In what experts are calling the first lawsuits of their kind since the technology of in vitro fertilization was introduced 17 years ago, two Rhode Island couples have sued the state's only fertility clinic, accusing it of losing nine embryos.
The suits, filed in July and August against Women and Infants Hospital in Providence, are the second set of serious charges leveled against a fertility clinic this year and have renewed calls for federal regulation of the growing reproductive technology industry.
In June, the University of California at Irvine closed its fertility clinic after accusations that doctors had transferred embryos from one patient to another without consent.
"These are mainstream programs," said Dr. Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics. "They aren't on the fringe, so for places this good to have these kinds of problems cements the case for real guidelines. This whole area of record-keeping, auditing and quality control in assisted-reproductive technology is simply showing up as inadequate."
Each year, 30,000 American women who are unable to become pregnant seek in vitro fertilization at the nation's 300 fertility clinics. A woman's eggs are fertilized by a man's sperm in a petri dish, producing about a dozen embryos.
A few embryos are transplanted into the woman's uterus; the remainder are frozen in case the pregnancy is not successful or the woman wants another child.
In the Rhode Island suits, Vickie and Robert Lamontagne accused Women and Infants Hospital of misplacing three embryos; Carol and David Frisina said the hospital had lost track of six embryos in the freezing process.
"In light of what happened in California," said David Oliveira, a lawyer representing both couples, "one of the possibilities is that the embryos went to someone else."
But Dr. Donald R. Coustan, the hospital's chief gynecologist and obstetrician, said, "Embryos haven't gone into the wrong patient, and we're sure on that."
Dr. Coustan said any embryo a couple believes to be missing would have died during routine procedures. Couples are required to sign waivers acknowledging that embryos often do not survive, generally because they get stuck in a petri dish, dry up, degenerate or are destroyed in lab accidents.
"These kinds of occurrences are common to every program," Dr. Coustan said.
Dr. Coustan said that 300 couples went through the in vitro process each year at Women and Infants and that the hospital's success rate -- defined as the percentage of women who give birth -- is 28 percent, compared with the national average of 22 percent.
Because of the lawsuits, Dr. Coustan said, the hospital is reviewing its record-keeping and has asked outside experts to evaluate the clinic. The Rhode Island Department of Health has also begun an investigation.
While fertility experts said Dr. Coustan was correct in explaining why embryos might not survive, such mishaps would not normally account for the nine embryos at issue in the lawsuits.
"One would expect a better explanation," said Victor Knutzen, the president of the Society for Assisted Reproductive Technologies, which sets voluntary standards for fertility clinics. "Maybe they knocked a dish over."
There are no state or federal regulations governing fertility clinics.