DePuy Hip Replacement Recall:
Malcomson Law are urging clients, and all patients affected, not to sign Patient Consent forms as the signing of such a from may be detrimental to patients’ interests. Previously, this Firm was at the forefront in indicating that the patient consent forms or access to medical records which DePuy sought to have signed by patients were inappropriate and detrimental to patient interests. This resulted in a situation where those patient consent forms were withdrawn and it was indicated that no patient would be required to produce their medical record detail to DePuy. It now transpires that a new effort to achieve advantage has occurred. Patient consent forms are being sent to patients under the auspices of both the HSE and the Independent Hospital Association of Ireland. For the avoidance of any doubt, no patient should sign these forms without legal advice. This Firm will not be advising clients to sign such forms as it is to patients’ own disadvantage to do so. We attach herewith a link to the patient consent form for release of explanted components together with the appendices attached to same.

Please note the following statement as made by the HSE and the Independent Hospital Association of Ireland:-
“In August 2010 DePuy issued a voluntary recall of the ASR hip system after reviewing new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post – market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interest of patients to voluntarily recall the ASR Hip System. This data showed a five year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System which was not in line with previously reported data”.

Comment.
This voluntary recall occurred in circumstances where the same products had been withdrawn in the Australian jurisdiction some two years previously. Also, it should be noted that an unfolding level of knowledge was occurring that was suggestive of problems with the ASR Hip System. This recall (termed a voluntary recall) occurred for a reason. The information available to this Firm is suggestive of a much higher rate of hip revision surgery in respect of the ASR Hip System which exceeds 50% within a five year time period. Further indications are as follows: “The Irish Medicines Board (IMB) is the regulatory body for medical devices in Ireland. In any device recall, the IMB requires the manufacturer to undertake an investigation into the reasons for the recall and provide a report specifying the root cause and corrective actions taken to prevent future occurrence. In connection with the voluntary recall of the ASR devices named above, DePuy International Limited will undertake an investigation of the ASR devices and provide the IMB with an investigation report. As part of this investigation, the IMB expects DePuy to be able to inspect any removed ASR devices (together with any tissue/ fluid samples) in order to aid the manufacturer in its investigation”.

Comment.
These excised implants are likely to be crucial proofs in any contemplated litigation action. Under no circumstances should control of same be delivered to the intended Defendant in contemplated Court proceedings, DePuy Orthopaedic Inc. Also, the integrity and safety of the excised implant must be guaranteed. The consent forms, proposed by the HSE that a patient would sign, as attached at appendix A to the release details, does not achieve that objective. The HSE/ Independent Hospital Association of Ireland indicate that: “The ASR devices (together with any soft tissue/ fluid samples) that are removed can only be released to DePuy with the patient’s consent.”

Comment.
This consent form therefore allows for the release of the ASR devices (together with any soft tissue/fluid samples) to DePuy. “It does not give consent for access to medical records by DePuy”. It is welcomed that DePuy no longer seek access to medical record detail. The release to DePuy is inappropriate in that what should occur is the excised implant should be retained by an independent third party to the order of the patient in circumstances where that third party guarantees the preservation of the integrity of the device for the benefit of the patient at DePuy’s expense. If DePuy accept responsibility or liability for the consequences associated with the defective implant device system, or the ASR Hip System, then the issue of maintenance of the excised implant would not occur and the device can be released to DePuy. It is noted that there has been no such admission of responsibility so delivered and, therefore, the preservation of this excised implant is of the utmost importance. The HSE/ Independent Hospital Association of Ireland indicate that: “If you provide your consent to your component being provided to DePuy the device can, upon your request, be returned to you or your Surgeon/Doctor in the future should you so wish”.

Comment.
Although the foregoing would seem to suggest that the patient has rights and entitlements for the return of the excised implant, when one looks at the actual document at appendix A, which the patient is required to sign, there is no such guarantee contained therein. Also, there are no consequences or penalties for failure to return the excised implant in its original state, nor is any responsibility apportioned to any party arising out of the failure to do so. In short, the patient release form is drafted to protect the HSE, DePuy and the Independent Hospital Association of Ireland (the Private Hospitals) as the drafting of such document occurred between those parties, i.e. it did not involve appropriate input from patients who are affected. The detail further specifies that: “If you do not consent to DePuy being provided with your ASR device and wish to retain the ASR device, regrettably, the HSE/Hospital is not in a position to decontaminate or store the ASR device on your behalf. Your explant will be vacuum sealed at the time of removal. You must advise the HSE/Hospital of suitable arrangements you have made for decontamination/storage within four weeks of the date of this letter. You will be liable for the costs of this decontamination and storage process. However, if you do not advise of suitable arrangements within the time specified, the explant will be disposed of”.

Comment.
The terminology utilised is for the purposes of encouraging all patients to sign the patient consent form authorising access to the excised implant for DePuy. The HSE/Independent Hospital Association of Ireland should have sought funding from DePuy to ensure the preservation of the excised implant by an independent entity under the control of the HSE for the benefit of the patient. The failure to provide independent storage/retention of the excised implant by the HSE has resulted in a situation where many patients may have lost the opportunity to have available to them an essential proof for investigation by independent experts. Whether such a process, as established under the auspices of the HSE, was done with intent to make it difficult for a patient to institute proceedings against DePuy, etc., is a matter of some conjecture.

Conclusion.
In short, the process in terms of addressing the retention, storage and preservation of excised DePuy hip implants is inappropriate to the extent that, like the original proposals for access to medical records on the part of DePuy, these proposals should also be reversed. It is urged that the HSE should reconsider the process that they are intending to implement for the purposes of protecting the patients who have become victims of a faulty medical device that now requires to be excised in circumstances where such persons have no responsibility for the events that have occurred and face significant medical/health consequences. The HSE has a duty at the very least to remain neutral and to ensure that all procedures that are implemented are impartial and practical, both from the perspective of DePuy and the patient. Unfortunately, the patient seems to be of secondary importance in terms of the formulation of documentation associated with this hip product recall.

If you have suffered harm or injury from a defective DePuy hip implant then please contact Malcomson Law on (01) 8744422.

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