DePuy ASR Hip Design Had Poor Testing Techniques, Per Trial Testify

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By: Austin Kirk | Published: February 5th, 2013

In California state court, the first trial over damages caused by the recalled DePuy ASR hip replacement has now entered the second week, resulting in additional testimony about what Johnson & Johnson allegedly knew about the problems with metal-on-metal hip designs before selling them to the public. 

The trial involves a product liability lawsuit brought by Loren Kransky and his wife, Sheryl, who are suing Johnson & Johnson subsidiary DePuy Orthopaedics for marketing, manufacturing and selling an allegedly defective hip implant, while failing to properly warn the public or healthcare professionals about the risk of loosening and other complications that may develop within a few years after surgery.

Kransky received a DePuy ASR hip implant, which was subsequently recalled in August 2010, amid reports that about one out of every eight was failing within five years. However, more than 93,000 of the artificial hips were sold worldwide before the public was informed about the risk of problems.

Testimony last week focused on what Johnson & Johnson knew and when, indicating that an internal review suggested that DePuy did not conduct a proper assessment of the risks associated with metal-on-metal hip replacements before selling the device to the public.

DePuy ASR Hip Problems Linked to Metal-on-Metal Design

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 by Kransky and thousands of other individuals who have filed similar 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.

According to testimony last week from Graham Isaac, a DePuy engineer, the company only tested one angle of implantation, and a compliance manager, Jimmy Smith, testified by video that the company failed to use the right engineering controls when trying to assess potential problems.

Smith said that the testing failed to predict how much wear the hip implants would experience and how much they could loosen. He was the manager of a 2011 review of the ASR metal hip design team’s safety standards.

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

Metal-on-Metal Hip Lawsuits

More than 10,000 DePuy ASR hip lawsuits have been filed against Johnson & Johnson and Kransky’s case is the first to go before a jury. Kransky was given an expedited trial date because Loren is suffering a terminal cancer.

The case is being closely watched by product liability lawyers throughout the country, as the jury’s reaction to certain testimony and evidence may indicate how other cases pending throughout the country may fare. The outcome may also help facilitate additional DePuy ASR settlement agreements by gauging the value cases may bring at trial.

In addition to lawsuits over the DePuy ASR, other metal-on-metal hip designs have been the focus on large numbers of complaints, 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.

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