Personal Injury News

How Hip Implant Manufacturers Decide to Issue a Hip Replacement Recall

Given that in the recent years there has been more than one hip replacement recall you would think manufacturers would be prudent in testing and recalling their products. But, from past experiences hip implant recalls are the usually the result of regulatory and economic pressures on the company. The hip implant manufacturers seem to do anything other than giving outright acknowledgment that one of their devices has an inherent flaw.

This effort to not take responsibility with medical device failure has come up again, and the August 2010 recall of the DePuy ASR  Acetabular System illustrates this neglect by quite well. Here is a timeline of the current recall, easily showing their lack of concern for their customers:

- In 2005, DePuy, the orthopedic branch of Johnson & Johnson, introduced the device in the United States under a 510(k) clearance from the Food and Drug Administration, meaning approval was granted without clinical trials.

- By 2008, the FDA had received more than 400 complaints about device failures with the ASR hips. It appears that in approximately 12-13% of cases, the implants fail within the first five years, leaving 1 in 8 patients facing a costly, painful, and potentially dangerous revision surgery.

- In early 2010, DePuy announced that it was withdrawing the ASR hips from the market due to declining sales and mentioned in a letter to doctors that data from the Australian Medical Registry showed a higher than expected rate of failure with the devices.

- On March 10, 2010, The New York Times published an article exposing the failure with the DePuy artificial hips, followed by a story in The London Times in May disclosing that some 40,000 of the implants were under review in Britain for the presence of medical debris that could cause non-cancerous tumors, muscle damage, and swelling.

- Kathleen Margunau, a woman in Florida who was forced to have her DePuy hip replaced less than a year after her initial surgery, filed the first lawsuit against the company on June 15, 2010.

- On July 17, 2010 the FDA announced the recall of the DePuy hips followed by a worldwide recall statement from the company itself on August 26. At that time, two products were actually taken off the market, the ASR XL Acetabular System, which was sold globally, and the ASR Hip Resurfacing System, which was sold outside the United States only.

It’s very clear the decision to issue the recall was a mixture of “bad press” and regulatory pressure. In fact the DePuy ASR hip replacement recall came almost two full years after the FDA had amassed more than 400 complaints, and that DePuy has continually said that the real fault for the failure rates lies with doctors who have not properly positioned the implant. To top this all off DePuy had to pull the device out of the Australian market in 2008 and KEPT SELLING THEM IN THE USA.

DePuy does not have the victims suffering from their faulty product in mind when it comes to this recall. From deceptive letters and phone calls they are also trying anything to pay the least amount possible out to people suffering from the ASR hip replacement recall. Its important to get an experienced hip recall lawyer to help you in your time of need.

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