The Health Service Executive (HSE) and the Independent Hospital Association of Ireland have revised their DePuy Patient Consent Forms following complaints from patients and their legal advisers. The demand from DePuy´s parent company – Johnson and Johnson – that they receive patient´s medical notes with the return of a faulty DePuy ASR Hip Replacement System has been dropped, however it is still advised that patients should not sign the DePuy Patient Consent Forms without professional legal advice.
On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson and Johnson, issued a worldwide recall for two of its metal-on-metal hip implant devices – the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. These hip replacement systems were withdrawn due to a “higher than expected” failure rate, which meant that people who had them implanted were much more likely to experience pain or swelling in the hip, hip fractures, hip dislocations and metal poisoning from the microscopic metal debris created by the friction between the device´s joints.
Johnson and Johnson originally consented to cover the costs of monitoring patients´ health, and revision surgery where required, on the proviso that those patients signed DePuy Patient Consent Forms which permitted the return of the ASR hip replacement device to Johnson and Johnson – together with tissue and fluid samples plus a copy of the patient´s medical records. Although the company have now dropped the condition that medical records are disclosed, it is still recommended that patients DO NOT SIGN THE DePUY PATIENT CONSENT FORMS without first taking legal advice.
The signing of the DePuy Patient Consent Form potentially damages any future claim a patient may have for personal injury compensation as it still requires that the excised implant is returned to Johnson and Johnson, thus removing the opportunity for the implant to be examined by an independent expert. Furthermore, the latest DePuy Patient Consent Forms being circulated by the HSE and the Independent Hospital Association of Ireland have been drafted in such a way to protect the two parties involved against personal injury claims, with no consideration for the patient.
Both these organisations are still potentially negligent in sanctioning the use of DePuy ASR Hip Replacement Systems long after studies had shown that there was a problem with them. Fine Gael spokeswoman on older citizens, Catherine Byrne, asked the HSE at the time of the recall to clarify why the joint replacement part was not recalled sooner in light of reports coming out of America and Australia indicating that there was a problem with the devices – she is yet to receive an answer.
The HSE has also failed to introduce a comprehensive screening program for neurological injury due to metallosis and cobaltism and claim on their website that only 10-15 per cent of people implanted with the faulty DePuy ASR Hip Replacement Systems may need revision surgery, whereas research published by the British Orthopaedic Association indicates that as many as 49% of the DePuy ASR Hip Replacement Systems implanted in Ireland since 2003 could fail within the next six years.
The British Orthopaedic Association research also confirmed that revision surgery for the faulty DePuy Hip Replacement Systems can be more complicated than the initial implant surgery – with a higher risk of infection, longer rehabilitation period and the potential requirement for hip reconstruction surgery to repair the damage caused by the DePuy systems. Under the Liability for Defective Products Act 1991, victims of this defective product could potentially sue Johnson and Johnson for health issues they may experience for the rest of their lives. The DePuy Patients Consent Form harms a patient´s right to claim damages against the company, and this is why it is recommended that patients DO NOT SIGN THE DePUY PATIENT CONSENT FORMS without first taking legal advice.