The death of a woman whose treatment with an unregistered drug was part of a Middlemore Hospital study will be analysed afresh by a coroner, 11 years after her death.
Deputy Solicitor-General Virginia Hardy has ordered the reopening of the cold-case of Ngamata Taio-Tekapo, who died aged 47 in 2004.
Auckland coroner Sarn Herdson decided not to hold an inquest and recorded the underlying cause of Mrs Taio-Tekapo's death as chronic kidney disease caused by gout and linked to liver damage.
But now, after a campaign by medicines importer Lance Gravatt, an organic chemist whose medical-student son Zac died after delays in treating him for meningococcal disease at Auckland City Hospital in 2009, Ms Hardy has ruled there are facts that were not available to Ms Herdson which warrant a fresh inquiry.
Mrs Taio-Tekapo's Middlemore doctor put her on the drug benzbromarone, which was withdrawn in Europe in 2003 because of liver toxicity. It is not registered in New Zealand. Doctors can legally prescribe unregistered drugs "off label", but carry greater responsibilities to explain their risks and benefits.
Ms Hardy said an inquiry was warranted by "new facts" including that evidence of the drug's liver toxicity "does not appear to have been before the coroner" and the possibility that benzbromarone "may have been a contributing cause of her death".
"If benzbromarone either did or did not contribute to Mrs Taio-Tekapo's death, it would be desirable to bring that to the attention of the medical community," Ms Hardy says in a report to chief coroner Judge Deborah Marshall.
Mrs Taio-Tekapo died from severe blood loss from a gout ulcer on her right foot.
The DHB declined to talk about the case while it is before a coroner, but Ms Hardy said it opposed reopening the case and argued no new facts existed.
It also denied Dr Gravatt's assertion that Mrs Taio-Tekapo and five other patients, whose benzbromarone treatment was described by Middlemore doctors in the New Zealand Medical Journal in 2005, were part of a clinical trial that would have required ethics committee approval.
Instead, the DHB told Crown Law, the drug was given as part of normal care and the journal article was based on an observational study, a retrospective audit of patients' clinical records.