A year before recalling an artificial hip product, an Executive at Johnson & Johnson reported in an internal e-mail that the Food and Drug Administration in the U.S.A had refused to approve the device. After reviewing company studies it showed that it had failed early with ‘significant’ numbers requiring revision surgeries.
Before recalling the device in August 2010, Johnson & Johnson had insisted that the device was safe and maintained that its own internal studies refuted complaints by surgeons and regulators that the device was flawed.
The e-mail was written in August 2009 by a Vice President of DePuy Orthopaedics, a Johnson & Johnson subsidiary. This was just days after the FDA had notified the device maker confidentially that it would not approve one version of the hip for sale in the U.S.A. In the e-mail the Executive, Ms. Pamela Plouhar explained the reasons for the agencies decision to three other top Executives. Ms. Plouhar reported that the device had not met FDA approval standards and that a major concern was its high rate of early failure or revision during clinical trials. She also cautioned that providing the FDA with more data might not change its stance and that it might take years to conduct studies of the hip, known as the ASR or articular surface replacement.
Over 3,500 patients in Ireland have had the device used in their surgeries and many hundreds now face further revision surgeries to remove and replace the devices. Many people also have high metal ion levels in their blood stream which is a cause of serious concern for them.
By 2008 data from orthopaedic databases showed that the ASR was failing at high rates in patients after just a few years. The device should last up to 20 years.
Liam Moloney a Healthcare Solicitor whose Firm is acting on behalf of many DePuy patients who received the ASR device said today ‘’ the fact that a high ranking Executive in DePuy Orthopaedics was openly discussing as early as 2009 the high rate of early failure during clinical trials of the ASR device showed that from that time the company was well aware of problems with this device. The company should not have continued to market the device when ASR data from national registries was showing higher revision rates for these implants. The Irish Medicines Board should immediately investigate what was known and when it was known by the company when it supplied these implants in Ireland for use by surgeons here”.
For further information, contact:
Liam Moloney, Solicitor
Phone: 045 898000