Criminal Probe Over Metal Toxicity of DePuy ASR Hip Considered in UK

British members of parliament are calling for a criminal probe into Johnson & Johnson over problems with the DePuy ASR hip implant, as more and more information comes to light indicating that the company knew the metal-on-metal hip replacement systems posed a risk of metal toxicity and an increased risk of failure, but continued to sell them anyway. 

Andrew Miller, a member of the British parliament (MP) who chairs the parliament’s Science and Technology Committee, has said that the police should be involved if it is proven that Johnson & Johnson’s DePuy Orthopaedics subsidiary knew from test results that the ASR metal-on-metal hip implants had higher than acceptable failure rates, but continued to sell the implant.

In the United States, trial is underway in the first of thousands of DePuy ASR metal hip lawsuit filed on behalf of individuals who experienced problems within a few years of receiving the implant. The first weeks of the trial have been filled with testimony from DePuy employees and internal documents have been released that suggest the manufacturer had concerns about failure rates long before recalling the ASR hip.

The DePuy ASR trial in California involves a lawsuit filed by Loren Kransky, who says his artificial hip suffered a catastrophic failure.

ASR Hip Failure Rate May Be As High as 37%

Johnson & Johnson issued a Depuy ASR recall in August 2010, but not before 93,000 people worldwide had already received the implant, including more than 10,000 in the U.K.

When the ASR metal-on-metal hip implants were recalled, the company said they had a failure rate of up to 13%. However, internal documents released as part of the litigation have revealed the manufacturer estimated the DePuy ASR failure rate could be as high as 37%.

The DePuy ASR hip design features a metal head that rotates within a metal cup, known as a metal-on-metal design.  According to allegations raised in product liability lawsuits over the DePuy ASR hip, the device is prone to early failure as a result of metal debris that is released into the surrounding tissue as the metal parts rub against each other.

In addition to lawsuits over the DePuy ASR, other metal-on-metal hip designs have been the focus of a large number of lawsuits, including the DePuy Pinnacle hip, Biomet M2A Magnum hip and Wright Medical Conserve Cup.

In January, the FDA released new guidance for metal-on-metal hip replacements. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market. Future metal-on-metal hip designs will have to undergo extensive human clinical trials before being made available for sale, the FDA decreed.