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

A change of direction toward legal topics

Why the change of topics?

When I started this blog I intended to dedicate it entirely to cover topics from the maritime industry. As a little kid I dreamed about being a boat captain. Lead by these childish dreams I wanted to create a blog that will cover news about boats, vessels, ships, captains and admiralty lawyers. Soon I realized that writing about what's happening on the seas requires a certain type of experience and expertise in those fields, which I definitely lack. This is a big setback, especially if I want to write about it on a weekly basis, although I hope that you liked my first post about oil rig accidents. That is why I decided to change the direction of this blog, steering it towards topics covering legal news about recent lawsuits, defective product litigation cases and personal injury stories, although I will not fully abandon my initial intentions and from time to time I'll certainly post some maritime stories too.

The story of  Depuy ASR hip implants

One of these new stories are about defective hip implants and there were plenty of news coverage about them lately because last week the FDA held an advisory committee meeting to address the concerns about metal on metal type of hip implants. These are medical devices that are surgically inserted to replicate the normal functioning of the hip joint, when the hip is damaged due to accidents or diseases like osteoarthritis, avascular necrosis, rheumatoid arthritis. The metal-on-metal implants, that are under scrutiny, have both the femoral head and the cup component made out of metal. Such implants caused the most problems when Depuy Orthopaedics Inc. introduced two hip implants the Depuy ASR XL Acetubular System and the Depuy ASR hip resurfacing system. These implants were widely adopted because they promised longer lifespan, and it could be used for patients wanting to lead a more active lifestyle, but it wasn't long before problems started to appear. Patients who received these, started complaining about pain and problems such as metal poisoning, tissue damage, tissue necrosis and high failure rates surfaced. Doctors and research studies indicated an above average failure rate of 12%, so instead of lasting 15 years, as it was first promised, these implants started failing only after 3 years with high frequency. Complaints kept rising and Depuy issued a recall of its ASR system in August 2010.

With the increase in the number of complaints by patients affected by these implants, lawsuits against the manufacturer have also kept rising. Patients are seeking compensation for damages caused by their defective Depuy ASR hip implants. The lawsuits are also seeking to prove if the company is liable for releasing a defectively designed implant and if it failed to adequately warn doctors and patients about the problems with their recalled implants.