Legally Speaking: Patient refuses cerclage, medication; delivers early

February 19, 2016
Andrew I. Kaplan, Esq

Mr. Kaplan is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP, specializing in medical malpractice defense and healthcare litigation.

Despite counseling, a patient is reluctant to follow her MFM specialist's advice.

Facts

An ob/gyn diagnosed a 26-year-old’s pregnancy on December 8, 2004. The patient had had 3 spontaneous abortions; 2 of which occurred during the first trimester, and 1 during the second trimester, at 4 months’ gestation. The placental pathology for the second-trimester miscarriage was consistent with chorioamnionitis. At the conclusion of the December 8 visit, the patient was advised to follow up in 2 weeks, and in the interim, to have an ultrasound (U/S).

An U/S performed on December 17 was consistent with a 12-week pregnancy. The cervical length was 3.5 cm. The patient was seen on December 22, and referred to the high-risk clinic at the defendant hospital. On December 29 the patient presented to the defendant hospital’s emergency department (ED) with complaints of abdominal pressure and vaginal bleeding. She was examined and underwent a U/S which was noted to be normal, and she was discharged in good condition.

More: Acute fatty liver disease in pregnancy results in stillbirth

The patient was seen by another attending ob/gyn on January 4, 2005, and her cervix was noted to be closed. An abnormal Pap smear necessitated a colposcopy on January 6 during which a benign cervical polyp was found. An U/S the next day revealed a cervical length of 3 to 3.4 cm. Routine prenatal blood testing revealed abnormal Protein S and antithrombin III antigen. The patient was sent to defendant Dr A, the chief of ob/gyn at the defendant hospital, who was certified in obstetrics as well as maternal-fetal medicine.

Dr A saw the patient on January 11 at the high-risk clinic. He took a detailed obstetrical history, including her chronic hypertension, prior pregnancy outcomes, and the possibility that the woman had an incompetent cervix. Dr A documented a long counseling session (more than a half hour) discussing the risk and benefits of a cerclage. The patient refused the cerclage, stating that she wanted to continue to monitor her cervical length. Dr A also discussed the risk of losing the pregnancy at 23–25 weeks. A discussion about the patient’s abnormal clotting factors was also held, and she refused Lovenox.

An U/S performed on January 21 at 17 weeks’ gestation revealed a normal cervical length of 4.1 cm. The patient was counseled to reconsider her refusal of Lovenox and once again declined the medication. The patient returned on February 1 at 18 5/7 weeks’ gestation. A February 10 U/S that revealed a cervical length of 1.3 cm was read by Dr A, who recommended that the patient be admitted to the hospital and consider a cerclage.

The patient was admitted to the defendant hospital on February 10 for observation, bed rest, and consideration of a cerclage. On February 14 U/S revealed a cervical length of 1.7 cm, and Dr A and defendant ob/gyn attending Dr B decided to perform a rescue cerclage. Dr B and the patient had an extensive informed consent discussion regarding the risks of preterm labor, premature rupture of membranes, and infection. The cerclage was placed and the patient was discharged on February 16 with a prescription for antibiotics and an appointment to follow up with Dr A at the high-risk clinic on February 23.

NEXT: More facts of the lawsuit

 

On February 23 the patient was examined and her cervix was noted to be closed and her cerclage in place. On her next visit on March 8 all was normal. An U/S on March 21 however, revealed a shortened cervix of 0.6 cm and a large funnel with a foot seen in it. Dr A ordered admission to the hospital for monitoring.

The patient was admitted to the defendant hospital on March 22 for bed rest in the Trendelenburg position to take pressure off her cervix. Fetal monitoring was commenced. The patient received 4 doses of dexamethasone to promote fetal lung maturity. She was seen daily by the attending ob/gyn physicians, and daily monitoring of the fetal wellbeing was performed.

More: How long is too long to crown?

Dr A next saw the patient on March 30 when he had a long discussion with her regarding the risks of premature delivery at 27 weeks. The plan was for continued bed rest and for Dr A to evaluate her expressed desire to be discharged from the hospital. The patient was next seen by Dr A on March 31. A U/S taken on March 30 revealed a cervical length of 0.6 cm with no change from the prior scan. Dr A reviewed the findings, prognosis and options with the patient and it was decided that the patient would remain in the hospital and continue to be monitored by the attending ob/gyn and the nursing staff, with a U/S every 14 days and a non-stress test daily. Dr B saw the patient on April 2 and recommended continuing conservative management.

The patient was seen by attending ob/gyn Dr O on April 3 for a complaint of bloody discharge after using the bathroom. On exam, the cerclage was intact, and there was no cervical dilation. Dr O counseled the patient to maintain bed rest to avoid pressure on her cervix. The patient continued to be monitored and maintained on bed rest in the Trendelenburg position.

On April 6 at 4 am the patient complained of abdominal pain. A nurse performed fetal monitoring for 20 minutes, which demonstrated a fetal heart rate (FHR) in the 140s with no contractions. At 5:40 am, a medical student along with defendant Dr D examined the patient and found her complaining of abdominal pain with no contractions. At 7 am the patient was examined by a nurse for complaints of lower back pain without contractions. At 7:15 am a nurse placed the patient on a FHR monitor. Mild irregular contractions were seen.

At 8 am, the patient’s water broke and she was seen by attending ob/gyn Dr O, who took the patient to the operating room and removed her cerclage. The woman’s cervix was found to be dilated 3 to 4 cm, and she was in preterm labor. Prophylactic antibiotics were administered. At 12:45 pm, a 27 6/7 week infant boy was delivered with Apgars of 8 and 8. The pediatric team was present in the delivery room and resuscitated the infant.

The infant developed normally for the first 13 days in the neonatal intensive care unit, under the care of codefendants Dr E and Dr F and was able to tolerate formula. On April 20, the infant began to show symptoms of infection and sepsis. He was placed on antibiotics, was made NPO and serial x-rays were performed. Doctors suspected that the infant had necrotizing enterocolitis, and he was transferred to another hospital.

NEXT: Allegations

 

Allegations

The plaintiff alleged failure to treat the patient as high risk; failure to timely and properly perform cerclage; failure to adequately monitor and evaluate the patient prenatally; that Dr D failed to properly examine the patient on April 5 and 6, failed to recognize and prevent premature labor and delivery, and failed to give tocolytics and properly assess dilatation, resulting in premature delivery and concordant physical and neurological insult to the infant.

Discovery

Our OB expert stated that it was clear from the hospital prenatal records that the defendants did indeed consider this a high-risk pregnancy, and correctly took a detailed medical history, including prior miscarriages and abnormal blood clotting tests, when the patient was referred to Dr A. As a result she was seen at the high-risk clinic on January 11. The records and Dr A’s testimony reflected a detailed informed consent discussion with the patient on January 11 regarding placement of a cerclage and the potential for losing the pregnancy at 23–25 weeks. The patient did not meet the criteria for a preventive or prophylactic cerclage, as those are performed when the patient has had 2 second-trimester miscarriages, and it was reasonable for Dr A to give his patient all the information needed to make an informed decision regarding her own treatment. After hearing all the treatment options, the patient decided to take a “wait and see” approach, to see if her cervix began to change and to decide if she would consent to having a cerclage placed. The patient also did not want to take Lovenox, which was prescribed due to her abnormal blood clotting tests. Our expert felt the patient was capable of making informed treatment decisions, and as long as he felt that there was no imminent danger to the fetus or the mother, Dr A, as her physician, had to allow her to do so.

More: Case hinges on timing of bowel perforation

When the U/S taken on February 10 was read by Dr A and revealed a cervical length of 1.3 cm, Dr A recommended admission to the hospital, bed rest. and consideration of cerclage. A repeat U/S on February 14 also revealed a shortened cervix, and both Dr B and Dr A had another long, detailed informed consent discussion with their patient explaining both the risks and the benefits of placing a rescue cerclage. Our expert opined that Dr B appropriately placed the cerclage on February 15. A rescue cerclage has a 50/50 change of maintaining a pregnancy to 28 weeks, and indeed no assurances were made by either physician that this procedure would allow the patient to carry this pregnancy to term.

NEXT: What's the verdict?

 

The patient was seen by Dr A on March 30, who once again had a long discussion with his patient regarding the risks of premature delivery at 27 weeks, and to dissuade the patient from her desire to leave the hospital. A repeat U/S was essentially unchanged and Dr A was able to convince the patient that the safest course for the fetus would be continued monitoring and bed rest at the hospital. Our expert opined that when Dr B last saw the patient on April 3, she correctly recommended continuing the conservative management, bed rest, and daily monitoring by attending ob/gyns and the nursing staff, and obtaining a U/S every 14 days and a daily non-stress test. This treatment plan, developed by Dr A and carried out by the attendings and the nursing staff at the defendant hospital, was appropriate and well within the standard of care.

Dr D testified that he had no independent recollection of the patient, but that he was the attending on call for the postpartum, antepartum and ED units from April 5 at 5 pm until April 6 at 8 am Dr D testified that he saw the patient on the morning of April 6, and documented that on physical exam, no contractions were noted. Dr D was aware that the patient began complaining of abdominal pain at 4 am and that for 20 minutes, during the time that the patient was complaining of abdominal pain, no contractions were noted on the FHR monitoring strips. Dr D testified that the tracings would have shown uterine activity or contractions if there had been any. He explained that labor is contractions that cause cervical change. In the case of a patient with a cerclage, a vaginal exam to assess dilation is done only when there is evidence of contractions, as the exam itself can cause cervical dilation. Our expert opined that at that time there was no indication to administer tocolytics, as the patient was not having contractions as demonstrated by the monitoring strips and by her physical exam. The rationale for administering tocolytics would be to possibly prolong the pregnancy long enough to administer dexamethasone to mature the fetus’s lungs. In this case, dexamethasone had been successfully administered on March 22 and 23.

Next: Resolutions for 2016

Finally, our expert agreed with Dr A that delivery had been imminent a full week prior to April 6. The sole reason that the patient went into preterm labor was her incompetent cervix, and no action or inaction on the part of Drs A, B, or D was the cause of the infant’s premature delivery or subsequent medical issues.

 

Resolution

Armed with the unassailable facts and strong expert support, we moved for summary judgment (dismissal) on behalf of Drs A, B and D, as well as the hospital’s prenatal facility, prior to trial. The plaintiff attempted to oppose this on the grounds that tocolytics “should have” been administered at 4 am on April 6. However, the record did not support the assertion that the patient was even having contractions at that time. In fact, the medical student’s note written at 5:40 am and cosigned by Dr D documented the continued absence of contractions.

Their expert then attempted to assert that the patient wasn’t properly managed with tocolytics when she was in “incipient preterm labor,” a theory our expert debunked with the assistance of the relevant American College of Obstetricians and Gynecologists Practice Bulletins, which do not advocate the use of tocolytics in the absence of contractions. The plaintiff’s expert went so far as to suggest that tocolytics should have been administered by Dr A after the patient’s membranes ruptured and she was 3–4 cm dilated, an opinion that was rejected by the Court as unfounded and contrary to accepted literature.

The verdict

Ultimately, summary judgment was granted as to our defendants: Drs A, B, D and the hospital’s prenatal group. Appeals and motion practice as to the remaining codefendants are pending.