08 Aug When Fertility Clinics Get it Wrong

Published by Forbes

By Naomi Cahn

Aug 8, 2019, 07:51am

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In 1994, Joseph and Jennifer Cartellone went to the Greater Cincinnati Institute for Reproductive Health and the Christ Hospital for help having a baby. They underwent in vitro fertilization, using Jennifer’s egg and Joseph’s sperm (or so they thought), and their daughter, Rebecca, was born later that year.

Last Christmas, Rebecca bought DNA test kits for her parents and her grandmother in order to explore their family tree. Two months later, they all learned that Rebecca was not the biological daughter of Joseph. They were shocked.

They have filed a lawsuit against their fertility clinic, and are represented by Peiffer Wolf Carr and Kane, the firm which is also pursuing litigation in other major fertility scandals.

Assisted reproductive technology (ART) has been an invaluable benefit, allowing millions of people throughout the world to create new families. In the United States, almost 2% of children are born each year with the help of ART, and more than 10 percent of women of childbearing age have sought infertility services. Yet as an increasing number of people use fertility services, the industry has outpaced regulation.

There are relatively few federal laws in the United States that are directly concerned with regulating assisted reproductive technology, and there is no single federal agency that is charged with oversight of the fertility industry.

First, laboratories dealing with human tissue, including eggs and sperm, are covered by the Clinical Laboratory Improvement Amendments Act of 1988. But the Act does not cover embryology labs, which means that it excludes egg retrieval and fertilization. Some states, like California, require that fertility labs be accredited, although Ohio – where the Cartellones live – does not.

Second, federal law provides that fertility clinics should report their pregnancy success rates to the Centers for Disease Control (CDC); the clinics that don’t comply continue operating.

Third, federal law directs the FDA to screen human donors and tissues for infectious disease and risks of communicable diseases. This doesn’t cover genetic testing, there is no verifying of much of the information, and the fertility industry convinced Congress to add an exception that prevents the FDA from “‘exercising supervision or control over the practice of medicine in assisted reproductive technology programs.'”

At the state level, laws are mostly limited to embryonic stem cell research, insurance coverage for infertility treatment, and surrogacy rules. A few states have moved to criminalize fertility fraud, although that doesn’t help with the damage caused to families like the Cartellones.

Self-regulatory organizations have established standards and guidelines, and reputable fertility clinics do follow them, but these are voluntary, and clearly don’t prevent abuse.

So why isn’t there more regulation? There are a variety of factors that explain this regulatory vacuum. First is the market-oriented outlook on reproduction that wants as little governmental control as possible lest it lead to a slippery slope or limit people’s reproductive rights. Plus, the politics of abortion loom over any efforts.

Second, the multibillion-dollar fertility industry claims the industry is highly regulated already and lobbies to prevent more. Third is the limited public support for regulating reproductive technology. There’s no wave of advocacy for further regulation – satisfied patients are satisfied customers.

Ultimately, as University of San Diego Law Prof Dov Fox summarizes the situation: “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.”

At a minimum, we can learn from the United Kingdom. That’s because, as Dr. Amel Alghrani, from the School of Law and Social Justice, University of Liverpool, explained: “The UK’s IVF practices are amongst the safest in the world because of its comprehensive regulatory framework in this area. The clear statutory framework, together with statutory body oversight, ensures fertility clinics and research centres comply with the law and agreed standards.”

Some of the more basic protections to implement are:

1. Strict licensure to operate fertility clinics and labs;

2. Tougher inspections of clinics and labs

3. Robust record-keeping standards, including of sperm and egg donation. Depending on who actually provided the sperm that resulted in her birth, Rebecca may have hundreds of siblings.

This is not a slippery slope, but a list of minimally necessary steps to impose sound quality control measure that will prevent future events that result in the types of damages that the Cartellone family is experiencing. Given the frequency of mishaps and liability, I hope the fertility industry joins in this effort. And, for those of us with IVF kids, this lawsuit may – or may not! – prompt us to pick up our own DNA kits.

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