Fertility clinics in San Francisco and Cleveland fail on same day
Thousands of embryos may be destroyed; lawsuits filed in Cleveland; more to come
When Kate and Jeremy Plants were making plans for their 2014 marriage, they had no idea the future they would face. Just months after they tied the knot, Kate was diagnosed with ovarian cancer, a deadly form that the American Cancer Society says takes more lives than any other female reproductive cancer.
Because treatment could affect Kate’s fertility, doctors encouraged the newlyweds to consider banking Kate’s embryos so they could have children someday.
“So every other day for two weeks, we drove 45 minutes each way to the doctor,” Kate recalled. “There were shots in stomach multiple times a day; I was high on hormones; it was very stressful. And the whole time, I don’t know if the cancer is spreading, and I’m thinking, ‘Do I have time for this?’ “
What happened next, says Kate, could only be called a blessing. In the world of in-vitro fertilization, or IVF, it’s not unusual for couples to undergo numerous rounds of expensive, painful procedures to obtain a viable embryo, if it happens at all.
Yet for Kate and Jeremy, the first and only round of IVF produced five excellent embryos.
“The fact that my one working ovary could produce those eggs was a miracle,” Kate said.
She and Jeremy decided to store their precious babies-to-be in a long-term cryopreservation tank at the same place she underwent treatment: Cleveland’s University Hospitals Fertility Center.
Then came another blessing. Despite being “gutted like a fish” by the surgery, Kate survived ovarian cancer, after a long, painful recovery. But, she says, her good fortune didn’t last. Another year had barely gone by when symptoms reappeared; this time the diagnosis was uterine cancer. Desperate to avoid “more ripping and tearing at my uterus,” and with her five backup blessings in mind, Kate opted for a full hysterectomy in May 2017.
For Kate, now 33, and Jeremy, 38, the rollercoaster still wasn’t over. Over the weekend of March 3, the cryopreservation tank at University Hospitals suddenly failed. The temperature of the liquid nitrogen keeping the contents at icy levels unexpectedly fluctuated, possibly damaging the frozen eggs and embryos inside.
“This was our main storage area,” said Mike Ferrari, senior media relations specialist for University Hospitals. “We think about 2,100 eggs and embryos were affected, but we have not verified that to date. It affected about 700 families, but this is an evolving situation and it could be less or more.”
“It hit me like a ton of bricks,” Kate said after reading what she calls the hospital’s “sterile” letter. “But Jeremy took it even harder. The rest of the world looks at it as eggs and embryos, but we look at it as our future children.”
“I actually was very angry,” said 37-year-old Amber Ash. She and her husband, Elliott, 36, have two embryos stored in the same cryopreservation unit. They had used a third to conceive their son, Ethan, 2½ years ago, and were recently considering expanding their family.
“There’s the sudden realization that our future family that was there last week is gone, in a moment,” Amber said. “It’s just shock and disbelief.”
“It makes me pause and ask, ‘what kind of safety methods are these fertility clinics taking?’ ” asked Amber’s husband, Elliott. “Perhaps protocols and practices need to be reviewed to insure they are protected.”
A ‘bizarre coincidence’
The question of safety became more urgent when news broke that another fertility clinic, Pacific Fertility Center in San Francisco, also had a mishap with one of its embryo storage units.
“A single piece of equipment in our cryo-storage laboratory lost liquid nitrogen for a brief period of time,” the center said in a statement. “As soon as the issue was discovered, our most senior embryologists took immediate action to transfer those tissues from the affected equipment to a new piece of equipment. We have brought in independent experts and are conducting a full investigation.”
Strangely enough, it appears both incidents happened on the same day: March 4.
“It’s a bizarre coincidence,” said Dr. Brian Levine of CCRM, a national network of fertility centers that also freeze eggs and embryos. “Two incidents in the same day. Both of these clinics are highly reputable, and I’m sure they had policies and procedures in place.”
“What’s amazing is that it hasn’t happened before,” said Dr. Richard Chetkowski, a fertility specialist in San Francisco who uses the Pacific Fertility Center to freeze some of his client’s embryos. “As far as I know it’s the first time first time human embryos have been jeopardized by failure of the storage tanks. It’s a shock to see this risk for a stage of the process we thought was risk free.”
Even though there are no official regulations governing the freezing of embryos, Levine says the gold standard for clinics is to arm every tank with independent sensors and probes that send audible warnings, such as a beep, as well as text and email alerts to a wide group of recipients 24/7 if something goes wrong.
“Sensors have to be checked,” Levine said. “We do it daily, with another set of different checks once a week. Alarms have battery backups and all are on landlines, not cell phones. We have enough liquid nitrogen to last weeks. It’s expensive but worth it to make sure we are prepared.”
Katie Miller is one of the women affected by the failure of the Pacific Fertility storage unit. She told CNN San Francisco affiliate KGO that she has two healthy children using embryos frozen by the facility and was undergoing treatments for a third when the news broke.
“It’s a real shock, because you know you put such faith in the process,” Miller said. “For some people, this is perhaps their only chance at having biological children.”
Pacific Fertility did not return calls for comment but referred to their prior statement: “The vast majority of the eggs and embryos in the lab were unaffected, and the facility is operating securely.”
“I haven’t told any of my patients that their embryos are damaged,” Chetkowski said. “We don’t know to what level the embryos were exposed to high temperature and how much they thawed.”
Chetkowski explained that if there was enough liquid nitrogen left in the tank, nitrogen steam or vapor could have remained. And while that’s not as good as being submerged in liquid nitrogen at minus-196 centigrade, it’s possible some tissue may still be viable after transfer to a new storage unit.
“It may turn out that some are more robust and survive and some may not,” Chetkowski said. “And there’s no way of eyeballing it. You don’t know the state of the embryo until the patient decides to undergo in-vitro fertilization and they’re thawed.”
As in Cleveland, the tank contained both new and much older embryos that could have been there for years.
Chetkowski is more hopeful for embryos frozen by a method called vitrification, a quick-freezing process that has been widely accepted over the last decade. Before that, he says, a slower and “less reliable” technique called equilibrium was the gold standard.
Lou Jones, the founder and CEO of Biogenics, a firm that makes warning equipment for cryopreservation units, is more pessimistic. He argues that eggs frozen via vitrification “will shatter” when put back into liquid nitrogen.
“If you add more liquid nitrogen, they are toast,” Jones said. “I’ve been trying to wave this flag for 10 years, telling them that they need separate tanks for vitrification and equilibrium processed tissue.”
Courts will decide
In Cleveland, affected families are starting to turn toward legal action after speaking to their doctors at University Hospitals Fertility Center.
“I’ve talked to 20 different patients directly, and all have been told their embryos are not viable,” said Tom Merriman, a partner at Landskroner Grieco Merriman LLC who is fielding calls from upset families. “I had another 15 emails Monday morning, and phone has been ringing all day.”
University Hospitals’ Mike Ferrari says the hospital will not comment on litigation and refers questions about the current state of embryos to the hospital’s March 8 statement, which says, “At this time, we don’t yet know the viability of these eggs and embryos.”
“We think this is a lot more catastrophic than what has been reported by the hospital,” said Mark DiCello of the Cleveland law firm DiCello Levitt & Casey. “The families we’ve spoken with who have had meetings with the hospital have not left with any sense of hope; instead there is a sense of utter devastation. We’re afraid it’s a total loss.”
DiCello, who is representing the Ashes, filed a class-action lawsuit against the hospital on Sunday. Merriman, who is representing the Plantses, says he will also soon file a lawsuit and expects to see more from other attorneys in Cleveland.
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“You can seek class-action status, but that’s something that’s ruled upon by the court,” Merriman said. “Class action or not, all of these cases are going to end up in front of one judge.”
Both the Ashes and the Plantses are hoping they can use their lawsuits to speak up and advocate for change.
“Our goal is to seek prevention and increased oversight so this can never happen again,” Amber Ash said. “So that other families don’t have to receive such devastating news.”
“Those families are not alone,” Kate Plants said, breaking into tears. “When I think about my own grief, I feel like I’m carrying them with me. It’s easy for me to be strong myself, but when I think about all the other women and families and all the sacrifices they made. Their options were taken from them forever.”