My take on the letter from FDA to Depuy Orthopaedics

Those who followed my previous post may already have a general idea of what hip implants are, and know a little more about the recalled Depuy ASR system about which I wrote there. The subject is highly publicized even today as the complaints and reports about injuries and complications are still surfacing, as well as new data from independent studies are continuously appearing. The multidistrict litigation on the Depuy ASR product liability lawsuits are also moving forward providing yet another subject to be written about.

Today I won't be covering the latest developments about the consolidated lawsuits, although I must mention that just two days ago on June 25, there was a Status Conference held before Judge David A. Katz on MDL 2197, setting the dates of the first bellwether trials for the Depuy ASR hip implant lawsuits at the United States District Court, Northern District of Ohio. More information on the Conference is available here. Instead I'll share my thoughts about a 2009 letter sent to Depuy Orthopaedics executives, that made the news early this year. Basicaly in the letter a Depuy vice president informs executive members of the company about the FDA's notification of not rejecting their premarket approval request for their ASR system. Thus far this wouldn't be much of a news, but the letter continues to present the concerns of the FDA regarding the results of the submitted clinical trials. There were mentioned concerns about a high number of required revision surgeries with the implant, incoherency between the chosen groups for the trial and not being able to prove "non-inferiority" to another product. All this happened in 2009, almost a year before Depuy issued the recall of their hip replcament products from the ASR line. This goes even further when the VP suggest to address the third issue with the exclusion of the "very poor results" from one group.

What is the conclusion from this letter? Actually I don't want to draw any conclusions here. The letter surely will be used as evidence by the attorneys representing the Depuy ASR victims and a final conclusion will come when the lawsuits filed against Depuy, alleging defective design of the Depuy ASR XL Acetabular system and Depuy's failure to warn about complications, will be settled.

Certainly there is another aspect to this story which comes as the response from Depuy when this email has been released by the media. In order to have a complete picture I urge you to read their statement. The whole story was covered by the NY Times where you can also find both the initial letter in question, as well as Depuy Orthopaedics statement as a response.

Those interested about in details about the 2010 Depuy ASR system recalls, more information is available here, including latest data about the failure rates, the associated problems and safety information.

This post covers a rather serious topics but I don't want to end it with a sombre finishing, that is why I'll share a legal meme about lawyers and failing hip implants.

Hip implant lawyer meme