07 Aug MAJOR NEW FERTILITY CENTER LAWSUIT UNDERSCORES “WILD WEST” NATURE OF UNREGULATED INDUSTRY WITH U.S. LAGGING FAR BEHIND MOST OTHER NATIONS
Lawsuit Filed By Ohio Family That Learned of Fertility Clinic Abuses From Christmas Gift Home-DNA Kits; New “Issue Briefer” Shows U.S. Nail Salons Better Regulated Than Fertility Centers, Identifies UK As Possible Model for Accountability.
WASHINGTON, D.C. – August 7, 2019 – In a new lawsuit filed today, Cincinnati’s Institute for Reproductive Health, the associated The Christ Hospital, and Ovation Fertility are accused of misconduct in the birth of a Columbus, Ohio, area woman who learned from a home DNA kit purchased as a Christmas gift that the man she thought was her biological father is not, and instead, may have been a doctor at the Cincinnati hospital.
The complaint filed by Peiffer Wolf Carr and Kane, APLC (Peiffer Wolf), on behalf of the Cartellone family of Ohio, is the latest in a surge of fertility center-related scandals in the U.S. Peiffer Wolf is currently working with hundreds of fertility center clients, 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 also is 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.
The roots and possible solutions to the worsening situation at such facilities are addressed in the new Peiffer Wolf issue briefer, “The Fertility Center Regulation Crisis in the U.S.”:
U.S. fertility centers are almost entirely unregulated today, unlike the tighter oversight in such nations as Estonia, Abu Dhabi, Germany and the United Kingdom. In this nation, nail salons are subject to far tighter state and federal controls than U.S. fertility clinics.
For U.S. fertility centers, the result is a near “Wild West” situation where meaningful oversight is absent, error reporting is essentially voluntary, and tragic cases of lost, destroyed or otherwise improperly handled embryos are on the rise, including more than 5,000 embryos and eggs known to have been lost or destroyed in less than two years. As one expert notes, America’s hands-off approach to oversight of reproductive practices has “left a gaping hole for a booming, unregulated market fraught with fraud and abuse.” In 2016, a national ratings website found that 18-24 percent of fertility patients reported damaged or destroyed samples, among a host of other errors.
Where could the United States turn to for a model to regulate fertility clinics? In the United Kingdom, a national agency requires that all facilities comply with a standard of professional conduct that covers “all details of the clinical and embryological practice associated with assisted reproductive technology.” That agency is the Human Fertilization and Embryology Authority (HFEA), which has been in operation since 1990, conducting regular fertility center inspections, seeking corrective measures where needed, and publicizing all regulatory actions.
Joseph Peiffer, attorney and managing partner, Peiffer Wolf, said: “The case we are filing today illustrates the lack of regulation governing fertility clinics in the United States. It was only after purchasing Ancestry.com DNA kits for her family, that daughter Rebecca learned Joseph is not her biological father. This tragedy should never have happened. We will get justice for the Cartellones. But, only through further litigation and sensible regulation can such nonsense be stopped. We need accountability for big fertility.”
Joseph Cartellone, of Delaware, OH, said: “Never in my worst nightmare did I think that the Christmas gift of DNA testing for my family would unveil this kind of abuse of our trust by the very professionals from whom we sought help. This has been extremely difficult for my family. I want to do whatever it takes to make sure no one else has to go through what we did.”
Participating in the news event today, Naomi Cahn, professor at George Washington University Law School and author of the book “Test Tube Families: Why the Fertility Market Needs Legal Regulation,” said: “Few laws in the United States are directly concerned with assisted reproductive technology. As an increasing number of people use fertility services, the industry has outpaced regulation. There is clearly a need for additional governmental oversight.”
Also speaking at today’s news conference, Dr. Amel Alghrani, reader in law and former associate dean (Education) in the School of Law and Social Justice, University of Liverpool, United Kingdom, and author of “Regulating Assisted Reproductive Technologies: New Horizons,” said: “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, in order to provide high quality care and research. Safe and effective regulation is imperative in order to protect the procreative rights of all those who utilise assisted reproductive services.”
Adam Wolf, attorney and partner, Peiffer Wolf, said: “My law firm has represented hundreds of families and individuals who have had their hopes and dreams dashed by outrageous conduct of the U.S. fertility industry. We think of fertility clinics as highly professional organizations governed by strict rules and staffed by caring experts. But, the truth is some of them are simply business people making billions of dollars in profits. We need to look to the U.K. and come up with a way of policing this industry here in the U.S., since it clearly is not capable of keeping its own house in order.”
Other key Peiffer Wolf issue briefer findings are as follows:
The $2.1 billion fertility center industry in the United States is big business.
More than one out of 10 women end up seeking out fertility-related services from 480 U.S. clinics, resulting in 69,000 live births a year – nearly 2 percent of all children born annually.
In the absence of meaningful state and regulatory oversight of the fertility center world, it would be comforting to think that a system of industry self-regulation would work as a substitute. But what self-regulation exists today is weak and full of holes.
The Human Fertilization and Embryology Authority oversees nearly every aspect of 69,000 fertility procedures a year at 131 licensed clinics in the United Kingdom. The key elements of the work of the Authority are as follows: (1) clinics must apply for a license from the Authority to operate; (2) licenses are granted for up to four years at a time; (3) inspections are carried out periodically and can be done on a surprise basis; (4) inspections can result in recommended changes to clinic practices and even outright license revocation; (5) the Authority sets standards for clinics to ensure high quality care; (6) it provides guidance to clinics and research centers on how to meet all legal requirements. The HFEA’s actions are highly transparent, including the online publication of the outcomes of all clinic inspections. It also provides the public with information about IVF and other procedures.
ABOUT THE LAW FIRM
Peiffer Wolf Carr & Kane is a national law firm with offices in Los Angeles, San Francisco, New York, Cleveland, St. Louis, Austin, and New Orleans. Peiffer Wolf is nationally recognized for representing victims in which fertility clinics were accused of misconduct, including destroying or losing eggs and embryos. This is a highly technical area of law and science; individuals seeking legal representation in such matters would be well advised to look to a law firm that has successfully handled such cases in the past. www.LostEmbryos.com
EDITOR’S NOTE: A live, one-way streaming webcast of the event and more information is available at lostembryos.com/regulatory-crisis.
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