Heartbreak and Liability : University Hospital’s Fertility Center Catastrophe
Many families know all too well the toll that infertility or other reproductive issues can take on a person’s mind, body and spirit. Since the 1980’s, families have been taking advantage of freezing eggs and embryos in order to preserve the option to have children or to undergo in vitro fertilization. Many women, such as those undergoing treatment for cancer or other illnesses that could affect fertility, have very few options. So, on the hope for a future family, these women and their families freeze their eggs and embryos; leaving some of the most precious parts of their lives with hospitals and fertility clinics.
According to the Washington Post, the number of embryos in cold storage has increased over the last several decades. In 2002, there were approximately 400,000 frozen embryos. In 2011, that figured increased to an estimated 600,000. Today, that number has been estimated to 1 million+. With 1 million+ eggs and embryos on ice, one would think that there would be safeguards in place to protect the future families depending on these frozen eggs and embryos for a brighter future. However, catastrophes occur when hospitals and fertility clinics play fast and loose with their equipment; catastrophes such as the one that occurred at the University Hospitals Ahuja Medical Center’s Reproductive and Fertility Center in Cleveland. Detailed below is the story of how a hospital’s mistake damaged more than 950 people’s lives and what liability the hospital may face because of it.
BACKGROUND AND HISTORY
On March 4th, 2018, the University Hospitals Ahuja Medical Center’s Reproductive Fertility Center in Cleveland had a system malfunction which affected more than 4,000 eggs and embryos. Those 4,000 eggs and embryos are believed to be non-viable as a result. The reason for the loss was reported as a temperature fluctuation due to sudden failure of the cryopreservation tank. At some point during the weekend of March 3rd and 4th, the temperature in a liquid nitrogen freezer at the University Hospital fertility center, used for frozen egg and embryo storage, started to rise. The storage tank has off-site monitoring and an alarm system designed to alert staff members of temperature changes. The alarm was going off the morning of March 4th when staff members arrived at the hospital. No one was in the facility overnight on March 3rd.
In the following days, the hospital sent letters to families letting them know of the tragic circumstances. Is has not yet been released the reason for the temperature rise as the tanks holding the eggs and embryos were plugged into the hospital’s emergency power supply. This emergency power supply was hooked up to a generator designed to switch on if the hospital lost power. Investigations have been conducted by multiple accreditation organizations including The College of American Pathology and The Joint Commissions. An additional investigation was conducted by the Ohio Department of Health.
A report was recently released from the Ohio Department of Health, which says “that the hospital failed to maintain and inspect a liquid nitrogen storage container used for eggs and embryos, they did not properly utilize alarms meant to alert staff that eggs and embryos in the storage tank were in danger, and used a “manual fill” technique with liquid nitrogen before the temperature rose.” The report goes on to say that the remote alarms set in place to alert staff of a malfunction were last tested in March/April 2017. However, a problem for University Hospital is that there are no documents that prove that those tests ever occurred. In addition, the monitoring logs for the storage containers holding the eggs and embryos lacked records for monitoring the amount of liquid nitrogen and the existence of vapors in the tanks.
SAFEGUARDS TO PREVENT MALFUNCTIONS
In order for eggs and embryos to be preserved for future implantation or use, the tank must be cooled with liquid nitrogen to -348.8 degrees Fahrenheit. Fluctuation in temperature causes damage to the eggs and embryos. The storage tanks where eggs and embryos are stored are not federally regulated, and there are no requirements to report incidents of tank failure or temperature fluctuation. Ohio reproductive labs don’t have to be accredited. However, University Hospital elects to accredit their facility with The College of American Pathology and The Joint Commission. Thus, they are required to uphold specific requirements, such as on-site inspections.
Another troubling concern is that fertility clinics such as University Hospital’s are not subject to standard procedures; procedures for these kinds of facilities differ across the nation. Some fertility clinics, such as one in Tucson Arizona, eggs and embryos for one patient are divided up and kept in different tanks. This is done so that in the event of one tank fails, there are still viable eggs and embryos that are safe in another tank. The FDA does oversee the registration of medical devices such as the tanks that hold the eggs and embryos. News sources have requested information from the FDA regarding University Hospital’s tanks but the FDA has stated that they will not disclose information related to the tanks.
University Hospital’s Fertility Clinic has been reported as knowing for weeks prior to the egg and embryo destruction, that two of its cryofreezers were malfunctioning. The Chairman of University Hospital’s Department of OB/GYN, Dr. James Liu, announced this information in late March. One of the two freezers were fixed but the other (the tank that lost all the samples on March 3-4) was not. The issues with the two tanks involved the autofill feature, which affected the way the freezers would refill the container with liquid nitrogen; the autofill was stuck open. The wrong technique was also employed when filling the tanks with liquid nitrogen. In all, the hospital was on notice of several issues but allowed the issues to persist.
After the loss of the eggs and embryos were found on the morning of March 4th, all patients who use the University Hospital’s facility were sent a letter from the hospital. The letter that was sent was very impersonal and generic. Not a thought was given to the hundreds of individuals who had their hopes crushed at the possibility of never being able to have their own children. Many found out about the loss of their eggs and embryos through social media or the televised news. Many waited weeks to hear back from their doctors with more information about whether their eggs or embryos were some of those destroyed. It was not until the end of March that the patients and families directly affected received a second letter that apologized for the loss and gave additional information about the events which caused the destruction.
University Hospital has since announced a correctional plan. This plan includes the purchase of four new liquid nitrogen tanks for the hospital’s fertility clinic, a lab director to oversee weekly audits, and a quality control council to further observe the compliance of University Hospital’s measures.
HOSPITAL’S RESTRAINING ORDER
The Cuyahoga Court of Common Pleas issued a temporary restraining order (TPO). This TPO forbids University Hospital through their doctors, representatives, or their legal department, from directly communicating with the patients who have lost their eggs and embryos. This TPO came about when it was brought to light that University Hospital and their employees were speaking directly to patients and offering free IVF treatments and reimbursement for storage fees in exchange for a settlement in lieu of filing a civil lawsuit. The TPO made clear the following rules:
- University Hospital cannot discuss a settlement directly with Plaintiffs
- University Hospital can speak to attorneys of the plaintiffs, or with the other 700 individuals who are not yet represented
- Hospital staff cannot contact patients to discuss free IVF procedures or reimbursements for storage fees
- University Hospital will release medical records with signed authorization
- The hospital will stop contacting plaintiffs to discuss lawsuits
OTHER TRAGIC AND SIMILAR SITUATIONS
Unfortunately, this is not an isolated incident. On the same day as the University Hospital incident, a San Francisco fertility clinic, Pacific Fertility Center, experienced a loss of thousands of eggs and embryos. Since Pacific released information that a storage freezer malfunction caused the loss of eggs and embryos, a class action suit has been filed by the patients affected. According to documents related to the lawsuit, “storage tank #4” lost liquid nitrogen for a period which resulted in some, if not all, of the eggs and embryos stored therein to be destroyed. Clearly, this type of tragedy affects hundreds of innocent families and causes both financial loss and emotional distress for all involved.
HAVE YOU OR A LOVED ONE LOST YOUR EGGS OR EMBRYOS IN A TRAGEDY LIKE UNIVERSITY HOSITAL’S?
If you or a loved one have been heartbroken by the loss of eggs or embryos that were stored by a fertility clinic, we have a team of tough, smart attorneys who can help. We can’t undo the pain of your loss, but we can help you get the compensation you deserve. To speak to one of our experienced attorneys at Dyer, Garofalo, Mann & Schultz L.P.A., contact us online or call us at 937-223-8888.
Written by: Rachel A. Lemaster