Saturday, November 26, 2011

Australian Senate Demands For Health Authorities To Act On Depuy

By: Katherine Russel

Johnson & Johnsons trouble with the DePuy Articular Surface Replacement (ASR) hip systems is not only raging in the United States but also in Australia wherein its Senate committee has demanded for the urgent action of its health authorities against the implant manufacturer. The Senate community affairs references committee described as intolerable and unacceptable the suffering that the hip implant has caused to hundreds of patients. Facing a number of lawsuits in connection to its implants high failure rate, DePuy is also being sued by its rival over hip implant design.

According to DePuy, 93,000 patients worldwide have received its ASR hip device. Of that number, 5,500 are Australians and many of them needed one or more revision surgeries. Patients fitted with the metal-on-metal hip implants also reported serious and systemic health problems extending beyond the initial complications caused by the device.

The Senate committee has described the issue as a ''ticking time bomb'' facing many patients. The Department of Health and Ageing have been told to prioritize alerting doctors, patients and the public about the issues associated with the DePuy devices as well as options for treatment and the reporting of adverse outcomes. The department was also urged by the committee to consider the best ways to monitor the levels of cobalt, chromium and other toxic metals which have been recorded in patients who received the metal-on-metal hip implants."

Independent Senator Nick Xenophon, who had called for the inquiry into the DePuy implants, said the issue highlighted major flaws in the way the Therapeutic Goods Administration (TGA) dealt with information detailing problems with the devices. The senator added that the TGA had not been receptive to concerns raised about the devices until December 2009, more than a year after the concerns had been raised. Patients had suffered from pain, multiple surgeries, extended hospital stays, financial loss and personal anguish, said committee chairwoman Greens Senator Rachel Siewert.

It had taken three years for the product to be recalled after evidence came out that the implants had a high failure rate back in 2006 as pointed out by orthopaedic expert Stephen Graves at a Senate committee hearing last September. Anthony Bishop, the Australian head of Johnson & Johnson, had expressed the companys regrets over the incident before the Senate committee last September. Johnson & Johnson reimbursed more than $21 million in claims to more than 3,500 patients in Australia who had registered with the company's claim processor.

According to Bishop, the company would not answer questions about its response to earlier advice of the product's failure and why it took so long to withdraw it due to legalities. The first country to withdraw the two DePuy hip implants is Australia back in December 2009. DePuy ASR lawsuit is not only rising in the United States but also in Australia after solicitors acting on behalf of people affected by the allegedly faulty hip implants filed an action against DePuy in the Federal Court last September seeking compensation for harm. Punitive Damages are also claimed by the claimants on the basis that DePuy, owned by the medical giant Johnson & Johnson, allowed the products to remain on the market despite sufficient evidence showing the devices were causing harm.

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