Private plasma collection company Grifols has significantly amended its past reports concerning serious injuries and fatalities among donors, now acknowledging just six incidents, including three deaths in Winnipeg, since 2018. Previously, the company had reported 25 such occurrences, but following a review of its records, Grifols concluded that many did not qualify as “serious adverse reactions” according to federal guidelines. This change comes amid ongoing investigations by Health Canada into the company’s operations.
Revised Incident Numbers Spark Controversy
Health Canada has accepted Grifols’s revised figures, which were revealed after a comprehensive review of reports submitted to the agency. The company, based in Barcelona, operates 17 plasma donation centres across six provinces in Canada, compensating donors for their contributions. The recalibration of incident numbers has raised eyebrows, especially considering the recent tragic deaths of two donors in Winnipeg and heightened scrutiny from regulatory bodies.
The company’s operations were temporarily suspended as of August 14, following multiple investigations by Health Canada into its clinics. Reports have surfaced detailing concerns from inspectors, including failures by staff to respond to alarms on donation machines and the inappropriate clearance of donors with potential health risks.
Understanding Serious Adverse Reactions
Health Canada defines a “serious adverse reaction” as an unexpected occurrence in a plasma donor that results in severe consequences, such as hospitalisation, significant disability, life-threatening conditions, or death. The regulations stipulate that collectors must notify Health Canada within 72 hours of any serious reaction and within 24 hours of a death.
In June, Health Canada disclosed that it had recorded 27 serious adverse reactions involving plasma donors since 2018, with 25 attributed to Grifols and its predecessor companies, while two were linked to Hema-Québec, a non-profit blood operator. Notably, Canadian Blood Services reported no serious incidents during this timeframe.
Regulatory Scrutiny and Legal Action
Grifols’s predecessors, including Prometic Plasma Resources and Canadian Plasma Resources, had operated various sites across Canada before Grifols’s acquisition of the companies in 2022 and 2023. The revised count of serious incidents now stands at nine, following adjustments made by both Grifols and Hema-Québec.
A notable legal case has emerged, with a Manitoba man alleging an acute kidney injury following a donation at the Taylor Avenue facility in 2023. Grifols maintains that donors are informed of the associated risks, and the case is currently pending in court.
Among the fatalities, 22-year-old university student Rodiyat Alabede’s death in 2025 has drawn particular attention. Family documents indicate that alarms on her donation machine went off five times over a 45-minute period before she tragically developed serious cardiac issues. Despite the circumstances surrounding her death, Health Canada has stated that there is “no linkage” between her passing and the donation process, adding that they do not determine causes of death during investigations.
Ongoing Concerns and Future Implications
The incidents now excluded from the serious adverse reaction count occurred between 2018 and 2025 across various locations, including Moncton, Saskatoon, Calgary, Regina, Edmonton, and Saint John. Health Canada has clarified that the reclassification of reports does not imply any changes to the details of the incidents but rather reflects the responsibility of blood collectors for accurate reporting.
Mark Johnson, a spokesperson for Health Canada, emphasised that all reports, including those that have been reclassified, were reviewed and did not necessitate further compliance measures or investigations.
Why it Matters
The revision of Grifols’s incident reports sheds light on the complexities surrounding donor safety and regulatory oversight in plasma collection practices. As the company navigates ongoing investigations and public scrutiny, the implications of these findings could significantly impact donor trust and the future of plasma donation in Canada. Ensuring stringent safety protocols and transparent reporting is crucial in maintaining the integrity of the health system and safeguarding the well-being of individuals who so generously contribute to it.
