Thursday, June 7, 2012

Was Johnson & Johnson Aware of Problems with the ASR Implant?

After the 2010 national recall of defective DePuy ASR hip implants, it was discovered that Johnson & Johnson may have been aware of problems with the product for as long as a year before the recall. The New York Times reported in February 2012 that an internal e-mail at Johnson and Johnson revealed knowledge of the flawed devices as early as 2009, prior to the recall. Johnson & Johnson decided to market and sell implants in its inventory before discontinuing the devices, despite the U.S. Food and Drug Administration (FDA) raising concerns about their safety in 2009.

The New York Times also reported that the company had been marketing the all-metal hip resurfacing system in Europe and other countries for approximately one year after the U.S. Food and Drug Administration’s non-approval of the device.

Although the U.S. Food and Drug Administration (FDA) approved DePuy’s ASR XL total hip replacement system in 2005, through a process called 510(k) that approval process did not require testing on humans. However, in 2007, DePuy filed a Premarket Approval Application (PMA) for the hip resurfacing version of the device. That approval process did require more extensive and stricter testing, which resulted in an August 2009 confidential letter to DePuy stating that its ASR Hip Resurfacing System had not been rejected.

In February 2012, The New York Times reported that an executive at Johnson & Johnson admitted through an internal email that the FDA had refused to approve the device because studies had revealed safety concerns where the device had been failing at high rates in patients, requiring further revision surgeries. Typically the devices would have lasted about 15 years in patients, but in these studies, the devices were failing within a few years.

The New York Times highlights that DePuy repeatedly stated that the resurfacing system was safe and disagreed with complaints from surgeons.

While the FDA rejected DePuy’s PMA for the ASR Hip Resurfacing System, it also told the company that blood tests of patients with the all-metal hip revealed a “high concentration of metal ions,” according to the New York Times, which accessed the confidential letter through the Freedom of Information Act.

The excessive amount of metal ions is concurrent with and suggests the wearing of metal components that can damage tissue and, in some cases, cripple patients, is linked to tumours and blood poisoning. According to research at the University of Bristol, has been linked to possible kidney and bladder cancers.

Author: Sullo & Sullo Attorneys

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