Fertility clinic suit highlights need for better regulation
TORONTO — A lawsuit filed by a Toronto woman against a fertility clinic that she claims was responsible for the loss of dozens of her eggs has drawn attention to a reproductive industry that doctors and medical regulators say is lacking in accountability and oversight.
Ella Zhang spent approximately $10,000 to have 65 eggs removed and stored at ReproMed clinic in west Toronto early this year, her statement of claim said. But the malfunction of a cryogenic storage tank destroyed the eggs in May, the suit said, leading to what Zhang described as the “end of a dream.”
“I was so sad, it was so painful,” Zhang said, through a Mandarin interpreter. “I thought everything would be secure, and I wouldn’t have to worry about anything.”
Zhang, a 39-year-old single mother with a seven-year-old daughter, is seeking $27.5 million in damages for alleged negligence, breach of contract and breach of statutory duties, according to the suit.
The suit, which also names ReproMed’s medical director and unidentified staff members along with the U.S. manufacturer and Canadian distributor of the cryogenic tank that malfunctioned, claims the clinic failed to “inspect, monitor or test” their storage tanks and failed to install proper alarm systems to alert staff of tank malfunctions, among other alleged transgressions.
“(ReproMed staff ) breached the duties owed to the ReproMed clients … failing to exercise the skill, knowledge and judgment of ordinary and prudent healthcare professionals working with irreplaceable biological material in a fertility clinic setting,” said Zhang’s statement of claim, which contains allegations that have not been proven in court.
ReproMed representatives declined to comment on the lawsuit. The two other companies named in the suit did not respond to interview requests.
Zhang and her lawyers say the suit highlights the need for better regulation of a fertility industry that critics have long said lacks the oversight and accountability that most other medical services benefit from.
“There is no federal oversight of fertility care,” said Dr. Heather Shapiro, a fertility specialist at Toronto’s Mount Sinai Hospital. “Some physicians practice in this field without formal training (and) standards are not consistent across the provinces.”
The Canadian Fertility & Andrology Society, which represents industry professionals, works to provide guidelines, said Shapiro, a former president of the society. But she noted the group does not have a mechanism to ensure those guidelines are universally followed.
Fertility services based in hospitals are subject to their hospital’s regular oversight policies and procedures, and some institutions develop specific guidelines for their fertility units, Shapiro said.
“In my experience these guidelines would be done in conjunction with the medical director of the fertility unit,” she said.
Out-of-hospital clinics, meanwhile, lack that level of accountability.
In 2015, Ontario’s Ministry of Health under then-premier Kathleen Wynne asked the province’s medical watchdog to “develop and implement a quality and inspections framework” that would cover fertility services in non-hospital settings.
Currently the College of Physicians and Surgeons of Ontario only has the power to inspect out-of-hospital facilities if they use specific forms of anesthesia or sedation, college spokesperson Shae Greenfield said.
“With respect to fertility clinics, we have the authority to inspect only the egg retrieval component of the IVF procedure, because this is the only part of the IVF process that requires anesthesia or sedation,” Greenfield said.