Informed Consent – More is Better

To the physician, calculations of size and time have precise clinical importance and provide the basis on which critical decisions can be made. To the layperson—either patient or juror—proper informed consent may depend on a discussion that includes must less exactness.

Dr. O is an obstetrician who saw a 33-year-old patient for prenatal care. By last menstrual period, the gestational age for the fetus was 10 weeks, 3 days. By sonogram on that visit, the crown-rump length measurement indicated a GA of 10 weeks, 0 days.

Two visits later, Dr. O’s office started the ACOG Antepartum record. The gestational age recorded on that third visit used the sonogram-derived GA of 16 weeks, (versus the by-dates age of 16 weeks, 3 days).

Dr. O’s office staff drew the patient’s blood for the MS-AFP screening test and sent the sample to the Department of Health Services California AFP Screening Program. Among the other data that accompanied that sample (birth date, ethnicity, weight, number of fetuses), Dr. O’s office gave the LMP date and stated that the gestational age at collection, based on the patient’s LMP, was 16 weeks, 3 days.

The screening result from the Department of Health gave an interpretation of “positive-low” and indicated that the risk of Down’s Syndrome of the pregnancy at 1 in 350. The test was negative for neural tube defects. The test result indicated “Action Required” and authorized the patient’s referral to the state-approved AFP prenatal diagnosis center at no cost to the patient. There, the patient would receive genetic counseling and advice on whether to elect an amniocentesis.

A series of telephone calls ensuing between AFP coordinators and Dr. O’s office (some of the contents of which were in dispute) resulted in the state health officials recalculating the findings based on a gestational age of 16 weeks, 0 days, taken from the doctor’s earlier sonogram reading. Using the new age, the test result turned negative for Down’s Syndrome.

During the next prenatal visit, Dr. O told the patient that the AFP test result was negative. (In depositions, Dr. O could not say whether he told the patient that the AFP coordinators changed the report from positive to negative or whether he simply told her that the result was negative. The patient firmly testified that Dr. O did not tell her that the negative result had been changed from a positive finding.)

The patient’s baby boy was later born with Down’s Syndrome. Plaintiff and her husband sued Dr. O alleging “wrongful life” and sought the cost for their son’s lifetime care, plus pain and suffering for the three of them.

Expert reviewers warned that Dr. O would have to confront a charge of lack of informed consent: When Dr. O received the modified result reflecting a negative screen, he should have realized that a difference in gestational age of just three days completely changed the result. This should have alerted him that the patient needed to be informed that she was on the borderline so that she could decide for herself whether to accept genetic counseling.

The medical profession must be entitled to trust the science that underlies clinical practice. When the science is inexact, however, the best practice is to give the patient more information, so that the burden of a monumental health care decision rests where it belongs: with the patient.

Gordon Ownby, CAP-MPT’s general counsel, can be reached at gownby@cap-mpt.com.