Delay in diagnosis: choriocarcinoma

Clinical presentation
A 36-year old woman was referred by her primary ob/gyn to another physician for a voluntary termination of pregnancy. The patient’s history included one prior vaginal delivery and a hyatidiform molar pregnancy six years earlier. A vaginal ultrasound ordered by the primary ob/gyn was performed at a hospital and identified a tiny gestational sac in the uterus. The patient had a serum Beta HCG titer of 39.

Physician action
At her initial visit for evaluation regarding termination, a repeat ultrasound was done in the physician’s office, but he could not identify a gestational sac. The patient reported her period only five weeks prior to the visit, so the physician recommended she return in two weeks to consider termination when the pregnancy was further along. The HCG level meant either a very early viable pregnancy or a nonviable pregnancy.

The patient returned two weeks later, and was diagnosed with an early intrauterine pregnancy by vaginal exam. The physician did not do a repeat ultrasound or HCG titer. The physician performed an office D & C, and reported seeing chorionic villi with his naked eye. Tissue samples were sent to pathology, but the request did not include the patient’s history of molar pregnancy six years earlier.

The pathologist reported seeing “no products of conception” on review of the tissue submitted. This report was sent to the office where the termination procedure was done. The patient returned to her primary gynecologist two weeks after the D & C. She still had some bleeding and a repeat Beta HCG titer of 35. A tubal ligation was scheduled the next day at an outpatient surgery center. On the day of the surgery, the primary ob/gyn’s nurse charted that she received a telephone call from the secondary ob/gyn’s office stating that the “pathology report from the D & C indicated normal products of conception.” The primary physician’s chart does not include a copy of the pathology report from the D & C procedure.

The patient returned to her primary gynecologist six days after the tubal ligation. The Beta HCG level was repeated and still slightly elevated. Realizing the elevated HCG needed to be followed to zero, the patient was to return in three weeks. This appointment was not kept and the practice did not follow up. The physician also did not chart her plan to repeat the HCG prior to the patient’s scheduled return for an annual exam. In this time frame, the patient changed physicians and the primary ob/gyn next heard about the patient upon receipt of a phone request for her records from a subsequent treating physician.

The patient died 16 months later due to choriocarcinoma, a very rare cancer. She was survived by a minor child.

Allegations
Incorrect pathology result communicated by office staff which contributed to delay in diagnosis/treatment of choriocarcinoma.
Practicing below the standard of care with the following actions: 1. failure to confirm the pregnancy by ultrasound prior to the D & C 2. relying on the unaided eye to identify products of conception 3. failure to provide the pathologist with a history of molar pregnancy 4. incorrectly advising the primary ob/gyn, in writing, that a 5-6 week pregnancy had been confirmed by vaginal ultrasound 5. delay in diagnosis and treatment by the primary ob/gyn.

Legal principle
Initially, expert consultants said the physician’s actions in this case were reasonable. The ob/gyn thought he was dealing with a pregnancy due to the observation of chorionic villi. He sent the specimen to pathology and did not attach much significance to the fact that the report did not reflect any products of conception. The ob/gyn considered the pathology report within normal limits, which is what he intended to be communicated to the patient’s primary ob/gyn. However, defense experts did concede that retrospectively, the ob/gyn fell below the standard of care in his failure to confirm the pregnancy on ultrasound; failure to provide the pathologist with a history of molar pregnancy; and his written statement to the primary ob/gyn that he confirmed the pregnancy by ultrasound when he did not.

Choriocarcinoma is an extremely rare disease, seen in about 1 in 30,000 gynecologic patients. Very few gynecologists ever see this form of cancer. There was some discussion as to whether or not the average gynecologist could detect this type of cancer or whether or not the diagnosis would have been made by pathology from the D & C. Defense experts also agreed that when the patient presented to the ob/gyn for a D & C, the tumor had been present since the molar pregnancy in 1992. It was unreasonable to assume that a diagnosis in the last six months would have saved the patient who had the tumor for 72 months. However, the plaintiffs’ attorney developed expert support for their contention that the cancer did not spread outside the uterus until after the ob/gyn’s treatment, and that the cancer could have been cured if caught before it spread. Plaintiffs’ experts theorized that absence of proof of pregnancy with an elevated HCG titer should have triggered more aggressive monitoring and tests with a potential for gestational trophoblastic neoplasm in a patient with a history of molar pregnancy.

Disposition
This case was settled during trial for seven figures on behalf of the physician who performed the termination. The case against the primary ob/gyn was settled for the mid-six figures. The pathologist was non-suited upon settlement

Risk management issues
Studies indicate that 28 percent of all malpractice claims involve mistakes or omissions by office staff. In this case, inaccurate information provided by a staff member directlycontributed to the main allegation of delay in treatment. Obviously this was a mistake by the office person but physicians are vicariously liable for the actions of their staff. In order to reduce the risk of errors such as this occurring in their office, physicians need to develop clearly defined job descriptions for their staff. Staff members should be aware of their responsibilities and limitations. In addition, personnel that will be dealing with clinical information would benefit from having written guidelines or protocols on how that information should be handled. In this case, a copy of the D & C pathology report should have been available to the primary ob/gyn for review prior to performing the tubal ligation.

Communication between the physicians in this case was not comprehensive. Access to complete patient information including a copy of the pathology report should be available to a physician before proceeding with another procedure, in this case, a tubal ligation. Physician practices should implement a process for referral follow up to assure receipt of all patient reports because they guide the physician in continuity of care and future treatment decisions.

Standard of care issues are common in malpractice cases. Experts agreed that in this case the secondary ob/gyn did not meet the standard of care in 1) failing to confirm the pregnancy on ultrasound; 2) failure to provide the pathologist with a history of molar pregnancy and; 3) his letter to the primary ob/gyn incorrectly documenting that he had confirmed the pregnancy by ultrasound. When deviation from the standard of care can be proven, the defense of a case is greatly compromised. Physicians are held to the standards of care developed within their specialty and practiced in their community. These standards of care serve a number of purposes in the practice of medicine. They are intended to enhance patient and clinician decision making, improve communication among practitioners, promote efficiency, and provide evidence of conformity to the applicable standard of care.

Responsibility for patient follow-up rests primarily on the physician. This patient’s HCG titer continued to be elevated after the tubal ligation and there was no proof of pregnancy. When she did not keep an appointment for a repeat titer, a method to flag the record for follow-up should have been triggered. When appointments are not kept, and patients have not called to reschedule, the reason for the visit needs to be evaluated. If it is an issue regarding continuity of care, that patient should be contacted and appropriate documentation made in the medical record.