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 in an interview as the "end of a dream."
"I was so sad, it was so painful," Zhang said in an interview, 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 health-care 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 anaesthesia or sedation, college spokesman Shea 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 anaesthesia or sedation," Greenfield said.
In February 2017, the College submitted a proposal to the Ministry of Health that would allow them to assess any facility that performs in vitro fertilization, artificial insemination, or the cryopreservation of sperm and egg cells.
After nearly a year and a half of deliberation, the Ministry of Health responded to the College of Physicians with formal comments earlier this month, which the watchdog will implement before resubmitting their proposal, Greenfield said.
At the federal level, Health Canada has the power to inspect facilities that collect, store, test or preserve semen donations, but their focus is on reducing the risk of infectious disease being transmitted in cases where a woman receives semen donated by a stranger, said department spokeswoman Rebecca Purdy. And Ottawa does not have any regulatory requirements for inspecting donated eggs, she added.
The federal government passed legislation to regulate assisted reproduction in 2004, but Health Canada says it "wound down" the body that administered and enforced those rules in 2012, after a Supreme Court ruling reduced Ottawa‘s role in the assisted reproduction field.
The government is now working to draft regulations that revive certain parts of the old legislation and add new components, Purdy said.
For Zhang, any new regulations will likely come too late.
She said ReproMed offered to retrieve more eggs from her body for free. But the process — an invasive procedure that comes after more than a week of daily drug injections, blood tests and other exams — is not one she feels she is physically or emotionally able to repeat.
"It‘s very rough," Zhang said. "I really, really don‘t think I can handle it a second time."