Simultaneous refrigeration failures at two fertility clinics in San Francisco and suburban Cleveland have damaged or destroyed potentially thousands of frozen eggs and embryos in the biggest such loss on record in the U.S. The malfunctions have left parents-to-be heartbroken and baffled experts.
Here are some questions and answers about the two cases.
In Ohio, University Hospitals Cleveland Medical Center estimates 2,000 eggs and embryos may have been damaged or destroyed when an unexplained storage tank malfunction caused temperatures to rise on March 4. The medical center apologized.
On the same day in San Francisco, an embryologist at the Pacific Fertility Clinic noticed the liquid nitrogen level in one tank was very low during a routine check, clinic president Dr. Carl Herbert told ABC. He said the tank was immediately replenished and the embryos were later transferred to a new tank.
There's no known connection between the two episodes, said Dr. Kevin Doody, lab director at the Center for Assisted Reproduction in Texas and past president of the Society for Assisted Reproductive Technology. He said such breakdowns are extremely rare, and two at once is "beyond stunning."
"It's two black swan events happening in the same day. One of them causes the beehive to buzz. Two? We're all in shock," Doody said.
Officials have yet to say exactly what went wrong.
Barbara Collura, president of the patient advocacy group RESOLVE, called for "a very open, transparent investigation where the results are clear and public for all of us."
"We all need to know what has happened," she said.
CAN THE EMBRYOS BE USED?
Scientists can easily tell by looking through a microscope whether an egg or embryo survived a thaw, said David Ball, another past president of the Society for Assisted Reproductive Technology.
If doctors were to implant a damaged embryo, it might not lead to a pregnancy, but if it did, it would not raise the danger of birth defects in the child, Ball said.
WHO WILL INVESTIGATE?
The American Society for Reproductive Medicine said it plans to review the incidents with the clinics and their equipment suppliers this week. The group will then make recommendations to its members.
"In the meantime, infertility clinics around the country have been double- and triple-checking their own procedures and equipment to ensure everything is working properly," the group said in a statement.
Accrediting bodies such as the College of American Pathology may also conduct reviews, and the clinics themselves will investigate or hire outside experts to do so, Doody said.
But government review is unlikely because there is minimal federal oversight of fertility clinics. The politics surrounding abortion have made federal regulation too tricky, said George Annas, a medical ethicist at the Boston University School of Public Health.
"We've never been able to separate the embryo debate from the abortion debate in the United States," Annas said.
WHAT RECOURSE DO PATIENTS HAVE?
At least two lawsuits have been filed against the Cleveland-area hospital by couples who were trying to conceive.
The patients will have to prove negligence, Annas said. "Nobody's going to be charging these clinics with murder or manslaughter," he said.
Determining any damages owed to the patients could involve looking at the cost of repeating a fertility treatment, which can run up to $15,000, he said, "unless it's the last embryo you could make because one partner is dead."
"It's hard to think it's worth more than the cost of making more embryos, unless you believe these are babies,"
2 fertility clinics respond to egg, embryo storage failures
CLEVELAND (AP) — Two fertility clinics across the country from each other experienced equipment failures on the same day that may have damaged hundreds of frozen eggs and embryos, something that a fertility expert called a stunning coincidence and that is already producing lawsuits from crestfallen couples.
Lawyers for Amber and Elliott Ash, of the Cleveland suburb of Bay Village, and an unidentified Pennsylvania couple have sued University Hospitals after its fertility clinic in suburban Cleveland discovered a storage tank malfunction March 4 and said last week that as many as 2,000 frozen eggs and embryos may have been damaged.
The lawsuits come as a San Francisco fertility clinic said thousands of frozen eggs and embryos may have been damaged in a liquid nitrogen failure in a storage tank on the same day.
Lawyers for the couples who went to the Ohio clinic are seeking class action status, which would require approval from a judge. The Ashes said they stored two embryos at a University Hospitals fertility clinic in suburban Cleveland after Elliott's cancer diagnosis in 2003. They said they were told over the weekend that their embryos are no longer viable.
"It's heartbreaking, just heartbreaking," Amber Ash told WEWS-TV. "The medical community calls it tissue. I like to think of it as my children."
The couple has a 2-year-old son conceived through in-vitro fertilization and hoped to bring him a genetic sibling.
"With this lawsuit, we will get answers and stop this from happening again," said Mark DiCello, an attorney for the Ashes.
The Pennsylvania couple was beginning to set up a time last week for transferring a frozen embryo to the woman's womb when they later were told something went wrong, attorneys said. They had spent eight years trying to become parents and were devastated, attorney Lydia Floyd said.
University Hospitals officials said that that they are determined to help the patients who lost eggs and embryos, and that the lawsuit will not affect an independent review.
Dr. Carl Herbert, president of the Pacific Fertility Clinic in San Francisco, told ABC News in an interview released Monday that a senior embryologist noticed the nitrogen level in one tank was very low during a routine check of the tanks March 4.
That embryologist, Herbert said, "immediately rectified" the problem by refilling the tank. The embryos, he said, were later transferred to a new tank.
The clinic is sending letters to about 500 patients "that may have been involved in this tank," Herbert said. It has put in place more failsafe measures to prevent a repeat.
Dr. Kevin Doody, lab director at the Center for Assisted Reproduction in Texas and past president of the Society for Assisted Reproductive Technology, told The Associated Press that the nearly simultaneous storage failures are "beyond stunning" but appear to be "just a bad, bad, bad coincidence."
"It's two black swan events happening in the same day," he said. "One of them causes the beehive to buzz. Two? We're all in shock,"
Nobody knows so far of any connection between the two failures, he said.
The industry in the long run will end up being safer because there will be investigations and other facilities will examine their own backup measures and alarm systems, he said.
AP Medical Writer Carla K. Johnson in Seattle contributed to this report.
he said. "Then it's hard to put a monetary value on it because it's so high."