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
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
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aware that their medical device had been withdrawn from the market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
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.
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The Sportscraft refunds and returns policy limitations went beyond consumer's rights under the Australian Consumer Law.
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