Malpractice is patient injury secondary to failure to exercise that degree of care used by reasonably careful physician of like qualifications
Negligence is failure to extend the degree of diligence and care that a reasonably and ordinarily prudent person would exercise
Informed consent is the physician’s fiduciary duty to give the patient all the information needed for the patient to make an intelligent decision about therapies offered.
Communication is the cornerstone of good care-verbal and written
CAP -communication, anticipation, preparation can help reduce medical errors, improve patient safety and reduce medical legal risk
The word malpractice evokes guttural responses in physicians and health care providers. This is perhaps most true in the areas of obstetrics and gynecology, where the physical damages are often catastrophic and the economic damages reach millions of dollars. The fear of being unjustly involved in litigation and judged by nonphysicians as liable, despite having provided reasonable and appropriate care, seems unavoidable to many conscientious health care providers. The little-known reality, however, is that the growing consensus of empirical data on outcomes of malpractice actions shows that the legal system actually works for the health care provider more often than it does not. Understanding how the system works and making minor practice modifications can greatly minimize the risk of legal exposure by avoiding claims and adverse outcomes.
A medical negligence case is composed of three basic elements: a deviation from the standard of care, proximate causation, and damages. Each of these elements is required to be proved by way of “competent” expert testimony . The definition of “competent” varies state to state, but all states are uniform in requiring a physician to agree that malpractice occurred and that it directly resulted in injury. A deviation from the standard of care, though a cumbersome legal phrase, is simply a failure to act reasonably compared with another health care provider in the same or similar clinical circumstance . A deviation from the standard of care can be an act (intraoperative bowel perforation, administration of the wrong medication, etc.) or an omission (failure to run the bowel intraoperatively if a bowel injury is possible or failure to review laboratory results in a timely manner).
Proximate causation is often a more medically complex component of a malpractice action. The law requires that the deviation from the standard of care be a direct, proximate cause of injury to the plaintiff. It is important to note that the deviation does not have to be the exclusive cause of injury, but rather need only be a direct proximate cause. Proximate cause, legally, merely means that with appropriate or reasonable treatment, the injury would not have occurred .
The final element of a malpractice claim is damages. Damages can be both economic and noneconomic . Economic damages include easily quantifiable losses such as past and future medical bills and past and future wage losses. Noneconomic damages include factors such as past and future physical pain, emotional suffering, and, in certain instances, wrongful death. To be successful, the plaintiff, through presentation of expert testimony, must prove each of these elements to a probability. A failure on any one of the elements will result in a verdict for the defendant.
As mentioned, many health care providers will be surprised to learn what the growing consensus of empirical data reflects regarding medical claims. A review of approximately 1400 closed malpractice claims from five different liability carriers showed that only 3% of claims filed had no verifiable medical injuries to justify a claim. Additionally, 37% of the 3% did not involve errors but rather would be what a physician would commonly refer to as “frivolous.” Despite common perceptions about runaway juries and lottery verdicts levied against faultless physicians, the study demonstrated that 84% of the claims that did not involve errors nonetheless resulted in nonpayment. Conversely, approximately six times that rate of claims resulted in nonpayment to the plaintiff, despite the presence of medical errors and verifiable injuries ( ) ( Box 6.1 ).
To successfully maintain a medical malpractice action, a plaintiff must be able to establish three distinct elements of his or her case by way of expert testimony:
Deviation from the standard of care: The health care provider deviated from what a reasonable provider would have done in the same or similar circumstances.
Causation: The deviation was a direct cause of the injury suffered.
Damages: Economic and noneconomic damages were suffered as result of the injury.
A 2017 study of 10,915 claims from the Physician Insurers’ Association of America data-sharing project specifically presented data in malpractice claims for obstetrics and gynecology procedures ( ). Fig. 6.1 shows the percent of claims by method of resolution of all closed claims. The majority (59.5%) were dropped, withdrawn, or dismissed. Claims most often related to gynecologic surgery, but obstetric procedures were more expensive. They also reported a 55% decrease in paid claims from 1992 to 2014. On the flip side, the average payment per pain claim rose 16% and there was an increase in payments greater than $1 million. Fig. 6.2 shows the procedures most commonly associated with closed claims.
Although these data should be heartening for health care providers, they do little to eliminate burdens of excessive litigation costs, time away from practice and families, and the stress of participating in litigation. The goal for conscientious providers must be one focused on risk management: balancing improved patient care and minimizing medical legal risk .
A safe health care system must further incorporate efficient redundancies that promote safety without being cost prohibitive. “Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy to do the right thing” ( ).
Realizing lawsuits will inevitably occur, what follows is a brief historical overview along with practical insights aimed at helping one enhance patient care and communication, minimize the risk of involvement in meritless litigation, and provide the best defense in the event a claim is made.
A doctor who knows nothing of the law and a lawyer who knows nothing of medicine are deficient in essential requisites of their professions. —David Paul Brown, 1795–1872
British North America inherited its law, as well as its language, from England. Most European countries originally occupied by the Romans adopted a form of law based on the Roman law codes. That law is called civil law. England’s law, on the other hand, was based mainly on Scandinavian (Danish) law with a dose of folk law of undetermined origin thrown in. It was called the common law. One should not be deceived by its name. It was not law designed to protect the common man. It takes its name from the fact that it was the law that was common to all of England by about the year 1240. The two forms of law differ significantly.
Civil law is a codified system of laws . That is, the laws are spelled out in a series of written statutes adopted by the jurisdiction. Civil law therefore tends to be fairly static. Common law is largely law made by judges . It may incorporate some statutory elements on specific issues, but even statutes are subject to judicial interpretation. Judges in the civil law are academics specially trained for their positions and act as prosecutor, judge, and jury. Civil law is therefore inquisitorial in nature and heavily dependent on the written word. In contrast, common law is an adversarial system in which the oral argument between the parties plays a much larger role. Judges are chosen from the practicing bar and are not usually academics. The judge is essentially a referee and instructs the jury, which makes the ultimate decision on the merits of the case. In common law, the law is made by judges who hear a disputed case on appeal. Those decisions become precedent for future cases. However, higher appellate courts or future appellate courts of the same level can overturn or overrule a prior decision if circumstances change or new information develops. Therefore change, albeit slow and irregular, is a constant element of the common law.
Under the early common law, to bring a civil action, a King’s Writ was needed; therefore little attention was paid to compensating the individual for personal wrongs (tort law). Doctors were essentially immune from suit for malpractice. Technically some suits might have been pursued as contract suits, but written contracts were highly unusual between a physician and his patient, and without the written document such suits became almost impossible for the plaintiff to win.
In 1346, the bubonic plague arrived in Italy. It spread over Europe rapidly but did not reach England until 1348. The major effect of the epidemic occurred between 1348 and 1351, but the bubonic plague became endemic and continued more or less uninterrupted until 1381. It is estimated that between 1348 and 1351, 50% of the population died, and by 1381, two-thirds of the English population was decimated by the epidemic. (Because there was no accurate census at the time, such figures are estimates based on church records, burial records, tax rolls, and contemporary accounts.)
The loss of manpower was a major blow to the English economy. Overnight, people became as important as real property (land) and personal property (including livestock) in the English economy. Therefore a physician’s mistake that deprived the economy of a worker became an important enough matter to be brought before the courts. Physicians suddenly lost their immunity for practice errors. Actually, it was an even worse scenario: The physician became strictly liable for an unfavorable outcome, and because there was no tort law (law compensating the individual for personal wrongs), the physician was prosecuted under the criminal law for mayhem. By 1364 it had become obvious that this was too draconian a remedy, and two property terms that had been previously used in livestock cases were introduced to permit civil malpractice cases. Trespass (trespass by force and arms) was charged for direct injury and trespass on the case for indirect injury.
These same concepts, refined over the centuries, were brought to the North American colonies and adopted almost entirely by the American court system after independence. In the early 1800s, the modern concept of negligence replaced trespass and trespass on the case. In the period of rapid industrialization after the Civil War, American courts refined these claims. The four elements of a cause of action for medical negligence are as follows:
Duty: The obligation created through physician patient relationship.
Breach: A deviation from the “standard of care” for a reasonable practitioner in the same clinical circumstance.
Proximate causation: A direct and foreseeable connection between breach and injury.
Damages: Economic (medical costs, wage loss, etc.) and noneconomic (physical and emotional pain and suffering).
There is no greater asset in risk management for the clinician than a strong physician-patient relationship . Patients are typically trusting and respectful of their providers, which gives the best opportunity to avoid litigation. The typical patient will become a plaintiff when he or she loses trust in the provider or fails to get understandable answers to the complex medical issues surrounding a less than optimal outcome. “I don’t know or understand either what happened or how this happened” is the statement that begins nearly all inquiries into the quality of care. This chapter provides insights that will allow the physician to supply answers to the patient, to document appropriately, and to participate more functionally in a medical-legal claim while maintaining a high level of care and professionalism.
Reproductive medicine and the courts
No area of medicine receives more court scrutiny, legal scholarly review, or social commentary (even including presidential directives) than the fields of obstetrics and gynecology. In addition, some of the most expensive categories of malpractice claims arise from the obstetrician/gynecologist’s practice (pregnancy/birth claims, operative procedures on the uterus, prescription medication errors, and failure to diagnose breast cancer). Practically speaking, nearly every malpractice issue that has been litigated in American courts deserves a volume of its own to discuss and dissect adequately. Indeed, a single chapter in a general textbook of gynecology can do little but cover the generalities and touch on the more important issues the courts have addressed. Overall, applying the four elements noted previously to most claims, a malpractice case is typically a review of case facts applied to the “standard of care” and “proximate cause” through medical testimony to determine whether care was simply “reasonable.” It is important to note that the care does not have to be perfect, nor do all decisions have to be correct. Instead, if care is attentive and the decisions rational, the provider will have a strong defense position regardless of outcome. In fact, a review of all paid claims for obstetrician/gynecologists reported a decrease in paid claims from 1992 compared with 2014 ( ).
Medical-legal risk management, at its core, centers on communication in both the written and verbal form . Awareness of the common pitfalls in the processes employed in communicating information to patients, patients’ family, and concurrent and subsequent care providers will be invaluable if problems or litigation arise. The medical record, institutional policies and guidelines, and information communicated to patients (prospective plaintiffs) are the only information attorneys, claim representatives, and reviewing expert physicians have available to judge the validity of a potential malpractice claim. The following discussion examines good practices to improve communications with patients (both before and after treatment), improve the accuracy of the medical records, and provide useful information about navigating the litigation process to your best outcome.
Communication with the patient
Physicians well understand that the relationship with a patient is in large measure a relationship of trust. More often than not, a perceived breach of that trust is the impetus for a patient to seek the advice of an outsider for explanations about unfortunate medical outcomes. It must become a routine practice for physicians to discuss potential problems with their patients thoroughly and carefully before treatment . Taking the time necessary to assess a patient’s understanding of the procedures and possible outcomes and answering all the patient’s questions are critical to managing and controlling expectations. Concurrent notations in the record that you have in fact reviewed all risks and benefits of a potential treatment, thoroughly explained alternative treatments or procedures, and answered all patient questions provide important evidence of careful and appropriate treatment should it later become necessary to demonstrate this ( Box 6.2 ).
The 11 words in the sample progress note shown in Box 6.2 are an invaluable resource in the event of a complication or litigation. Although this is brief documentation, it does indicate the physician personally reviewed the critical elements mentioned earlier and allowed for questions. This note portrays the provider discussing the case with the patient, which will supplement the standard preprinted consent that is more “legalese” than substantive documentation.
Informed consent, informed refusal of care, surgical documentation, and postoperative care
Surgery in particular requires more discussion and documentation than office visits . A thorough note tells a story of why a surgery is necessary or indicated:
Surgical indication (diagnosis and nature of condition or illness calling for intervention)
Supportive diagnostic testing
Correlation with proposed surgery and clinical symptoms
Conservative treatment course and failure
Impact of preoperative condition on the patient’s activities and quality of life
Patient goals and concerns
Informed consent is a process, not just a signed piece of paper. It is the conversation that occurred with the patient to review the details of the forms and documents:
Alternatives to surgery (including the option of taking no action)
Benefits of surgery
Discussion of major risks
Probability of success (no result should ever be guaranteed)
Consider underlining or highlighting the major risk or risks listed on your consent form, such as bleeding, infection, and damage to nearby organs, nerves, and muscles. If you use an online version for informed consent, consider printing it out so you can add items in the lines provided and underline particular sections relevant to the patient’s surgery. The form can be scanned in.
Many decision aids have been developed to help with patient education. The American College of Obstetricians and Gynecologists has partnered with the Choosing Wisely campaign. This program promotes conversations between clinicians and patients by helping patients choose care that is supported by evidence, not duplicative of other tests or procedures already received, free from harm, and truly necessary. There are specialty-specific lists of “Things Providers and Patients Should Question.” This does not dictate care, but the patient-friendly materials are meant to spur conversation about what is appropriate and necessary treatment. Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits and harms, and helping clarify congruence between decisions and personal values. Decision aids may be pamphlets, videos, or web-based tools. People can use decision aids when there is more than one option and neither is clearly better or when options have benefits and harms that people value differently. Compared with usual care across a wide variety of decision contexts, people exposed to decision aids felt more knowledgeable, better informed, and clearer about their values and had more accurate risk perception. The median effect of decision aids on length of consultation was 2.6 minutes longer (24 vs. 21; 7.5% increase) ( ). Patient decision aids are associated with improved decision quality and decision-making processes without worse patient or health system outcomes.
The electronic medical record can be helpful for documentation using smart phrases for the previously mentioned topics, as well as for documenting the following:
Patient education materials given
YouTube videos recommended
Specific website recommendations
Shared decision-making steps ( )
Questions answered and concerns addressed ( )
Details of postoperative limitations regarding missing work or caring for children
Of course, any smart phrases must be edited for individual patient circumstances.
These steps will help anticipate what could go wrong and help mitigate risk by planning ahead.
Patients can refuse medical treatment. Every reasonable effort should be made to protect the patient’s health, but autonomy should be respected . Document the need for a test, medication, intervention, or surgery. Explain the needed intervention in language the patient can understand. Explain the risks of not having the intervention so the patient can make a decision. In nonemergency situations, a patient may need to speak with other people. Keep the conversation open. In emergencies, document that the patient chose to leave against medical advice; that all the risks, benefits, and alternatives were discussed; and that the patient chose to leave. Consultation with others might be sought.
Detailed surgical templates can be helpful. However, using templates without adding important surgical details and findings for individual patients is careless and potentially dangerous. Document the following:
Intraoperative findings, especially unexpected findings
Equipment and devices used
Key events (e.g., how the ureter was identified)
Abandonment of or change in procedure and the reasons this occurred
Postoperative care and examination is an area of concern because documentation of this phase of care is often lacking . Postoperative pain level is important to attend to. You or a colleague needs to be available during the postoperative period to care for the patient and to answer patient, family and/or nursing questions. Be careful not to disregard questionable postoperative findings or laboratory results. However distressing it may be, do not delay a return to the operating room when necessary. Call for consultation when appropriate for potential urologic or bowel complications, serious infection concerns, or bleeding emergencies. Because most surgeries are performed on an outpatient basis now, a phone call the next day by the physician or nurse is not only appreciated but provides a chance to review medications and instructions.
Maintaining an adequate procedural volume and appropriate technical competence and judgment for procedures is likely necessary to avoid adverse outcomes and to avoid litigation risk.
In the unfortunate event of a poor outcome, it is imperative for the physician to communicate more, not less, with the patient or the patient’s family where appropriate. Health care providers often dramatically change, or end entirely, their relationship with patients after a maloccurrence. For example, in situations in which the patient may have ongoing care issues but is transferred to a tertiary center or a different specialist, there is often minimal or no ongoing relationship. Despite what may be the urge to distance yourself from an unpleasant or uncomfortable interaction, keep in mind that your patient and his or her family members will begin to assess whether you are forthcoming with them at this very time. If there is an attempt to avoid interaction it can, and likely will, be misperceived as an attempt to avoid explaining the cause or causes of the bad outcome. It is important that your trust relationship with the patient and the patient’s family continues at this crucial time and that they feel you are willing to answer all questions.
When discussing the outcome or problem, revisit the discussion of risks and outcomes at the time of the informed consent. Reiterate the information you previously provided, and explain how this result is related to the risks previously discussed, if appropriate. Finally, it is also important that you are involved in establishing the plan for care going forward, even if it is outside your specialty. Remaining involved preserves the physician-patient relationship. Patients are far less likely to file claims against physicians with whom they have an ongoing, trusting relationship. It is therefore important to make yourself available as long as is necessary to assure the patient and his or her family that you are answering all their questions. Absence or avoidance will create suspicion by the patient or another family member and can ultimately lead them to seek answers to their questions from an outside source, most often an attorney.
Once again, it is imperative you write contemporaneous and accurate notes. The timing of such notes, combined with their detail and clarity, will begin to establish a good defense in the event the records are reviewed for a possible claim. It is easy to defend conscientious care, regardless of outcome, if the record supports you ( Box 6.3 ).
Communication with the patient when a problem occurs is an opportunity to explain how, despite vigilance, the poor outcome happened. Patients will naturally have questions, and most who contact a malpractice attorney are doing so to get answers to questions they feel were not sufficiently answered by the health care provider.
When patients are lost to follow up after a complication, possibly when transferred to a tertiary medical center or another service, legal inquiries often start when the medical bills are turned over to collections. Do not pick a fight with a patient who had a poor outcome.
Times are changing in regard to communication, disclosure, and apologies in medicine. Some hospitals offer disclosure training to help with difficult discussions regarding poor outcomes ( ). Each state may have different apology statutes, so always check with your risk management team and insurance carrier. However, clinicians should not under- or over-rely on each statute. A sincere, empathetic statement might be appreciated. For example:
“I am so sorry you are going through this.”
“I am so sorry you suffered the complication.”
These statements are very different from the message conveyed by a statement such as “I am sorry, this is my fault. I cut the ureter and did not recognize prior to closure.”
The first two apologies show empathy without admitting fault. That is protected and maintains a relationship in this critical period. However, in some states the apology may not shield the provider from the factual admissions that follow. A recent study found almost three times as many participants receiving a full apology would (probably/definitely) recommend the hospital compared with those receiving no apology (34.1% vs 13.6% respectively [p < 0.0001]) ( ).
Managing a poor outcome well is critical and can require skills that are not taught in medical school ( ).
Cancellations and “no shows”
Cancellations and “no shows” of patients’ follow-up appointments are often ignored in the busy clinic or office; however, they commonly lead to subsequent malpractice suits. Each cancellation or no show should be documented in the chart. The treating physician should then review the chart, and, where appropriate, a letter or phone call should be made to the patient. All efforts to communicate with the patient should be documented.
As mentioned earlier, improper coverage arrangements may lead to charges of abandonment. Poor communication among coverage groups often leads to offended patients and can be the first step on the path to a malpractice suit. Developing thorough patient sign-out protocols can aid in transmitting important information during patient handoffs. In a prospective resident handoff improvement program at nine hospitals with more than 10,740 patient admissions, the medical error rate decreased by 23% from the preintervention period to the postintervention period, and the rate of preventable adverse events decreased by 30% ( ).
About 1.5 million people are injured each year in the United States as a result of medication errors, according to a 2006 review of medication management in the U.S. health care system by the Institute of Medicine (now the National Academy of Medicine) ( ). In a 2017 study of all medical specialties, medication errors and medication treatment made up a large share of medical malpractice cases (24.5%), although for obstetrician/gynecologists this was lower (8.8%). The results can range from minor allergic response to death. Medications pose a liability risk to both the institution and the provider.
The reasons for this include but are not limited to the frequency with which patients are being prescribed medication, the popularity of at-home prescription administration, and the many lookalike, sound-alike drugs. The Institute of Medicine report states, “The extra medical cost of treating drug-related injuries occurring in hospitals alone conservatively amounts to $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs” ( ).
Medication errors are always preventable through system and personal practice modifications . Data show that 400,000 preventable drug-related injuries occur each year in hospitals ( ). Another report states that adverse drug events cause more than 770,000 injuries and deaths each year and cost up to $5.6 million per hospital ( ). Prescribing via the electronic medical record has reduced some errors and probably explains the drop in overall malpractice claims paid.
The National Coordinating Council for Medication Error and Prevention has approved the following definition of medication error:
Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. ( )
The reality of practice is that many orders are verbal, telephonic, or standing. Verbal or telephonic orders should always be read back to the provider to verify drug, dosage, frequency, and method of administration . This minimizes the likelihood of a communication lapse. Furthermore, telephonic orders are often signed after the medication is administered. Closely review these to be sure you are not validating the error as your own order. Litigation often occurs more than a year later, and remembering the details of a specific order will be difficult with an inconsistent record. If on review an error is noted, correct it in the record with a single line and the corrected information at the side. Note the time and date of your correction as well. Timely signing of electronic orders provides that date and time. Limiting verbal orders except in emergencies reduces errors.
Be aware of your orders and those of other providers as well, such as anesthesiologists, infectious disease specialists, and so on, to monitor for medication interactions. Standing orders often pose a risk in this circumstance.
Communication through medical records
Once the litigation process has commenced, a plaintiff attorney’s best friend is inaccurate or inconsistent documentation of the care provided. Inaccurate documentation can stem from a genuine standard-of-care issue; however, inaccuracies can also arise from use of inappropriate nomenclature. In either situation, the health care provider will be in the untenable position of attempting to defend a narrative note or deposition testimony that is factually inconsistent with literature, policies, or objective data in the medical record. Needless to say, in a courtroom, inconsistencies never favor the inconsistent party. Careful attention to record keeping will not only demonstrate attentive care and rationally based treatment decisions but will ultimately become a provider’s best defense in a courtroom.
Within your hospital, facility, office, and charts, you must use nomenclature designed to standardize the verbiage used among providers. Unfortunately, despite the attempts at standardization, many health care providers have been slow to adapt. This is often based on variable levels of education by health care providers and is also generational. This increases not only the risk of inaccurate communication among health care providers but also the risk of a medical record replete with inconsistencies. Inconsistencies can be easily used to portray a provider as incompetent or disingenuous.
From a medicolegal risk management standpoint, it is critical to keep in mind that when a plaintiff’s counsel attempts to determine whether medical malpractice may have occurred, the medical record is the primary (and often the only) source of information available to evaluate the potential claim. Any narrative notes supplied will be read against subsequent health care providers’ notes and the objective data, such as laboratory results and imaging. As stated earlier, clearly noted and accurate recognition and description of reassuring and nonreassuring findings in the record will demonstrate attentive and competent care. However, inaccurate terminology, when read against the objective data, could result in the commencement of litigation.
The electronic medical record had introduced a new set of documentation problems. The following practices can help to avoid these problems:
Avoid cutting and pasting from another patient’s chart.
Close notes in a timely fashion.
Carrying forward notes from a past visit without carefully updating can lead to inaccuracies and potential fraudulent billing.
Many institutions have “open notes” where patients can read all of their chart notes now. This can be beneficial as patients may communicate errors that can be corrected.
Beyond the initial review phase of a potential claim, inconsistent and inaccurate nomenclature and record keeping will continue to present obstacles to a favorable resolution of the claim during the testimonial phase of trial. When a witness employs modified or nonstandardized nomenclature, other health care providers, including expert medical witnesses, do not necessarily understand the full extent of what is meant. This unclear communication can result in actual medical errors among providers or, at a minimum, the appearance of errors within a medical record ( Box 6.4 ).