Hip replacement implant manufacturer DePuy knew of design flaws years before recall, class action hears

Thursday, July 5, 2018

Joseph Pereira is part of the class action against medical giants DePuy and Johnson & Johnson. Photo: Steven SiewertWe were guinea pigs: victims

The medical corporation that manufactured thousands of faulty hip replacement implants was well aware that the poor design of the device was causing serious medical complications years before it took any action to recall them, a major class action has been told.

And when the company did finally act, it initially issued a voluntary recall which it blamed on “inventory reduction”.

The revelations emerged on Tuesday during the largest medical implant class action in Australia’s history, which is taking place in the Federal Court.

Nearly 2000 people are suing the medical giants DePuy and Johnson & Johnson over the manufacture and distribution of two ASR implants, which they say has left them with horrific health complications such as heavy metal poisoning and chronic pain.

On Tuesday, counsel for the patients produced a stream of detailed medical studies dating back to 2006 – of which DePuy was fully aware – that revealed critical design flaws.

The flaws left the implants susceptible, the studies found, to wear of the metal components and thus the release of cobalt and chromium into patient’s blood streams, and damage to the bones and soft tissue around the hip.

“During 2007, an engineer employed by DePuy or one of its related companies gave a presentation at a medical conference in Dallas … in which he reported that, two years after one of the implants had been implanted, approximately 30 per cent of women and 7.5 per cent  of men had markedly raised metal ion concentrations in their blood,” the statement of claim for the patients states.

At the same time, the number of implant recipients forced to have the devices removed began to soar, increasing from 5 per cent to 39 per cent for one device in the space of five years.

Counsel for the patients produced a series of internal DePuy emails showing that, rather than moving to protect patients, the company was devising strategies to defend it.

In one document entitled “Situation Assessment” DePuy executives considered whether surgeon error or poor patient selection could be blamed for the failures.

Various options were considered such as “phasing out” the device for all but a “few surgeons who were big cutters”.

In 2009, more than three years after DePuy became aware of the design flaws, it issued a “voluntary withdrawal”.

Rather than coming clean about the problems, the company said the implants were being withdrawn as part of a “streamlining of the hip portfolio” and “inventory reduction initiatives”.

“The simple fact that they were seeking a return of the products seems to give the lie to the claim that it was an inventory reduction initiative,” counsel for the patients, John Sheahan, QC, said.

In 2010 DePuy finally issued a global recall of the ASR implant, citing “higher than anticipated revision rates”.

Johnson & Johnson and DePuy’s position in the class action is that the ASR implants are no more susceptible to wear than any equivalent device.

The companies say the devices were designed with skill and care and checked for any foreseeable risk.

They are expected to argue that many patients had become unnecessarily excited and some had undergone  “unnecessary” revision surgeries.

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