News / 13 September 2012, 1:37pm / Laea Medley and Noelene Barbeau
Durban - An eManzimtoti woman is among 60 South Africans poised to launch an international lawsuit in London against a prosthetics company for dud hip replacements.
Ina Volschenk, 54, received a metal-on-metal hip replacement costing R86 000 at Westville Hospital in 2005, and is now one of the group about to sue the device’s manufacturer, American company DePuy.
An affiliate of medical devices, pharmaceutical and consumer packaged goods giant Johnson & Johnson, it recalled about 93 000 devices worldwide in August 2010 after a growing body of evidence that they were problematic.
Volschenk, a preschool teacher, said she was told the metal implants were the latest on the market, but not about the possible risks.
“I started walking again about six weeks after the surgery, but my leg was still very stiff, despite seeing a physiotherapist regularly. Eventually, I couldn’t walk at all,” she said.
“After a year, my whole body starting itching. I went from doctor to doctor thinking it was some kind of rash caused by a food allergy. My whole body was red and the only way to relieve the itching was to stand under a hot shower.”
It was only after the implants were recalled – four years after her surgery – that Volschenk and her doctor discovered that she was allergic to the nickel and titanium in them.
The implants also contained chrome and cobalt.
A recent study by the British Medical Journal revealed that cobalt and chromium ions can seep into the tissues of patients with metal hip implants, causing local reactions that destroy muscle and bone, leaving some patients with long-term disability.
The trouble apparently arose from a design fault in the metal cup in the pelvis, which, if not angled correctly, caused wear to the metal used to replace the top of the femur.
Volschenk then contacted a medical malpractice law firm for help.
“DePuy has since accepted responsibility for the recall and has indicated that it is not unwilling to pay for the removal of the hip prosthesis and subsequent revision hip surgery,” said Sunelle van Heerden, a professional consultant with the firm.
In February last year, DePuy paid R32 790 for Volschenk to have a second operation – replacing the metal implant with a ceramic one.
But Volschenk was not satisfied. “The surgery was successful, but because I had been walking with a stiff leg for four years, I now have back problems,” she said. “I have to take anti-inflammatory medication every day and I find it very difficult to walk.”
She said working with young children was also hard on her back, because it required a lot of bending down and picking them up.
“I have two young grandchildren who I want to live to see grow up, and I have to work,” she said.
“I want DePuy to pay for my back problems to be fixed, and for general pain and suffering which they caused.”
Since her first surgery, Volschenk said she had spent about R20 000 on physiotherapy.
“I am just not a happy person anymore, and I can’t let these people get away with this,” she said.
South African medical malpractice law firm, CP van Zyl Incorporated, has been working with local device recipients and is due to launch legal action in the UK, serving summonses next month.
Lawyer Stoffel van Zyl said they were forced to serve the summonses in Britain because DePuy’s South African attorneys apparently did not want to accept them.
The main DePuy distribution centre that delivered the devices to this country is also based in Britain.
Van Zyl is currently working on choosing at least eight test cases to submit to a British barrister, Hugh Preston, who is in turn expected to select one or two of them to include in his cases from New Zealand, Fiji and Holland.
Van Zyl said Volschenk’s case could be one of the eight submitted.
“Our first test cases will be summoned in October… the question about jurisdiction will be argued in December/January. Then the rest of our cases will follow,” he explained. Van Zyl said they did not inform their clients how much they would sue DePuy for because it was a “very grey area”.
“The amount differs from client to client, but the damages can range from about R300 000 to about R3 million,” he said.
There are currently consolidated lawsuits pending in the US, with a trial date set down for September, 2014. In August, American media reported that DePuy’s parent company, Johnson & Johnson, settled three consolidated cases that were set down for trial in December.
In March, Durban hip replacement specialist and president of the SA Arthroplasty Society, Rob McLennan-Smith, warned surgeons in the country to carry out checks on patients with suspected failed metal-on-metal hip implants, saying the illness caused by these implants could be very serious.
“Surgeons should do X-rays, blood tests, and physically examine the patients,” he said.
Van Zyl said that unlike other countries, South Africa had no register of the number of devices distributed.
It is estimated that 3 000 devices were delivered and about 25 percent were defective.
Maurice Rankin, DePuy’s UK spokesman, confirmed there was no South African register and one would have to check with each hospital for the number of devices sold.
He confirmed the company was willing to pay for revision surgery and that patients would be reimbursed for “out-of-pocket expenses” such as travelling costs and loss of earnings for the day.
On further lawsuits for damages, pain and suffering, as well as future loss of income, Rankin said this would be dealt with on a case by case basis. - Daily News