Karen Thorne

Karen Ann Thorne (hereinafter referred to as Deceased") died at Salford Royal Hospital, Eccles Old Road, Salford on the 13th June 2016. In 2005 the Deceased was diagnosed with Multiple Sclerosis and she had two relapses in 2010, which fulfilled the clinical criteria for rapidly evolving severe Multiple Sclerosis, and in December 2010 she attended Salford Royal delay "the

NHS Foundation Trust to discuss treatment options for her Multiple Sclerosis with the Neurology Consultant:
3. In April 2011, the treatment for rapidly evolving severe Multiple Sclerosis commenced with Natalizumab, which is drug given 28 days by infusion. The Deceased was advised that the drug carried small risk of a serious condition called Progressive Multifocal Leukoencephalopathy (hereinafter referred to as PML), which is a potentially life-threatening progressive viral disease that affects the brain, and the Deceased was monitored for the potential effects of PML annual Magnetic Resinance Scans (hereinafter referred to as MR Scans) of the brain with an annual Neurology clinic review. The MR Scans and the annual clinic reviews continued until May 2015 when the annual Scan was changed to a four monthly MR Scan following a re-assessment of the risk of PML, MR Scan was conducted on the 20t May 2015 and the Scan showed subtle changes consistent with PML but the subtle changes were not identified by the radiology report at the time The radiology report was not received for period of 50 days following the Scan on the 20t 2015 and during that time the Natalizumab infusions continued every 28
5. The next MR Scan was conducted on October 2015, which showed clear evidence of PML on the Scan but the report of the Scan did not identify PML and the Deceased continued to receive infusions of Natalizumab The report of the Scan was not received for 65 days following the Scan, during which time the infusion of Natalizumab continued: 6_ The Deceased deteriorated in December 2016 and a further MR Scan was conducted on 8th February 2016 which identified PML and which was reported as PML At that time the Natalizumab was stopped and on the 18th February 2016 Plasma Exchange treatment was commenced: The appropriate treatment for PML is to stop the Natalizumab infusion and commence Plasma Exchange treatment: The Deceased developed immune reconstitution inflammatory syndrome; which is a recognised complication of Plasma Exchange treatment; following the commencement of Plasma Exchange treatment and she subsequently died on the 13th June 2016 as a consequence of recognised complication of PML and a recognised complication of plasma exchange treatment:
8. It was accepted by the Salford Roval NHS Foundation Trust that the delay in the diagnosis of PML together with the in treatment for PML led to an adverse effect on the Deceased's response to treatment and the prognosis: every using May days. the days: every the delay

9. The Trust also accepted that the delay in reporting the Scans for a period of 50 days in 2015 and a of 65 days in October 2015, together with fact that PML was not reported, led to additional infusions of Natalizumab, which would have been stopped if Scan had been reported within a reasonable period and the reporting of the Scan had identified PML, bearing in mind the infusion was given every 28 days. It was accepted that the Scans should be reported before the next infusion of Natalizumab, which would avoid inappropriate additional infusions after the available diagnosis of PML and which would improve patient's response to Plasma Exchange treatment and the prognosis: