Kevin C. Giordano, Esq

: We began discussing issues of apology and regret in our 

. Let’s say I've just been involved in an unfortunate case involving a major fetal complication, namely a shoulder dystocia and there are problems with how the case was managed. The patient was an obese para 2, having previously delivered 2 infants (8 lbs and 8 lbs 5 oz) following rapid labor on each occasion. Each infant was born without complication or need for anesthesia and with only minor vaginal tears.  For her present pregnancy her antepartum course was medically unremarkable although throughout her prenatal care, she was a poor historian and difficult to examine. She was a frequent no-show and resistant to recommendations. I felt I never had much rapport with her in the office.  Her lab work throughout was normal and a GTT was interpreted as normal. The fetal weight estimate at 38 weeks was < 3500 grams.  

Following the commencement of labor, she went to the hospital directly without calling my service. After her arrival at the hospital, there was a delay in calling me. Unfortunately, she experienced a precipitous delivery. I was contacted only after the infant’s head presented. Fortunately, I was on the unit evaluating another patient. When I arrived, the nurse reported rapid cranial delivery followed by retraction. Mom was out of control, in knee-chest with the head protruding. The scene was a bit chaotic. I have to admit that I froze and then did a number of things inconsistent with my practice and how I was trained. Eventually we delivered a 3950 gram boy with Erb Duchenne-type palsy. His dysfunction has not improved since the delivery about 24 hours ago. There was also a postpartum hemorrhage due to uterine atony, requiring interventions of fluid, uterotonics and finally, the transfusion of 2 units.

Now, what should I do? The family is not happy.  I feel terrible about this case. I know that care was delayed and that nursing did not do a good job performing their intrapartum care or assisting me in this difficult delivery.  I also know that I did not conform to my own standards in effectuating delivery. Given that the patient was unpleasant in the few interactions I had with her prior to delivery, the current events have certainly likely made things worse. I am concerned about the possibility of being sued and worry that anything I say to the family will only make things worse. I am also worried that if I apologize or try to explain the events that led to her baby’s injuries, anything I disclose will be used against me should litigation be initiated.  How would you counsel me?  



.: Well, we need to start with this absolute-- there needs to be communication with the patient concerning this delivery. But keep in mind that my absolute is based upon only one facet of your hypothetical case-- that there was an unexpected outcome; a baby with an Erb Duchenne-type palsy and mom having a post postpartum hemorrhage attributed to atony. 
             
Obviously, beginning this type of conversation with a patient is easier and more straightforward when the adverse outcome is not due to provider error or mistake, but instead was an unavoidable complication.  It is a significantly more difficult conversation when the situation involves a potentially avoidable outcome and the lead-up to disclosure becomes more complex because many interests may be involved including those of other care providers (i.e. nursing), the institution, and the respective malpractice insurers. So, in the case that you present, the approach needs to start by immediately bringing together the stakeholders to discuss the case, identify what happened and determine how best to commence disclosing information to the patient. 



: I have read about apology as a theoretic issue before and have heard that it can be an effective tool to decrease the chances of being sued.  In my mind, I feel that I can act properly in virtually any obstetrical situation, but in this setting, I find myself uncertain, frustrated, angry and distressed. I am concerned about apologizing and appearing to accept responsibility for the outcome since I believe that I was put in a very difficult situation by events outside of my control. In addition to these emotions, I am also concerned that my apology will be meaningless since friction --or at least a lack of rapport--existed between the patient and myself before the delivery.  I do understand your point about complexity and the myriad of interests involved, but the other thing is, if we are going to proceed with an apology discussion, I do not think it can wait six weeks for a committee opinion before speaking to this woman and her family. 

But there is another consideration. A colleague has reminded me that many, if not most, unilateral brachial plexus palsies will improve over time. So perhaps I shouldn't say anything now and simply hope that things for the infant will get better? Also it may be that the injury would have occurred even if I was called earlier. If I do say something, might I be creating a lawsuit by telling her that something was done wrong? Will this essentially result in her using my apology against me? 



: So it’s a natural impulse to question whether to say anything at all. In this case, you have a difficult patient who you have no reason to believe will be accepting of your empathy or forgiving with the admission of mistakes. Furthermore, depending upon your state's laws, although a statement of empathy may be protected, your acknowledgment of medical error has the potential to be used as an admission of liability against you at trial, particularly if you later attempt to disown it during litigation. Of course how any of these statements are treated in the courtroom obviously will depend upon the particular law of your jurisdiction. But here’s the thing: If the purpose for considering disclosure is merely an effort to blunt the potential for litigation while at the same time avoid making any statements that you’re concerned might become evidence against you, then the apology is likely going to be inadequate and probably viewed as fulfilling a self-interest of the physician or institution; a risk management tool if you will. This would likely do more harm than good, jeopardize an already tenuous relationship given the adverse outcome, and have the effect of increasing, rather than diminishing, the potential for litigation. 
 
I would counsel you to shift the paradigm. Transparency and ethical responsibilities argue for early and effective disclosure --after consultation with all the players who have an identified stake in the outcome. This does need to be done expeditiously.  Unfortunately, celerity does not characterize most hospital proceedings.  Conversely however, haste should not forsake a thorough consideration of each of the provider’s interests. The ability of any system of transparency to create improved safety depends in large part upon health care providers identifying and reporting adverse events or near-misses early.  Therefore providers must believe that a serious effort will be undertaken to consider and evaluate their respective positions. The investigation into the clinical events is crucial in order to objectively determine what happened and then guide the approach to apology. If there is culpability, then all stakeholders must be involved in the process for determining the root cause(s) of that harm. Guidance from the institution is needed on how to convey that information to the patient. Ultimately, regardless of whether disclosure will be solely empathetic in nature or include acknowledgement of error, preparation is crucial before undertaking sitting down with the patient. 

The difficulty in ob/gyn cases is that it is not unusual for the issues to be complex and the final injury not to be immediately known. For instance, in our case, the reasons for any delay in care must be examined, as well as an evaluation of the efforts that were involved once maneuvers were undertaken to address the dystocia. But it must also be considered that once there is a dystocia, injuries cannot always be avoided and furthermore, many Erb Duchenne-type palsies can improve with time. It may be that this infant will fall into that category. 

So it would need to be understood by all, that once a decision is made about the extent of the apology to be given, the process may require more than one meeting while the outcome of an investigation is pending and also allowing a sufficient amount of time to pass in order to determine the extent of any injury.  During the interim, the institution may seek to identify needs that the patient may have and determine if it makes sense to assist in any way with those needs. If. ultimately as part of the process, an offer of compensation is going to be made in an effort to legally resolve the case with the patient, this should most often be done apart from any meeting where the initial apology being communicated.  

Ultimately, each case will proceed differently and in most instances should be led by the institution. Individual health care professionals should be leery of undertaking this process on their own particularly if the disclosure will be something more than a statement of empathy. 



: While I was having these thoughts and preparing my discussion paper for you, I discovered that the nurses had filed an Incident Report which obviously is based upon their perhaps biased recollections of the events and my actions. Although I understand that they have acknowledged some errors in not summoning me as promptly as they should have, I also understand that they might be suggesting that they called me earlier than they did. This report may be for Quality Assurance purposes and presumably protected from discovery, but I am concerned that they are drawing battle lines as I noted that they were also feverishly adding retrospective notes to the chart after their meeting with the nursing supervisor. Upon reviewing the computer entries, I’m not comfortable with their phraseology as some of it remains ambiguous.  I worry that by putting my version of the events into the medical record after theirs will only highlight the existence of a controversy. So, what should I do next? Should I write a post-event note also, outlining what I experienced in the delivery beyond my original dictated delivery note? What does all this say about the potential for collaborating on the issue of disclosure?



: Focusing on the disclosure aspect, if the current activity is intended to assuage the chart to protect someone’s interests, essentially hiding or smoothing over errors that caused or contributed to the bad outcome, then it's going to be difficult if not impossible to have an effective disclosure process.  If providers are going to attempt to shift blame or run from mistakes, a culture of denial will persist and improvements in care will be blocked. Instead, it is best to objectively review the record and then work collaboratively to identify all the deficiencies in care. The focus should not be upon allocating blame, but instead upon an honest appraisal of the events in order to improve systems and provider / birth attendant performance. As in most complex events, often there are missed opportunities at different levels to avoid a bad outcome and rarely is an adverse event the result of only one actor. Often, for a patient disclosure process to be effective, it will include discussing with the patient the methods the institution will be undertaking to avoid similar problems with care in the future. Therefore, unless there has been an honest assessment of all care provided, there is risk that the patient will be less than satisfied with the disclosure and the mistakes remain destined to be repeated.
    
That said, regarding the medical documentation, if in retrospect, there is new information or if you perceive that your original note is inaccurate or incomplete, then you can certainly dictate or write a post event note that clearly identifies it as such. However any addendum should be factual in nature and must avoid finger pointing as well as the appearance of being self-serving.  An incident report can also be created solely for purpose of Quality Assurance which, if done in accordance with hospital policy, will likely be precluded from discovery.  



: So my take-away seems to be that, given the complexity of issues presented in the case presented, as well as the many varied interests that may be involved, the apology and disclosure process needs to be led by the institution and not the individual providers. The success of the apology process will likely only come about if there is full transparency surrounding the events of the delivery.  And I can see, that if there is true transparency, it could lead to real change.  It seems that institutions must move any apology and disclosure procedure beyond the Administrative level so that this culture is vested at every level within the hospital.  It seems that we have agreed to flush this out some of these points in our next submission.
 

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Our malpractice lawyer counsels on a complicated case involving a delivery with an unexpected outcome and multiple health care providers involved.

Exploring Transparency Through Apology and Disclosure

:  A number of us were recently discussing complications of pregnancy and surgery.  The issue of “apology and disclosure” for bad results was raised.  This led to a spirited discussion and a good deal of disagreement. I and several others thought that the idea of  offering an apology for a bad result along with a disclosure of what went wrong –when this can be discerned --, combined with a  financial reimbursement of a patient’s unanticipated  hospital costs was a good idea. Further, in some instances additional payments might be reasonable in consideration of the severity of injury. However, other of our colleagues were strongly in disagreement, believing that doing this was a serious mistake. They strongly argued that a system of “Apology and Disclosure” would result higher risk of creating lawsuits and payments in situations where legal action was not even going to be contemplated, let alone pursued.  Thus, you would simply be creating issues and increasing costs to the system. Furthermore, you would be asking physicians to take on roles that they haven’t been trained to perform and may not be adept at ameliorating patient dissatisfaction. 

These physicians thought this idea to be simply unworkable. Those with private insurance argued that they had no ability to commit an insurance company to any payment scheme. They also opined that the mere act of apology might place in jeopardy their insurance coverage. That is, the apology would be an admission of “guilt” that would later be used against them by the patient and so the malpractice insurer would claim that they violated the contract by not cooperating with the defense. So, if the process/offer was not previously approved by the insurance carrier it could possibly result in a denial of coverage. 
               
So, who is correct? As an aside, I note that a number of institutions have established such systems for expressing regret and /or apology. Those organizing these schemes obviously believe that this can have a beneficial effect, short circuiting potential suits, improving relationships with unhappy patients and improving care by identifying problems with health care delivery sooner. So certainly somebody thinks it’s a good idea.
              


: Apology and Disclosure programs do have their place in resolving conflicts that develop within the patient / health care provider relationship. But, you have to have clear goals in mind. I believe that there is a misconception about the promises of such programs. If they work as suggested, such programs should identify potential cases of liability early on followed by reaching out to the patient and/or their family.  In so doing, patients are compensated sooner, are less hostile and vested in an adversarial relationship, so cases are resolved sooner and for less money in indemnity dollars and litigation costs. So arguably one would see a savings of the institutional resources.   Although there is some evidence to suggest that such a program, if implemented carefully and thoughtfully, will not increase costs to a self-insured health care institution, I am not convinced yet that there is sufficient evidence-based data to support that such a program will save money.
           
Thus, for me, Apology and Disclosure programs should strive to change the culture within any institution that does not effectively acknowledge errors to one in which transparency is created in an effort to improve health systems and delivery of care.  Then, arising out of that culture, a concomitant effort to redress a patient and perhaps the needs of their family as soon as practicable if an injury was caused by a failure to meet applicable standards. 



: I don’t understand, as I have always seen discussion of Apology and Disclosure in the context of saving overall costs. If health care providers identify cases right away where there has been malpractice, and then disclose that to the family with an apology, what is the downside? More importantly doesn’t that kind of bedside manner often dissuade patients from bring lawsuits and thereby avoiding litigation altogether? Even if we have to come armed with cash, aren’t both indemnity payments and attorney’s fees going to be much less if all this is done before the parties are lawyered-up?  Not for nothing, but you do have a horse in this race, no? 


: Ok, let me try and explain what I’m saying.  First though, it’s important to understand that since we are only discussing the merits of Apology and Disclosure, at least at least at this point, we need to limit the conversation to the concept rather than the implementation.  Whether any individual physician or practice should attempt to do this unilaterally is a complex question that we can take on next time.  So for our consideration of Apology and Disclosure as a concept, let’s put place it in the setting of a self-insured institution, as many are these days.  This helps us simplify the approach with a limited number of variables as often institutions are responsible for both the care that was provided as well as the litigations costs and indemnity dollars.                 
    
I do agree that Apology and Disclosure programs have an important place-as part of an overall effort to implement a culture of safety that identifies adverse outcomes as well as a tool to resolve conflict and to reduce patient distress-including financial compensation if a cash settlement of a patient injury is appropriate.  I would go a step further and suggest that the health institution have an ethical obligation to initiate policies that create transparency and promote disclosing the reason(s) for a bad outcome, as best these are known.  As seen in the airline industry, when the approach to safety is a major goal and a program is implemented to identify potential safety errors with careful analysis of both “near misses”  and problem outcomes, and the lessons incorporated into the systems then the number of  “bad events” related to human error decreases.  Apology and Disclosure policies contribute to that culture and thus hopefully lead to a heightened awareness and identification of unsafe practices. Does this result in cost savings? Certainly, by reducing bad outcomes, you can hopefully reduce future indemnity dollars. To the extent that a policy of transparency with an apology reduces actual indemnity dollars for each respective case because the resolution occurs in a setting of goodwill as opposed to an adversarial process, or the legal costs to the system are reduced by avoiding protracted litigation, then obviously that is a tremendous benefit. But I simply do not believe the evidence at this point allows us to draw a cause and effect conclusion between the implementation of these programs and costs savings.  
                
So, why do I say that? Remember, in many instances the decision whether to reach out to the patient in some manner will be easier than the decision about whether compensation is in order. Some of these issues will be rather complex. In the end, I would argue that an expression of empathy will be offered in many cases of a bad outcome, but compensation only in selected circumstances.  Obstetrical cases are a significant cost to any insurer. Now, if the costs to the health care system in defending these cases primarily arise where the bad outcome was caused by malpractice, then significant cost reductions may be possible. It would of course depend upon being able to settle the case through an amicable resolution early on for less money that the combination of the settlement value and legal expense if settled during adversarial litigation. Yet, as is my experience, if the majority of obstetric cases that end up as lawsuits are either defensible because the standard of care was followed, or at the very least, liability is not clear cut, then many cases will fall outside the boundaries of compensation programs. Patients may accept the explanation and not pursue anything further.  However conversely, many will still proceed with filing a lawsuit. Also, we have to factor in that many cases that occur in both obstetrical and non-obstetrical litigation arise when the discovery of injury is made months if not years after the alleged injury.  Thus, in my mind, the potential for cost reduction is likely to be more limited than the designers initially anticipated.  
    
To me, the good news is that data to date tends to support that Apology and Disclosure programs that are implemented thoughtfully do not add additional costs to the institution. Those institutions that have initiated a full transparency program, in a thoughtful way, are not creating more lawsuits and more indemnity dollars by doing so. If further studies bear this out, or in fact establish that costs can be reduced, this strengthens the argument for implementing such programs. 



: In my opinion a lot of the distrust and skepticism exists because of the Deny and Defend philosophy that has existed for so long, especially in reference to obstetric complications.  It is a lot to ask of providers to now embrace a new philosophy of Apology and Disclosure. This is especially true when the clinical circumstances surrounding many complications are not clear cut and the process of ascertaining “responsibility” is complex, the standard of care is fuzzy, or best practice is not fixed. I imagine that many physicians need more insight into how these Apology and Disclosure schemes work before they fully embrace the concept. But on top of that, if this is the future, a lot of us--and not just me alone--are going to need Charm School!
 


: We do need to talk about this in more detail.  Perhaps we can explore this further in our next article. Don’t worry; there is always room for you in Charm School! 
 

A physician and a malpractice attorney discuss the merits of ‘Apology and Disclosure’ programs and their role in obstetrical practice. Do they cut costs or create trouble?

Apology and Disclosure Programs: Should they Play a Role in Obstetrical Practice?

There is a good deal of emerging literature concerning the new automated multi-arrays utilizing peripheral blood samples for the identification of genetic abnormalities. Testing for 100 or more occult genetic disorders can now be rapidly processed by automated machinery with highly reproducible and reliable results.  With this type of testing, routine surveillance for many potentially important genetic conditions - many of which are recessive - can be performed at low cost.  So, given the availability of this innovation which is now being marketed to clinicians, what does the standard of care dictate regarding implementing such surveillance tests into our practice? Is not performing the test, or at least, not offering the test a deviation from a care standard? If testing using these new arrays is currently not the standard, how do practitioners know when, if ever, the transition to becoming the standard of care is made?

 These are interesting questions, and not easily answered.  You have to remember in most scenarios, the law does not determine the standard of care.  Instead, the standard of care is determined by the professionals in the field of practice. It is for this reason that expert witnesses are required to testify pertaining to the duty that was owed.  Generally speaking, malpractice in its truest sense is either failing to do something that the average qualified practitioner would have done under the particular circumstances, or conversely undertaking an action that the average qualified practitioner would not have done. So the standard of care is not supposed to be determined by “outsiders” so to speak, meaning that plaintiff’s lawyers and juries do not impose their will as to what they think the standard of care ought to be, but instead determine the standard based upon the testimony of expert witnesses. In the setting of multi-array genetic testing, the question then is when, if ever, does it become accepted within the specialty of ob/gyn that the average qualified practitioner should be ordering such testing and in what circumstances? So even if the testing is reliable and cost-effective, but if it’s not embraced by the field as something that should be offered by practitioners, then failing to do so should not be malpractice.

 But it seems that with the availability of information that is accessible, advances in medicine can be rapidly transmitted throughout the medical world, especially given the of access to new information via the web, e-journals, and in light of the many CME programs now available on line. Doesn’t this create a burden upon physician to incorporate such advancements more expeditiously?

There is a duty that physicians and other health care physicians must stay current with literature and advancements in the field.  And certainly, the age of information technology has allowed for advancements in medical technology to become widespread very quickly.  But information and/or knowledge does not necessarily mean that the standard of care changes with the knowledge.  It requires acceptance and a collective movement towards its implementation.  Furthermore, except in a situation of like universal screening, the definition of the standard of care generally includes reference to a physician’s judgment in a given clinical circumstance. Thus, from my perspective the basis for determining the standard of care is pretty much a mirror image of the practitioner’s medical decision-making process--employing sound medical judgment given the known clinical facts with consideration given to the advancements in the field.

I recently tried an interesting case involving Topamax, a medication for migraine headaches.  In rare instances the drug can cause acute angle glaucoma. A cautionary statement was included in the PDR regarding this complication.  However, there had been relatively few cases.  Glaucoma specialists in large referral centers were seeing the complication and the discussion was slowly making its way into the specialty journals.  However, the risk was not, and probably still is not, something that is well known by internists nor was it described at the time in online prescribing resources like UpToDate.  In that case, the plaintiff’s expert was not allowed to argue what the standard of care should have been given what was known at the time.  Instead, he was constrained to discuss the standard of care applicable to internists at the time based upon what should have been known by the average qualified primary care physician. The expert had to establish not what primary care physicians as a body of providers should have been doing, but instead what they were doing. And to that you again look to the treatises and promulgations by learned bodies and other evidence to support the testimony. Unfortunately, even without evidence to support his propositions, this did not stop the plaintiff’s expert from giving an opinion that the doctor was negligent, however thankfully the jury did not agree with him.

  But the problem for practitioners it seems is that those of us who follow the pronouncements of ACOG and other learned bodies believe that they are often quite slow in making or changing their recommendations and  pronouncements - and even much slower in weighing in on the advances reported in the literature. So, if ACOG or other “learned bodies” do not currently suggest such testing, cannot this simply be characterized as misplaced conservatism?  After all, as I understand it ACOG does not determine the standard of care for many conditions.

 Again, the law is not supposed to lead the discussion, practitioners are.  The legal principle presupposes that the collective wisdom within a specialty will implement those practices that are in the best interests of patients. So in determining the standard of care, statements by learned bodies are considered, but they are not “authoritative,” just as articles that comprise the medical literature may support either the plaintiff or defendant’s expert articulations.  Many ob/gyn cases are tried without reference to ACOG guidelines or medical literature and thus convincing the jury rests upon solely the credibility of the evidence and testimony of experts.  But when either side can rely upon pronouncements, or literature that is unequivocal, even though it may not be determinative of the standard care, it can often be pretty presumptive evidence.  From a practice perspective though, the thing is, for the reasons you stated, practitioners cannot presume that because a learned body has not made a recommendation, that the standard of care still won’t require the practice.

 It seems like there is a large area of gray that could be exploited by an expert who is a “hired gun.”  If the law does not establish the standard of care, nor does ACOG or learned treatises, then couldn’t an expert be called to testify that something is the standard of care, when it really isn’t. For instance, rely upon the studies about the reliability of multi-array testing, and then if it is true that it’s economically feasible, testify that the standard of care requires prenatal screening.  He can clearly establish that the lack of any comment by ACOG, or other promulgation of a learned body does not negate the standard of care. So one expert can establish the standard of care and call upon the defendant to negate it, correct?

  It is true, that the standard of care in a given circumstance, or the timing of when something is generally accepted as being the standard, is often subjective. Hopefully when the respective expert takes the information and assimilates it with the clinical situation to provide opinions as to whether there has been a deviation from the standard of care,  they do that in a principled manner implementing sound medical reasoning and evidence based medicine.  Unfortunately, this is not always the case with experts, and can be exploited by a “hired gun.”  But there are some safeguards in place that try to keep out opinions that aren’t evidence-based.  Most importantly though, although health care professionals are often distrusting of juries, a strong majority of the jury verdicts favor them.  I think the case I described above is just one example of that.

   I am not sure that you are ever going to get health care professionals to trust the jury system, but perhaps that is a conversation for another day.

There is a good deal of emerging literature concerning the new automated multi-arrays utilizing peripheral blood samples for the identification of genetic abnormalities. Testing for 100 or more occult genetic disorders can now be rapidly processed by automated machinery with highly reproducible and reliable results.

Changing Standards of Care and Your Malpractice Risk

Physicians performing laparoscopic surgery recognize that if they do enough procedures, they will eventually encounter complications. This is because all surgical procedures involve an inherent risk.  Physicians also recognize that when performing an exploratory laparoscopy, some pathology may not be visualized at the time the procedure is performed. In this two-part series, John O’Grady, MD, and Kevin Giordano, Esq., explore whether the concept of an “accepted complication”-or the identified limitations of medical science-shields a physician from malpractice claims. Further, is a malpractice claim ever justified as the legal penalty for an observed complication, regardless of cause?
 

Read Laparoscopic Surgery & Malpractice Risk, Part 1: Diagnostic Laparoscopy

: Is it possible that the same event in one case might be considered the standard of practice but in another might not? Let’s consider two cases involving a laparoscopic hysterectomy. In each case there is an occult ureteric injury.  In one case the surgery was required by clinical indications such as severe pain or the suspicion of internal bleeding. While, in the other circumstance, surgery is performed electively for benign uterine disease. But, in this second case there were prior uterine surgeries and thus multiple adhesions resulting in a long and tedious dissection. In this latter case there was aberrant anatomy and difficult visualization due to scarring. How is the standard of care defined in these cases when there are what we might term extenuating circumstances?

: Again, what we are describing is a recognized complication and that is the defense.  The plaintiff’s lawyer points out that just because the injury that occurred is a recognized risk of the procedure, it does not mean in every instance it was an inevitable complication. They will suggest that sometimes complications do happen because of malpractice. In other words, take the example of shoulder dystocia for instance. We know that injury can occur to the infant that was unavoidable. A plaintiff’s lawyer will concede that, but counter with the response that some injuries occur because of excessive traction or might be ascribed to the use of poor technique (e.g., fundal pressure).  So with this argument before them, how is a jury to parse this out? 

Perhaps, in the first case the doctor truly did not do anything wrong; He was the person in the room with the most experience in performing the procedure and he clearly is knowledgeable and experienced in doing so.  According to his testimony, he describes performing the surgery according to good and accepted practice and did a thorough inspection prior to completing the procedure. His operative note, dictated before the diagnosis of any complication, describes the procedure in detail and there are no inconsistencies. Follow up care is timely and the surgeon maintains an adequate index of suspicion for possible surgical complications and so the diagnosis is made without substantial delay. There is a reasonable likelihood that the jury will determine that the injury was not the result of negligence and all the factors tend to support this. In the second case let’s assume that it is all a bit murkier-the operative note was not dictated in a timely manner; perhaps instead it was dictated after the complication was identified.  Furthermore, inconsistencies were noted between the operative note and the doctor’s testimony (or perhaps a pre-printed operative note was used); and there is concern that the physician was not attentive to the early clinical manifestations of injury and thought the patient was exaggerating.  In this particular scenario, a jury may find that it seems more likely to have occurred due to poor surgical technique and look unfavorably on the physician.

: We may confidently predict that the latter situation would not play very well in court!

: No.  But we should not minimize how difficult it may be for a juror in a setting where an injury that is a recognized complication occurs to determine when it is, or isn’t, due to medical negligence.  So you defend the case, trying to point out that the doctor did not rush into the surgical procedure and essentially had exhausted medical therapy; the doctor has done a lot of laparoscopic procedures and was experienced at the time of procedure; the risks were explained and the consent discussion was documented. Further, the operative note was dictated in a timely manner and the dictation describes how the procedure was performed.  Thus, given this background, there is every confidence that when the surgeon testifies that there is evidence of  adherence to good surgical technique. But, in another case, it might not square up so well that the doctor adhered to proper surgical techniques despite what the physician says in his or her testimony. Ultimately, in this setting it may be easier for the physician who has actually been careless or negligent to defend himself under the concept of a known risk than it is for a physician who adheres to good practice but has deficient documentation to be found negligent. 

: So, when occult injuries are considered, the issue may be less about the occurrence itself and instead it becomes how attentive was the physician to the inevitable but delayed signs and symptoms? Thus, the clinical question becomes: How attentive was the practitioner to the needs of the patient, both in initially diagnosing the problem as well as managing any unanticipated postoperative complications?

Correct. I would say that for most cases involving laparoscopic procedures and occult injuries there are allegations that the diagnosis of a postoperative complication was not made in a timely manner. These claims are often the most problematic aspect of the case, not the fact that the injury occurred. The defense, for instance, that a thermal burn is a complication of electric cautery used during the procedure is only strong if the clinical signs of the injury were ignored, thus making the patient’s injury worse.

At the end of the day, proceeding on the basis of good clinical reasoning is always important. It is also important to have discussed the limits of a diagnostic procedure with the patient along with the usual potential risks and complications. Post-operatively, it is necessary to maintain clinical surveillance to diagnose complications. The possibility of an original misdiagnosis, especially if the procedure is an exploration and the true diagnosis was not known preoperatively, must always be considered.

Kevin Giordano, Esq. and John O’Grady, MD, examine two laparoscopic hysterectomies that resulted in occult ureteric injury.Is it possible that the same event might be considered the standard of practice in one case but not the other?

Laparoscopic Surgery & Malpractice Risk, Part 2: Laparoscopic Hysterectomy


Physicians performing laparoscopic surgery recognize that if they do enough procedures, they will eventually encounter complications. This is because all surgical procedures involve an inherent risk.  Physicians also recognize that when performing an exploratory laparoscopy, some pathology may not be visualized at the time the procedure is performed. In this two-part series, John O’Grady, MD, and Kevin Giordano, Esq., explore whether the concept of an “accepted complication”-or the identified limitations of medical science-shields a physician from malpractice claims. Further, is a malpractice claim ever justified as the legal penalty for an observed complication, regardless of cause?

: Let us take the case of a physician who performs a laparoscopy for a suspected ectopic pregnancy. A preoperative evaluation is performed, presumably with laboratory evaluation. In the operating room the clinician visualizes the pelvis in the usual manner and decides that no pathology is present. The procedure is then terminated. There are no apparent operative complications. However, on subsequent follow-up  the patient turns out to have an ectopic anyway.  She is displeased and seeks legal redress There are complex issues of follow-up in such cases that we will address later.

Several clinical scenarios might lead to such an outcome. My question is, legally, does the failure to have diagnosed the problem (i.e. visualized and treated the ectopic at the time of the initial surgery) mean that there was malpractice-assuming that the laparoscopy was performed for standard indications in the usual fashion and without a surgical complication?

: The answer to your specific question is no.  In law, a patient must prove some departure from good and accepted practice in order to be successful and recover a monetary award. Rarely in the malpractice setting does the mere occurrence of a bad outcome by itself mean that there has been medical malpractice. So in the setting of laparoscopic surgery, a misdiagnosis or a complication arising from the procedure, although that may form the basis of a claim, does not in and of itself mean that there has been malpractice. You need to examine the particular circumstances and determine whether there has been good surgical technique in the case, proper medical evaluation before the surgery, and often most importantly, appropriate follow-up care.

: Well, the concern among physicians is that our society often plays the blame game.  If the patient develops a complication, you must have done something wrong. 

:  Of course you worry about the physician who has apparently followed accepted practice and yet is found negligent at trial. Unfortunately, such outcomes are possible.  However, despite what may be common perception, such outcomes are really not the norm, even in the most sympathetic of cases. The mere fact that some harm occurs that arises out of medical care does not mean that there is malpractice. Conversely, it does not that mean that every time an injury occurs that arises out of something that was inevitable or unavoidable, it never represents malpractice. Perhaps the original event, or miss, itself was inevitable or unavoidable, but doctors may have to anticipate such clinical outcomes and takes steps to minimize any exacerbation of the problem. Ultimately it is the unique clinical circumstances that are critical.

John O’Grady, MD: Well, my example derives from a recent experience. A patient had symptoms suggestive of an ectopic. She had a positive serum HCG, albeit at low titer. The transvaginal ultrasound study was equivocal for an adnexal mass (limited visualization), fluid was noted in the cul de sac and the patient complained of abdominal pain. She also reported an uncertain last menstrual period.  Further, when the uterus was visualized, no intrauterine gestational sac was noted.  Inevitably, while no discrete adnexal masses were observed, the exam was reported as “difficult.” The radiologist, appropriately enough, reported that “an ectopic cannot be excluded.”

In this setting, the obstetrician judged that there was some risk of ectopic gestation or other occult pathology. A diagnostic laparoscopy was performed, driven primarily, I believe, by the symptoms. The medical record was unclear if the patient wished to continue the gestation if it was intrauterine.

:  Ok, so the indications for doing the procedure were apparently within the range of what a clinician would consider “appropriate” under the specific circumstances of the case. The obstetrician-as dictated by the standard of care-performed the right test under clinical circumstances to rule out an ectopic pregnancy, which was perceived as the primary risk.  So, what is the explanation for why the ectopic pregnancy was missed and complications of internal hemorrhage subsequently occurred?

: In retrospect, at the time of the original surgery it was simply too early to make the diagnosis. Thus, the ultrasound and the laparoscopy could neither confirm nor entirely exclude either an ectopic or an intrauterine pregnancy. The problem here is multifaceted, and the ultrasonic and laboratory diagnosis of ectopic vs. intrauterine gestation is not always secure. As an example, we have learned to our sorrow that the previously established “discriminatory zone” for HCG concentrations and visualization of the fetal sac is not always reliable. Also, there were other problems in this case to consider. No concomitant curettage was performed at the time of the laparoscopy. Nonetheless, the diagnosis of an intrauterine pregnancy with miscarriage was made after the negative laproscopic visualization. While there was a judgment issue in initiating the surgery, the more important problem became how closely the physician followed the patient’s signs, symptoms, and HCG levels after the procedure. Further, it was unclear from the record if the patient had been warned of the possibility that there could be either an intrauterine or an ectopic pregnancy unidentified by either the original ultrasound examination or the supposedly definitive laparoscopy.

:  So the first issue is whether the failure to make the diagnosis by laparoscope is malpractice. Although there are always exceptions, I think most individuals and most juries can understand that there are limitations to the science of medicine. The defense position would be that even in the best of hands, an ectopic pregnancy may not be evident as it is simply “too early” to make the diagnosis in some instances.  Now certainly, it is very helpful if those limitations have been discussed with the patient, especially when as in this case where follow-up care is important. That said, we cannot stop the analysis there. In this specific case, fault may lie in that the clinician should have anticipated the possibility of a “negative” exploration. If so, then preparation of the patient preoperatively and careful evaluation postoperatively becomes critical. Post-op follow-up responsibilities cannot be shirked in the setting where there is significant risk of a false negative. So the issue is whether, armed with the knowledge that the original exploratory laparoscopy and the other tests performed all had limitations, what should the average practicing obstetrician to do in this setting? Thus, this should be the focus of what is the applicable standard of care. 

: As a physician, my opinion is that moving to a laparoscopy was acceptable in this case given the signs and symptoms and the equivocal nature of the preoperative data. The issue is what should have happened next, following the grossly unremarkable surgical exploration, and is more problematic for the clinician. The problem is that when a pregnancy is missed under such circumstances, it can proceed as either a normal gestation or as an ectopic. Unfortunately, in the case I encountered, serial study of HCG concentrations or other laboratory testing was not performed and the woman was followed clinically until she finally presented with an acute hemoperitoneum from ectopic rupture. There apparently was no consideration for the use of methotrexate as it was interpreted that a spontaneous abortion had occurred and that the original laparoscopy had excluded an ectopic.

:  So from a legal perspective, in our situation, the OB did not consider the potential limitations of both the surgical procedure and the other testing that was performed. The physician went about his business believing that  pathology was “ruled out” when in fact the pathology was still present, but merely unseen. Therein lies the problem with defending this case.

In my own experience pertaining to laparoscopic procedures, malpractice cases arise because although the physician has ample indication to do the original surgery and adheres to all the proper surgical techniques, there is either an intraoperative complication or, as in this case, there is a failure to identify important pathology (i.e., a “false negative” exploration). The potential liability issues do not necessarily relate to the occurrence of an injury or the failure to make an accurate preoperative diagnosis, but center around the fact that the complication was not recognized in a timely fashion, or that the surgeon did not recognize the diagnostic limitations of the procedure and/or testing and failed to follow up appropriately.

: So if in our scenario, the patient turns out to have an ectopic and gets into serious trouble three or four weeks later, you are saying that the failure to diagnosis at the time of the laparoscopic procedure may not be malpractice because proper technique was adhered to and because at that time the true diagnosis could not made.

However, that does not resolve the issue for the woman. The pregnancy is still ongoing and given the limitations of the procedure, the clinician’s potential liability rests in what should be common knowledge: that the procedure and tests that were performed did not exclude a pregnancy. 
 

Is the concept of an “accepted complication”-or the identified limitations of medical science-a shield to malpractice claims? Kevin Giordano, Esq. and John O’Grady, MD, explore liability risks of diagnostic laparoscopy.