Lawsuit Evidence and FDA Actions Doom Metal Hip Implants

A front page article in the January 23 New York Times, Maker Aware of 40% Failure in Hip Implant, revealed that Johnson & Johnson knew of widespread failure with the troubled all-metal hip joint it had recalled in 2010. Even as the company became aware of the extent of the products failure, it continued to publicly play down similar findings from the British implant registry.
The internal study, conducted by Johnson & Johnson, is just one of hundreds of documents expected to be made public as the first of over 10,000 lawsuits begins this week in California superior court in Los Angeles.
In the analysis, Johnson & Johnson found that nearly 40 percent of the patients who received the now-recalled Articular Surface Replacement, or ASR joint, would experience failure within five years. It also found that thousands more patients will likely experience premature failure in up-coming years and be forced to undergo painful and costly replacement surgery.
The trial is expected to uncover what officials of Johnson & Johnson’s DePuy Orthopedics division knew about the device’s problems, both pre- and post-recall, and what actions they took. This episode represents one of the biggest medical device failures in decades and these early documents bring into question how forthright DePuy was in dealing with the problem. Even after the company recalled the device in 2010 it continued to challenge the validity of the British registry findings, which had found a failure rate in at least one-third of patients with the device.
Metal hip implants made by all manufacturers have been failing at an unacceptable rate for years. The DuPuy ASR joint was only the first to be recalled. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint.
As a result of these failures the FDA recently posted a proposed order addressing metal hip implants. The new order, if approved, will require all hip implant manufacturers to go through Premarket Approval Process to keep any existing metal-on-metal hip implant on the market or to put a new metal on metal product on the market.
Metal on Metal joints still on the market such as The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates. Ironically the new order and PMA process faced by these manufacturers might allow them to avoid recalls. By citing the prohibitive cost of preparing a PMA application they can simply cease production without ever acknowledging an admission of failure in the joints.
So, as the trial prepares to begin in California this week, the early release of documents showing that DePuy long knew of the high failure rate while simultaneously trying to downplay the situation would indicate the company was more concerned with limiting its financial liability than being forthright with patients. Even after the company instituted its own recall of the suspect joint in 2010 it methodically continued to challenge medical findings that indicated a high failure rate.
Continued public disclosure of documents from the civil lawsuits and the data collected by the FDA will help protect the public from companies that put their own profits ahead of safety.