The family of an ex-Catholic priest is reportedly taking Novartis to court after he allegedly suffered brain injury from participating in a clinical trial assessing Jakavi (ruxolitinib).

Law firm Leigh Day says a legal claim against the Swiss drug giant will be filed at the High Court this month on behalf of Adrian Hailer, in which lawyers will argue that taking part in the trial left the 76 year-old severely disabled and unable to care for himself.

It is claimed that two months into the trial - which took place at London’s Hammersmith Hospital in 2012 and involved patients with the bone marrow disorder myelofibrosis - Hailer began suffering from confusion and memory loss and, by the end of the year, catastrophic brain damage from progressive multifocal leukoencephalopathy (PML), a serious viral brain infection that can develop in severely immuno-compromised patients.

According to Leigh Day, which also handled compensation cases resulting from the disaster at Northwick Park TGN1412 clinical trials in 2006, Novartis has “repeatedly refused to assist the family” of Hailer, apart from the offer of a goodwill payment bound by a “strict gagging clause”.

Novartis refuses to accept link, will contest case

The firm says Novartis “refuses to accept that there was a link between the trial drug and Mr Hailer’s injuries, and states ‘the ABPI Guidelines for Compensation do not apply’ and “there is no purpose in holding a mediation’,”. But Leigh Day partner Gene Matthews argues that “it seems clear from the expert evidence available that those injuries were caused by the trial drug”. 

A spokesperson for Novartis told PharmaTImes Digitial that under Association of the British Pharmaceutical Industry guidelines, sponsors of clinical trials agree to provide compensation to patients who have experienced an adverse event caused by participation in a drugs trial "provided causation has been established on the balance of probabilities", and that "based on the medical evidence received from independent medical experts Novartis is unable to establish on the balance of probabilities that Mr Hailer’s development of PML was caused by his participation in the ROBUST trial."

"As a result, Novartis intends to contest the legal case brought by Mr Hailer and we are unable to provide any further comments", the spokesperson said.