Hip-makers sold faulty units a year after finding flaws

Patients given faulty hip replacements may have received a boost to their case for compensation following the revelation that the manufacturers continued to sell the defective devices a year after discovering their flaws.

In Ireland, 3,282 people were fitted with the faulty hip implants made by the DePuy company which is part of the international Johnson and Johnson conglomerate. Several hundred have already been told they need surgery to replace the implants while many others need regular tests to check if their implants are deteriorating.

While the hospitals and DePuy are taking care of medical costs for affected patients, a growing number are considering suing the company for pain, distress and inconvenience.

Solicitor Peter McDonnell who is dealing with almost 150 patients said yesterday their case for a class action against DePuy and/or Johnson and Johnson was strengthening all the time.

The New York Times published an email sent from one executive at the conglomerate to three others in Aug 2009 in which she informed them that the Food and Drug Administration, the US equivalent of the Irish Medicines Board, had refused approval for use of the implants in the US because records showed a high failure rate with them.

Regardless of that knowledge, the implants continued to be marketed and sold in Europe for another year before they were withdrawn amid growing concerns by medical practictioners using them and the failure rate.

DePuy has disputed the significance of the email, saying it was part of the process of reviewing the implant over time which eventually led to the decision to withdraw it.

However, Mr McDonnell said it undermined any defence the company would seek to make in legal proceedings taken against it here or in other jurisdictions. Preparations for class actions are under way in the US, the UK, and Australia.

“Medical negligence cases are always difficult and every case has to be won on its merits but the point about this case is that a hip op is a massive surgery that leaves a huge scar, usually shortens the bone and leaves people with a limp and requires a lengthy period of rehabilitation afterwards. To have to go through that twice because of a faulty implant is an ordeal nobody should have had to face.”

Mr McDonnell is so confident of success that he has already begun paying for the collection and specialist storage of removed implants in laboratory conditions in the UK.

The HSE is advising patients to allow hospitals to send on their old implants to the London Implant Retrieval Centre which has been commissioned by DePuy to investigate why the devices failed but Mr McDonnell said patients would have more confidence in an arrangement that was not paid for by DePuy.

“Really the HSE should be arranging independently for the storage and examination of the implants.” He said he would be contacting the HSE shortly to request a meeting to discuss this issue and other concerns relating to the speed at which patients were being assessed and how thoroughly they were being examined.