Dozens of embryos are thought to have been affected, and more patients plan lawsuits, an attorney for two of the couples who filed complaints in Orange County, Calif., told The Washington Post. Adam Wolf, the attorney, accused Ovation of transferring compromised embryos into patients over multiple weeks.
“This is a complete tragedy that was entirely needless,” Wolf said. He said he represents two additional patients who plan to sue.
The company said in a statement that “a very small number” of patients were affected.
Some of the lawsuits allege that clinic staff cleaned an incubator — where embryos are placed ahead of transfer into a patient’s uterus — with an “extremely unsafe” amount of hydrogen peroxide. Staff then put embryos into the incubator, which effectively destroyed them, making them no longer viable. Still, they were transferred into the patients.
That information is based on what the Ovation office told some patients, Wolf said. Rob Marcereau, an attorney for other plaintiffs, told the City News Service in Los Angeles that the clinic “has given different stories” to various patients.
The clinic did not know the embryos weren’t viable, Ovation Fertility said in the statement, realizing something might have gone wrong only after the transfers didn’t result in pregnancies.
“As soon as we recognized that pregnancy numbers were lower than our usually high success rates, we immediately initiated an investigation,” the statement said. “We did not knowingly transfer nonviable embryos for implantation.”
Ovation blamed “an unintended laboratory technician error” for what it called an isolated incident and said the clinic had rigorous protocols in place to protect embryos.
IVF involves retrieving eggs from a patient’s uterus, fertilizing them to create embryos and transferring embryos to the uterus. It can be a lengthy and difficult process, and disappointments are common for couples experiencing infertility.
Some couples don’t get many embryos from the treatment, and not all embryos result in pregnancies, so every one is valuable.
Wolf said he knew of some patients who had used their last embryos in the transfer.
“Plaintiffs have been deprived of the opportunity to use their embryos,” the lawsuit said.
IVF has been in the spotlight since the Alabama Supreme Court’s ruling in February that frozen embryos are people — a decision that set off a political firestorm, alarmed couples in treatment and led Alabama lawmakers to give providers legal cover. That case stemmed from a lawsuit filed by couples whose embryos had been destroyed by a hospital patient who allegedly accessed and dropped a container holding them.
How strictly to regulate IVF has long been a topic of debate in the United States. Reproductive technology has been the target of criticism from some conservatives, while clinicians say it is sufficiently regulated. The American Society of Reproductive Medicine, which represents providers, says state, federal and professional regulation ensures safety.
“Incidents like this are exceedingly rare,” said Gerard Letterie, a reproductive endocrinologist and partner at Seattle Reproductive Medicine in Washington state.
Though IVF clinics are certified by independent regulatory bodies, more federal or state regulation could enforce standards more stringently, said Naomi R. Cahn, who co-directs the Family Law Center at the University of Virginia and researches reproductive technology.
“Currently, lawsuits are serving as a way of regulating the industry,” Cahn said. “We need to work toward prevention of these mishaps.”
She added that the Newport Beach case demonstrates “the need for better monitoring and regulation of IVF clinics.” She said it is difficult to estimate how many errors occur in labs because only the most egregious cases are usually publicized.
The suits accuse Ovation of negligent misrepresentation, fraud and medical battery and seek monetary and punitive damages.
“It’s hard to describe just how deeply traumatic this is for would-be parents,” Wolf said. “A fertility journey is hard enough when everything goes perfectly, and it’s just inexcusable when a fertility clinic is so reckless and indifferent.”
