Clodagh Bradley KC, instructed by Moritz Schirmeister of Thomson Heath Jenkins & Associates, successfully defended the Assisted Reproduction and Gynaecology Centre (the ARGC) and its Medical Director, Mr Mohamed Taranissi, Senior Consultant in Obstetrics and Gynaecology, specialising in the provision of reproductive medicine at an 8-day clinical negligence preliminary issue trial on liability before HHJ Luke Ashby at Central London County Court.
The ARGC is one of the world’s leading IVF clinics and it has consistently held the UK’s highest success rates per IVF treatment cycle started since its inception in 1995, as evidenced by the HFEA’s published statistics. The majority of its patients have received unsuccessful treatment elsewhere prior to receiving treatment at the ARGC.
The claim related to fertility advice and treatment between February 2018 and April 2018 for a 43-year old patient who was treated with IVF and intravenous immunoglobulin (IVIg) and she had a stroke 10 days following treatment. Subsequent to her stroke, it was discovered that she had an undiagnosed patent foramen ovale (PFO) or hole in the heart, which of itself creates a risk of stroke.
The Claimant consulted the ARGC with a history of recurrent miscarriage. She had previously undergone 3 unsuccessful cycles of IVF and other immune therapy (intralipid) at another clinic. The Claimant alleged that she had not given informed consent to IVF and/or IVIg treatment because (i) the advice she had been given about her prospects of success was negligent, and (ii) she had not been warned about what she alleged to be an increased risk of thrombosis from IVIg, as distinct from the risk of thrombosis from IVF, nor had she been advised about the controversies surrounding the use of IVIg in fertility treatment.
In cross-examination the Claimant accepted that she knew about the risk of thrombosis from IVF and from pregnancy and accepted that risk due to the intended benefit of having a baby, knowing that Clexane and low dose aspirin was being given in part to mitigate that risk, and that she had received the same blood thinning medication in her previous cycles of IVF elsewhere. Furthermore, she agreed that she did in fact know that there were two schools of thought about the efficacy and safety of IVIg. Through its ‘traffic light system’, the HFEA doubted the efficacy and safety of immune therapies because it based its opinion solely on randomised controlled trials (which are scarce in the fertility sector), rather than a wider evidence base, and applied it to ‘most patients’, rather than specific patient groups, such as those with a history of recurrent miscarriage, like the Claimant. The Court found that there is an evidence base of both efficacy and safety of IVIg use in fertility treatment in the medical literature and in clinical experience, although there are alternative views, as there are in so many fields of medicine.
On 12 November 2025, the Court dismissed the Claimant’s claim, applying Bolam, Bolitho and Montgomery in finding that a responsible body of medical opinion would have offered IVIg treatment in April 2018, that the Claimant’s prospects of success were not as low as she contended and that, on factual causation, the Claimant would have consented to IVF and IVIg treatment in any event. Furthermore, there was no requirement to advise about any additional risk of thrombosis in relation to IVIg specifically (as opposed to IVF) as there were no reported cases of thrombosis arising out of IVIg therapy in the context of fertility treatment, where low doses are given and they involve different patient groups to the patients where there has been an increased incidence of thrombosis, namely older, male patients with comorbidities receiving higher and more frequent doses of IVIg therapy.
On medical causation, the haematology experts agreed that the Claimant’s PFO was the major risk factor for her stroke. The Court found that the Defendants’ expert, Dr Karen Breen, Consultant Haematologist, was pre-eminent in the subspecialist field of thrombosis and the Judge accepted her evidence that it could not be demonstrated on the balance of probabilities that the IVIg treatment had made any material contribution to her stroke.
