Medical Device Product Liability

An editorial published last month by the New York Times raises important questions about the legal and moral responsibility medical device manufacturers have, or ought to have, concerning their products.

The newspaper focused on all-metal hip implants in general and the actions of DePuy Orthopaedics in particular. DePuy is a division of pharmaceutical and medical supply giant Johnson and Johnson. The paper writes that “about 93,000 patients around the world” received DePuy’s all-metal Articular Surface Replacement (ASR) model hip implant until it was recalled in 2010. However, the paper notes, “documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed.” The article goes on to note: “That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies.”
In response DePuy’s president wrote to the Times this week to take issue with the editorial, noting that the ASR had been approved by federal regulatory authorities and that when data indicated that numerous patients were requiring early replacement of their implants the company “recalled the product and immediately supported patients with a reimbursement program for their medical costs.”
Considering that, according to the Times, the company is now facing over 10,000 suits filed by patients or loved-ones in relation to the faulty implants, the question this begs is where one draws the line of responsibility? Our courts are here to help victims obtain justice in cases like these, but, as an Oregon unsafe products lawyer with an interest in medical devices, one must ask why a responsible company would let data pile up for any length of time, especially concerning something as crucial to a patient’s day-to-day life as a hip replacement? Allegations like these are especially serious because correcting a hip replacement is a far more complicated, and less certain, process than replacing the hip in the first place.

Victims in situations like these need to understand that government approval, while obviously important and necessary, does not absolve a manufacturer from responsibility to produce and market a safe product. The fact that DePuy chose to continue selling the ASR even after its own data indicated that the product was flawed and dangerous is reprehensible. Hopefully the injured patients and their families will be able to have their day in court, giving a jury the opportunity to send a message that behavior like this won’t be tolerated in 21st century America.

New York Times: What a Company Knew About its Metal Hips

New York Times Letters: Hip Replacement Device