Expert Outlines Litigation Risks Related to ART


CABO SAN LUCAS, MEXICO — Higher rates of complications in babies born through assisted reproductive technology have led to malpractice lawsuits, Aubrey Milunsky, M.B., said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

“There is a medicolegal industry that is evolving at breakneck speed” related to ART, said Dr. Milunsky, who chaired the conference and is professor of human genetics, pediatrics, ob.gyn., and pathology at Boston University. ART plays a role in approximately 1% of the 4 million births in the United States each year, said Dr. Milunsky, who is also director of the Center for Human Genetics, Boston.

Compared with naturally conceived pregnancies, ART pregnancies carry nearly a threefold increased risk for low birth weight and more than a fivefold increased risk for fetal or infant death. Singletons delivered after ART are 40% more likely to be small for gestational age, 54% more likely to be delivered by cesarean section, and 27% more likely to require intensive care, compared with naturally conceived singletons. Multifetal pregnancies are more common with ART.

Maternal serum screening produces more false-positive results in ART pregnancies than in naturally conceived ones.

The overall rate of birth defects is 40%‐200% higher in ART pregnancies than the background rate of 3%‐4% in the general population. Three rare “imprinting” birth defects (disorders that appear to develop more in one sex than in the other) have been reported in a handful of ART pregnancies: Beckwith-Wiedemann syndrome, Angelman's syndrome, and retinoblastoma.

When parents have gone to such great lengths to conceive a child through ART and are desperate to have a successful pregnancy, anything less than a “perfect” baby may be extra disappointing, and complications may seem extra burdensome, he added.

Sean Tipton, spokesman for the American Society for Reproductive Medicine in Washington, commented in a subsequent telephone interview, “We're not aware of any explosion in litigation in this area. It's certainly not news to anyone that children of infertility patients are not as healthy as children of healthy people.”

Complications in ART pregnancies could be attributed to the underlying cause of the infertility, the advanced age of many women who seek ART, or issues related to multiple gestations, he said.

At the meeting, Dr. Milunsky highlighted some of the key areas for potential litigation related to ART:

▸ Informed consent. It is difficult and probably rare to get truly informed consent for all stages of ART a patient may go through, such as hormonal therapy, intracytoplasmic sperm injection, manipulation of the gamete or zygote in vitro, or insertion of cells into the womb.

▸ Extreme prematurity. Birth weights under 2,500 g are 70% more common in ART singletons than in naturally conceived ones. “Even though the technology is so phenomenal in terms of saving them … the outcome is intellectually disastrous” for many of the extremely small babies, he said. As in non-ART pregnancies, damaged babies lead to lawsuits that often try to pin the blame on medical personnel.

▸ Erroneous diagnosis. Chromosomal testing of a blastomere biopsy can miss problems absent in one cell but present in others. “It's surprising, if not amazing, how often the embryo is made up of two sets of cells—normal and abnormal,” he said.

When a fertilized egg multiplies into 8‐16 cells in vitro, a gene analysis for cystic fibrosis (CF) typically involves one of those cells. But in some cases allele dropout occurs in the cell chosen for analysis, giving the false impression that the cell—and hence the blastomere—does not contain a CF mutation. At least two lawsuits resulted from missed CF diagnoses due to allele dropout.

▸ Genetic counseling. Failure to refer both parents for genetic counseling results in inadequate information gathering. “People undergoing ART rarely have a full genetic evaluation, I find,” Dr. Milunsky said at the meeting, sponsored by Boston University and the Center for Human Genetics.

▸ Targeted ultrasound. Given the higher risks for complications in ART pregnancies, targeted ultrasound should be done during the second trimester in all ART pregnancies to search for detectable abnormalities.

▸ Chorionic villus sampling/amniocentesis. Don't let the parents' drive to succeed in pregnancy keep you from offering invasive testing, which can endanger the pregnancy. Your responsibility is to communicate any increased risk to the parents and give them options for management. “Let them make the choice, and you make the documentation,” he said.

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