February 19, 2024
Sodium Valproate (Epilim) Inquiry
In November 2020, the Minister for Health, Mr Stephen Donnelly, announced that an inquiry would take place into the historical licensing and use of the epilepsy drug Sodium Valproate (also...
Children’s Health Ireland (“CHI”) issued a report on 8th August 2023, outlining findings and recommendations from two formal reviews – both internal and external – which were conducted on Spina Bifida patients at Temple Street Children’s Hospital (“Temple Street”).
The report highlighted many serious issues and failings in respect of the quality of spinal surgeries and patient care in Temple Street. The families of affected patients and advocacy groups said that the report was not wholly transparent, and they have subsequently called for the commission of a detailed external review and government intervention.
Recently, the Health Service Executive (“HSE”) appointed a Liverpool-based orthopaedics expert, Mr Selvadurai Nayagam, to carry out an external review into post-operative complications and use of springs not medically approved in complex spinal surgeries at Temple Street.
Minister for Health, Mr Stephen Donnelly, also announced that the scope of this review will be widened to examine services provided by CHI within several hospitals in the hope of finding ways to reduce waiting list times. The families and advocacy groups will have an opportunity to directly speak with Mr Nayagam ahead of the external review to outline their concerns.
Oireachtas Committee on Health
On 28th September 2023, the executives from CHI appeared before the Oireachtas Committee on Health. The Committee heard that Temple Street only became aware of unlicensed, non-medical grade devices which were implanted into three children when Mr Paul Murphy, a People Before Profit TD, raised the issues during parliamentary questions. The Clinical Director of CHI, Mr Ike Okafor, told the Committee that he conducted investigations upon hearing the parliamentary questions and he found the use of these unlicensed devices.
Furthermore, the CEO of CHI, Ms. Eilísh Hardiman, faced scrutiny in relation to a letter which was allegedly sent from the consultant orthopaedic surgeon at the centre of the crisis, Mr Connor Green, to Ms. Hardiman in 2020. This letter discussed “experimental techniques” which were used on scoliosis patients and noted that non-medical grade devices were used during complex spinal surgeries. However, Ms. Hardiman stated that she has no record of receiving such letter. The letter will now form part of the external review and it is hoped that further clarity will be given on this matter.
The Taoiseach, Mr Leo Varadkar, and Mr Donnelly met with the families and advocacy groups on 29th September 2023 in an attempt to alleviate their concerns, particularly concerns relating to the external review. However, a representative of the Spina Bifida and Hydrocephalus Pediatric Advocacy Group, said that the families are still not “trusting of the process”, and all trust and confidence in the HSE, CHI and Mr Donnelly has been eroded.
During the meeting, the families and advocacy groups made proposals that they think will improve the quality of the review process. One example is that the families and advocacy groups have called for the removal of Mr Nayagam from the review process as he is not a spinal surgeon and therefore lacks expertise in the area. Furthermore, the families and advocacy groups believe that a taskforce should be established to improve spinal surgery waiting times and oversee spinal surgeries.
The Taoiseach has stated that the external review will be “independent and comprehensive”. However, the families and advocacy groups believe that the review in its current format does not meet the said criteria. In the weeks ahead, it is hoped that the HSE and the government’s approach will change and that they take into consideration the proposals made by the families and advocacy groups, as the families deserve full unambiguous clarity and disclosure on this matter.
Lavelle Partners are currently advising clients on this matter. For further advice or if you have been affected by these recent developments, please contact Avril Scally, Partner and Head of our award-winning Medical Negligence Team.
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