Defective Hip Replacements – Implications for Doctors and Hospitals
The recall of DePuy metal on metal hip replacements (manufactured by Johnson & Johnson Medical and implanted in approximately 5,500 Australian patients) has been widely publicised. The devices have been found to fail at a much higher rate than normal, and also to have released concerning levels of cobalt and chromium into the tissues of patients.
The higher than anticipated rate of repeat surgery was first noted by the Australian Joint Replacement Registry (AJRR) in patients with the implant in 2006. This was communicated to the Therapeutic Goods Authority (TGA). Higher failure rates were confirmed by the AJRR in 2007, and again communicated to the TGA. The TGA established an expert advisory group, and after a series of further reviews recommended in December 2009 that the product be withdrawn.
Patients say that as well as requiring replacement of the implants, the devices have damaged their hip joints and compromised the success of revision surgery, so requiring multiple operations. Some patients believe they have suffered ill effects from cobalt and chromium released by the metal on metal joint.
Johnson and Johnson is now dealing with around 3,500 claims and has paid out more than $21 million. At least two class actions are on foot.
The failure of the devices has prompted a Senate Committee report into regulatory standards for the approval of medical devices in Australia. The Senate Committee was shocked by the ‘intolerable, and unacceptable’ experiences of patients provided with the hip replacements. It indicated that the TGA ‘could have done more’ and that Johnson & Johnson Medical ‘did not serve patients well’. The Senate Committee also noted that many consumers only became aware that their medical device had been withdrawn from the market through the media or at their annual review, and that this was ‘clearly unacceptable’.
Claims relating to the DePuy prosthesis may not be solely directed to the manufacturer. Doctors and hospitals could be exposed where they were (or should have been) aware of the issue with the implants and did not take reasonable steps to warn of or manage the risk.
The Committee made 18 recommendations aimed at improving the regulation and monitoring of medical devices, including;
- A mandatory requirement be imposed upon health practitioners to report problems with medical devices in certain circumstances;
- The Department of Health and Aging (the Department) urgently prepare a comprehensive communications strategy to inform medical practitioners, patients and the general public about the issues with the hip replacements; and
- The Department undertake further work to address the issue of inducements paid by medical device manufacturers and pharmaceutical companies to doctors and teaching hospitals.
The extent to which the recommendations of the Committee are adopted by the legislature remains to be seen. The DePuy hip replacement saga will likely see another notch added to the belt of Australia’s class action specialists. It may also result in further mandatory reporting requirements for doctors and hospitals and a legislative rather than voluntary requirement that doctors and hospitals disclose any inducements received from manufacturers of medical devices or pharmaceuticals.
Article by Andrew Drynan, Senior Associate