The University Hospitals Fertility Clinic in Cleveland is facing dozens of legal actions after the failure in early March of a cryopreservation tank containing approximately 4,000 eggs and embryos belonging to at least 950 families.
"We currently represent well over 100 clients whose cases we will pursue as individual claims. That number is growing by the day," Cleveland attorney Tom Merriman said Monday.
Lawsuit numbers are growing over the failure of a tank of frozen embryos and eggs
Some of the families are calling for regulatory change
Also Monday, attorney Gloria Allred threw her hat into the ring, announcing litigation on behalf of three Pittsburgh women who are all cancer survivors.
"I risked my life and delayed my chemotherapy treatments because having a family was so important to me," said 30-year-old Sarah Deer, who underwent fertility shots and harvested 29 viable eggs before undergoing chemo, radiation and a double mastectomy.
"I wanted a baby of my own," Deer said through tears. "I am a woman, wounded; robbed by cancer of my health and the body that I once knew and robbed by University Hospitals of my future."
Danelle Yerkey, who developed breast cancer at age 34 and underwent 16 rounds of chemotherapy, 25 rounds of radiation and a double mastectomy, said that "losing my fertility was not an option for me." Because of the chemo, she can no longer produce viable eggs.
When she heard the news about the tank failure, Yerkey said, she "felt as if I was dying, and I wanted to die. Everything has been stolen from me."
Breast cancer survivor Rachel Mehl lost 19 eggs in the tank failure. "While other kids dreamed of being lawyers or doctors, I dreamt of being a mother," the 40-year-old said, breaking into tears.
She said she spent most of 2016 undergoing surgery, chemotherapy and 30 rounds of radiation, only to have the cancer come back at Christmas and force her back into chemotherapy.
"As either a direct or indirect result of cancer, I have lost so, so much: my hair, my freedom, my memory," Mehl said. "And because of the carelessness of University Hospitals, I have now lost all hopes of having biological children."
Allred, who is well known for taking on high-profile celebrity clients, said she decided to become co-counsel for these women because of the nature of their loss.
"This is a very serious issue of reproductive rights," she said, "and these are among the most vulnerable of victims. It's horrible that it happened to anyone, but for it to be endured by cancer victims who have suffered so much."
When the tank failure was found on March 4, University Hospitals said the loss was expected to be only 2,000 specimens, or nearly half of the tank's contents. Many families held out hope that their eggs or embryos might have been saved.
That was not to be. University Hospitals delivered the news that all contents of the tank had been lost -- more than 4,000 eggs and embryos -- in a letter to the 950 families dated March 26.
"We are heartbroken to tell you that it's unlikely any are viable," the letter said, adding that the tank had been turned off by an unknown person.
"An alarm should have been sent and received. We don't know who turned off the remote alarm nor do we know how long it was off, but it appears to have been off for a period of time. We are still seeking those answers," the letter said.
In an emailed statement, the tank's manufacturer, Custom Biogenic Systems, denied allegations that the tank malfunctioned and made it clear that the alarm system was not its responsibility.
"Based upon our initial investigation, we have concluded that our equipment did not malfunction. The early stages of our investigation into this unfortunate incident indicate it was the result of human error," the statement said, adding that the company "did not design, manufacture, install, control, or monitor the remote alarm system that was reportedly 'off' during the time of this incident."
In its letter to the families, University Hospitals also said that the tank had been undergoing preventive maintenance, with advice from Custom Biogenic Systems, for several weeks before the temperature rose. The autofill mechanism had quit working, University Hospitals said, and employees were filling the tank by manually pouring in liquid nitrogen.
The manufacturer had been working with the hospital on how to re-enable the autofill feature, Custom Biogenic Systems said, but it claims that hospital staff had stopped its "recommended practice at least several days before the incident." When employees began filling the tank from the top, the manufacturer said, they made a serious error.
"The tank is not designed to be filled by liquid nitrogen being 'poured into the top of the tank,' as UH admits it was doing in its letter. This is an incorrect fill method and will cause liquid nitrogen to come into contact with the stored samples."
In addition, by pouring liquid nitrogen into the top, the manufacturer said, the employees bypassed the system that monitors the levels in the tank.
"Rather, the read-out measures the level of liquid nitrogen in the liquid nitrogen reservoir, which was bypassed by UH's use of the 'container filling' method," its statement said.
Working toward change
Many families have not yet filed lawsuits.
"This is a very careful, thoughtful, bright group of people," attorney Greg Kennedy, who is representing a number of families, said Monday. Perhaps because of the emotional nature of the loss, he said, many of them were taking their time to decide what to do. "They come back two and three times to ask questions."
In addition, he said, "we don't even know what judge we have yet. A variety of judges have these cases, and there is a motion to consolidate, which is something that needs to be cleared up."
Allred said the lawsuits she filed Monday allege negligence, gross negligence, recklessness, breach of contract, breach of implied warranty of fitness for a particular purpose and violation of the Magnuson-Moss Warranty Act, a federal statute that governs warranties on consumer products.
While seeking compensatory and punitive damages, all three of the women also said they want to funnel their pain and anger into advocacy for change.
"As the flagrant disregard for our dreams -- our children -- has surfaced, you'd better believe I am now angry," Mehl said. "All fertility clinics must be held to a higher standard, and safer practices must be enforced."
Allred said, "this industry is unregulated. I think the FDA should be regulating as medical devices, which they are not. Regulation is not a dirty word if it can ensure consumer safety.
"There are clinics all over this country," she added. "So this can certainly happen again."