatever superior knowledge and skill (he, she) possesses, even if the knowledge and skill exceeds that possessed by the average specialist in the medical community where the doctor practices.
By undertaking to perform a medical service, a doctor does not guarantee a good result. The fact that there was a bad result to the patient, by itself, does not make the doctor liable. The doctor is liable only if (he, she) was negligent. Whether the doctor was negligent is to be decided on the basis of the facts and conditions existing at the time of the claimed negligence.
A doctor is not liable for an error in judgment if (he, she) does what (he, she) decides is best after careful evaluation if it is a judgment that a reasonably prudent doctor could have made under the circumstances.
If the doctor is negligent, that is, lacks the skill or knowledge required of (him, her) in providing a medical service, or fails to use reasonable care in providing the service, or fails to exercise his or her best judgment, and such failure is a substantial factor in causing harm to the patient, then the doctor is responsible for the injury or harm caused.
Malpractice litigation is a form of tort, or civil (as opposed to criminal), litigation wherein a patient, termed the “plaintiff,” brings the action accusing a physician, the defendant, of a civil wrong. That civil wrong is negligence: failure to act as a “reasonable person” or to adhere to a particular standard of care. Negligence by a professional is termed “malpractice,” and by a physician or hospital “medical malpractice.” The burden of proving every essential element that constitutes malpractice in any given case remains with the patient from institution of the proceeding until verdict is rendered and judgment entered.
In medical malpractice litigation, the standard of care arises from the physician’s responsibility to possess and apply that reasonable degree of skill, learning, and ability ordinarily possessed by physicians within the community in which he or she practices. The standard of care within the community in which the defendant practices changes on a case-by-case basis, because prior trial court decisions in similar actions have no precedential or binding effect. There is no set standard of care adherent to the performance of vasectomy, nor could there be one, irrespective of the existence of published guidelines by any number of urologic associations. Although persuasive evidence of a practitioner’s breach from what is considered accepted protocol in the urologic community, absent concession that they are “authoritative” or “controlling,” guidelines are just that, guidelines. Deviation from them is not, standing alone, evidence of per se negligence. In each individual situation it is the duty of the fact-finder (the jury) and occasionally of the appellate courts, in situations where the jury’s decision is inconsistent with the facts or the law presented, to determine just what the applicable standard of care is in any given situation and to determine whether that standard was met by the defendant physician.
To establish a claim for civil negligence, there must first be proof of a duty owed (a “physician-patient relationship”). That relationship arises any time a physician undertakes to diagnose or treat urologic conditions, whether it be during examination within the confines of the office, operating in a hospital or ambulatory care facility, rendering advice over the telephone to one’s own patient, or while on call for a colleague.
Once it has been established that a duty to render appropriate care exists, the next prong in establishing a claim for medical malpractice lies in proving a breach of that duty (commonly defined as a departure or deviation from good and accepted practice or care). Whether or not the physician breached is a determination made by the jury based on the medical evidence in the case and the testimony of the witnesses. More often than not, it is the testimony and the credibility of the expert witnesses in the case on the subjects of standard of care in the community and whether the particular practitioner on trial adhered to or departed from that standard that influences a jury’s decision. Those experts are subject to cross-examination by opposing counsel, not only on the medical testimony given on the stand but on their qualifications, credibility, and in the face of inconsistent sworn testimony they may have given previously on similar topics in other courts of law.
Medical treatises or guidelines applicable to the period of treatment at issue, and the defendant’s own prior testimony, publications, and office protocols, may also come into play in the jury’s analysis. Most courts adhere to the common rule that a text or treatise must first be acknowledged as authoritative in the field before it may be read to the jury, but once acknowledged as such it may be used to establish that the defendant practitioner deviated from the authoritative standards as set forth within the publication and committed malpractice.
Most attorneys who select juries on behalf of patients tell those juries that they are not claiming that the practitioner acted or failed to act intentionally, or that they are “bad” doctors. Instead, they allege one act or series of acts of malpractice as isolated incidents of breach of care in a longer history of good practice. Without a “bad result,” meaning without injury, there is no case, but every jury is charged that a bad result, in and of itself, is not evidence of malpractice. It is not the result that legally determines if there was negligence. Practically speaking, however, a jury faced with a bad result undoubtedly considers that result in the exercise of deliberation.
An error in medical judgment is not evidence of malpractice. In context, the use of the word “judgment” here has a specific meaning. Judgment comes into play in the arena of malpractice litigation where, and only where, there are two or more ways for a physician to approach a situation. If there are two ways to deal with the situation, each acceptable in the medical community, the choice by the physician of the one over the other is the exercise of judgment, and if exercised appropriately the physician can be defended even if the chosen treatment failed.
Many a practitioner has attempted to defend an allegation of malpractice by asserting that an exercise of judgment cannot constitute negligence, and many a tribunal has allowed the pursuit of just such a defense. In reality, however, almost every action involving a physician’s decision making as it pertained to a patient could conceivably be defended as such, and so the courts have attempted to limit the defense of “judgment” to those situations where the practitioner had two very real and very acceptable treatment options available and chose one over the other to the unfortunate but unpredictable detriment of the patient.
In that regard, jurors are cautioned against casting their judgment on the defendant physician based on outcome, but rather are directed to consider what the physician had in front of him or her at the time care was rendered and decisions made. The reason for this directive is that in hindsight almost all are correct.
The third and most essential prong in establishing medical malpractice is causation. It must be shown that the practitioner’s action or inaction was the competent, or primary, producing cause of injury to the patient. The burden is on the patient to prove that, more likely than not, earlier or alternative diagnosis or treatment would have positively affected outcome. It is not the patient’s burden to establish that appropriate care would have resulted in some guaranteed result (although in some situations that is the very allegation made, particularly when it comes to the subject of “permanent sterilization”). Rather, it is enough to establish that it would have impacted the quality and duration of life to the patient’s benefit. So significant is the subject of causation that it maintains its own pattern jury instruction. Proximate cause is defined in the Pattern Jury Instructions as follows ( Box 2 ):
An act or omission is regarded as a cause of an injury if it was a substantial factor in bringing about the injury, that is, if it had such an effect in producing the injury that reasonable people would regard it as a cause of the injury. There may be more than one cause of an injury, but to be substantial, it cannot be slight or trivial. You may, however, decide that a cause is substantial even if you assign a relatively small percentage to it.
Acknowledging that a delay in diagnosis (even a negligent delay) may not affect the patient’s ultimate outcome, or that surgical “error” or postoperative management may not cause or contribute to the specific injury claimed, the law interposes the evidentiary requirement of “proximate cause” on plaintiffs seeking monetary damages in medical malpractice cases. Technically, if a physician’s negligence did not cause harm, the patient should be unable to make out what is known as a “prima facie,” or sufficient on its face, case of medical malpractice that survives dismissal at the close of plaintiff’s evidence rather than reaches the deliberation of the jury. In reality, however, rare is the action in which medical negligence is proved yet the claim dismissed by Court or jury. As discussed further, the public perceives that accurate diagnosis and treatment alters outcome, and the public is often unwilling to forgive the practitioner who has breached the standard of care or accept that “it didn’t make a difference.”
The final prong in establishing a claim of medical malpractice is that the patient must have sustained an actual injury as a result of the practitioner’s malpractice to obtain reward for final damages. Although punitive or punishment damage awards are rare, juries are instructed that under the appropriate circumstances they can award noneconomic damages for pain and suffering and loss of consortium or society (an award made for harm to a close relationship, such as with a spouse or child). It is common for a patient’s spouse to be named as coplaintiff in a malpractice action, to seek redress for loss of society, comfort, and companionship because of the injuries alleged, and to obtain remuneration in significant amounts in those cases wherein a jury determines that plaintiffs have proved their claims.
Economic damages, such as loss of earnings incurred to date and in the future, medical costs, rehabilitation and therapy costs, and out-of-pocket expenses for goods and services can be granted and often constitute a hefty portion of the fees awarded. Cases involving allegations of wrongful conception are controversial, and although few jurisdictions award damages consistent with the cost of raising a healthy but “unwanted” child, most offer both spouses avenue to pursue compensatory damages for injuries inflicted (discussed later).
As a caveat, although the burden of proof in all cases rests on the party asserting the claim, the defense must prove those issues raised by the defense, which are deemed “affirmative defenses,” and which must be set forth in the initial answer to the complaint. Perhaps the most significant of these affirmative defenses in the realm of vasectomy litigation is termed “culpable conduct,” or more correctly, “comparative negligence,” which is conduct by the patient that caused or contributed to their own damages and may reduce the ultimate verdict by the percentage of that culpability.
In the area of vasectomy litigation, this usually means that the patient did not follow an instruction that, if followed, would have improved his outcome or prognosis. Quite frequently it involves ignorance of admonitions to submit semen samples for analysis or to avoid unprotected sexual relations until a specified number of postoperative fertility studies can be performed, but it can be as simple as ignoring a surgeon’s warnings regarding postoperative hygiene, which contributes to wound breakdown, poor healing, and infection. Because in many instances in this area of litigation the patient has sought a “guaranteed” means of sterilization for personal, economic, or even emotional reasons, this defense is one approached with care and trepidation. The patient’s attorney attempts to portray the defense and the doctor as “blaming the patient.” To be effective, such a defense must not only be medically valid, but the basis for the defense must be well documented in the defendant physician’s records and supported by the records of other nonparty treating practitioners, such as the family physician.
Who Sues Whom and Why?
It has been the author’s experience that almost any surgeon with a busy practice invariably ends up on the “wrong side” of a malpractice suit. That is not to suggest that all practitioners find themselves defendants in a lawsuit, or that only those with a high-volume practice get sued. But more often than not, today’s practitioner faces the service of a summons and complaint, or at least the specter of a malpractice claim.
Research reveals that a significant percentage of malpractice lawsuits involving the performance of vasectomy sound in “wrongful conception” or “wrongful pregnancy,” an action brought by the parents of a healthy, but unexpected, unplanned, or unwanted child for alleged negligence leading to conception or pregnancy. The simple fact of the matter, however, is that every interaction with a patient in this litigious society is rife with the potential for a malpractice claim. The referral, the initial intake, the history and physical examination, and the consent to surgery are all potential avenues of omission or commission that can give strength or support to a patient’s claim of surgical negligence. The actual physical performance of surgery itself, replete with risks and complications, is the focal point of many a malpractice claim sounding in vasectomy. Postoperative evaluation, recommendation, and, in particular, fertility testing, however, can be equally as perilous.
With that in mind, the initial consultative visit takes on increased importance and must be approached with the patient’s anxiety in mind. As with any legal situation, documentation is the key, but the creation of a physician-patient relationship and particularly the ephemeral forging of trust can decrease the risk of subsequent exposure. Time should be taken to answer any and all patient questions and those questions should be encouraged. The procedure itself should be discussed along with risks, potential complications, and any contraindications. If a patient is willing to bring his spouse or partner along for the visit, all the better, because a second witness to a detailed conversation regarding what to expect affords the attorney more opportunity to obtain helpful testimony should the case proceed to deposition.
From a litigation perspective, that consultative visit, as routine as it may be, warrants a clear, concise progress note in the patient’s chart. Simply writing “initial consultation,” although expedient and likely illustrative to the practitioner, leaves little to support the extent and thoroughness of the conversation with the patient on that date. Better at least to outline the fact that risks, complications, and the nature of the procedure were discussed (without necessarily outlining each and every risk and complication, because invariably one will arise that has been omitted, and will afford opposing counsel ammunition to argue it was never discussed or contemplated, but its disclosure was warranted).
Assuming time is taken to discuss the nature of the procedure and brochures are given, or models or illustrations used, documentation of this in the initial progress note is helpful. Often, incredulous testimony can be stretched to the breaking point in the face of such specificity, particularly the use of demonstrative evidence. If the patient agrees to undergo the procedure at this initial visit, the consent forms should be signed and copies placed in the patient’s chart, accurately dated, and witnessed. If the physician or practitioner can take the extra step of having the patient execute a consent form, verifying that the patient was encouraged to ask any questions that came to mind and that all questions were answered to the patient’s satisfaction, all the better.
If the procedure itself was discussed at the initial consultation, clear instructions in printed form should be given to the patient for both preoperative and postoperative procedures. The patient should be told in detail what he needs to do to prepare for the surgery and what he can expect postoperatively. The concepts of rest, limited activities, bathing or swimming, sexual intercourse, and even the need to ejaculate postoperatively to clear the sperm ducts should be discussed and documented with the patient signing off on receipt of both preoperative and postoperative instructions. Carbons of those executed acknowledgments should be made part of the patient’s chart or scanned into the computer file.
Research and experience reveal that a cause of action sounding in lack of informed consent (the alleged failure to adequately warn or instruct the patient as to the potential risks, benefits, and alternatives of the planned procedure, combined with the plaintiff’s claim that had he been made aware of those potential pitfalls, no matter how remote, he would have deferred surgery or sought alternative care) is invariably part and parcel of a patient’s claim. Careful, reasonable documentation of those conversations is the most effective weapon in the physician’s arsenal.
By way of illustration, consider the 1996 California case of Cole v. Korcek , JVR No. 183,897 (Cal.Superior), 1996 WL 643,370. A husband and wife with two daughters sued for wrongful conception after the patient underwent vasectomy and his wife subsequently gave birth to their third child. They contended they could not afford the cost of another child and that they drove vintage 1969 Mustangs and could not equip the vehicles for five people. The plaintiffs insisted that the defendant physician advised them that a single postoperative semen sample was negative, and that this was sufficient to permit them to engage in unprotected intercourse. The plaintiff added a cause of action for lack of informed consent, contending he would not have elected to undergo the vasectomy if he had been made aware of the failure rates.
Fortunately for the defendant physician, his chart accurately reflected his admonition that the semen sample was positive and that the patient was advised to continue to use protective measures during intercourse. A follow-up letter was sent and a copy annexed to the chart reminding the patient to bring another semen sample to the office for testing. The jury accepted that it was the sole responsibility of the patient to submit specimens for analysis, and rejected the consent claim, finding that no reasonable person who wished to undergo sterilization would refuse based on the miniscule failure rate. A verdict in favor of the defense was awarded.
Although most vasectomy-related lawsuits surround wrongful conception, the other more routine complications of vasectomy should be discussed, and do occasionally form the basis of claims. Patients have brought suits for infection, sperm granuloma, sperm congestion, or the development of sperm antibodies. Lawsuits have been commenced as a result of chronic testicular pain, which lasts long-term after vasectomy, even though these are published and accepted complications of the procedure. Claims sounding in informed consent are bolstered by the plaintiff’s attestation that had he known or been made aware of these complications, he would have opted not to have surgery.
In cases involving vasectomy, because of the reluctance and anxiety involved (not to mention the sensitive anatomy) jurors might be more apt to accept that a patient would have deferred an undesirable and elective procedure based on the knowledge of untoward complications than in cases, for example, sounding in the need to remove potentially metastatic tumors or repair obstructed bowel. By the same token, however, research and experience reflect that in the face of well-documented, contemporaneous disclosure of the risks and potential complications to a patient who appreciates them, jurors are inclined to take a “you knew what you were getting yourself into” demeanor in the courtroom.
Consider the recent Texas case of Holt v. Frankel , 2007 WL 4,623,848, (Collin Cty, Texas, 2007). The evening after his vasectomy, the patient called the defendant physician to complain of pain, swelling, and a discolored scrotum. After being told his symptoms were “normal” for postoperative day number 1, the patient called back 2 days later to reiterate his complaints and was again told not to worry. Two days later he wound up in a local hospital after his scrotum swelled to twice its normal size and a testicular ultrasound revealed no blood flow to the left testicle. It was removed the following morning. The patient sued for medical expenses, pain and suffering, mental anguish, and loss of body member and disfigurement, alleging the physician was negligent in failing to warn of the dangers of vasectomy, failing properly and timely to treat the patient, and failing to recognize the symptoms as serious complications of the surgery. His wife sued to recover damages for her loss of consortium and household services.
The defendant contended that there was no evidence of when the loss of blood flow occurred and that it likely was an acute event on the day of hospitalization. He further contended that his records accurately reflected a thorough consent conversation, including the patient’s understanding of the risks of bleeding and infection and damage to adjacent organs, inclusive of the patient’s scrotum and testes. The jury found for the defendant. It seems that in this instance, the patient strained his own credibility by insisting he had never been instructed by the defendant in the dangers of vasectomy, particularly when the chart suggested otherwise. This led the jury to decide the ever crucial credibility battle in favor of the physician, and forgive his theoretical delay in diagnosis.
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