DePuy ASR Hip Problems Acknowledged At Least One Year Before Recall

According to internal company emails, executives at DePuy Orthopedics knew about potential problems with their ASR metal hip replacement system at least a year before the implants were recalled. 

A recent report by the New York Times indicates that DePuy executive Pam Plouhar noted in an August 2009 email that there were “a significant number of revisions” among recipients of the DePuy ASR hip systems. The comments were made during a discussion about the FDA’s decision to reject a variation of the system used for hip resurfacing procedures.

Although the FDA decided not to approve the DePuy ASR Hip Resurfacing system, the company went on to sell the implant in Europe and pushed through a similar implant used for more traditional hip replacements, the ASR XL Acetabular system, through an accellerated FDA approval process, which only required the company to establish that the design was substantially equivalent to another product that was already on the market.

In August 2010, about one year after the comments were made, the company issued a DePuy ASR hip recall, after acknowledging that post-marketing data suggested that about one out of every 8 individuals who receive the implant may experience problems within a few years after surgery. However, by the time the recall was issued, thousands of people in the United States and throughout the world already had the defectively designed implant placed inside their bodies.

The e-mail appears to indicate that DePuy knew there were problems long before it removed the ASR hip from the market, and also contradicts some of the recent claims made by the company that suggested the failures may have been caused by orthopedic surgeons who failed to follow proper procedures or techniques.

Last week, in response to a New York Times article that highlighted how the DePuy ASR resurfacing implant was sold abroad even after U.S. regulators rejected it, DePuy Orthopaedics President Andrew Ekdahl said that the article unfairly implies there were safety problems. Ekdahl said any such insinuations were untrue.

That statement seems to be directly contradicted by Plouhar’s internal e-mail, which discussed specifically why the FDA rejected the ASR Hip Resurfacing System. The very first reason Plouhar gives in her e-mail are the number of incidents where patients had to have revision surgery due to failed ASR hip implants.

“There have been a significant number of revisions within the ASR group… as opposed to very few in the control group,” Plouhar wrote. Later, she notes that further clinical trials probably won’t produce any better results. “The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority with additional downside risk.”

The e-mail also points out that high revision rates were already being reported in Australia and United Kingdom national registries.

Following the recall, the manufacturer now faces a growing number of product liability lawsuits filed by individuals who have experienced DePuy ASR hip problems. So far, about 3,500 DePuy ASR lawsuits have been filed in state and federal courts throughout the United States.