A second clinic, the Pacific Fertility Center in San Francisco, disclosed to The Washington Post on Sunday that it also had suffered a malfunction last week in a steel tank where hundreds of patients’ eggs and embryos were stored. Members of the American Academy of Assisted Reproductive Technology Attorneys said Monday that they were not aware of legal action against the California clinic but expected filings soon.
The impulse of couples to translate their anger or grief into legal action represents a new consumer activism in a realm of medical technology that has been proliferating and remains unevenly regulated.
The number of embryos in cold storage has skyrocketed since the turn of the century. A 2002 survey estimated the number to be almost 400,000. By 2011, it was 600,000. Fertility experts say it is probably well over 1 million today — more than the population of Austin.
How often frozen eggs or cells are damaged is unclear because there is no central reporting mechanism. Within the federal government, the Centers for Medicare and Medicaid Services and the Food and Drug Administration oversee only certain aspects of fertility labs, and the Centers for Disease Control and Prevention collects data about in vitro fertilization. The agencies do not inspect clinics’ storage tanks or track reports of eggs or embryos being damaged.
Officials at the College of American Pathologists, which accredits more than 400 fertility laboratories, said Monday that they were aware of incidents in which frozen eggs and embryos had been thawed accidentally but that such events tended to be small scale. They characterized the malfunctions in Cleveland and San Francisco as “extremely rare” but declined to provide figures.
Denise Driscoll, the organization’s senior director of accreditation and regulatory affairs, described a rigorous biannual inspection process that involves about 560 checklist items, including backup systems for cryopreservation tanks and 24-hour monitoring of alarm systems. Both the Cleveland clinic, on April 26, 2016, and the San Francisco clinic, on Jan. 23, 2017, met those criteria.
The oversight of fertility labs differs by state. California, for instance, requires that they be accredited. Ohio does not.
The first lawsuit, filed Sunday in the Cuyahoga County Court of Common Pleas, is on behalf of Amber and Elliot Ash, who live just west of Cleveland.
Elliot, 37 and an engineer, said that he had stored sperm in his early 20s, just before he had treatment for cancer. Once he and Amber married nearly five years ago, he drove the frozen sperm from the Columbus facility where it had been stored, not trusting the transit to anyone else.
“The most important drive of your life,” he said Monday, recalling how he strapped the domed, liquid-nitrogen filled container he dubbed R2-D2 into the back seat.
On a third try at the Cleveland center, Amber became pregnant by in vitro fertilization with their son, Ethan, now 2½ . That left two embryos for the future.
She first learned of the facility’s problem Thursday from her mother, who was watching television when a news report came on. The next day, she followed instructions to call a hospital hotline. She spoke with her doctor, who confirmed that the embryos had been in the affected tank and were unusable. “My heart just sank,” she said. “I spent the day very, very sick.
“Obviously, something went wrong,” said Amber, a 37-year-old social workers. “Our goal with this whole lawsuit . . . is to focus on preventing this from ever happening again.”
The Ashes’ attorney, Robert DiCello, is asking the court to certify the case as a class action. “Since the news broke, our office phones have been ringing,” he said.
Another Cleveland attorney, Tom Merriman, also said that the morning after the problem became public, he arrived at his office to find emails from 15 people wanting him to represent them.
“I’ve been on the phone or meeting with people — women, couples — ever since,” he said. He plans to file his first lawsuit Tuesday.
One of his new clients, Kate Plants, had a rushed round of fertility treatments at the University Hospitals clinic to retrieve eggs when, months after she and her husband, Jeremy, married in fall 2014, a softball-sized cyst turned out to be ovarian cancer.
“The fact I got five and we were able to fertilize all of them was a miracle,” said Plants, 33, who lives in a suburb southwest of Cleveland. Then, on Valentine’s Day last year, she was diagnosed with an unrelated uterine cancer.
After rounds of surgery, she is unable to carry a pregnancy, she said, but two relatives have offered to be surrogates once everyone is ready. But late last week, one of her bridesmaids texted her out of the blue. “Oh, Kate does this affect you?” the text said.
“With everything that has happened, I just knew our embryos were done,” Plants said. “Them saying sorry is not enough. They need to fix this, and they need to be held accountable legally.”
At in vitro fertilization clinics, the process of creating an embryo outside the body involves manual steps. “I’ve been in lab medicine for 50 years and can tell you there has been an enormous increase in the amount of automation and mechanism, and it minimizes impact of human error — but it does not eliminate it,” said Paul Bachner, an adviser to the pathology college’s accreditation committee.
Many clinics still use older cryopreservation tanks that must be filled with liquid nitrogen by hand, and there is no standard set-up for alarms. CAP officials, investigating the Ohio and California incidents, said they have not gotten far enough to answer questions about the equipment and alarms at the two clinics.