Executive Discussed Failures of DePuy Hip Replacement Prior to FDA Warning

February 27, 2012, 5:00AM. By Charles Benson

Washington, DCA year before recalling an artificial hip, an executive at Johnson & Johnson reported in an internal e-mail that the US Food and Drug Administration had refused to approve a DePuy Hip Replacement after reviewing company studies that showed it had failed prematurely in "significant" numbers, leading to repeat surgeries for patients, The New York Times reported.

According to the news source, the statements that were made in the e-mail contrast sharply with those made by the company in recent years concerning the ASR hip replacement.

Before recalling the product amid rising failure rates in 2010, Johnson & Johnson allegedly insisted it was safe and maintained that internal studies refuted complaints that were made by surgeons and regulators abroad that the hip replacement was flawed.

According to the Times, the device that the FDA turned down was only sold overseas, but a companion version that was recalled at the same time by the drugmaker was used in 30,000 patients in the US.

The e-mail that has recently raised eyebrows was written in August 2009 by a vice president of DePuy Orthopaedics, only days after the FDA confidentially notified the maker of the device that it would not approve one version of the hip replacement.

According to the news source, the executive, Pamela Plouhar, explained the reasons given by the FDA to three other top executives, including DePuy President David Floyd.

She went on to report that the device had not met FDA approval standards and that a major concern was its high rate of failure during clinical trials, cautioning that providing the agency with more information would not help it get approval for the product.

"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," Plouhar said in the e-mail.

Mass Device reported that DePuy was being urged by Australian regulators to pull the products off the market at the time of the e-mail, and Johnson & Johnson pulled the hip replacement shortly thereafter, stating that it was due to lackluster sales and a softening market.