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ProAssurance Risk ManagementMay 20245 min read

Failure to Document Risks of Methotrexate Treatment Complicates the Defense

Failure to Document Risks of Methotrexate Treatment Complicates the Defense
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Allegation

The ob-gyn negligently failed to inform the patient of the general risks of birth anomalies associated with methotrexate treatment and the associated risk of conceiving within three months of undergoing treatment, and failed to recommend supplementation with folic acid when the patient conceived within that time period.

Case Details

Inadequate documentation of the informed consent process can significantly affect the defensibility of a malpractice lawsuit. This Malpractice Case Study presents a closed claim involving an ob-gyn whose records were silent on key informed consent issues.

A 35 YOW presented to her ob-gyn following a positive home pregnancy test. At the office, a repeat pregnancy test was positive, but an ultrasound was negative for an intrauterine pregnancy. Ultrasound at a follow-up visit also did not show an intrauterine pregnancy. The ob-gyn diagnosed an ectopic pregnancy. He performed a laparoscopy and milked the fallopian tube to terminate the pregnancy. Following the procedure, however, the patient’s hCG levels continued to increase. Therefore, the ob-gyn ordered an injection of methotrexate to terminate the pregnancy. This also proved to be unsuccessful, and the patient ultimately required a salpingectomy.

Approximately fifty-seven days after methotrexate administration, the patient became pregnant. She gave birth to a full-term infant with spina bifida, hydrocephalus, club feet, seizure disorder, and Arnold’s Chiari II. He underwent multiple surgeries, including VP shunt placement, closure of meningomyelocele, permanent tracheostomy for home ventilation, cranial reconstructive surgery, and placement of a feeding tube. He was incontinent of bladder and bowel, wheelchair bound, and had limited ability to communicate. These were presumed life-long conditions.

Both parents were expected to testify at trial that the ob-gyn failed to provide them with information about the risks or side effects of methotrexate on fetal health in future pregnancies, including when they could safely resume unprotected sexual intercourse. Although there was nothing in the medical records, the ob-gyn was expected to testify in his defense that he advised the patient to wait until her hCG levels returned to baseline, and then, an additional 1-2 menstrual cycles before trying to conceive again. Additionally, the parents were expected to testify that the ob-gyn did not recommend folic acid supplements, which allegedly would have moderated the effects of methotrexate on the developing fetus. In his defense, the ob-gyn would testify that it was his customary practice to prescribe prenatal vitamins containing folic acid, even though he did not document doing so.

Expert Testimony

Plaintiffs’ experts testified that the ob-gyn breached the standard of care by failing to obtain appropriate informed consent for methotrexate administration, failing to instruct the patient not to become pregnant for at least three months afterwards, and failing to provide the patient with supplemental folic acid upon learning she was pregnant.

Plaintiffs’ causation experts testified that methotrexate exposure 57 days before conception caused the infant’s birth defects. They contended that methotrexate metabolites remain after half-life elimination, adversely affecting maternal folic acid levels, which can cause neural tube defects. They opined that prescribing folic acid early in pregnancy, could have prevented the infant’s birth defects.

Defense experts would further testify that the infant’s abnormalities were not consistent with methotrexate embryology, but were instead consistent with spina bifida, which is not attributable to any particular cause. Defense experts also testified that there was no literature supporting plaintiff’s theory that a preconception dose of methotrexate caused the infant’s neural tube defects. Despite the lack of literature, however, several physicians on the infant’s care team documented the possibility that methotrexate or a folate deficiency resulting from it may have caused the birth defects. Further, shortly after the infant’s birth, the treating pediatric neurologist wrote an article concluding that conceiving within weeks after methotrexate treatment can cause birth defects. This muddied the defense argument about a lack of published clinical support for the plaintiff’s methotrexate causation theories.

Another complicating factor for the defense were the potential damages. Plaintiffs’ economic experts estimated that the cost of providing care to the child over the course of his lifetime was $18-24 million.

Resolution

The policyholder was concerned about the potential for an excess verdict and demanded settlement. Although there was expert support for the ob-gyn, the lack of documentation associated with key issues in the case would be problematic. Consequently, the case was settled.

Risk Reduction Strategies

A physician is responsible for educating the patient about a proposed course of treatment, and to discuss the associated risks, benefits, and alternatives, including no treatment. Informed consent is a process that encompasses three elements: discussion, decision, and documentation.

The purpose of an informed consent discussion is to encourage questions, dialogue, and understanding, allowing the patient to make an informed decision about whether to proceed with the physician’s recommendations. Explain what is known, what is suspected, and the risks of foregoing recommended treatment. Conduct discussions in easily understood terms, giving the patient ample opportunity for asking questions.

Medical record documentation of the informed consent process is evidence that it occurred. Documentation should include:

  • The risks, benefits, and alternatives that were discussed.
  • The patient’s questions, physician’s answers, and if there were no questions verification that the patient had an opportunity to ask them.
  • Confirmation of the patient’s understanding of the risks and alternatives, and agreement to proceed.
  • If the patient received or viewed educational materials, a description or copy of them.
  • If the patient refuses treatment.

Conclusion

Insufficient informed consent documentation can significantly affect the defensibility of a malpractice lawsuit. In this case, the ob-gyn’s records were silent on key informed consent issues, including the birth anomaly risks associated with methotrexate, a timeframe in which the patient should avoid conception after termination of an ectopic pregnancy, and a recommendation for folic acid supplementation during pregnancy. Had these items been documented, this lawsuit might never have been filed.

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If you have questions on this topic, please email RiskAdvisor@ProAssurance.com or call 844-223-9648.

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ProAssurance Risk Management

The ProAssurance Risk Management department is here to help you promote patient safety, minimize risk, and improve defensibility of claims by providing comprehensive assessment and training resources that are relevant and easy to share. If you have a question you would like to discuss with a risk consultant, email RiskAdvisor@ProAssurance.com or call 844-223-9648.

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