A number of Irish patients affected by the recent worldwide recall of faulty hip replacements are considering suing the manufacturer of the device, it was confirmed today.
Raymond Bradley from the Malcomson Law firm in Dublin said he had been "instructed on behalf of more than 12 people" at this stage in relation to problems they encountered as a result of having the ASR Hip System made by DePuy Orthopaedics fitted.
Late last month, when the recall was announced, the Irish Medicines Board said it had received reports of just 12 incidents involving the ASR Hip System since it was introduced in 2004.
Some 3,500 Irish patients who received the hip implant are to be contacted by their hospital in coming weeks. Based on UK data, which has revealed problems in about 12 per cent of devices, more than 400 Irish patients could require corrective procedures to remedy the problems experienced with the product.
Meanwhile DePuy Orthopaedics, which said it would cover the cost of corrective surgery in any patients affected, has informed doctors by letter that patients will have to consent to all their medical records being supplied to it, as well as the removed faulty implant, before it will fund the corrective surgery.
Mr Bradley, in a letter to all orthopaedic surgeons across the State, has said they should under no circumstances order patients to sign forms releasing these to DePuy as it could hinder them in any legal action they might wish to subsequently take.
"We note that DePuy have indicated that they require their patients to sign an authorisation for the purposes of having access both to their medical record detail and, more importantly, access to the actual original hip replacement that was inserted. We have advised our clients that it is inappropriate, to say the least, to sign this authorisation in circumstances where the effect will be that the original hip replacement will come under the control of DePuy and, furthermore, that unfettered and untrammelled access shall be facilitated to medical record detail over and above the normal constraints that apply in circumstances of a legal process or action," the letter said.
"We would urge that you would inform your patient of the inappropriateness associated with granting such unfettered access," it added.
DePuy has said it will use the information it has sought from patients to process claims efficiently and "to help DePuy to better understand the causes of the problems with the ASR Hip System".
The HSE is holding discussions with DePuy on how medical costs will be covered.