Nearly 1000 patients were notified in March, 2018 that their frozen eggs and embryos at the University Hospitals Fertility Center in Ohio were catastrophically lost. The 4000 frozen eggs and embryos stored at the fertility clinic were destroyed as a result of human error according to the facility. How such a significant loss could have occurred is still being investigated by the facility, but this is not the first time that the manufacturer of the tanks containing the embryos has encountered equipment defects leading to devastating losses.

Fertility Clinic Acknowledges Alarm System Disengaged

Fertility clinics maintain embryos in freezers filled with liquid nitrogen. The system chills tissue to -196 Celsius until it is time for the embryos to be transferred to the patient. The fertility clinic admitted that the remote alarm system on the tank was turned off during the weekend of March 3. If the system had been functioning properly, it would have alerted employees to temperature fluctuations that required immediate action. During that time, the temperature rose and destroyed the viability of the eggs and embryos in the tank. The center has said that it does not have information about who shut off the tank or why it was tampered with during that weekend. At least 18 plaintiffs have already filed lawsuits against the clinic for negligence and breach of contract.

Defect in Custom Biogenic Systems’ Freezers May Play a Role

There are reports suggesting that the temperature fluctuation in the tank may be related to a more systematic technical defect. The storage tank at University Hospitals Fertility Center is manufactured by Custom BioGenic Systems (CBS). Other tanks manufactured by this company have experienced similar malfunctions in the past. In 2003, Andrew Southwood froze sperm after his cancer diagnosis, which was maintained in a storage facility outfitted with CBS freezers in the United Kingdom. Shortly thereafter, the freezer used to store the sperm had malfunctioned and the Southwoods were told that the sperm had been destroyed.

Regulatory authorities in the United Kingdom issued a warning after 21 similar incidents of malfunctioning freezers were reported. Freezers produced by CBS contained a serious deficiency – their automatic filing mechanisms did not operate properly. The warning was soon retracted after the company informed the regulatory agency that 95% of the devices had been fixed or returned with the remaining 5% to be repaired shortly. But despite announcing that the problem had been remedied, two years after the alert was first publicized, 60 male patients in Florida reported losing frozen sperm as a result of a defective tank also manufactured by CBS.

CBS denied that the auto-filling mechanism constituted a technical problem with the system that contributed to the loss of embryos at University Hospitals Fertility Center in Ohio. However, the clinic reported contacting CBS in the weeks before the incident to inform them that the auto-fill system was experiencing difficulties and needed maintenance. Staff at the clinic confirmed that CBS was aware of the problem. While CBS did not design or maintain the alarm system which was admittedly dismantled, questions remain about whether the company had prior knowledge of difficulties with the mechanism itself and what role this may have played in the destruction of the embryos.

Lawsuits Against the Fertility Clinic Have Been Filed

Meanwhile, lawsuits have been filed against the clinic claiming negligence related to the malfunctioning of the alarm system, the failure to maintain a back-up alarm system and irregularities in how liquid nitrogen was added to the tank to ensure the viability of the embryos.

There is almost no regulatory oversight for fertility clinics. Mistakes and negligent conduct that lead to grave losses to patients are not tracked or reported, making it difficult to know how common they are. The FDA does not oversee freezers used to store embryos and sperm for reproductive use since they are not regarded as medical devices. If you have used these resources in anticipation of having a child one day, you have the right to expect that your biological material is well maintained, safe and stored in properly functioning equipment.

Levy Konigsberg LLP is a nationally recognized law firm that litigates cases involving catastrophic injuries. Our firm has successfully brought cases against companies and individuals whose conduct or failure to act has led to all kinds of injuries and losses. We can help you get the compensation you deserve. If you or a member of your family has been a victim of negligence on the part of a fertility center or a manufacturer of devices used to store embryos, please contact our lawyers at (800) 315-3806 or submit an email inquiry.


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