Top executives for Johnson & Johnson subsidiary DePuy Orthopaedics had evidence that one of the company’s all-metal artificial hip devices was failing prematurely in patients a year before the device was recalled, but withheld this information and continued to market the device.
The evidence is found in an August 2009 email sent to three top executives at DePuy from a vice president at the company regarding another hip device. The company had sought approval from the Food and Drug Administration (FDA) for its ASR hip implant used for a relatively new hip replacement procedure called resurfacing.
Typically, the vast majority of “moderate risk” medical devices, including artificial hips, are approved for use in the United States through an expedited process that allows them to be cleared without clinical testing to prove safety and efficacy if they are similar to devices already on the market. But the FDA rejected DePuy’s ASR hip resurfacing system because it was a new type of device. In order to approve the resurfacing system, the FDA wanted data from clinical trials. Since the device was introduced in other countries as early as 2003, data was available. But, it was damning.
In the email to her colleagues, DePuy vice president Pamela Plouhar said that data from overseas was showing that the ASR devices were failing at a higher than expected rate, and that the all-metal devices were dropping bits of metal into the joint space, causing a host of other problems. Ms. Plouhar cautioned that if the company gathered more data on the devices in hopes of finding better results, the process could take years. Even then, there was no guarantee that the FDA would approve the device.
She also references complaints about the ASR hip implant from doctors and medical device regulators in other countries, including Australia, which had been pressuring DePuy to recall the faulty device.
But it wasn’t a total bust for DePuy. The company already had a hip device from its all-metal ASR family already on the market in the United States. The DePuy ASR hip replacement system – a more traditional-style implant than the resurfacing device – was similar to hip replacement devices already on the market. Thus, it was easily approved in 2005 through the FDA’s expedited process.
By then, data on the ASR family of hip devices was already beginning to look dim. And, by 2009, shortly after Ms. Plouhar sent the email to other DePuy executives, the company made the decision to phase out the ASR devices. It proved to be too little, too late. In 2010, DePuy had no choice but to issue a worldwide recall on the products. An estimated 93,000 people are affected by the action, one-third of whom received their hip replacements in the United States.
DePuy faces thousands of lawsuits from patients affected by the faulty devices. Some speculate that this latest discovery could prove that DePuy had knowledge of problems a year before the hip implants were recalled but continued to market the devices to doctors and patients anyway.
Source: New York Times