21.1 Standard and Substandard Care Concepts

Ovum pickup (OPU) or egg retrieval, also known as follicular or follicle puncture, is instrumental in carrying out in vitro fertilization (IVF) procedures.

It is a surgical process aimed at harvesting oocytes from the ovarian follicles. The intervention in itself is swiftly performed, usually under anesthesia (sedation). By virtue of ovum-retrieval being an invasive kind of practice, it is consequently prone to bringing about adverse events, throughout the various stages of the procedure, from hormonal stimulation to management of retrieved oocytes, in addition to possible mishaps occurring in the pickup phase.

Guidelines have been devised as a means to facilitate clinical practice and to provide, beforehand, a set of standards of conduct to be adopted as guiding principles in health care practice. Over time, guidelines have, de facto, taken up ever greater legal significance, since they have been applied as parameters of judgment in almost all nations, even across different legal and judicial systems, for the purpose of formulating assessments as to the suitability and soundness of health care choices made by professionals.

It is therefore safe to say that the main assessment criteria applicable to evaluate the clinical and legal tenability of any given medical procedure, including MAP and egg retrieval, is the compliance with relevant sets of guidelines pertaining to a given medical specialty [1].

In some instances, however, there may not be specific guidelines for a certain field of medicine, or those available may not be universally acknowledged. In such cases, the judiciary has often shown a tendency to rely on good practices, which are typically based on scientific literature and research findings of recognized merit. Those standards constitute the cornerstone, from a legal perspective, needed to outline the standards of care. Any health care choice that fails to meet those standards, which prove unwarranted by either available guidelines or best practices, is likely to be deemed unorthodox, inappropriate, liable to be punishable in a court of law, especially if a connection is proven with adverse outcomes following such actions (the so-called substandard of care, i.e., a breach of standards of care). In that respect, it is worth pointing out that the very definition of complication, however, widely used, may often prove unsatisfactory and hazy, in order to properly identify an area of non-liability, unlike the notion of malpractice, clearly associated with punishable events.

The medical concept of complication stands for any damaging event arising during treatment which may result in an unfavorable deviation with respect to the expected clinical path, whatever the cause may be.

Such definition, widely accepted in medicine, does not satisfy fundamental law requirements, as often observed in medicolegal disputes (Fig. 21.1).

In fact, legal approaches which came about in the field of medical malpractice both in Anglo-Saxon countries (common law) and in those of Roman tradition (civil law) do not consider nullifying the fact that clinical statistics foresee a particular adverse event as a complication. In legal proceeding terms, the concept of complication is much more restrictive than that provided in medicine.

In fact, the complication that does not involve responsibility is only the so-called unpredictable or unavoidable event. In particular, unpredictability or inevitability of complications excludes liability if the expected favorable outcome is not feasible in practice, not just on the basis of the statistical data. In Italy, this principle has been repeatedly stated in court decisions and has been recently confirmed by the Italian Supreme Court [2].

The logic behind this approach is: in treatments of choice (i.e., treatments performed not in emergency-urgency conditions) a favorable outcome should follow the treatment on the basis of the principle of clinical-statistical regularity. The latter is closely related to the doctrine of res ipsa loquitur, which is applied in most European countries and in the United States.

This doctrine, peculiar of the Anglo-Saxon jurisprudence, affects the burden of proof between the plaintiff and the defendant and consists in a rule of evidence that involves the presumption that the surgeon acted negligently for the very fact that the claimed damage occurred. In the commonly accepted interpretation, the presumptive liability, in order to be applied, must see to meet three conditions:

Experience demonstrates that this rule is applied by the courts in a less strict way than the original version, and in cases of uncertainty the judgment is usually in favor of the damaged parties.

Based on the actual features of the arising complication, physicians may avoid the debt of liability only if said developments could not be avoided in that specific case. In all other cases, it is likely that surgeons are held responsible.

Moreover, even in those cases of unavoidable complications, the physician’s responsibility is considered as factual if complications were not treated according to the standard of care, which anyhow was inadequate. This evaluation, which should be made case by case, unavoidably calls for the consultation of experts that the courts rely on in the case of legal disputes that require specific technical knowledge. They should have expertise on both the methodology under discussion and the medical testimony, also in order to avoid any procedural error in the evaluation of the responsibilities that could lead to legally invalidate the assessing procedure.

A person can testify as a medical expert only after his/her credentials are established before the court. An attorney can assess the medical expert credentials by asking questions about their education, training, skills, and experience within a particular field. Once the required qualifications for an expert witness status have been established, a judge will qualify the witness as an expert. Most expert witnesses must be paid to testify on behalf of one of the parties. There may be more than one medical expert witness in a case [3]. Since it is difficult that only one professional has both technical-operational skills and expertise as expert fitness in medical litigations, the collective legal assessment is becoming a legal practice (a physician actually applying the method and a professional medical expert witness).

This practice is supported by some codes of medical ethics [4], and in Italy by a law enacted on article 15 of 8th March 2017 [5].

This awareness justifies the great interest on the issue of complications, both in terms of improving the individual performance of each operator and the ability to prevent and manage possible damages in order to avoid charges of malpractice or, at least, reduce the consequences.

21.2 The Issue of Informed Consent

Egg-retrieval procedures and IVF must be carried out in compliance with available guidelines, such as those laid out by the European Society of Human Reproduction and Embryology, and after gaining informed consent from patients made fully aware of the risks involved in the procedures.

As with any medical procedure, patients must provide informed consent to fertility treatments such as artificial insemination and in vitro fertilization (IVF).

Informed consent occurs when a patient understands the nature of the proposed treatment as well as the potential benefits and risks of the treatment and potential alternatives, and voluntarily chooses to proceed with the treatment.

Many fertility clinics have standardized forms for patients to complete as part of the informed consent process. Typically, the physician will have the informed consent discussion with patients simultaneously with the completion of the informed consent paperwork. However, it is unrealistic to expect a physician to understand the nuances of the unsettled field of parentage law.

The informed consent paperwork often goes beyond the concepts of procedures, benefits and risks, and delves into issues such as the establishment and relinquishment of parental rights [6].

Clinic consent forms have played an important role in litigation surrounding the use of cryopreserved genetic material following the divorce of the intended parents. Courts have taken different approaches toward evaluating the preferences expressed in the clinic consent forms.

The clinical consent forms at issue would typically be filled out by the intended parents before the creation of the embryos, at a time when the patients’ interests are typically focused only on maximizing the chance of success of their upcoming IVF cycle.

Thoughtful deliberation is necessary to determine the ultimate disposition of their unused embryos at this stage of the process.

It should be highlighted that the definition of the main complications as part of the informed consent procedure is not in itself sufficient to ensure that gynecologists will not incur in charges in case any of these complications occur. In deciding whether the physician is free from any responsibility, the judge will consider only the inevitable or unforeseeable complications. However, timely and complete information avoids the charge of violating the patient’s self-determination freedom that a poor information does not allow.

From a practical point of view, it is therefore necessary to consider the problem of what are the minimum requirements of the information to be given to patients. In theory, any form of information could be disputed for being inappropriate, most frequently due to its being somehow incomplete.

However, respecting some logical criteria (which could constitute a sort of checklist of the information to be given to the patient) the risks can be limited to a minimum.

The necessary information requirements, according to the patient’s right-to-know should include:

This aspect should not be underestimated because in many countries, especially in Italy, courts can punish physicians who have not fulfilled this obligation even when the procedure used has a favorable outcome, by imposing a compensation calculated on the basis of a fair, equitable method (discretionary), if the patient claims that the information provided was insufficient and the physician is not able to demonstrate that there was no lack of information [7].

21.3 Ovum PickUp Related Injuries: All Potential Claims

Ovum pickup associated complications may include damage to pelvic organs, hemorrhage, and infection (Fig. 21.2) [8].

Thorough information, as previously pointed out, entails that such potential developments should be explained to prospective donors. The provision of thorough information, however, is not necessarily enough to stave off lawsuits in case of adverse outcomes. It can be confidently asserted that almost all kinds of complications laid out in scientific literature may give rise to doctors being sued. The main kinds of recurring damages are outlined below, in terms of their assessed potential to lead to indemnity payments being awarded.

21.3.1 Candidate Selection. Obesity-Related Risks and Medicolegal Issues

Obesity is a growing problem in many parts of the world. It is generally defined using the body mass index (BMI) measurement in the units, kg/m².

Based on World Health Organization (WHO) standards, a BMI of 18.5–24.9 is considered normal, 25–29.9 overweight, and ≥30 as obese.

In obese patients, the egg retrieval technique is more challenging, difficult, and dangerous (Fig. 21.3) [9]. For this reason, many IVF centers have imposed various cutoffs for BMI and IVF egg retrievals under conscious sedation [10].

Some women with a BMI over 40 (morbid obesity) may not be able to proceed to egg retrieval and conscious sedation. At Fertility Centers of Illinois, any obese women with a BMI over 35 must obtain counseling regarding the increased risks to both the mom and baby, and provide authorization to proceed with IVF in light of the risks [11].

In addition, any woman whose BMI is between 40 and 50 may proceed with IVF and anesthesia, as long as they pass medical clearance and anesthesia clearance. A consultation with a Maternal Fetal Medicine specialist may also be required to discuss potential risks to mother and baby. In regards to the effect of obesity on oocyte retrieval: a review reflects that eight studies reported lower numbers and nine found no difference; oocyte quality or maturity: six studies found an adverse effect and one found no effect [12].

Women with polycystic ovarian syndrome (PCOS) and obesity were also reported to have smaller oocyte diameter at the time of retrieval [13].

Because of the heightened associated risks, patients with a BMI over 50 will not be permitted to proceed with fertility treatment [14].

Obesity can result in fewer mature follicles and a decreased chance for oocyte retrieval [15–17]. Any failure to abide by the disqualifying criteria (BMI > 50, for instance) would be bound to lead to malpractice claims against doctors.

21.3.2 Ovum PickUp and Anesthetic Complications

A retrospective study of 1.031 patients showed that OPU is a safe and well-tolerated procedure. In this study, there were no anesthetic complications in patients who underwent sedoanalgesia or local anesthesia [18].

Two studies in the literature reported complications due to anesthesia performed for OPU; one was conducted on a series of 542 patients, and intensive care was needed for two patients due to bronchospasm, which occurred after general anesthesia [19, 20]. The harmful potential of these adverse events is relative because these are usually reversible events.

Additional complications may result from the administration of intravenous sedation or general anesthesia. These include asphyxia caused by airway obstruction, apnea, hypotension, and pulmonary aspiration of stomach contents (Fig. 21.4) [21]. Such developments result in high likelihood of generating legal claims, especially relative to the possibility of brain damage arising from them.

The second complication type, described in a not so recent case report, was cardiac conduction disorder, which occurred in a patient who received paracervical anesthesia with 400 mg mepivacaine [22]. This event turned out to be reversible. Aside from these cases, no other anesthesia-induced complications were found in the literature [23].

21.3.3 Hemorrhagic Complications

Limited vaginal bleeding is relatively common (8%) at the entrance site of the OPU needle; this can often be stopped by compression, although suturing is sometimes required [24].

Acute hemorrhage from the ovary (Fig. 21.5), and bleeding or hematomas due to vascular damage in the uterus, ovary, and iliac vein are very rare (0.04–0.07%), but may require surgical intervention when they do occur [25].

Ovarian hemorrhage after transvaginal oocyte retrieval (TVOR) is a potentially catastrophic complication, even life-threatening, and has been observed to occur more often in lean patients with polycystic ovary syndrome [26]. Such a risk factor must be carefully assessed in women candidate to procedure. Luckily this is an event rarely detected in literature.

In the realm of such events, it is often difficult to draw the line between complication (i.e., unavoidable adverse event) and malpractice [27]. Courts of law have frequently shown a tendency to take into account the scope of consequences, thus opting for a principle of proportionality between risks and achievable benefits: the more severe the event turns out, the less excusable it is deemed, particularly when it occurs in healthy patients.

21.3.4 Ovarian Hyperstimulation Syndrome (OHSS) and Liability

HCG injections as a trigger for ovulation may give rise to the risk of ovarian hyperstimulation syndrome (OHSS), especially in patients suffering from polycystic ovary syndrome who may have been hyperstimulated during previous assisted reproduction cycles. Most cases involving patients who undergo egg retrieval are mild to moderate cases that resolve themselves within a few days.

In order to stave off these complications, patients should undergo a thorough female pelvic ultrasound exam to prevent fluid from accumulating in the pouch of Douglas. In that clinical field, the use of diagnostic ultrasonography could go a long way in warding off malpractice litigation, based on the allegedly untimely detection and treatment of OHSS; in that regard, ultrasonography should be combined with a thorough documentation process of all tests and monitoring activities implemented, as it is the case in other gynecological specialties [28].

Patient follow-up studies from Canada indicate that about one-third of women who undergo ovarian stimulation suffer “mild” OHSS. In a British study tracking 339 women, roughly 14% were hospitalized for OHSS after stimulation cycles yielded more than 20 eggs [29].

The results of a study by Kramer et al. seem to be in agreement with previous reports of the prevalence of OHSS following ovarian stimulation, now recognized as a common adverse effect [30].

Ovarian hyperstimulation entails a significant degree of risk, which seems to become worse with the number of cycles undergone. Provided that five or fewer successive stimulation cycles do not seem to impair ovarian response, the American Society of Reproductive Medicine (ASRM) [31] cautions that the number of adverse events after a given number of procedures is additive and, therefore, recommends a maximum limit of six cycles of oocyte donation [32].

Patients experiencing mild OHSS may complain of mild pain, bloated feeling, mild abdominal swelling, mild nausea, mild weight gain, and diarrhea [33].

Moderate OHSS presents symptoms similar to mild OHSS, but the swelling and bloating is worse, as are abdominal pain and vomit. There might be fluid build-up in the abdominal cavity causing discomfort. Severe OHSS carries even worse swelling and bloating in addition to abdominal pain and vomiting (Fig. 21.6).

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