Report Questions DePuy ASR Hip Implant Recall Maneuvers

Johnson & Johnson has hired a contractor to handle its <"">DePuy ASR hip implant recall. According to a report from Reuters, critics have called the move unusual, and say it could allow Johnson & Johnson to limit payments to victims of defective DePuy ASR hip implants. At the same time, the device maker could end up controlling medical records and other information that could be used against DePuy ASR hip implant plaintiffs in their lawsuits.

The DePuy ASR Hip Resurfacing System was recalled last year, along with the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Before they were recalled, 93,000 ASR hip implants were implanted in patients worldwide.

Johnson & Johnson and its subsidiary, DePuy Orthopaedics, have since been named in more than 2,000 product liability lawsuits over the defective device. DePuy ASR hip implant lawsuits allege the all-metal devices allow microscopic shards of cobalt and chromium to make their way into the bloodstream, leading to dangerous levels of metal in blood and body tissues. As we’ve reported in the past, this can lead to even more serious long-term health problems including tissue breakdown, bone loss, and even the formation of non-cancerous tumors.

According to Reuters, Johnson & Johnson has hired Broadspire Services Inc. to administer patient claims for out-of-pocket medical costs associated with the DePuy ASR hip implant recall. The move is unusual, as most recalls are handled by device makers and their lawyers directly. But Johnson & Johnson claims use of a third party contactor will make the process more DePuy ASR hip implant recall more efficient.

But patient advocates have their doubts. For one thing, DePuy is requiring that doctors from Broadspire – not a patient’s own physician – determine whether a DePuy ASR hip implant recipient should undergo revision surgery. If a Broadspire physician doesn’t agree a revision is appropriate, DePuy won’t cover the cost of surgery.

“Doctors who are evaluating these cases are being paid indirectly by DePuy, and research suggests that even when we are very well-intentioned we can be influenced by conflicts of interest,” Kristin Smith-Crowe, associate professor of management at the University of Utah, who specializes in business ethics, told Reuters. “This is a bit of a red flag in terms of the way this situation is set up.”

Lawyers representing patients are also concerned about the amount of information being collected by Broadspire.

“Normally a company would not get the kind of information Broadspire is asking for until a case was in litigation, and even if the case was in litigation, in no circumstance would the defendant be allowed to have their own physician talk to the patient’s physician privately, as Broadspire is demanding,” one plaintiffs’ lawyer told Reuters.

This isn’t the first time Johnson & Johnson and DePuy have caused controversy over the way they’ve handled the ASR hip implant recall. Last year, Newsinferno reported that the companies had confirmed that payment for doctor’s costs, X-rays and any repair surgery is conditional on the patient agreeing to provide DePuy with all medical records, as well as the faulty hip implant. Patients were required to sign a consent form to this effect. According to the new Reuters report, DePuy offered doctors $50 for each completed set of forms. DePuy and Johnson & Johnson also sent letters to orthopedic surgeons, asking that they turn over any removed devices to the companies

At the time plaintiffs’ attorneys cautioned against this, stating the original hip replacement should be preserved as evidence. Lawyers also advised patients not to sign any authorization that would allow their removed device to be returned to DePuy.

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