On March 4, 2018, two devastating cryo-storage failures resulted in the loss of thousands of eggs and embryos, along with the dreams of hundreds of hopeful parents. Those losses don’t even include the tens of thousands of dollars — or more — each patient had invested in their reproductive journey to that point. The incidents — one in Cleveland and one in San Francisco — bizarrely occurred on the same day, although, to be clear, there is no evidence that any anti-fertility terrorist saboteur was involved in the disasters.
Since March 4, the lawyers and lawsuits have come out, understandably and to no one’s surprise. (Some patients are even represented by Gloria Allred.) The clinics are being sued on numerous fronts. So far, we have seen at least one clinic, University Hospitals in Ohio, responding by denying liability, and pointing to the broad consent forms signed by patients that, by their strict terms, waive most legal claims.
In a time of crisis for many hopeful parents, we have also seen some positive, kind news. One couple with stored viable embryos came forward to donate their extra embryos to those who had lost theirs. That doesn’t replace the victims’ desire for a genetically related child. But at least it provides another potential path to parenthood, which would be a world of difference for those who don’t have the funds or the medical ability to go through the embryo formation process again.
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A Legislative Step In the Right Direction?
One Ohio state senator is working to prevent this from happening to other hopeful parents. Senator Joe Shiavoni (D) has announced efforts on a bill requiring clinics to put in place certain safeguards, and to face stiffer penalties if they fail to do so. While the details are still being worked out, it is expected that the bill will include a requirement that clinics have 24-hour monitoring of their storage facilities by an on-site person, and that relevant employees are trained in the handling of liquid nitrogen. Additionally, the bill might require that the clinic store multiple tissue samples from one patient in different storage tanks. That way, the risk of loss is distributed in several different locations. The bill might also include additional reporting requirements for facilities, such as when there is movement of tissue, as well as when incidents of damage or destruction occur.
I asked Rachel Loftspring, a Surrogacy Attorney with Essig & Evans LLP who practices in Ohio, what she thought of the potential for legislation. She told me “legislation must fastidiously incorporate the recommendations of relevant stakeholders and experts to create appropriate regulation, preventing future failures and the devastating consequences that result.” To that end, she added, “it is encouraging that Senator Schiavoni and his office are seeking input from the American Society of Reproductive Medicine, College of American Pathologists, RESOLVE, and University Hospitals.”
But Cleveland and San Francisco Were Just The Tip Of The Iceberg
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I also followed up with a friend of this column, San Diego Professor Dov Fox (of reproductive negligence fame), on his thoughts. Fox thought it a bill like the one being floated in Ohio would be an important first step. Such a bill “would make Ohio the first state to adopt any measure to protect against negligent accidents in assisted reproduction.” But Fox also stated that even the potential bill being discussed in Ohio “doesn’t go nearly far enough.” Fox noted that “its exclusive focus on cryostorage responds to the recent freezer malfunctions in Cleveland and San Francisco, but misses the vast majority of reproductive negligence.” For instance, separate and apart from freezer failures, Fox cites “a 2008 survey of nearly half of all U.S. fertility clinics found that more than one in five misdiagnosed, mislabeled, or mishandled embryos and samples.”
While reproductive negligence claims continue to leave courts with difficult choices, it’s good news that legislatures are tackling an issue that isn’t well-suited for judges to handle. Indeed, it’s a little strange that a bill requiring basic safeguards to avoid catastrophic malfunctions would be so novel, if it becomes law. As Fox stated, “it reveals just how conspicuously the U.S. stands out among developed countries like Canada, Israel, and most of Western Europe in failing to monitor or supervise sperm banks, egg vendors, or fertility clinics in any meaningful way.” In the United Kingdom, for example, a national agency requires that all facilities comply with an exacting standard of conduct that covers all details of the clinical and embryological practice associated with assisted reproductive technology.
The Down Side
Fox importantly noted that, of course, regulations come with unintended consequences. More red tape means higher legal exposure for clinics, and greater compliance costs associated with maintaining their businesses. It also means that new clinics must front higher sums before they can serve even their first customer. Naturally, much of these costs is passed on to patients, who already face mounting costs in growing their families. So while I’m happy to see that more families may be protected by safeguards to ensure that there’s never another accidental freezer failure, I agree with Fox in hoping that new regulations will be sensitive to the burdens they place on clinics and storage facilities.
Ellen Trachman is the Managing Attorney of Trachman Law Center, LLC, a Denver-based law firm specializing in assisted reproductive technology law, and co-host of the podcast I Want To Put A Baby In You. You can reach her at [email protected].