A retired railway signalman has settled on confidential terms his High Court action over an allegedly defective artificial hip replacement which, it was claimed, “rotted the tissue”.
John Heeney (67), Upper Bohernamona Road, Thurles, Co Tipperary, sued the hip replacement manufacturers, Depuy International Ltd, and the HSE, in the first of a number of cases over the company’s hip products
Depuy, whose parent is health care multinational Johnson and Johnson, denied the product was faulty and denied liability.
The HSE denied negligence, denied it was aware of failure rates of the product and denied it failed to obtain appropriate consent for the replacement procedure. If Mr Heeney suffered damage, liability rested with Depuy, the HSE pleaded.
Following talks after the case opened on Wednesday, Aidan Doyle SC, for Mr Heeney, told Mr Justice Anthony Barr it had been settled and could be struck out with an order for costs. The details of the settlement were confidential, counsel said.
Earlier, Mr Doyle said the court would hear evidence, as a result of the defective nature of the Depuy product, debris from friction between its metal components had got into his bloodstream which in turn “rotted the tissue and into the bone”.
The court heard Mr Heeney was given a Depuy ASRXL replacement hip in July 2008 and two months later was suffering pain which got progressively worse.
Following attempts to deal with it through medication over the next two years, the artificial hip had to be removed in October 2010 in an emergency operation and replaced with a device from another manufacturer, Mr Doyle said.
In August 2010, Depuy issued an international recall for all ASRXL and ASR type products, of which 95,000 had been sold worldwide, counsel said. Around 3,500 Depuy products had been used in Ireland, a higher proportion than in many other countries, he said.
Depuy also wrote around the same time to the US FDA (Food and Drugs Administration) to say the ASRXL was defective and likely to cause health problems, counsel said.
There was “an outcry” about the product around the world, particularly in Australia where Depuy withdrew the product in November 2009, he said.
There are a number of manufacturers of these hip replacement products and the industry standard for failures was around four per cent. In England, the Depuy products recorded a 13 per cent rejection rate after five years and 44 per cent after seven years, counsel said. In Finland, it was recorded as 48 per cent after seven years.
Essentially what was wrong with the Depuy product was that the ball-and-socket joint of the hip, the acetabula cup replacement into which the replacement femoral head fits, was too shallow, counsel said.
There was also too little clearance between the two connecting parts to provide there would be natural lubrication when they moved.
This resulted in a “toggle effect”, due to a large head on the small neck of an artificial limb, which caused excessive friction and led to debris building up in the blood and tissues and consequent damage, Mr Doyle said.
There would also be evidence Depuy had gone against the received wisdom and created a groove or taper in the femoral head which was another feature culminating in friction and metal debris.
There would be evidence, if the operation was performed “spot on” there might be some chance of it working correctly, counsel said.
Mr Heeney had also sued for aggravated damages on the basis, when told about the problems, Depuy, whose designers insisted it was not defective, responded to doctors “you are not doing it right”, counsel said.
The court would have heard evidence, as a result of the damage caused by the allegedly defective product, Mr Heeney will have to have the second hip he received replaced again in his 70s.
This surgery will be significantly more complicated as the fear is the damage from the Depuy product had made the hip un-reconstructable.
The court also heard, as part of his action, Mr Heeney, whose wife is now his carer, claimed €16,000 in special damages for past and future care.