Dr Amel Alghrani offers expert advice in Washington DC

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Dr Amel Alghrani, speaking at PWCK Press Conference, 7 August 2019

Last month, Dr Amel Alghrani of the School of Law and Social Justice was invited Washington DC to provide an expert opinion on UK law for a lawsuit brought by an Ohio family against a fertility clinic. Dr Alghrani is an expert on reproductive law and has published extensively on the topic, including a recent monograph (Regulating Reproductive Technologies, New Horizons published with Cambridge University Press, 2018).

Victims of fertility scandals and IVF mix-ups in the United States continue to emerge and last month was no exception. In the suit filed by law firm Peiffer Wolf Carr & Kane on behalf of the Cartellones family, the Institute for Reproductive Health, The Christ Hospital, and Ovation Fertility are accused of misconduct in the birth of Rebecca Cartellone.

Joseph Cartellone and his wife Jennifer Cartellone had undergone successful fertility treatment to help them in their desire to have a biologically related child together. Almost 24 years later, their daughter bought DNA test kits for her parents and her grandmother as a Christmas gift in order to explore her father’s Italian heritage. To their shock and dismay when the results arrived, they discovered their 25-year-old daughter is not biologically related to her father. Revealing how his family made the discovery Joseph Cartellone told reporters:

“I never would have imagined the Christmas gift of a home DNA kit would unveil this kind of abuse of our trust”, further that “It’s hard to explain the shock and agony when you find out someone you love and care for — your own daughter — is not genetically related to you."

Image: Joseph Cartellone speaking at the PWCK Press Conference.


American law firm Peiffer Wolf Carr and Kane (PWCK), highlighted how this is merely the latest in a surge of fertility center-related scandals in the U.S. The firm  is currently working with hundreds of complainants of fertility treatment, including the Los Angeles couple who had their fertilized embryo implanted in a stranger in New York and then had to go to court after the child was born. Peiffer Wolf is also a major presence in litigation surrounding the large-scale embryo losses during the spring of 2018 at Pacific Fertility Center in San Francisco and University Hospitals Fertility Center in Cleveland. (1).  

Why are there so many fertility scandals emerging from the US?


The weak and ineffective regulation of the fertility industry has been cited as the cause of these fertility scandals in a report filed by PWCK on 7th August 2019. Partners of the firm, Adam Wolf and Joeseph Pieffer highlighted how nail salons are better regulated than fertility centres in the U.S. and claimed the Cartellone case underscored the “Wild West” nature of the unregulated fertility industry, with the U.S. lagging far behind most other nations.

As Professor Naomi Cahn of Georgetown University explained in a Forbes post about the case there are relatively few federal laws in the United States that are concerned with regulating assisted reproductive technology, and no single federal agency is charged with oversight of the fertility industry. It is left to States and voluntary guidelines. Professor Dov Fox of San Diego University highlights how "The political economy of assisted reproduction in the United States wards off the meaningful oversight or enforceable rules that operate to deter misconduct in other countries." (2). Following a steady emergence of IVF mix ups and fertility scandals, there are now calls for legal reform and the U.K. regulatory scheme has been lauded as a possible model of accountability that could be adopted in the U.S. (3).


What lessons can the US learn from the UK?


Alghrani argues that the U.S stands are a stark reminder of the effects of poor regulation of a controversial and lucrative fertility market. At the Press Conference, she explained that the UK was the first in the world to implement a comprehensive regulatory framework to govern this controversial branch of medicine. Regulation of the fertility industry and clinic in the UK is primarily via statute, namely the Human Fertilisation and Embryology Act 1990, later amended in 2008. The legislation sets out clear rules governing the handling of human embryos and the delivery of fertility treatment, and research. (4). Failure to comply with the legislation is a criminal offence which can be punished by a fine and/ or a custodial sentence.

Additionally, the legislation also provided for the creation of the world’s first national statutory body of its kind to oversee regulation, The Human Fertilisation and Embryology Authority (HFEA). Clinics are also legally mandated to follow the high standards in a Code of Practice which the Authority oversees compliance, via inspections. To prevent IVF mix ups, the Code mandates a number of strict identification and cross-checking and double witnessing procedures when handling human eggs, sperm or embryos.

Highlighting successes of the UK regulatory system, she noted that in the UK in 2017/18 out of over 80,000 IVF treatment cycles carried out, adverse incidents occurred in less than 1%. Where such incidents do arise, they must be reported within 12-24 hours and the Authority then investigates all adverse incidents and near misses and publishes its findings on its website. Such a rigorous process for monitoring adverse incidents promotes transparency, maximises opportunity for learning for the whole sector and ultimately prevents their recurrence.

Alghrani stated that the UK presents an established model that works and warns that unless the US takes heed of those pushing for reform of US regulation in this area, unfortunate cases such as that of the Cartellone family will continue to emerge.


Further information

Dr Amel Alghrani is a Reader in Law at the School of Law and Social Justice and is a founding director of The Health Law and Regulation Unit. She has published extensively on the subject of the regulation of assisted reproductive technologies, including the regulation of IVF, surrogacy, uterus transplantation, ectogenesis (arttifical wombs) and the procreative rights of trans individuals. 

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