Heartbreak, anxiety, lawsuits: The egg-freezing disaster a year later

The agency regulates medical devices, but it does not regulate egg-freezer tanks at fertility centers because they aren’t labeled or marketed as medical devices by their manufacturers.The FDA regulates cryostorage tanks “only when these devices are specifically labeled for use in assisted reproduction technology (ART) procedures.”Neither of the tanks that failed last year is labeled or marketed by the manufacturers specifically for that use.An FDA spokesman told NBC News “FDA is not aware of any” that are.“There is almost no regulation or oversight of any kind that relates directly to the prevention of mistakes like these,” Dov Fox, Professor of Law and director of the Center for Health Law Policy and Bioethics at the University of San Diego, said.In 1992, then-U.S. Rep. Ron Wyden, D-Ore., introduced legislation that created some requirements for the emerging fertility industry.The Fertility Clinic Success Rate and Certification Act, which became a federal law that year, required the CDC to collect and report data on pregnancy success rates at fertility centers in the U.S.It also directed the CDC to develop a certification program that states would carry out. “Clinics may use products for off-label uses if they deem it appropriate for the practice of medicine.”NBC News searched the track record of the tanks and their manufacturers and discovered other incidents involving malfunctions of liquid nitrogen storage tanks that had similarly caused the loss of patients’ reproductive material.Media reports and regulatory alerts from other countries showed that Michigan-based Custom Biogenic Systems tanks, the same brand used at University Hospitals Fertility Center, had experienced previous malfunctions in the United Kingdom in 2003 and at the University of Florida’s Women's Health Center in Gainesville in 2005.The incident with the tank in the U.K. generated a “medical device alert” from its Medicines and Healthcare products Regulatory Agency, which described a problem involving an automatic filling mechanism by which the appropriate levels of liquid nitrogen are maintained.The alert warned that a sensor tube regulating the filling process can malfunction.But there was no warning or alert from the FDA.The mechanical failure of the Custom Biogenic Systems tank at the University of Florida fertility center occurred in October 2005 but had gone unreported to the general public for almost a year. An Associated Press article in September 2006 reported that the failure occurred “when a faulty sensor on a nitrogen-filled tank apparently failed to alert workers that the temperature had risen to a level that jeopardized the sperm's viability.”A University of Florida Health official said that after the incident, the facility had switched to a different liquid nitrogen storage technology and had added “multiple additional levels of safeguards to help protect specimens, including a 24/7 centrally monitored temperature system and the ability to move cells to auxiliary storage locations if there is an unacceptable variation in temperature.”The University of Florida Health official said it had also reported the occurrence to the FDA, “as required.”Still, there was no warning or alert from the FDA to the general public or to the fertility industry.It would be very helpful to have full knowledge of why things go wrong.Amy Sparks, president of the Society for Assisted Reproductive TechnologyAfter the incident at its fertility center near Cleveland last year, University Hospitals described in a letter to patients a problem with its Custom Biogenic Systems tank similar to those in the previous incidents. “Just know that there are a lot of us that are working very hard to improve things.”The incident at the Pacific Fertility Center in San Francisco involved a storage tank manufactured by Georgia-based Chart Industries Inc.The center sent patients who lost reproductive material an email more than a month later, telling them that the findings of an investigation indicated that the incident “likely involved a failure of the tank’s vacuum seal.”According to an amended complaint in a federal lawsuit filed on behalf of the patients, four days after the date of that email, April 23, 2018, “Chart recalled several of its cryopreservation tanks, citing ‘reports of a vacuum leak or failure that could compromise the product.’”NBC News searched for publicly available alerts about the Chart recall and found none from the FDA or other U.S. agencies, but there were several on government regulatory websites of other countries, including the actual recall document, posted on the Kingdom of Saudi Arabia’s Food and Drug Authority’s National Center for Medical Devices Reporting.Although the technical problem described to the Pacific Fertility Center’s patients and in the recall notice seem similar, Chart Industries CEO Jillian Evanko said that “the tank involved in the incident at the Pacific Fertility Center was not part of the recall.”Two months after the incident at the Pacific Fertility Center, a Chart Industries tank that had been part of that recall allegedly malfunctioned in Canada, according to a public filing by the company with the U.S. Securities and Exchange Commission.According to the filing, that alleged failure has led to “purported class action lawsuits filed in the Ontario Superior Court of Justice against the company and other defendants.”Chart is also one of the defendants in a class action lawsuit filed in the U.S. District Court for the Northern District of California, involving the incident at the Pacific Fertility Center.In a new public filing with SEC last month, Chart stated that the tank in that incident “has been out of our custody for the past six years” since “it was sold to the Pacific Fertility Center through an independent distributor.”Pacific Fertility Center is also a defendant in that lawsuit. Pacific Fertility Center did not respond to an NBC News email and phone call.In its online “Cryopreservation” catalog for the product line that includes the exact model of liquid nitrogen freezer storage tank involved in the incident at Pacific Fertility Center, MVE 808AF-GB, Chart Industries describes a primary intended use as the storage of semen and embryos, but for the agricultural breeding industry.“The MVE Stock Series,” the catalog description states, “provides the ultimate in security for the breeding industry and are primarily used to store semen and embryos.”With no immediate plans for increased oversight or regulation, American consumers — and some embryo laboratory directors who are not privy to internal industry reporting — have been left in the dark about previous adverse incidents and warnings about storage equipment and practices.Wendy and Rick Penniman filed one of at least 82 lawsuits against University Hospitals over the loss of their three embryos, which they had planned to use to create siblings for their two children.Wendy Penniman said the disclosures about equipment malfunctions and lab mismanagement made public by the incident, and the subsequent media reports and litigation, have changed her views from a year ago.After going through the initial stages of grief and sadness, she said, now she is angry.“After the incident, it was like, ‘Oh, it must have been an accident,’” she said. we have made significant enhancements at the Fertility Center, provided affected patients with ongoing, free fertility services tailored to their individual clinical needs, and we continue to reinforce a culture that encourages our physicians, nurses and staff to speak up when they see ways to further increase the quality of care we provide to patients.”Fertility center operators elsewhere have also begun to react to the damage to their reputations.“Lab directors started thinking, ‘Could this happen here?’” said Barb Collura, president of RESOLVE: The National Infertility Association, a national patient advocacy organization.Collura said she noticed clinics highlighting safety protocols and backup plans on their websites within days of the breakdowns in California and Ohio.In the months after last year’s incidents, members of the American Society for Reproductive Medicine worked with the accrediting organizations to update the checklists.The revised checklists added more specific questions probing how facilities using liquid nitrogen storage tanks measure and monitor levels to make sure they are correct, and whether they have backup systems, including empty-but-prepared “standby” tanks in case the primary tanks fail.Sparks, of the University of Iowa, said those actions were in direct response to the March 2018 incidents to include more specific questions about monitoring and measuring levels of liquid nitrogen in storage tanks.“Those are some of the things that the inspectors are now looking for,” she said.The College of American Pathologists released its revised checklists last August.Accredited labs had previously been required to have “an emergency procedure to provide backup units with adequate storage capacity” in case the ones in use fail.But the CAP’s revised checklists added new requirements, including that facilities visually inspect storage tanks, and monitor liquid nitrogen levels continuously, as well as maintain enough additional liquid nitrogen supplies onsite to fill a backup unit.The new checklists also add a requirement that laboratories show how the alarm system works and how they will respond to alarms.