Two years ago today, on March 4, 2018, embryo storage disasters resulted in the catastrophic loss of thousands of human ova (eggs) and embryos. Bizarrely occurring on the same day — but thousands of miles away from each other — storage tanks in San Francisco, California, and Cleveland, Ohio, experienced failures, critically impairing the reproductive options for over a thousand patients. That’s because for many patients, the destroyed embryos were stored before age or serious medical conditions reduced their chance of traditional conception to essentially zero. The lost genetic material, in other words, was for many patients, their only hope of ever becoming a parent with a genetic connection to their hoped-for future children.
Understandably, numerous lawsuits resulted, as well as some movement to provide greater oversight and regulation of embryo storage facilities. The lawsuits continue. On the legislative front, many efforts have fizzled out over the past two years. However, New Jersey recently succeeded at becoming the first state to pass a law requiring the state to oversee and regulate facilities storing embryos. Is the law going to make a difference?
So What Does This New Law Do?
The new law was enacted on December 4, 2019, and requires that 14 months after the effective date — which means approximately early 2021 — any facility storing human embryos in New Jersey must be licensed to do so by the New Jersey Department of Health. In the meantime, an advisory panel is figuring out the actual substantive details. These details include the nitty gritty of what standards, exactly, a storage facility must comply with, and what hoops it has to jump through in order to hold and maintain the now-mandated license.
What Will The Regulations Say?
To learn more about what we can expect from the advisory panel, I spoke with Debra Guston, a New Jersey attorney who specializes in adoption and assisted reproductive technology law. Guston is also in a uniquely good position to tell us what we can expect from the advisory panel, since she is an appointed member of the newly formed panel! I’m glad to hear that they have qualified people on board!
Guston, along with fellow well-credentialed panel members, are already working to promulgate thoughtful rules for embryo storage that safeguard hopeful parents’ family building dreams. It is a public process, with draft regulations expected to be published this summer for public comment. Importantly, Guston explained that the panel was also being very cognizant and careful not to over-regulate the storage process. While the panel is prioritizing protecting embryos with standardized safeguards, it is also aiming not to significantly increase costs to patients, or cause storage of embryos to be moved out of state to avoid regulation. It’s a fair concern that whatever the cost of compliance will be, storage clinics may simply pass those along to hopeful parents, who are already paying substantial sums to grow their families.
To regulate without significantly increasing costs? That’s a fine line to walk! But if anyone can help make it happen, it’s Guston. After all, she was one of the driving forces behind reversing New Jersey surrogacy law, which outlawed the practice for 30 years before now specifically permitting and protecting surrogacy arrangements in the state. In short, Guston is deeply familiar with the issues surrounding assisted reproduction in the Garden State.
How Serious Is New Jersey About This? Very.
While the panel works on what the standards will be, it’s obvious that failing to meet those standards will have severe consequences. For instance, once the licensing requirement goes into effect, any “person who operates or assists in the operation of an embryo storage facility which does not have a license …, who offers, advertises, or provides any service not authorized by a valid license… shall be guilty of a crime of the third degree.” That sounds bad. So I looked it up. Apparently the potential penalties for a third degree crime in New Jersey include a term of incarceration ranging from 3 to 5 years, a fine of up to $15,000, and a felony conviction on your criminal record. So get those licenses, folks, and don’t go to jail!
Of course, the worst part about the 2018 mass loss of embryos was that those losses were, for the most part, entirely preventable. Both locations had experienced numerous false alarms prior to the incident. Then, when the real incidents started, no one was alerted, or able to recognize a real alarm from a false alarm. Given the utter devastation caused by the loss of human embryos, it’s quite understandable that state government would want to get involved and try to stop such preventable heartbreak from happening to anyone else. Frankly, it’s surprising that other states have not already put statutory safeguards in place. I suspect others will be following in New Jersey’s footsteps.
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 babies@abovethelaw.com.