Harsh new glare falls on fertility clinics’ booming business after major mishaps

ivf-300x271Equipment failures in two clinics in Cleveland and San Francisco not only resulted in the loss of thousands of frozen human embryos and eggs, the incidents also have raised new concerns about safeguards and regulation of booming and costly fertility programs.

Experts said the mishaps were uncommon, and they were hard pressed to explain how advanced refrigeration systems, with rigorous checks and back-ups, could have malfunctioned at large, respected facilities, leading to a likely boom of lawsuits by women and couples against the University Hospitals Ahuja Medical Center’s Fertility Center in Cleveland and the  Pacific Fertility Center in San Francisco.

The centers serve different types of women and couples, with the San Francisco facility dealing with younger, career-driven, and international patients eager to freeze eggs and embryos in hopes of starting families later in life. It has attracted public notice, partly because high-tech firms in the nearby Silicon Valley offer financial assistance to women employees who want to freeze their eggs. The Cleveland center, meantime, seeks to assist women and couples in the city’s western suburbs with infertility issues, especially through in vitro fertilization.

Medical services at both centers, as well as those of the 500 or so fertility centers  nationwide, can be expensive. Women and couples typically decide to freeze multiple eggs or embryos, in hopes of carefully storing them and successfully implanting them later to produce healthy children. Each egg or embryo stored and the procedures before and after can cost $14,000 to $18,000. Experts estimate that roughly 1 million eggs or embryos are now in a suspended state, supposedly protected and frozen in tanks of liquid nitrogen and awaiting revival and implantation.

Those kinds of numbers, combined with the complexity of infertility treatment and the rising popularity, particularly among career-oriented women and couples, of delaying pregnancy and instead freezing eggs, has caught investors’ attention, reported Stat, an online health information news site. Private equity firms are sinking money into fertility clinics, allowing them to expand, network, advertise, and market themselves. Investors see profit potential in this area of medicine as they see data on women’s choosing to bear children later and later in life, as well as the rise of and acceptance for same sex couples eager to parent.

The problems in Cleveland and San Francisco, however, rattled many present and potential fertility center patients. The New York Times, Washington Post, and the Cleveland Plain-Dealer have posted Q-and-A’s for the concerned, addressing, for example, the various regulators of the facilities, including the College of American Pathologists, the Joint Commission, the Centers for Medicare and Medicaid Services (CMS), and state health departments.

Fertility clinics are accredited by the pathologists’ college but operate under federal rules that are overseen by CMS (the Medicare/Medicaid overseer), the federal Food and Drug Administration, and to some extent, the Centers for Disease Control and Prevention. States vary in their oversight of the facilities.

In my practice, I see the significant harms that patients suffer while seeking medical services, including treatment for infertility. Even with advances in this field, patients — even when medically sound — can suffer disappointment and frustration when trying to conceive a child, and the costs of multiple rounds of IVF and other treatments can add up to big sums.

It’s crucial for patients to be fully informed about and to understand the tough math involved in this area, including statistics both on successful revival of frozen tissues and the chances of fertilization, implantation, and delivery of a healthy baby. It’s even more dispiriting and worrying now for aspiring parents now to think that mechanical failures could rob them of the joys of parenthood.

The San Francisco and Cleveland incidents may result not only in lots of cases for the courts to sort out but also better, more rigorous oversight of a burgeoning area of medical services, as well as even tougher research and questioning by women and couples eager for fertility services. That could be a good result from sad events.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information