Medicolegal Issues

Pregnancy test missed before IUD placement? Your liability.

A patient is pregnant at intrauterine device placement, physician fails to administer pregnancy test. What is the outcome of this case?

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CASE: Gynecologist accused of placing an IUD without performing a pregnancy test

A 34-year-old woman (G4 P3013) presents to her gynecologist for planned placement of the Mirena Intrauterine System (Bayer HealthCare). She was divorced 2 months ago and is interested in birth control. She smokes 1.5 packs per day, and her history includes irregular menses, an earlier Pap smear result of atypical squamous cells of undetermined significance (ASCUS) with negative colposcopy results, polycystic ovary syndrome, obesity, migraine headaches with aura, bilateral carpel tunnel surgery, and a herniated L4.5 disc treated conservatively. She has no history of any psychiatric problems.

One week before intrauterine device (IUD) placement, she discussed the options with her gynecologist and received a Mirena patient brochure. At the office visit for IUD placement, the patient stated she had a negative home pregnancy test 1 week earlier. She did not tell the gynecologist that she had taken Plan B One-Step (levonorgestrel, 1.5 mg) emergency contraception 2 weeks prior to presenting to her gynecologist after receiving it from a Planned Parenthood office following condom breakage during coitus. IUD placement was uncomplicated.

After noting spotting several weeks later, she contacted her gynecologist’s office. Results of an office urine pregnancy test were positive; the serum human chorionic gonadotropin (hCG) level was reported at 65,000 mIU/mL.The results of a pelvic sonogram showed a 12 5/7-week intrauterine gestation. The gynecologist unsuccessfully tried to remove the IUD. Options for termination or continuation of the pregnancy were discussed. The patient felt the gynecologist strongly encouraged, “almost insisting on,” termination. Termination could not be performed locally as her state laws did not allow second trimester abortion; the gynecologist provided out-of-state clinic options.

The patient aborted the pregnancy in a neighboring state. She was opposed to the termination but decided it was not a good time for her to have a baby. She felt the staff at the facility were “cold” and had a “we got to get this done attitude.” As she left the clinic, she saw people picketing outside and found the whole process “psychologically traumatic.” When bleeding persisted, she sought care from another gynecologist. Pelvic sonography results showed retained products of conception (POC). The new gynecologist performed operative hysteroscopy to remove the POC. The patient became depressed and felt as if she was a victim of pain and suffering.

The patient’s attorney filed a medical malpractice claim against the gynecologist who inserted the IUD, accusing her of negligence for not performing a pregnancy test immediately before IUD insertion.

In a deposition, the patient stated she bought the home pregnancy test in a “dollar store” and was worried about its accuracy, but never told the gynecologist. Conception probably occurred 2 weeks prior to IUD insertion, correlating with the broken condom and taking of Plan B. She did not think the gynecologist needed to know this as it “would not have made any difference in her care.”

The gynecologist confirmed that the patient’s record included “Patient stated ‘pregnancy test negative within 1 week of IUD placement.’” The gynecologist did not feel that obtaining the date of the patient’s last menstrual period (LMP) was required since she asked if the patient had protected coitus since her LMP and the patient answered yes. The gynecologist thought that if a pregnancy were in utero, Mirena placement would prevent implantation. She believed that she had obtained proper informed consent and that the patient acknowledged receiving and reading the Mirena patient information prior to placement. The gynecologist stated she also provided other birth control options.

The patient’s expert witness testified that the gynecologist fell below the standard of care by not obtaining a pregnancy test prior to IUD insertion.

The gynecologist’s expert witness argued that the patient told the gynecologist that she did not have unprotected coitus. The patient herself withheld information from the gynecologist that she had taken Plan B due to condom breakage. The physician’s attorney also noted that the pelvic exam at time of IUD placement was normal.

What’s the verdict?

The patient has a fairly good case. The gynecologist may not have been sufficiently careful, given all of the facts in this case, to ensure that the patient was not pregnant. An expert is testifying that this fell below the acceptable level of care in the profession. At the same time, the failure of the patient to reveal some information may result in reduced damages through “comparative negligence.” Because there will be several questions of fact for a jury to decide, as well as some emotional elements in this case, the outcome of a trial is uncertain. This suggests that a negotiated settlement before trial should be considered.

Read about medical considerations of a pregnancy with an IUD.

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