Tip of the Iceberg: Liability Associated with IVF Cryptopreservation
This blog post originally appeared in the DTLA Advocate Newsletter April 2022 Edition
Cryopreservation—storing frozen specimens for future use—is an essential tool in the field of assisted reproductive technology, of which in vitro fertilization (IVF) is the best known. The rapid technological improvement of cryopreservation has accompanied a booming societal interest in family planning. As individuals increasingly choose to cryopreserve oocytes, sperm, or fertilized embryos, the legal
consequences of an IVF facility’s failure in the cryopreservation process flags a largely unresolved legal question: Is such a failure an act of medical negligence, negligence, contract, or all (or none) of the above?
Under Delaware law, as in most states, the answer is unclear. The upshot for Delaware plaintiffs’ attorneys presents a gamble of sorts: whether to plead the case as a medical negligence case (with the added expert costs) or not.
A Brief History of IVF, Cryopreservation, and Regulation
The first birth from IVF occurred in 1978.i Today, IVF births account for 1-3% of all births every year in the U.S. and Europe. IVF therapy is expensive and frequently only partially (if at all) covered by insurance. One cycle of IVF may cost as much as $25,000, including medications.ii IVF frequently requires more than one cycle.
Cryopreservation is the process of cooling cells and tissue to subzero temperatures to cease all biologic activity and preserve them for future use.iii The first birth from a frozen embryo occurred in 1984. At the time, cryopreservation involved a “slow-freeze” technique. A programmable freezer slowly decreased the temperature of the container to dehydrate the specimen.
However, the development of the modern technique, vitrification, has rendered cryopreservation more reliable and increased the success rate of costly IVF therapy. Vitrification is a flash-freeze. It uses “high initial concentrations of cryoprotectant and ultra-rapid cooling to solidify the cell into a glass-like state without the formation of ice.”iv
Cryopreservation may be included in the costs of IVF therapy or be offered as a standalone service with a recurring storage fee.
The agencies that regulate fertility practices are the Joint Commission on Accreditation of Healthcare Organizations and the College of American Pathologists. The facility may also be affiliated with the Society of Assisted Reproductive Technology, an affiliate of the American Society for Reproductive Medicine, which performs audits of facilities and retains data on outcomes.
Delaware’s Medical Negligence Statute
According to 18 Del. C. § 6801(4), “Health care” is defined as “any act or treatment performed or furnished, or which should have been performed or furnished, by any health- care provider for, to or on behalf of a patient during the patient’s medical care, treatment or confinement.” “Health-care provider” is defined as “a person, corporation, facility or institution licensed by this State pursuant to Title 24 . . . to provide healthcare or professional services or any officers, employees or agents thereof acting within the scope of their employment.” § 6801(5).
In Delaware, an Affidavit of Merit is required to accompany a complaint alleging medical negligence unless the allegations involve three narrow exceptions. § 6853. However, where an action arises out of conduct at a “health-care provider,” but the conduct does not intuitively involve the provision of “health-care,” the test under Delaware law is whether the alleged conduct was a “garden variety tort,” such as a slip-and-fall (involving ordinary negligence) versus one involving medical judgment.v
Theories of Liability for a Cryopreservation Failure
Cryopreservation is a tool used during the IVF process. IVF is undoubtedly healthcare as defined under Delaware law. But errors peripheral to cryopreservation, such as an IVF facility’s administrative error that damages or destroys the stored specimen, seem to fall on the “garden variety tort” spectrum. Nationally, plaintiffs’ lawyers have tested a number of theories involving cryopreservation failures,
including: res ipsa loquitur; fraud; conversion; intentional/negligent infliction of emotional distress; bailment; breach of fiduciary duty; battery; breach of contract; negligent supervision; and wrongful death. A recent retrospective analysis published in Fertility and Sterility, a publication of the American Society for Reproductive Medicine, evaluated causes of action from 2009 to 2019 involving lost or damaged frozen embryos.vi Of the 133 total cases analyzed, 122 were filed in state court and 11 in federal court. Allegations of negligence and breach of contract led the way as the most common theories of liability asserted. Professional negligence, medical malpractice, and medical negligence were 16th, 17th, and 18th respectively on the list of 25 theories of liability (the final being libel).
As for potential experts in these cases, IVF and cryopreservation fall within the field of Reproductive Endocrinology and Infertility (REI). Experts in this field are trained in Obstetrics and Gynecology before specializing in REI. They may also be board-certified through the American Board of Obstetrics and Gynecology. Experts in healthcare administration, human factors, or biomedical engineering may also serve as experts in cases involving cryopreservation failures.
Under Delaware law, a medical negligence action requires upfront costs for experts to opine confidentially that a reasonable basis exists to believe that healthcare negligence occurred. § 6853(a)(1). Failure to comply with this requirement may lead to the dismissal of the case.
Delaware’s statutory definition of healthcare is broad and over inclusive for torts tangentially related to healthcare rendered at hospitals and practices. As such, a failure at an IVF facility that leads to the destruction of frozen specimens presents unresolved questions about how Delaware courts might view allegations of ordinary negligence in this unique healthcare setting. Until those issues are resolved, Delaware plaintiffs’ lawyers should consider pleading medical negligence in the alternative and obtain an Affidavit of Merit to prevent from later being frozen out on legal grounds.
Ashley M. Eskew & Emily S. Jungheim, A History of Developments to Improve In Vitro Fertilization, 114 MISSOURI MED. 156 (May/June 2017).
ii Amy Klein, “I.V.F. Is Expensive. Here’s How to Bring Down the Cost,” THE NEW YORK TIMES (Apr. 18, 2020), available at https://www.nytimes.com/article/ivf- treatment-costs-guide.html (last accessed Mar. 23, 2022).
iii American Society for Reproductive Medicine, Mature Oocyte Cryopreservation: A Guideline, 99 FERTIL. STERIL. REP. 37 (Jan. 2013).
v See Greenwald v. Caballero-Goehringer, 2014 WL 7008959 (Del. Super. Nov. 25, 2014) (summarizing Delaware case law).
vi Gerard Letterie & Dov Fox, Lawsuit Frequency and Claims Basis Over Lost, Damaged, and Destroyed Frozen Embryos Over a 10-Year Period, 1 FERTIL. STERIL. REP. 78 (Sept. 2020).