Cleveland Medical Malpractice Lawyers Investigating the Damage to the Eggs & Embryos at University Hospital Fertility Clinic

Almost 1,000 Patients Devastated by Incident at UH Fertility Clinic

Welcoming a little boy or girl into the world is a major milestone for most families, and it’s emotionally devastating when that dream is ripped away. This month, 950 patients received the tragic and traumatic news that they may never have children due to a temperature malfunction at University Hospital’s (UH) fertility clinic.
If you’re searching for answers during this difficult time, the attorneys at Tittle & Perlmuter are familiar with the case and can help. Here is what we know so far:

4,000 Eggs & Embryos No Longer Viable After Temperature Fluctuation

Hundreds of patients trusted that their eggs and embryos would be safe in the fertility clinic at UH’s Ahuja Medical Center. However, between March 3 and 4, a rise in temperature in two of the facility’s liquid nitrogen freezers damaged as many as 4,000 eggs and embryos; all are ruined and no longer viable.
The eggs and embryos, some dating back to the 1980s, were intended for in vitro fertilization (IVF), which are procedures used to treat infertility. Each treatment assists in fertility, but at a high cost. Single rounds of IVF can cost up to $12,000 without insurance, and storage costs for eggs or embryos can come out to hundreds of dollars each year. On average, a cycle of IVF takes around two weeks. Not only does IVF hit the bank account hard, but it also exacts a physical and emotional toll on patients.
For many people, these eggs and embryos at UH were their last opportunity to have biological children. Factors such as age, medical complications, or cost prevents numerous affected individuals from doing IVF again. As an unfortunate result, many are now grieving the loss of their hope to one day have a child of their own.

What is IVF and how does the procedure work?

IVF is a type of assisted reproductive technology, which helps women conceive children. IVF is an option for individuals who are having infertility issues or have a genetic problem that prevents them from having children without assistance. Reasons for turning to IVF include the following medical conditions:

• Damage or blockage to the fallopian tube
• Ovulation disorders
• Endometriosis
• Uterine fibroids
• Premature ovarian failure
• Genetic disorders
• Impaired sperm production
• Preservation of eggs due to cancer

The way the procedure happens is that, if you’re using your own eggs, a woman with take synthetic hormones so multiple eggs are produced at once. After one or two weeks the eggs are then retrieved from the ovaries. Then, no matter if you use your own eggs or a donor’s eggs, they will be fertilized outside of the body. The sperm is either mixed with the egg, which is known as insemination, or the sperm is injected directly into the egg. Two to six days after this step, the embryo is transferred back into the patient’s uterus. After another 12 days to two weeks, the doctor will test the woman’s blood to determine if she’s pregnant.
According to the Society for Assisted Reproductive Technology, there’s been a large increase in the amount of women who opt in to freeze their eggs for one reason or another. In 2009, there were only 475 women reported as freezing their eggs; in 2015 the number rose to 8,000 women.

What is Known About the Fertility Clinic Temperature Fluctuation?

According to reports, the storage tank malfunction happened at the fertility clinic overnight between March 3 and 4. Staff left the clinic on the Saturday afternoon, and another staff member did not come back until Sunday morning. This means that there wasn’t anyone at the fertility clinic overnight. Inside the affected storage tanks were extra viable embryos, and eggs from donors or women delaying their pregnancy.
The tank did have off-site monitoring, as well as an audible alarm that went off to indicate the temperature rose to an unsafe level. However, since no one was there during the night the alarm wasn’t heard until staff came in the following morning. It was found that the temperature increased at the top of the storage tank, but the bottom section stayed at the appropriate conditions. Each vial stored in the tank contained two or three eggs or embryos. 
The eggs and embryos were then moved to a different storage tank, and is being monitored 24/7. However, as they’ve thawed, medical professionals have deemed the samples as non viable; crushing the hope for hundreds to have a baby.
At this moment, the hospital is laying blame to a series of human errors for this tragic event. A remote alarm system, that alerts lab technicians to any temperature changes, was shut off or deactivated during the night of March 3. Within the investigation of the incident, officials are still unsure of who shut off this alarm and why.

Updates in the Investigation

In a new report from the Ohio Department of Health, it says “that the hospital failed to maintain and inspect a liquid nitrogen storage container used for eggs and embryos, 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 also explained that the remote alarms set in place to alert staff of a malfunction were last tested in March or April 2017. However, UH had no documentation of those tests. Additionally, the hospital only had one off-site contact to receive alerts of malfunctions when the recommended number is three. Furthermore, 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. All of these are negligent actions attributed to the devastating loss that occurred in March.

What are the Procedures in Fertility Clinics to Prevent Malfunctions?

During IVF, when eggs or embryos are waiting to be fertilized or transferred back into the uterus, they are kept in storage tanks and frozen with liquid nitrogen. The temperature needs to be lower than -384.8 degrees Fahrenheit at all times to prevent damage.
As News5Cleveland reported on this developing story, what they uncovered in their research is concerning. The storage tanks where eggs and embryos are stored are not federally regulated, and there is no requirement to report incidents such as this. In addition, in Ohio reproductive labs don’t have to be accredited. UH does elect accreditation, meaning that they are required to uphold specific requirements, such as on-site inspections.
It’s also unsettling that standard procedures differ across fertility clinics throughout the nation. For example, a clinic in Arizona does not keep all of the eggs and embryos from each patient in one storage tank, as a precaution in case a tank malfunctions. Other procedures include having employees check on nitrogen levels each day, and equipping the tanks with sensors or alarms to alert staff if anything goes wrong.
As updates come in about the heartbreaking event, it’s come to light that the hospital had known for weeks prior to the egg and embryo destruction, that two of its cryofreezers were malfunctioning. Dr. James Liu, the chairman of UH’s Department of OB/GYN announced this information during the last week of March. One freezer was fixed, but the other containing 4,000 samples was not. The issue with both tanks involved the autofill feature, which affected the way the freezers would refill the container with liquid nitrogen. The autofill was stuck open.
In addition to the tank not working properly, the staff in the fertility clinic also used the wrong technique to fill the tanks with liquid nitrogen. Instead of using a hose to connect the freezers to the liquid nitrogen tanks as they had originally done, employees were refilling the tanks by pouring the liquid nitrogen through the top of the container. This process did not allow sensors to accurately monitor the temperature levels.
It’s also reported that the issues with the tank malfunctions could have started as long ago as August of 2017. The company who provides these freezers, Custom BioGenics Systems, said that UH ordered an extra tank from them. They had the tank available for the hospital in August, and delivered it on November 2, 2017.

How did University Hospital Respond to this Tragedy?

Patients impacted from this fertility tragedy received a letter in the mail from UH. The letter read:
“Over the weekend, an unexpected temperature fluctuation occurred at our tissue storage bank, where frozen eggs and embryos are stored. We are investigating all of the facts to better understand the cause of this issue.” It is still unknown whether a mechanical or human error caused the incident.
Even though UH reached out to patients, they did so in an impersonal way. Affected patients described the letters as generic, with stamped signatures and openings that said, “Dear community member.” Hundreds of individuals were impacted by the damage at the fertility clinic; each with specific hopes for their future that are no longer possible. However, they were addressed as one entity via an informal letter, and told to call in if they had questions. Many found out through social media or hearing the news on TV, and in some instances patients had to wait up to a week to hear back from their doctors for more information.
The hospital sent a second letter in the last week of March to the affected patients, again apologizing for their loss and bringing light to new information they have about the event and what caused the destructive temperature change.
At Tittle & Perlmuter, we will treat you as more than just a number. With each case we take on, we dedicate our time and focus our attention to every client we work with.

UH Correctional Plan

The hospital announced a correctional plan, which put them in compliance with Medicare requirements. This plan includes the purchase of four new liquid nitrogen tanks for the fertility clinic. In addition, a lab director oversee weekly audits to ensure requirements are upheld. The lab director will send the audits to a quality control council to further observe the compliance of UH’s measures.

What can I do if I my eggs or embryos were damaged at UH?

There are currently 22 individuals or couples filing lawsuits against UH. At Tittle & Perlmuter, we have been retained by several folks who have suffered losses. Instead of filing lawsuits blindly, we are in the process of gathering information and our investigation continues. Likely, we will have to file suit quickly to expedite our investigation.
As attorneys are hired and lawsuits are filed, different orders and regulations are happening that dictate how UH is allowed to communicate with patients who were victims of the fertility clinic incident. The best action affected individuals can take is to hire an attorney in order to stay informed of updates with regards to communications, lawsuits, and how to receive the rightful compensation for the loss you’ve suffered.

Communication Changes Between UH and Patients

Earlier this month, Judge Russo from the Cuyahoga Court of Common Pleas issued a temporary restraining ordering that University Hospitals, through their doctors and legal department, were not permitted to directly communicate with the patients who have suffered the loss of their egg and embryos.  In other words, this restraining order prevented UH from discussing settlements with the patients.
The reason for the restraining order was because the hospital and its doctors were speaking directly to patients offering free IVF treatments and reimbursement for storage fees in exchange for out-of-court settlements. However, a new order removed the restraining order and University Hospitals agreed to new terms for the time being.
According to cleveland.com these terms include:

• University Hospitals cannot discuss a settlement directly with plaintiffs
• UH can speak to attorneys of plaintiffs, or with the other 700 individuals who are not yet represented
• Hospital staff can contact patients for medical purposes, or discuss free IVF procedures or reimbursements for storage fees
• UH will release medical records with signed authorization
• The hospital will stop contacting plaintiff’s to discuss lawsuits

UH explained that they are offering patients who had stored eggs and embryos at their facility the opportunity to have IVF procedures tailored specifically to them. Additionally, the hospital will refund storage fees, and waive storage fees for up to seven years. If people opt into this, it will hurt their chance of receiving the amount of compensation they deserve for the damages they suffered. It will also strip them of their opportunity to participate in a class action.
Additionally, offering free IVF treatments and covering storage fees will not right the wrong for every victim. Many people aren’t physically able to do another round of IVF treatments due to their age or medical conditions. Or they don’t want to repeat the invasive, time-consuming, and emotionally draining process.
Due to changing regulations and terms between the hospital, attorneys, and victims, it is important to retain an attorney as soon as possible. If you or anyone you know feels that they should be compensated, contact our office. We can help, and let you know what your legal options are.

What if I signed a consent form? Can I still file a lawsuit?

Yes, you can still file a lawsuit. Everyone who goes through the IVF process signs a consent form, recognizing the risk associated with the procedure. However, the consent form does not indicate how failures are handled or how victims are compensated.
If you’re one of the patients affected by the incident at UH’s fertility clinic, we are sorry you have to go through this heartbreaking experience. What happened is unacceptable. Nothing can replace the birth of a baby girl or boy, teaching them about life, and watching them grow up and succeed. However, by hiring an attorney at Tittle & Perlmuter, we will be with you every step of the way as we help you get justice for your loss.
If you have questions, are looking for guidance, or simply want to tell someone about what happened our office is here for you. Don’t hesitate to give our office a call at 216-308-1522.