Criticism Over Handling of DePuy Hip Replacement Recall


. By Heidi Turner

The DePuy Hip Replacement recall is once again under scrutiny, this time after news of how Johnson & Johnson is handling the DePuy hip replacement recall. Meanwhile, reports indicate that metal-on-metal hip devices could be a costly problem, causing pain and possibly further surgeries for patients who received the DePuy hip.

According to Reuters (08/22/11), Johnson & Johnson has hired a third party—Broadspire Services Inc.—to deal with claims patients make for out-of-pocket medical expenses related to the recall of the DePuy hip. Critics of the move say it will allow Johnson & Johnson to limit the payments made to patients and will also allow the company to obtain patients' medical records.

Reuters notes that the move means that Broadspire's physicians—not the patient's physician—will determine whether a hip should be replaced. This means that even if the patient's physician recommends replacing the hip, if a Broadspire physician disagrees with the decision, Johnson & Johnson may not pay to cover the costs of that surgery.

A spokesperson for DePuy said that the company will only review whether the hip problems are the result of the recall and because of another issue, such as a fall. But critics say DePuy and Broadspire have demanded information such as medical records and have requested patients sign a medical release, which would give their physician the authority to share information with DePuy.

Amid news of Johnson & Johnson's handling of the DePuy hip replacement recall is news that another lawsuit has been filed against the two companies. According to The Southeast Texas Record (08/29/11), a woman in Texas filed a lawsuit against DePuy and Johnson & Johnson, alleging the companies knew the hip replacement devices were prone to failure but marketed them as lasting more than 15 years.

The plaintiff, Carrie Patrizi, says if she had known that she would face a second surgery to remove the DePuy hip implant, she would not have had it in the first place.

The DePuy ASR is a metal-on-metal device that was thought to be more durable than ceramic-on-metal devices. The all-metal ASR device was recalled in 2010, after reports indicated a higher than normal failure rate. Patients may also be at risk for metallosis, a condition in which metal debris from the hip device comes loose and is absorbed by surrounding tissue. That can lead to high levels of cobalt and/or chromium in the patient's tissue.

An article in The New York Times (08/22/11), reports that the US Food and Drug Administration (FDA) has received more than 5,000 reports of problems with metal-on-metal hip devices since January 2011. Most of those complaints involved the DePuy ASR device and reflect patients who have had or will soon have revision surgery to remove a failed device.

Some experts reportedly worry that the metal-on-metal hip device problems will be the most costly medical implant problem since the Medtronic heart device recall. Approximately 75 percent of the complaints reviewed by The New York Times involved the DePuy ASR.


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