Woman sues fertility clinic, claims dozens of her eggs lost

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 andmedical regulators say is lacking in accountability and oversight.

Ella Zhang, a 39-year-old single mother with a seven-year-olddaughter, spent approximately $10,000 to have 65 eggs removedand stored at ReproMed clinic in west Toronto early this year, herstatement of claim said. But the malfunction of a cryogenic storagetank destroyed the eggs in May, the suit said, leading to what Zhangdescribed 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 besecure, and I wouldn't have to worry about anything."

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,claims the clinic failed to "inspect, monitor or test" their storage tanks and failed to install proper alarm systems to alertstaff of tank malfunctions, among other alleged transgressions.

"[ReproMed staff]breached the duties owed to the ReproMedclients failing to exercise the skill, knowledge and judgment ofordinary and prudent health care professionals working withirreplaceable biological material in a fertility clinic setting,"said Zhang's statement of claim, which contains allegations thathave not been proven in court.

The suit seeks$27.5 million in damages.

'No federal oversight'

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 betterregulation of a fertility industry that critics have long said lacksthe oversight and accountability that most other medical servicesbenefit from.

Standards are not consistent across the provinces.- Dr.Heather Shapiro,Mount Sinai Hospital

"There is no federal oversight of fertility care," said Dr.Heather Shapiro, a fertility specialist at Toronto's Mount Sinai Hospital. "Some physicians practise in this field without formaltraining, [and]standards are not consistent across the provinces."

The Canadian Fertility & Andrology Society, which representsindustry professionals, works to provide guidelines, said Shapiro, aformer president of the society. But she noted the group does nothave a mechanism to ensure those guidelines are universallyfollowed.

Fertility services based in hospitals are subject to theirhospital'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 conjunctionwith the medical director of the fertility unit," she said.

Out-of-hospital clinics, meanwhile, lack that level ofaccountability.

'It's very rough'

In 2015, Ontario's Ministry of Health under then-premier KathleenWynne asked the province's medical watchdog to "develop andimplement a quality and inspections framework" that would coverfertility services in non-hospital settings.

Currently the College of Physicians and Surgeons of Ontario onlyhas the power to inspect out-of-hospital facilities if they usespecific forms of anesthesia or sedation, college spokesperson SheaGreenfield said.

"With respect to fertility clinics, we have the authority toinspect only the egg retrieval component of the IVF procedure, because this is the only part of the IVF process that requiresanesthesia or sedation," Greenfield said.

In February 2017, the college submitted a proposal to the province's Ministry of Health that would allow it to assess any facility thatperforms in vitro fertilization, artificial inseminationor thecryopreservation of sperm and egg cells.

After nearly a year and a half of deliberation, the Ministry ofHealth responded to the college with formal comments earlier this month, which the regulatory body will implement beforeresubmitting its proposal, Greenfield said.

At the federal level, Health Canada has the power to inspectfacilities that collect, store, test or preserve semen donations,but their focus is on reducing the risk of infectious disease beingtransmitted in cases where a woman receives semen donated by astranger, said department spokesperson Rebecca Purdy.

Ottawa doesnot have any regulatory requirements for inspecting donated eggs,she added.

The federal government passed legislation to regulate assistedreproduction in 2004, but Health Canada says it "wound down" thebody that administered and enforced those rules in 2012, after aSupreme Court ruling reduced Ottawa's role in the assistedreproduction field.

The government is now working to draft regulations that revivecertain parts of the old legislation and add new components, Purdysaid.

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 morethan 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 Ican handle it a second time."