James M. Shwayder, MD, JD

The patient in this case was a 36-year-old G3P2002, who presented to the emergency department (ED) on May 30 with complaints of lower abdominal pain (8 out of 10) and prior vaginal spotting. A urine pregnancy test was positive, with a subsequent quantitative human chorionic gonadotropin (hCG) level of 209 mIU/mL. Her vital signs were stable, with hemoglobin and hematocrit (H/H) levels of 12.7 g/dL and 35.9%, respectively. 

An ultrasound revealed an endometrium that was 11 mm thick, with no visualized intrauterine gestational sac. There were no adnexal masses or fluid in the cul-de-sac. 

A right ovarian cyst measuring 1.5 cm was seen. The report noted no intrauterine gestational sac and the right ovarian cyst and gave a differential diagnosis of an early intrauterine pregnancy, ectopic pregnancy, or abortion. Correlation with hCG levels and a possible follow-up ultrasound were recommended. 

The patient was seen in the same ED 5 days later, on June 4, with complaints of abdominal and right lower quadrant pain. She had an hCG level of 2,399 mIU/mL, with H/H levels of 12.6 g/dL and 36%. An ultrasound on this date revealed a small fluid collection within the endometrial cavity. 

The radiologic interpretation noted the development of a fluid collection within the endometrium, which may represent an early gestational sac approximately 5 mm in diameter, too early to determine the fetal age. The right ovary had a 1.2-cm ovarian cyst. No adnexal masses were seen.

Three days later, on June 7, the patient was seen in the physician’s office. The note documented that the patient was seen in the ED for pain, with the last hCG level being 2,399 mIU/mL. The note also stated that a right ovarian cyst was seen, with no free fluid. An ultrasound in the physician’s office was interpreted as showing a double ring–like structure in the right adnexa less than 2 cm in diameter. The assessment was an ectopic pregnancy. 

The plan was to obtain an hCG level and administer methotrexate. 

Methotrexate was administered prior to the return of the hCG level, which was 6484 mIU/mL. A repeat hCG level reading 4 days later was 13,232 mIU/mL. The patient was seen in the physician’s office 7 days later, on June 14, with an ultrasound interpreted as showing normal ovaries bilaterally and a right 3-cm adnexal cyst. On June 17, 3 days later, the patient was seen in the ED with an hCG level of 10,409 mIU/mL and H/H levels of 12.8 g/dL and 35.9%. 

An abdominal ultrasound performed in the radiology department revealed an intrauterine pregnancy, with a crown rump length of 2.8 mm, with no cardiac activity identified. A resolving corpus luteum in the right ovary was noted. The patient was advised in the ED to follow up with her physician for obstetrical care and genetic counseling due to the previously administered methotrexate.

The patient was seen in the physician’s office on June 19, where a repeat ultrasound revealed a crown rump length of 4.7 mm, with no cardiac activity visualized. The diagnosis was a fetal demise, with a dropping hCG level. Subsequently, a dilation and curettage were performed.

The patient ultimately sued the physician for an incorrect diagnosis of an ectopic pregnancy and the negligent use of methotrexate in an intrauterine pregnancy.

the plaintiff’s witnesses testified that the ultrasound on June 7, although of poor quality, was sufficient to identify an intrauterine gestational sac. In addition, the right ovarian “double ring” structure, interpreted to be an ectopic pregnancy, was actually the previously visualized right ovarian cyst, most likely a corpus luteum. Had the physician reviewed the prior studies, this would have been obvious. 

Methotrexate was administered prior to the return of the hCG level, which increased appropriately to 6484 mIU/mL. The experts opined that this was a further breach of the standard of care. 

Had the physician waited for the hCG level to return, methotrexate administration would have been delayed until the clinical situation was clearer. Thus, the correct diagnosis of an intrauterine pregnancy would have been made. In addition, there was no need to intervene on June 7, as the patient was clinically stable. The plaintiff’s experts further testified that the administration of methotrexate likely led to the early embryonic demise.


The use of methotrexate in an early intrauterine pregnancy is a current and ongoing concern. In this case, despite the weight of the evidence, the jury rendered a defense verdict, highlighting the fact that juries often find for physicians in malpractice cases. This was a fortunate outcome. However, the defense had to address several issues that made the case more difficult to defend.


In a stable patient, the physician is advised not to treat a suspected ectopic pregnancy with methotrexate based on a single hCG level, unless the ultrasound is definitive in the diagnosis. This patient had serial hCG levels that were rising appropriately. Although an appropriate increase in hCG level does not preclude the diagnosis of an ectopic pregnancy, it should cause the physician to reevaluate the diagnosis and treatment plan. For several reasons, the physician should know the hCG level results before administering methotrexate. An appropriate increase, as in this case, should prompt a reassessment of the patient. In addition, the hCG may be at such a level that, even in the case of a definite ectopic pregnancy, methotrexate may have a higher failure rate. Thus, surgical treatment may be more appropriate for the patient.


Physicians should review prior imaging studies and compare the findings with current studies. Electronic health records, which often allow remote access to staff physicians, have facilitated this. A review of prior ultrasound findings, including the images if available, is helpful in constructing a timeline and arriving at the appropriate diagnosis.


Ultrasounds were performed in the physician’s office with several different machines. The images were of relatively poor quality, likely related to the age of the ultrasound machines. Contemporary ultrasound machines should be used to acquire appropriate images. In addition, machines should undergo preventive maintenance on an annual basis to assure ongoing quality imaging.


Images from the various studies were saved on thermal print paper, as is done frequently in offices. However, retaining images in a digital format is preferable, to maintain the quality of the originals. This can be done by using a picture archiving and communication system (PACS), in a local server, in the hospital’s PACS system, or in one of the various cloud-based PACS systems. Alternatively, one can migrate the images stored on an ultrasound machine’s hard drive to a DVD on a monthly basis and save the DVD in a secure location for the statute of limitations of one’s state.


Office documentation was sparse and did not meet the then current guidelines for evaluation and management documentation. The history and physical findings should be adequately documented and correlated with laboratory and imaging findings. The assessment and plan should reflect one’s diagnostic assessment and treatment options. Finally, a discussion of the risks of the planned treatment and alternatives should be documented.

The defense experts stated that the patient had 2 ultrasounds, on May 30 and June 4, which did not confirm an intrauterine pregnancy. Further, on June 4, when the hCG level was more than 2000 mIU/mL (actual level, 2399 mIU/mL), an ultrasound should have revealed an intrauterine pregnancy if it was developing normally. Otherwise, a nonviable intrauterine pregnancy or ectopic pregnancy must be considered. 

The defense further claimed that with the patient’s history of vaginal bleeding and continued abdominal pain, an ectopic pregnancy must be considered. The physician claimed that the ultrasound on June 7 was properly interpreted, with no visualized intrauterine gestational sac and a double ring–like structure in the right adnexa, consistent with an ectopic pregnancy. As such, the administration of methotrexate was appropriate.

After 4 hours of deliberation, the jury returned a defense verdict.

The ultrasound images and interpretation did not meet applicable guidelines. Guidelines from the American Institute of Ultrasound in Medicine for appropriate imaging for both obstetrics and gynecology are available 

. Documentation guidelines are also available 

If one adheres to such guidelines, a case is more defensible.

Articles

Methotrexate in an Intrauterine Pregnancy – An Interesting Twist

A 32-year-old gravida 0 was seen for her wellness visit in March. She had no complaints. Her pelvic examination revealed adnexal fullness. An ultrasound performed in the physician’s office revealed a slightly enlarged left ovary, measuring 6 cm by 4 cm, with two cysts, 1.9 cm and 1.7 cm in diameter. 

The right ovary was not visualized on the vaginal ultrasound. An abdominal ultrasound was not performed. An evaluation 3 months later (June) again revealed adnexal fullness. An ultrasound identified a right ovary measuring 7 cm by 3.9 cm, with 3 small cysts. 

The left ovary was 4.5 cm by 2.9 cm, with a 1 cm cyst. A 6-month follow-up was recommended. The patient was seen the following December with complaints of postcoital bleeding. An endometrial biopsy revealed proliferative endometrium.

The patient was seen for her annual exam the following March, at the age of 33 years. 

It was noted that she had been on sertraline (Zoloft) for 2 years for treatment of depression. Her examination was normal. No additional studies or laboratory testing were performed. Four months later (July) she was seen in the emergency department for abdominal and pelvic pain. A CT revealed ovarian cysts bilaterally, the right measuring 5.2 cm by 4.6 cm by 3.5 cm, and the left measuring 5.1 cm by 4.9 cm by 3.5 cm.

. Documentation is critical to defending a one’s actions. Although some states have passed laws that allow brief, truncated documentation, eg, “RBA (risks, benefits, alternatives) discussed” as adequate to reflect informed consent, it is prudent to know the requirements in one’s own state. In general, adequate informed consent requires a discussion of the medical condition or finding requiring treatment or surgery, the planned procedure, the alternatives for treatment, including observation only, and the substantial risks of the procedure. Such documentation enhances patient understanding while enhancing the defensibility if litigation occurs.

. The patient in her initial interview with her attorney stated that she wanted to hear an explanation of why things were handled the way they were. She wanted an explanation and an apology. Had this been done, she may not have sued. It is recognized that the lack of clear communication is one of the main issues that lead to litigation. This case illustrates how an open and clear explanation of what happened, with an empathetic approach to the patient’s concerns, may have avoided litigation altogether.

. The expert for the plaintiff had an excellent presence in the courtroom. He was down to earth, established an immediate rapport with the jury, and was able to explain complex concepts in a clear, understandable manner. The concessions addressed during his testimony further established credibility. Too often, experts on both sides take an uncompromising position that antagonizes jurors. Balanced testimony enhances the jury’s acceptance of an expert and their opinions.

. The defendant presented a defensive posture without displaying empathy for the patient. Such posturing leads to a poor connection with the jury, which may lead to a less favorable ruling.

The patient was seen by her gynecologist 3 months later (October). She requested testing for ovarian cancer as her mother had recently been diagnosed with breast cancer. 

Her physician ordered an ultrasound and a CA 125. The patient was seen for her annual exam 3 months later (January), at 34 years of age. She relayed increasing difficulties in her marriage and noted she was now on citalopram (Celexa) for depression. A review of a recent pelvic ultrasound revealed a right adnexal cyst measuring 7.3 cm by 8.5 cm by 6.7 cm, with no further description. A CA 125 obtained on the day of the ultrasound was 46 U/mL. The patient was placed on combined oral contraceptives, with follow-up planned in 3 months.

The patient was seen in April, about 25 months from her initial presentation. An ultrasound revealed an enlarging right ovary, now 14.4 cm by 8.5 cm by 9.8 cm. Although her gynecologist recommended surgical treatment, the patient was reluctant to undergo surgery at that time due to an unstable work situation. 

She was seen one month later (May), with an exam confirming an adnexal mass. She underwent another pelvic ultrasound that revealed a right ovarian cyst measuring 10 cm by 11 cm with a smaller secondary cyst. 

The gynecologist’s impression was, “Adnexal cyst, probably benign.” The patient was scheduled for surgery. Her preoperative consultation documentation was, “Surgery discussed, consents signed.” There was no additional documentation of the discussion, nor mention of more extensive surgery. The consent for surgery indicated, “Exploratory laparotomy with probable removal of ovary.”

The patient underwent an exploratory laparotomy via a transverse lower abdominal incision. An enlarged right ovary measuring 10 cm by 16 cm was removed and sent for frozen section, which found a serous tumor of at least low malignant potential (LMP). A left ovarian cyst was removed and sent for frozen section. The gynecologist elected to proceed with a total abdominal hysterectomy and bilateral salpingo-oophorectomy (BSO) before the results of the frozen section returned, which revealed a benign serous cyst. 

The total surgical time was 1 hour and 10 minutes. Final pathology revealed a uterus weighing 100 grams, with adenomyosis and a small leiomyoma. The right ovary had a serous tumor of LMP. The left ovary had endosalpingiosis and a benign serous cyst. Peritoneal washings were negative. The patient had an uncomplicated recovery from surgery. However, she did experience significant difficulties with hot flashes, which were poorly responsive to estrogen replacement therapy. She had worsening depression that significantly impacted her marriage, which ended in divorce 9 months following surgery.

The patient changed physicians about 1 year later. Her new gynecologist noted she was experiencing lots of hot flashes, significant memory change, and an exacerbation of depressive symptoms. Over the next 9 months, the new gynecologist received several calls from the patient requesting medications for worsening premenstrual syndrome. This culminated in a call in which the patient described panic attacks and worsening anxiety. 

She requested sertraline (Zoloft). The physician prescribed diazepam (Valium) and made an appointment for the following day, advising her that no further medications would be prescribed until she was seen. The patient did not show for this scheduled appointment.

About two months later, the patient filed a malpractice suit against the original gynecologist claiming the performance of unnecessary surgery, specifically a hysterectomy and BSO; a breach of the standard of care by not referring to a gynecologic oncologist; the loss of procreative potential; significant pain and suffering, including uncontrollable symptoms related to surgical menopause; and worsening depression and anxiety, ultimately resulting in dissolution of her marriage.

Following discovery, the case went to trial. The plaintiff’s gynecology expert stated that an abdominal ultrasound should have been performed when the right ovary was not identified on the initial vaginal ultrasound. 

Noting that the right ovary was visualized on the study 3 months later, measuring 7. by x 3.9 cm, with 3 small cysts, it was conceded that immediate surgical intervention was not required. Further, this expert volunteered that the two-year delay in performing surgery did not appreciably impact the patient’s prognosis with a tumor of LMP.

This expert opined that the documentation was lacking. There was inadequate documentation of the preoperative counseling, particularly addressing the probable diagnosis and treatment options. There is no documentation about the possibility of a hysterectomy and BSO, with resultant surgical menopause and the difficulties often encountered in treating related symptoms in younger women. Simply documenting, “Surgery discussed, consents signed,” was deemed wholly inadequate. Further, the patient’s consent did not reflect the possibility of a complete hysterectomy and removal of both ovaries.

The expert testified that controversy exists whether surgical staging is required for LMP tumors. However, with a frozen section revealing a serous tumor of LMP, a right oophorectomy or right salpingo-oophorectomy would have been appropriate and adequate, with staging performed at a later date if necessary. The expert further opined that although it would have been ideal, a gynecologic oncology consultation was not required preoperatively or intraoperatively.

The plaintiff’s expert opined that surgical castration was unwarranted. Before proceeding with surgical castration, the surgeon should have consulted with the patient’s husband regarding the probable diagnosis and immediate treatment options. The expert opined that there was no surgical emergency necessitating removal of the uterus and the remaining tube and ovary. Even with cancer, conservative surgery with staging can be appropriate in a nulliparous patient.

A social worker testified that the patient likely would remain childless. It was highly unlikely that she had the option of adoption, particularly with her relatively recent divorce.

A psychologic expert for the plaintiff testified that despite having premenstrual dysphoric syndrome and long-standing depression, surgery triggered a posttraumatic response that remarkably exacerbated her symptoms. 

As a result, her treatment had become much more difficult, resulting in major difficulties with interpersonal relationships, one outcome being the dissolution of her marriage.

The patient testified that she felt a mistake had been made, specifically the performance of the hysterectomy and removal of her “good” ovary. 

She wanted to hear an explanation of why things were handled the way they were. She felt there was a complete lack of recognizing the impact that surgery had on her life. She wanted an explanation and an apology. As a result, she was angry and felt betrayed.

The defense’s gynecologic expert stated that although the CA 125 was mildly elevated, it can be elevated in conditions unrelated to malignancies. Thus, gynecologic oncology consultation was not required before or during surgery. The documentation of the preoperative consultation, although brief, memorializes a more extensive discussion. It is not expected that such documentation includes every facet of that discussion. 

Further, the operative consent included a statement consenting to indicated procedures, thus covering the performance of the performed surgery. This expert opined that hysterectomy and BSO are perfectly appropriate, as a tumor of low malignant potential can recur and may even progress to more severe disease with metastasis. 

Further, acknowledging that surgical menopause in younger women can present unique challenges in managing menopausal symptoms, her physician tried various estrogen formulations and nonhormonal therapies to no avail.

A psychological expert for defense stated that the patient’s preexisting and long-standing depression, which required several changes in her medication, had significant potential to progress even without surgery. It was noted that at a gynecology appointment almost 6 months before the surgery, the patient relayed that there were significant difficulties in her marriage. 

Thus, the dissolution of her marriage was a result of long-standing and unresolved issues, rather than the surgery.

After 6 hours of deliberation, the jury found for the plaintiff, awarding $700,000 in damages.

Polling of the jurors following the trial’s conclusion revealed that they placed great credence in the plaintiff’s expert. He conceded some issues while clearly explaining the rationale behind his expressed opinions. 

He explained complicated concepts clearly, appeared empathetic, and seemed to “connect” with the jury. Conversely, the defendant was defensive and gave evasive answers to direct questions. Further, the jurors said, the defendant seemed dismissive and lacked empathy. 

This case illustrates how a clear explanation and empathy for the patient’s concerns may have avoided litigation altogether.

Was a Hysterectomy and Bilateral Salpingo-oophorectomy Necessary?

A 19-year-old G1P0 was seen for her initial obstetrical visit by a certified nurse-midwife (CNM) at 9 weeks, 2 days by dates. Her exam revealed a height of 5’1”, weight of 141 lb, with a body mass index of 26.6 kg/m². Her exam revealed a gynaecoid pelvis, with a diagonal conjugate >11.5 cm, which was felt to be “adequate.” 

Shwayder is Professor of Obstetrics and Gynecology and former Chair at the University of Mississippi Medical Center. 

He is a graduate of the University of Denver College of Law and is a nationally and internationally recognized expert in gynecology ultrasound and minimally invasive surgery. 

He actively consults on legal matters in medicine, including liability in ultrasound and gynecologic surgery, as well as issues surrounding privileging and insurance fraud.

The patient underwent an ultrasound at 13 weeks, 2 days, which confirmed her dates, with a subsequent ultrasound at 22 weeks, 1 day, consistent with the previous study and with appropriate interval fetal growth. The patient had an uncomplicated pregnancy.

The patient presented to the hospital at 39 weeks, 2 days with irregular contractions. She was evaluated by the CNM at 3 a.m. with her cervix being 1.5-cm dilated, 50% effaced, with a vertex at a -2 station. She was felt to be in early labor, with the fetal heart rate (FHR) in the 140s, with good variability (a Category 1). 

For context, the hospital is a private academic hospital with an ob/gyn residency, and a full-time CNM service, which works collaboratively with the residents and the attending physicians. The CNMs are hospital employees who deliver patients in a birthing unit located in Labor and Delivery.

Despite being in very early labor, the patient did not feel comfortable going home. Thus, she was allowed to rest throughout the night. 

A re-examination at 7:45 a.m. revealed a cervix being 2.5 cm dilated, 100% effaced, a vertex at a -2 station, with a bulging bag of water (BBOW). The estimated fetal weight (EFW) was 7 lb 2 oz. There was a Category 1 FHR tracing. The patient was allowed to ambulate throughout the morning, with periodic FHR monitoring confirming a continued Category 1 tracing. At 11:30 a.m., her cervix was 3-cm dilated, 100% effaced, a vertex at a -1 station, with a BBOW.

A Category 1 tracing documented contractions every 5 to 7 minutes of mild to moderate strength. At 3 p.m., there was no change in the patient’s examination. 

Thus, membranes were ruptured, noting clear fluid. At 5 p.m., the cervix was 4- to 5-cm dilated, 100% effaced, with a vertex at a -2 station. Contractions were every 2 to 5 minutes of moderate strength.

., the cervix was 5-cm dilated, 100% effaced, with the vertex at a -1 station, in a left occiput posterior (LOP) position. Contractions were every 2 to 6 minutes of moderate strength, lasting 60 seconds. There was a Category 1 tracing. At 7:15 p.m., her exam remained unchanged. A continuous lumbar epidural was placed.

At 8 p.m., her cervix was 5- to 6-cm dilated, 100% effaced, the vertex was at a -1 station, with caput at a 0 station. It was elected to augment labor with oxytocin. An intrauterine pressure catheter was placed. 

, the cervix was 6-cm dilated, 100% effaced, with the vertex at a -1 station, in a LOP position. There were occasional mild variable decelerations, with the baseline FHR in the 140s. The oxytocin was increased to 8 mU/minute, with occasional coupling and tripling. 

At 11 p.m., the cervix was 6 to 7 cm, with the vertex at a -1 station, 100% effaced, in a persistent LOP position. The FHR was in the 170s. The patient’s temperature was 101.4º F. The CNM consulted with the chief resident (R4), who consulted with the attending physician. It was elected to begin antibiotics and acetaminophen, with a diagnosis of chorioamnionitis. At 1:20 a.m., the cervix was 7-cm dilated, 100% effaced, with the vertex at a 0 station. The contractions were irregular with occasional variables. 

The attending physician’s note at 1:30 a.m. indicated that they would proceed with a cesarean delivery if there were repetitive late decelerations or there was no progress in the next 2 hours. At 3:45 a.m., the R4 examined the patient with the CNM. The patient’s cervix was 7-cm dilated, 80% effaced, at a 0 station. It was elected to recheck the patient in 2 hours, at which time the cervix was 8-cm dilated, 100% effaced, at a 0 station. 

, a new CNM assumed care of the patient. Her exam revealed the cervix being 8- to 9-cm dilated, 100% effaced, with molding to a +1 station. The EFW was 8.5 lb. The oxytocin was at 30 mU/min. The documented diagnosis was “Protracted active phase. Consult MD at 9 a.m.” 

., there were two episodes of prolonged decelerations, the lowest being to the 60s for 4 minutes, returning to the 120s and upward to the 140s. A fetal scalp electrode was placed. 

At 7:57 a.m., the previous R4 and a new attending physician evaluated the patient. Oxygen was placed via nasal cannula at 10 L/minute. At 8 a.m., the R4 and attending physician were called to the room when the FHR had spontaneous decelerations to the 70s and 80s for 4 to 5 minutes. The oxytocin was turned off. The attending physician discussed a cesarean delivery with the patient. There was good documentation of the risks of surgery and options in management.

., a male infant was delivered, weighing 7 lb 9 oz, with Apgar scores of 9 and 9, at 1 and 5 minutes, respectively.

Umbilical cord gases were obtained with the following results:

Arterial=7.30 (Normal = 7.18-7.38);
PCO² = 43 mmHg
(Normal = 32-66 mmHg);
HCO³ <40
(Normal = 17-27 mmol/L);
Base excess = -5.7
(Normal -8 to 0 mmol/L)

 = 31 mmHg;
HCO³ <40; Base excess = -4.9

The placenta was delivered manually at 9:21 a.m., with oxytocin administered shortly thereafter.

Methylergonovine, 0.2 mg IM, was administered at 9:23 a.m. due to excessive bleeding. With continued bleeding, misoprostol, 800 mcg, was placed rectally at 9:34 a.m. At 9:40 a.m., carboprost, 0.25 mg, was administered, as the patient’s bleeding was not responsive to the prior medications. 

, a “Code White” was called as a general alert for excessive bleeding, which brought additional resources and personnel to the operating suite. Surgical maneuvers performed included a B-Lynch suture and O’Leary stitches. They considered and rejected uterine artery embolization. An attempt was made to place an intrauterine compression balloon, which was unsuccessful. 

, the attending decided to perform a hysterectomy. A second opinion was provided by the department chair. A supracervical hysterectomy was performed without complication. The procedure, which was completed at 11:49 a.m., had an estimated blood loss of 3000 mL, and 4200 mL of crystalloid fluids was administered intraoperatively. 

Blood product replacement included 6 units of packed red blood cells, 4 units of fresh frozen plasma, with 1 unit of apheresis platelets. It was noted that labs sent at 11:04 a.m. revealed early disseminated intravascular coagulation (DIC).

Pertinent labs included a hemoglobin and hematocrit with the following levels:

The baby had a normal hospital and neonatal course. The patient had an uncomplicated postoperative and postpartum course. 

Of note, the anesthesiologist, while evaluating the patient on the day following surgery, documented the following, “She expressed confidence that proper decisions were made, and she is grateful for her life and her baby.”

Two years later, the patient filed a suit against the physicians and the hospital for an unnecessary hysterectomy following her cesarean delivery. As a result, the patient and her husband have suffered significant pain and suffering. 

After discovery, the case proceeded to trial. The plaintiff’s maternal-fetal medicine (MFM) expert opined that there were remarkable changes in the FHR, with fetal tachycardia, decreased beat-to-beat variability, and intermittent decelerations. Further, there was abnormal progress in labor, with a failure to descend. As such, the patient should have been delivered by a cesarean at 3:30 a.m. 

In addition, due to poor communication, there was a lack of personal involvement of the attending physician in managing the patient, which led to a delay in performing the cesarean delivery. 

The delay, with the resultant uterine atony, resulted in the need for a hysterectomy. Uterine atony was predictable, as the patient had been on oxytocin for more than 12 hours and she had chorioamnionitis. The expert quoted literature stating that 71% of such patients experience atony. 

Thus, the patient should have been appropriately counseled preoperatively about the need for a hysterectomy. As a result of the unnecessary hysterectomy, the patient will not be able to have further children.

The defense’s MFM expert testified that the record reflected ongoing, timely, and appropriate evaluation and communication regarding the patient’s status by the CNMs, the chief resident, and the attending physicians. 

He further testified that the collaboration among these care providers was well within the standard of care required in the setting of a delivery primarily managed by a CNM and met all applicable hospital protocols. Oxytocin was appropriately and timely initiated and was appropriately monitored and adjusted throughout the labor. He testified that the signs and symptoms of chorioamnionitis were timely and appropriately recognized and treated. 

Chorioamnionitis can lead to a protracted labor, which, with generally reassuring maternal and fetal status, does not compel an earlier cesarean delivery. In addition, an occiput posterior position can lead to a desultory labor. However, with no evidence of fetal macrosomia, pursuing a vaginal delivery was appropriate. 

In addition, despite being desultory, the patient did not meet the American College of Obstetricians and Gynecologists’ definition for an arrest of labor in the first stage, which requires either 4 or more hours of adequate contractions, or at least 6 hours of inadequate contractions, and no cervical change. He further testified that there is no literature to support the contention that an earlier cesarean would have prevented the ultimate need for hysterectomy.

This case presented a unique dynamic, with CNMs providing the primary management of the patient. In contrast to a separate birthing center, this hospital had established a birthing unit in Labor and Delivery, allowing CNMs to manage patients with immediate physician consultation if needed. 

The hospital had established protocols with guidelines for CNM consultation with a senior resident or the attending physician. This patient’s management complied with these protocols. Of note, some departments are reluctant to have such protocols, fearful that they will be used against physicians in the event of a malpractice suit. 

Although deviations from protocols, without appropriate documentation, can place providers at risk, deviations with documented reasoning are quite defensible. However, as in this case, following protocols enhances the defense of a case.

Documentation of the rationale for various interventions, e.g. oxytocin augmentation and antibiotic treatment, resident and attending involvement, and surgical counseling, was excellent. Such documentation enhances case defensibility. Oxytocin use is often present in obstetrical malpractice actions. 

Thus, clear documentation regarding the decision to use oxytocin, as well as carefully documented monitoring is critical. Although the patient initially expressed that she was satisfied with her care, the realization that she could have no further children naturally resulted in her questioning her prior care. Being sensitive to such concerns and addressing them during future appointments can often allay a patient’s misgivings. Studies support that good communication with the patient is one of the best ways to avert litigation. 

Find more Legally Speaking columns here. 

This case presents a unique dynamic involving certified nurse midwives; following protocols enhanced defensibility.

Cesarean delivery leads to unexpected outcome

A 39-year-old G2P1102 presented to her gynecologist with a complaint of pelvic pressure. She had regular menses and no loss of urine. Her history was significant only for a postpartum bilateral tubal ligation 2 years earlier.

The woman’s examination revealed prolapse of the uterus, with the cervix visible at the introitus. An ultrasound performed by the physician 1 week after her initial presentation revealed a 4.8 4.5 6.8-cm left ovarian cyst. The physician recommended a laparoscopically assisted vaginal hysterectomy (LAVH) and left salpingo-oophorectomy (SP). 

The woman was presented with several options for management, including a total abdominal hysterectomy and left salpingo-oophorectomy. The gynecologist reviewed the risks of surgery and potential complications. All the patient’s questions were answered and operative permissions were signed. 

The surgery was scheduled for 1 week later. 

During surgery, insertion of the Veress needle was without incident. However, upon insertion of the umbilical trocar, profuse bleeding was noted and the patient became bradycardic and hypotensive and experienced cardiac arrest. 

She was resuscitated, following which, the gynecologist made a midline vertical incision and noted a laceration in the area of the aorta. A general surgeon was consulted, who could not fully control the bleeding. Thus, pressure was applied to the aorta and the patient was transferred to a tertiary hospital 40 minutes away that had a vascular surgeon.

Upon arrival at the tertiary hospital, the patient was taken immediately to surgery. The vascular surgeon noted transaction of the anterior wall of the common iliac artery encompassing almost half the diameter of the artery. Also noted was a duodenal serosal tear, presumably from the pressure held during transport. 

The vascular surgeon also noted thrombi of the common iliac artery, and the right and left iliac arteries. The surgeon repaired the vascular injury with an end-to-end anastomosis, and performed right and left iliofemoral thrombectomies, as well as from the common iliac artery, restoring flow to the right and left common iliac arteries. He then noted that both the patient’s feet had good capillary refill. 

The duodenal laceration was repaired without consequence. The patient had a relatively uncomplicated recovery, with the exception of residual neuropathy in her right leg and hip, with foot drop that persisted despite months of occupational and physical therapy.

Approximately 9 months after the attempted LAVH, the patient sought the care of another gynecologist, who noted that her uterus was protruding to the introitus with valsalva. 

An ultrasound was obtained, which was interpreted as normal, with no pelvic or ovarian masses or cysts. The physician recommended a total vaginal hysterectomy. Despite being “scared to death,” the patient elected to go forward with the procedure, which was performed without incident. Surgical findings stated that “both tubes and ovaries appeared normal.”

Ultimately, the patient filed suit against the original gynecologist, alleging inadequate and inappropriate preoperative evaluation, improperly performed surgery, with resultant complications, long-term physical deficits, pain and suffering, and loss of life’s enjoyment.

Deposition of the defendant gynecologist revealed several potential concerns. 

When questioned if it would be an option to wait and see if the cyst would go away on its own, the gynecologist stated, “I would not consider that to be an option in this case. I was trained that anything over 5 cm is a problem.”

During questioning about the performance of the surgery, the gynecologist described a closed-entry technique, using a Veress needle. A saline-drop test was used to confirm intraperitoneal placement of the Veress needle. 

The opening pressure was 7 mmHg. To establish the pneumoperitoneum, the abdomen was insufflated with 2 L of CO2. When questioned if the surgeon insufflates to a particular pressure, for example 15 or 20 mmHg, the gynecologist replied that he does not use a pressure cut off. His reasoning was that “nobody is ever totally relaxed.” 

is Professor of Obstetrics and Gynecology and former Chair at the University of Mississippi Medical Center. He is a graduate of the University of Denver College of Law and is a nationally and internationally recognized expert in gynecology ultrasound and minimally invasive surgery. 

Following establishment of the pneumoperitoneum, the patient was placed in Trendelenburg, her abdomen was elevated with the surgeon’s hand, and the trocar was inserted at a 45º angle into the pelvis. The gynecologist suspected that the vascular injury occurred with insertion of the trocar.

In reviewing the gynecologist’s surgical experience, he stated that he had performed thousands of laparoscopies and had assisted on or performed LAVHs since 1990. It was noted that the physician had completed his residency in 1984. 

Unfortunately, he could not document any formal continuing education courses, nor additional training or education in ultrasound or more advanced laparoscopy since that time. The physician was board-certified and was current with his maintenance of certification.

The plaintiff’s ultrasound expert reviewed the original ultrasound images and noted a 6.80 4.86 4.49-cm simple, unilocular cyst, consistent with a persistent follicular cyst or a serous cyst. 

This expert opined that the current recommendation for follow-up of such a cyst in reproductive-aged women is a repeat ultrasound in 2 to 6 months. Thus, immediate intervention was not indicated. Subsequently, prior to the TVH, an ultrasound revealed that the cyst had completely resolved, confirming that surgical intervention for the ovarian cyst was not required. 

Thus, one could have avoided the risk of laparoscopy altogether, particularly with the primary surgical indication of uterine prolapse.

The plaintiff’s laparoscopy expert noted several breeches in the standard of care. Although a closed-entry technique, and even a direct-insertion technique without a pneumoperitoneum, is an acceptable alternative, the method the defendant described was not within the standard of care. Insufflating a specific amount of CO2, for example 2 L, is not adequate. 

Contrary to the defendant’s statement, patients are paralyzed for the procedure, and thus, they are totally relaxed. One cannot assume that 2 L of CO2 provides an adequate pneumoperitoneum in all patients. Thus, current practice is to infuse enough CO2 to establish an intraperitoneal pressure of 12 to 15 mmHg prior to insertion of the primary trocar. 

In fact, many surgeons insufflate to a pressure of 20 mmHg for initial trocar insertion, reducing this pressure to 12 to 15 mmHg for placement of the secondary trocars. Inadequate intraperitoneal distension subjects the patient to a greater risk of vascular injury, as occurred in this case. 

The placement of a patient in Trendelenburg for insertion of the umbilical trocar is not currently recommended. The Trendelenburg position places the aorta and the common iliac vessels in direct line with insertion of a trocar at a 45º angle. 

Although this was common practice in the past, current recommendations, literally for several decades, are to maintain the patient in a supine position, with the abdominal wall elevated, for insertion of the umbilical trocar, only changing to the Trendelenburg position for insertion of the secondary trocars. 

The plaintiff’s expert opined that placing the patient in the Trendelenburg position for insertion of the umbilical trocar was a breech of the standard of care. Doing so places the patient at risk for the exact vascular injury encountered in this case.

No criticisms were levied against the care of the general surgeon, the vascular surgeon, or the subsequent postoperative care and rehabilitative services. Thus, the defense focused on the criticisms levied against the preoperative evaluation and the surgical technique.

In evaluating the defensibility of the case, the identified lack of documented continuing education and additional surgical training placed the case defense at risk. Unfortunately, proceeding to trial posed a significant risk of losing the case, with subsequent exorbitant damages. It was elected to settle the case prior to trial for $900,000.

This case highlights the importance of remaining cognizant of current literature and surgical practices. All too often, physicians fail to remain current in the various areas of their practices. 

One would assume that maintenance of certification would allow physicians to stay current in their practice. However, ongoing education in specific practice areas may be required. Ultrasound, a valuable adjunct to our care of patients, is rapidly changing. 

The approach to adnexal masses is constantly evolving, with consensus guidance for management available. In this case, the physician’s lack of awareness of these newer guidelines impacted the preferred management option: observation. If there is any question about diagnosis or management, one can always seek a second opinion from a more experienced sonologist. 

As in this case, this functional cyst resolved, negating the need for an abdominal approach. Thus, the physician could have pursued a vaginal hysterectomy, the preferred route, which was ultimately performed, avoiding the risk of laparoscopy.

The need to adapt one’s surgical techniques is particularly true in the rapidly changing surgical environment of minimally invasive surgery. Changes in accepted techniques were not adopted in the current case. 

With the physician’s lack of documented continuing education and additional surgical training, this case was at greater risk. The cited breeches rendered the case one with a significant risk of losing at trial. Thus, the best perceived option was settlement.

an Adjunct Professor at the University of Florida.

 He is a graduate of the University of Denver College of Law and is a nationally and internationally recognized expert in gynecology ultrasound and minimally invasive surgery. He actively consults on legal matters in medicine, including liability in ultrasound and gynecologic surgery, as well as issues surrounding privileging and insurance fraud.

An LVAH case underscores the importance of continuing education.

James M. Shwayder, MD, JD

Articles

Methotrexate in an Intrauterine Pregnancy – An Interesting Twist

Was a Hysterectomy and Bilateral Salpingo-oophorectomy Necessary?

Cesarean delivery leads to unexpected outcome

Major vascular injury incurred at laparoscopy