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High Court legal action after 76 year old catastrophically injured during Novartis clinical trial

High Court fight after claims that clinical trial left ex-priest with catastrophic brain injury

Posted on 18 January 2015

A legal claim against the drug company Novartis will be filed this month at the High Court after a 76 year old former priest from Berkshire was left severely disabled and unable to care for himself following his participation in a clinical drug trial, which his lawyers argue has left him with a catastrophic brain injury.

Adrian Hailer from Slough participated in a clinical trial of medication being tested for use in a new condition at Hammersmith Hospital in the summer of 2012.

The trial, run by drugs giant Novartis, was aimed at investigating the drug ruxolitinib (known as Jakavi), which is licensed and marketed in Europe by Novartis, for patients who suffer from a condition known as myelofibrosis, a serious bone marrow disorder that disrupts the body's normal production of blood cells.

Around two months after starting the trial, Mr Hailer began suffering from confusion and memory loss. By the end of 2012, he had suffered catastrophic brain damage as a result of a condition known as progressive multifocal leukoencephalopathy (PML), a serious viral infection of the brain that normally arises in individuals with severely compromised immune systems.

Mr Hailer’s family approached Novartis asking them to assist with paying for his significant care and rehabilitation costs. However, the company has repeatedly refused to assist the family. An initial offer was made to make a payment as a “goodwill gesture” only, but only if Mr Hailer signed a strict gagging clause, preventing him from discussing his experiences with anyone.

The family refused and instead instructed lawyers from law firm Leigh Day, who worked on the Northwick Park TGN1412 clinical trials that went disastrously wrong in 2006.

According to his lawyers, Novartis are now refusing to pay anything at all, stating that there is no proven link between the medication and the injury Mr Hailer suffered. This is despite the fact that Novartis are signed up to the clinical trial compensation guidelines of the Association of British Pharmaceutical Industry (ABPI), the spirit of which encourages expeditious resolution of cases like Mr Hailer’s.

The company 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.”

According to the family, they have now used up most of their savings, and those of their extended family, trying to cover the cost of carers to assist Mr Hailer.

Mr Hailer now has no choice but to go to Court to attempt to force the company to abide by its promise to pay compensation for injuries arising as a result of their trial.

Gene Matthews, partner at Leigh Day, said:

“Novartis’ net sales were USD 57.9 billion in the last financial year. Mr Hailer and his family are seeking assistance with funding his care needs that are a result of the injuries he suffered during the clinical trial. It seems clear from the expert evidence available that those injuries were caused by the trial drug. It is quite staggering that a large pharmaceutical company, which tests its drugs on human volunteers, can simply argue that the ABPI Guidelines do not apply because, in their view, a link between the drug and the injury has not been proved.

"The whole point of the Guidelines is to assist in the fair resolution of situations like Mr Hailer’s. We will be arguing not only that Novartis are legally responsible for Mr Hailer’s care, but also that, being a member of the ABPI, they ought to comply with the spirit of its guidelines. Novartis has a duty of care towards patients who voluntarily participate in clinical trials of their drugs and their refusal to engage in meaningful negotiations with Mr Hailer is frankly astonishing.”