Articles Posted in DePuy Hip Implants

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Though widely hailed as breakthrough medical devices when they first came onto the market, experts now recommend that patients avoid them. The onslaught of problems (which seems to span all metal hip implants, regardless of manufacturer) is one reason that Johnson & Johnson has been phasing out their DePuy ASR implants. Of course, the phase-out allows a manufacturer to retire a device gracefully, despite the fact that a full-blown hip implant recall is warranted in these cases.

What did Johnson & Johnson (DePuy) Do Wrong To Cause Hip Implant Injuries?

As the authors of the British Medical Journal, The Lancet, said, the problems with metal hip implants that surgeons have discovered, could have been determined with adequate pre-market studies and regulation. If Johnson & Johnson did their homework, there would be a lot fewer people with these hip implant problems. The reality, though, is that a medical device manufacturer always makes more money by sending a defective device to the market than they do by canceling a project.

In 2009, the FDA told Johnson & Johnson that it was rejecting the DePuy ASR hip resurfacing system. That letter went one step further by telling Johnson & Johnson that all the DePuy metal-on-metal implants were suspect because of metal poisoning problems (See Hip Device Phaseout Followed FDA Data Request, New York Times). Regardless, these implants are still being implanted into patients.

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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 this will increase to 4 million patients because of 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 were 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 a 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% of patients), it is a serious complication associated with these devices. Metallic debris can occur because of malpositioning of the implant, subluxation, or jamming of the femoral head.

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On Monday, a U.S. Judicial Panel on Multidistrict Litigation assigned all DePuy Pinnacle hip implant recall lawsuits pending in federal courts nationwide to Judge James E. Kinkeade in the U.S. District Court for the Northern District of Texas.

The whole idea of the MDL process confuses victims? Are the DePuy claims a class action lawsuit?

The answer is the DePuy hip claims are “sort of” a class action lawsuit. The federal cases will be consolidated in Texas for what is called core discovery – interrogatories (written questions) to DePuy, depositions of key DePuy witnesses and experts on both sides, and other discovery procedures to determine the facts of these lawsuits. Typically, the MDL judge may preside over a few trials to help both sides better understand the value of the cases. If there is not a global “class action settlement” at that point, the cases are sent back to their home state for specific discovery and trial.

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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, besides 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 implant’s life. 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.

The 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 shows that the problem is much larger) from patients or their doctors about the early failure of the device.