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Articles Posted in DePuy Orthopaedics

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It is easy to forget what a rarity hip replacement surgery used to be. Today, people with artificial hips are ubiquitous. Direct costs of hip and knee replacements exceed $35 billion in the United States. More than 285,000 hip replacements are performed annually in the United States and it is projected that total joint replacement will increase to 4 million patients annually due to the aging population. Until very recently, hip replacements have been applauded as a wonderful, revolutionary way to get people back on their feet with less or no pain. But with this revolution came medical device makers looking to make as much money, and get as much market share, as possible.

The temptations for hip makers was extraordinary. Hip replacement surgery may be recommended in cases where hip pain limits daily activities, continues while resting (night or day), limits the ability to move or lift the leg, or in cases where pain relief is not provided by physical therapy, walking supports or anti-inflammatory drugs. Hip replacement surgery has a high rate of success, due to improvements in surgical techniques and technology. Total hip arthroplasty (total hip replacement) involves removing the damaged bone and cartilage and replacing it with prosthetic components. These components did not come cheaply but health insurance companies readily admitted that this was the appropriate treatment for people with compromised hips.

Though many hip replacement surgeries are successful, there is risk for infection, failure, and other adverse effects. Concerns have been raised in peer reviewed publications relating to metallosis, the build up of metal debris in soft tissues or blood. Reports are generally restricted to metal-on-metal devices, or those constructed with acetabular polyethylene liner. Metal-on-metal devices often contain cobalt or chromium. Although the occurrence is rare (occurring in approximately 5.3% patients), it is a serious complication associated with these devices. Metallic debris can occur due to malpositioning of the implant, subluxation, or jamming of the femoral head.

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DePuy’s president resigned yesterday. What does this mean for settlement of the DePuy hip replacement lawsuits?

My question is: who replaces him? If it is someone outside of DePuy, it increases the likelihood the DePuy hip lawsuits settle faster. Why? It is always easier to accept the pain that comes with settling cases when you were not the person on the line making the decisions that caused the problems in the first place. Would a new DePuy president from outside of the company – outside DePuy, not necessarily J&J – be more inclined to pay a reasonable settlement value on the thousands of hip implant cases that are out there? Of course.

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History tells us that it is not the crime but the cover-up that often causes the most damage. In drug and medical device cases, there is usually a Nixonian leitmotif: what did you know and when did you know it with respect to the potential harm caused by the drug.

Last month, another DePuy class action lawsuit was filed. The claim is an interesting cover-up allegation. The class action claims that after the DePuy ASR recall, the company deceived patients by agreeing to make things right and in exchange, getting access to hip recall victims’ medical records. Of course, making things right is relative. DePuy has essentially promised victims nothing in exchange for something, which is the essence of this class action lawsuit.

This byproduct DePuy hip recall lawsuit is probably a sideshow to the core of these hip implant lawsuits. Rummaging through plaintiffs’ medical records while pretending to promise them something in exchange is awful. It is a clear end run artifice designed to fool plaintiffs into believing they don’t need a lawyer. But the compensation for this inappropriate conduct pales in comparison to the real injuries that stem from the DePuy ASR hip recall. But this class action lawsuit underscores that people are mad and DePuy is not making things any better by not playing it straight with victims.

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Contrary to the good corporate responsibility of Boston Scientific for their quickly recalled defibrillators, DePuy seems to have taken their sweet time with their ASR hip implants, in addition to trying (and failing) to direct public misinformation on the issue.

DePuy-ASR-03-17-10.jpgFirst the background: the DePuy ASR hip implant is used for hip resurfacing (which is apparently not an issue), and more traditional hip replacement, which is at issue. The device is a metal-on-metal ball and socket, which can cause metal debris early in the life of the implant. That metal debris causes inflammation, and can lead to damaged muscles and soft tissue. The end result is that a very expensive and painful replacement surgery intended to last about 15 years ends up needing revision within two or three years.

Use of the device in the United States started in 2005. Since 2008, the FDA has received approximately 300 complaints (most people don’t complain to the FDA, so this indicates that the problem is much larger) from patients or their doctors about the early failure of the device.