What took DePuy so long?

DePuy Orthopaedics, a unit of Johnson & Johnson that makes hip implants among other devices, has been aware for quite some time that its ASR XL Acetabular System has had higher-than-expected failure rates.

The company quietly announced in late 2009 that it would phase out the product, claiming low sales were the reason. About that same time, DePuy recalled the implant altogether in Australia after the Australian Orthopaedic Association published an evaluation that found the DePuy ASR had higher failure rates than normal.

The company tried to blame surgeons for the mounting problems (more than 400 complaints to the Food and Drug Administration of failures, many of which required revision surgeries). They say proper patient screening and placement of the ASR implant was all that was needed for it to work right.

But now, several months later, Johnson & Johnson and DePuy Orthopaedics are finally admitting that the product is defective. Now, after 93,000 people - many of which likely have already undergone revision surgeries or will need one - worldwide have received this hip implant

If DePuy thought the danger to patients was significant enough to recall the hip implant in 2009 Australia, why not show the same level of concern and responsibility to patients in the United States and throughout the world? Why did the larger recall take nearly nine more months?

It makes one wonder about the company. The New York Times reported that the FDA recently sent DePuy a warning letter about illegally marketing an unapproved knee device and selling a hip implant for an unapproved use. Anyone with half an ear tuned to the news is aware that Johnson & Johnson has been involved with several major recalls (Children's Tylenol and Zyrtec, Acuvue contact lenses) in recent months.

William Trombetta, a professor of pharmaceutical marketing at Saint Joseph's University in Philadelphia may have said it best when he was quoted in The New York Times:

"This is a company that was purer than Caesar's wife, this was the gold standard, and all of a sudden it just seems like things are breaking down."