A Toronto company that was paid to store potentially life-saving stem cells from the children of roughly 3,000 clients across Canada removed the samples from storage before providing Health Canada access to its lab during a surprise inspection last week, according to the federal department.
In a strongly worded public statement issued Monday, Health Canada stated it wanted to “set the record straight” about “false” claims made on the Cord Blood Bank of Canada’s (CBBC) website by owner Bernartka Ellison.
Ellison — who uses they/them pronouns and previously went by another name — updated the company’s website last Thursday with a letter to clients stating that Health Canada gave them “no other option” but to remove all the cord blood samples from storage on Aug. 4 and as a result, the samples are being disposed of “in accordance with all applicable rules and regulations.”
Health Canada denies that it gave any indication to CBBC that it should remove the cord blood from storage or to stop maintaining the samples.
The Health Canada inspection — and removal and disposal of all of CBBC clients’ cord blood samples — occurred just over a week after CBC News reported on a lawsuit in which Ellison claims that all the samples stored by the business were destroyed nearly three years ago.
Clients have previously said they were never told their children’s samples had been destroyed, and some parents were charged annual storage fees the year after the samples were allegedly destroyed.
That news, along with the latest developments from Ellison and Health Canada, have left clients like Teresa Sniezek infuriated, and feeling “cheated” out of a chance to help their children, should they need the stem cells in their cord blood for treatment.
“I feel taken advantage of,” said Sniezek. “That one chance that you get has been taken away from me … without even notification.”
The Grande Prairie, Alta., mom paid to store her twin daughters’ cord blood with CBBC in 2011.
Sniezek has been trying to get answers from CBBC ever since she was overcharged for annual storage in 2017. That same year, she was one of the first clients CBC News spoke with about the Toronto company when it came to light that CBBC had failed a Health Canada inspection in 2015 and never notified clients.
Alberta client still looking for accountability
Despite learning the samples are now gone, Sniezek still wants answers from Ellison.
“I want to know if I was paying for something that was actually there,” she said. “I want to know that [Ellison] will be held accountable for [their] actions if things were not done properly.”
In an email, Ellison told CBC News they provided a detailed disposal plan for the samples to Health Canada “on or around” Aug. 4, the day of the inspection, which would have allowed for all the company’s clients “to be heard in advance of their samples’ disposal.”
But Ellison says by not offering clients the “courtesy” of delaying the inspection, Health Canada denied clients the opportunity to be heard.
That argument is based on Ellison’s claim that the Aug. 4 site visit would have resulted in Health Canada ordering the company to dispose of the samples as medical waste.
“We feel as [if] Health Canada is oppressing the clients of Cord Blood Bank of Canada,” said Ellison. “We respectfully ask that Health Canada retract and correct their false and misleading and defamatory statements.”
Ellison has not answered questions from CBC News about why clients weren’t informed the samples were destroyed soon after the business owner alleges that happened, nearly three years ago in October 2018.
Health Canada’s assessment is ongoing
In its statement, Health Canada said its inspectors conducted an unannounced site visit on Aug. 4 to verify CBBC’s compliance with the Food and Drugs Act, “including the storage conditions of the cord blood units.”
The federal department also said it never indicated that the company’s clients should not be afforded a hearing regarding the cord blood units.
“Health Canada’s assessment and verification of compliance is ongoing,” said the statement.
In emails concerning previous CBC News coverage last month, Ellison stated they “are in the process of gathering information for Cord Blood Bank of Canada clients who are in good standing to join in the certification of our class-action lawsuit” against those the company alleges destroyed the samples.
Alleged destruction of samples relates to police investigation
Ellison’s claim that all of the samples were destroyed in 2018 relates to a client’s efforts to transfer their child’s cord blood.
Toronto police executed a search warrant at the Cord Blood Bank of Canada’s lab in the city’s east end in October 2018 to obtain an Ontario couple’s samples as part of an extortion investigation against Ellison, according to a copy of the information to obtain (ITO) used to justify the search warrant.
In April, Ellison sued the Toronto Police Service, the Ontario couple, University Health Network (UHN) and other individuals for a combined $3.5 million in relation to the police investigation and the execution of the warrants.
No statements of defence have yet been filed in the case, which is still before the courts.
In a statement of claim, Ellison alleges that while executing the search warrant, UHN employees and police removed the Ontario couple’s samples and “rummaged through the storage unit at the lab, removing hundreds of samples from storage temperatures of approximately –150 degrees and exposing them to room temperature, which is known to cause degradation of cord blood.”
Ellison took that claim a step further this June, in the second of two defamation lawsuits Ellison has filed against the CBC.
“All of the samples at [Ellison’s] business were destroyed by two employees of the University Health Network under the direction of Toronto Police Services,” Ellison alleges in the statement of claim.
A UHN spokesperson told CBC News in an email it has no record of the individuals named in the lawsuit being employed at UHN and it’s in the process of responding to the claims made against it.
Toronto police confirmed that it has not laid any charges against Ellison, but couldn’t comment further because of a public complaint made to the Office of the Independent Police Review Director (OIPRD) in connection to the investigation.