by Mary Hough April-14-2016 in Healthcare Law
Background
In August 2010, DePuy International, manufacturers of prosthetic hip replacements, issued a voluntary international recall for all ASR Hip Resurfacing Systems and ASR XL Acetabular System M after studies showed high failure rates in the hip implants. At the time of the recall, DePuy said it had made the decision because of the number of patients who required revision surgery to remove the devices after they had failed. In revision surgery, the existing hip implant is removed and is replaced with a new hip implant.
Data recorded from an independent registry in the UK which monitors the performance and outcomes of implants noted that whilst the majority of patients with the hip implant did not require further surgery, the percentage of patients who needed additional surgery was not in accordance with data previously recorded in that registry.
The DePuy systems first became available in 2003 and it is reported that the products have been implanted in more than 93,000 patients internationally, with over 3,000 used in Ireland.
Prior to the recall, studies noted various side effects associated with the hip systems, including:
- Loosening – the implant does not stay attached
- Allergic reaction to metallic debris
- Pseudotumors (soft tissue mass that can form as a result of reactions to excess metallic
- debris)
- Dislocation – the two parts of the implant move against each other
Arising from the recall of the faulty hip replacements in 2010, DePuy International Limited is facing thousands of claims for damages.
Test case
In what is viewed as a test case brought by Ms R Murphy against the manufacturers, Ms Justice Faherty of the High Court ruled that, in order for a claim to be brought against the company, an Injuries Board authorisation is required. Ms Murphy alleged that her injuries arose from advice and surgical treatment and, as such her claim fell within the parameters of a “health service”, rendering an authorisation unnecessary. She claimed that she suffered severe pain and distress following hip implant surgery in 2005 which resulted in further hip surgery in May 2010, prior to the recall of ASR systems. Counsel for DePuy argued that the process of manufacture of the implants could not be considered as alleged medical negligence as they had not carried out a medical procedure or treatment on Ms Murphy.
Dealing with the preliminary issue regarding the necessity of an authorisation, Justice Faherty denied Ms Murphy’s claim and found that her case related to the manufacture, provision and supply of the defective implant system and did not arise from the provisions of a health care service.
Alternative dispute resolution
In December 2015, an alternative dispute resolution system was approved by the High Court. It is hoped that this will allow all casesagainst DePuy International to be resolved promptly, in turn freeing up the High Court personal injury list. It is further noted that cases currently listed for hearing will not be transferred to this system as only new cases are encouraged to proceed in this manner.
It is reported that this voluntary scheme will be made up of a panel of ten people, including retired Judges. The scheme is expected to have an evaluation team to review the individual medical reports and all documentation with a view to the giving of a decision within six weeks of receipt of the relevant documentation. The scheme will be headed by a chairperson to whom the manager of the scheme will report on all on-going cases at six monthly intervals, the status of each case at six month intervals.
The exact number of claims settled by DePuy International to date is unknown. However, it is noted that the company have yet to compensate individuals in the circumstances where there was no revision surgery.
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About the Author
Mary Hough
Mary is a partner and Head of the Healthcare team at Hayes solicitors. She specialises in professional indemnity defence litigation and in particular dealing with high value clinical negligence claims. Mary has extensive experience in civil litigation, acting for insurance companies, indemnifiers and plaintiffs.