Print this page

Letter Furnished to Consultant Orthopaedic Surgeons

Re:- All Components for the ASR™ Acetabular System and DePuy ASR™ Hip Resurfacing Platform from DePuy Orthopaedics Inc.

Dear X

As you may already be aware, we have been instructed in relation to certain hip replacement revision procedures, either undertaken or to be undertaken, arising out of the circumstances surrounding a defective product as set out above, namely a hip implant manufactured by DePuy.

Authorisation re. Medical Records / Original Hip Implant
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.

In all likelihood you will be undertaking such revision procedures in the coming months and years and we would urge that you would inform your patient of the inappropriateness associated with granting such unfettered access. It is likely that, as time progresses, methodology with DePuy will be agreed by Solicitors acting on behalf of Plaintiffs or potential Plaintiffs and DePuy for the purposes of ensuring that the evidence that would be required to advance Defective Product claims is not solely placed within the control of the intended Defendant, i.e. DePuy.

As you will undoubtedly appreciate, it is likely that any such litigation that will occur will be against DePuy, its parent company and associates arising from the consequence of a defective product i.e. such litigation will be seeking to impose liability upon a manufacturer/distributor to an almost strict liability extent under the Liability for Defective Products Act 1991. As a consequence of the nature of the claim, i.e. a defective product, it is unlikely that medical practitioners would be named in any proceedings associated with such a defective product unless a Defendant, i.e. the manufacturer, decided to do so for the purposes of apportioning responsibility.

Orthopaedic Expert Witnesses
As there are 3,500 potential Claimants arising out of the circumstances surrounding these defective hip products, it is likely that a significant proportion of such persons may contemplate the advancement of court proceedings. Although the UK statistics indicate that 12-13% of hip implants/replacements inserted, etc. are potentially defective, it is possible or probable that as time progresses and knowledge increases that the statistical detail will similarly increase. We are endeavouring to put together a panel of Consultant Orthopaedic Surgeons who would be willing to assist in terms of the advancement of such litigation proceedings. Obviously, it will be necessary for such an Orthopaedic Surgeon to be willing to be a court witness, to review medical record detail, assess the type of hip replacement inserted, indicate the difficulties associated with such a hip replacement and, furthermore, to deliver a prognosis in respect of the consequences associated with the hip revision undertaken. All of the foregoing would indicate that the treating physician, if willing to assist, would be a suitable Orthopaedic expert witness in the circumstances of a particular patient i.e. his/her patient. Yet, in many instances, our experience has been that Irish experts are reticent to become involved in litigation of this nature and in this instance, where it is clear that the allegation is that the Defendant is the manufacturer of a defective product, such a reticence should not apply to the same extent.

Perhaps you would be kind enough to indicate as to whether you would be in a position to assist in respect of your patients or, alternatively, review other patients who require hip revisions in circumstances where their own Consultant Orthopaedic Surgeons are not in a position to assist, i.e. by being willing to prepare orthopaedic reports, deliver evidence, etc.

It should be noted that we would envisage that the costs associated with time involved in respect of the preparation of medical reports, time expended in relation to court attendance, etc. would be discharged as part of the usual recompense process in relation to the advancement of these contemplated proceedings.

Conclusion
We must emphasise that, from the perspective of the patient and/or the potential Plaintiff, it is of the utmost importance that the original hip replacement is preserved and not returned to any third party, i.e. any potential Defendant in circumstances where the ability of the patient/potential Plaintiff to advance his/her action may be compromised. It should be noted that DePuy are seeking authorisations from patients to enable the return of the original hip replacement/implant to them prior to DePuy considering funding hip revision procedures. We attach herewith details of DePuy correspondence received which includes:-

a.Copy Healthcare Professional letter from Pamela L. Plouhar Ph.D VP, Worldwide Clinical Affairs, DePuy
b.Copy Patient Letter
c.Copy Urgent Field Safety Notice
d.Copy Information for Patients
e.Copy Patient Consent Form (for disclosure of records)
f.Copy Authorisation to use on disclosure information.

Under no circumstances should any hip replacement/implant be returned to DePuy in circumstances where such an authorisation has not been signed by a patient/ client. Furthermore, we believe that it is incumbent upon such patients to have access to independent legal advice for the purposes of appreciating the full extent and ramifications of signing such an authorisation as it is far too extensive in its remit. As you are now aware that it is not in patients' interest to allow unfettered control to DePuy we would hope that you would advise your patients of such an independent advice issue. We understand that DePuy have set up a process to discharge all medical costs associated with re-implantation which should not influence patients' entitlements to protect their general position from a legal perspective.

We appreciate that the insertion of these DePuy hips were undertaken in good faith by all Consultant Orthopaedic Surgeons involved and in reliance upon the belief that the hip implant was a quality product. We understand that the difficulties that have now materialised have caused significant personal strife, angst and indeed trauma, not only for the patients for but also for the treating physicians and support personnel involved. Consequently, it is in all parties' interest that a fair, appropriate and transparent process now occurs.

Perhaps you would be kind enough to revert and indicate as to whether you would be willing to assist in relation to this potential litigation in the manner set out above i.e. by delivering expert reports, being willing to deliver evidence etc. relating to and on behalf of your patient. If you are so willing, perhaps you would indicate as to whether you would be similarly willing to assist in terms of reviewing the patients of other Consultant Orthopaedic Surgeon if such an Orthopaedic Surgeon is not prepared to become involved in the litigation process concerned against DePuy etc.

We await hearing from you.

Yours sincerely

___________________
Raymond Bradley
Managing Partner
Malcomson Law

This news section contains stories of interest from publicly available news sources. Where we are representing the clients referred to in the news material we will say so. Where we do not represent individuals or bodies mentioned or quoted, the inclusion of the news story in our news section is not intended nor should it be taken to imply that we act for the individual or body concerned.