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DEFECTIVE PRODUCTS

DePuy Hip Implant Problems – Pain, Metal Ion Release, Early Revision and Replacement

Suffered harm from a defective DePuy Hip Implant? You may have a Defective Product Claim based upon the principles of negligence and/or the Liability for Defective Products Act, 1991.

Artificial hip replacement procedures have become relatively common in Ireland in circumstances where it is now believed that in excess of 3,500 patients have received a DePuy Hip Implant since 2004. The numbers of persons who undergo hip implants has increased and it should be emphasised that the vast majority of patients are satisfied with the overall result, i.e. a durable, comfortable and properly moving hip joint. However, as more procedures are completed, many new products and technologies have entered the field of hip replacement where it now appears that not all of these technologies are adequate or appropriate. One relatively new type of hip replacement, known in the orthopaedic world as a 'metal-on-metal implant', has caused complications for doctors performing surgery and has presented a danger to patients. The materials used in the metal-on-metal hip implants (usually cobalt/chrome and molybdenum) were believed to be more durable than the older model ceramic counterparts. Although that may appear to be true, other serious consequences have materialised.

One of the largest manufacturers of metal-on-metal hip replacements, DePuy Orthopaedics, has been the subject of a written notice from the HSE where the HSE has informed all hospital orthopaedic units that they should remove from stock a hip replacement device manufactured by that company. This notification occurred on or about 27th August 2010. Also, it should be noted that, in the United States, DePuy Orthopaedics recalled its metal-on-metal Hip Replacement System, called the ASR™, effective from March 2010. It would appear that the reason for such a recall was either in relation to serious defects with the design of the ASR™ Hip Implant, the installation of said implants by Surgeons, or both. In addition, it is understood that certain research disclosed that these products, instead of resulting in longer lasting and durable new hip replacements, often sloughed off metal ions into the surrounding tissue, causing tissue damage, bone loss and, in some cases, immediate and intense pain.

Even before the DePuy ASR™ recall in the United States, the failure rate for metal-on-metal implants had been unusually high, resulting in expensive surgeries to isolate the cause and replace the defective part, not to mention the awful pain and suffering that occurs with having further damage to tissue and bone. Metal-on-metal hip replacements like the DePuy ASR™ were used in a significant proportion of hip replacements in Ireland, yet the failure rates of such metal-on-metal implants has now been estimated, in the circumstances of DePuy ASR™ System, as ranging between 12%-13%.

DePuy's ASR™ Hip Replacement System has come under particularly intense scrutiny arising from the considerable body of evolving evidence that DePuy Orthopaedics knew that the implants were defective and inappropriate for the market before their recall in March 2010. This perception is made on the basis of the number of adverse reaction notifications to the FDA in advance of that date. Also, there may be some doubt as to whether the ASR™ Hip Replacement was ever deemed to be appropriately safe. The large number of recent failures of metal-on-metal implants has raised many issues for hip replacement practitioners and indeed for their patients. The responsibility for the pain caused by defective ASR™ Implants can, in all likelihood, lie with DePuy or, alternatively, it may be contended by DePuy, as a Defendant to any contemplated proceedings, that such a responsibility for failure could lie instead with Doctors and Surgeons who implanted the metal-on-metal replacements without paying proper attention to the orientation of the device cups.

Also, studies have shown that the coverage angle range for the acetabular component of the DePuy ASR™ Implant is a critical factor in the likelihood of unsafe levels of toxins entering the body. Also, the cup position and design for hip resurfacing is also of critical importance for preventing the release of metal ions as the cup rotates. It now appears that an improper cup position could implicate the skill level of the Surgeon who installed the hip replacement component, yet poor design and poor choice of materials might indicate error on the part of the manufacturer, DePuy. Although studies have established the importance of the angle and position, it is still relatively unclear as to the optimal coverage angle, if any exists. In those circumstances, it appears that in most situations potential Plaintiffs will be seeking to apportion blame to DePuy rather than the treating Physician or Surgeon. Time will tell as to whether DePuy will seek to offload responsibility on to the Surgeon who undertook the hip replacement or on to the HSE.

Consequently, if you or your loved one has suffered the consequences associated with a defective implant from DePuy Orthopaedics, advice should be sought from a Solicitor for the purposes of ascertaining your legal position. It should be noted that any right to financial compensation or any form of legal redress is dependent upon proactively protecting your legal entitlements arising from the fact that strict limitation periods apply. In those circumstances, we advise that you act promptly for the purposes of protecting any legal rights that may exist and, furthermore, to ensure that any entitlement that may exist to fair and equitable compensation is preserved.

Raymond Bradley, Managing Partner of Malcomson Law on RTE News, click here to view.

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

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