Private plasma collector Grifols has significantly revised its earlier reports concerning serious injuries and deaths among donors, now acknowledging a total of six incidents, including three fatalities in Winnipeg, since 2018. This marks a drastic reduction from the previously reported 25 cases. The company asserts that many of the earlier incidents did not qualify as “serious adverse reactions” under federal regulations, a claim that has been accepted by Health Canada.
Review of Reports
Following a comprehensive internal review, Grifols, headquartered in Barcelona, has recalibrated its records submitted to Health Canada. The firm clarified that the reported incidents over the years did not align with the defined criteria for serious adverse reactions as per Health Canada guidelines. These guidelines classify a serious adverse reaction as an unexpected response in a plasma donor that leads to significant medical consequences, including hospitalisation, disability, or death.
Grifols operates 17 plasma donation centres across six provinces in Canada, where donors are compensated for their contributions. The company temporarily halted its collection operations on August 14 amidst ongoing investigations by Health Canada regarding its facilities.
Background of Investigation
The scrutiny surrounding Grifols intensified after two donor fatalities in Winnipeg came to light, alongside troubling reports from Health Canada inspectors. Concerns were raised regarding staff responses to alarms on donation machines and the clearance of donors who presented potential disease risks. These factors have compounded worries about donor safety in plasma collection facilities.
Health Canada had initially reported 27 serious adverse reactions involving plasma donors since 2018, with 25 linked to Grifols or its predecessor companies. The regulator also noted that two incidents occurred at Hema-Québec, the province’s non-profit blood operator. Canadian Blood Services, by contrast, reported no serious adverse reactions during the same timeframe.
Details of Incidents
The reassessment by Grifols indicates that the correct number of serious incidents is six, which includes:
– One incident at Prometic’s Winnipeg clinic in 2018
– Another at the same clinic in 2021
– One at a Canadian Plasma Resources facility in Saskatoon in 2023
– Two at a facility on Taylor Avenue in Winnipeg (2023 and 2025)
– One at the Innovation Drive site in Winnipeg in 2026
A report from Health Canada has since revised the total number of serious incidents to nine, taking into account the updates from Grifols and Hema-Québec.
While the specifics of these reactions remain largely undisclosed, there have been legal actions arising from donor experiences, including a case where a Manitoba man alleges he suffered an acute kidney injury due to donation at the Taylor Avenue site. Grifols has defended its practices, asserting that donors are made aware of the risks involved.
Ongoing Concerns and Investigations
Health Canada previously confirmed that the incidents in Winnipeg in 2018, 2025, and 2026 resulted in donor fatalities. One of the deceased, 22-year-old university student Rodiyat Alabede, reportedly experienced multiple alarms from her donation machine before developing severe cardiac issues and later being pronounced dead in hospital. Despite the family’s concerns regarding the investigation into her death, Health Canada has stated it is not responsible for determining causality in such cases.
The incidents that have been reclassified as not serious occurred across various locations, including Moncton, Saskatoon, Calgary, Regina, Edmonton, and Saint John between 2018 and 2025.
Health Canada spokesperson Mark Johnson emphasised that the classification and reporting of these reactions rest with the blood collector, asserting that none of Grifols’s reports warranted additional compliance measures or investigations following their review.
Why it Matters
The revision of serious adverse reaction reports by Grifols raises significant questions about donor safety and regulatory oversight in Canada’s plasma collection industry. The acknowledgment of fewer incidents may alleviate some immediate concerns but also highlights the necessity for stringent monitoring and transparency in the sector. As Grifols navigates ongoing investigations, the implications for public trust in plasma donation practices remain critical, impacting not only donor safety but also the availability of vital medical resources derived from plasma.