Texas DePuy Hip Replacement LawyerMarch 22, 2012 — The New York Times is reporting that they obtained a letter that the U.S. Food and Drug Administration (FDA) sent to DePuy Orthopaedics in 2009, which requested additional safety data regarding the ASR hip replacements. A couple weeks later, DePuy executives decided to slowly phase out the ASR model and sell remaining stocks. Once stocks were nearly depleted, DePuy executives issued an official recall of the ASR hip replacement and the Pinnacle hip replacement. Both were a metal-on-metal design, linked to high rates of premature failure. They also leaked toxic metal debris into nearby tissues.

In the letter, the FDA requested that DePuy provide the agency with more safety information about the product. The agency was concerned about several issues, including the quality of the safety information DePuy provided to the FDA. The agency cited an Australian safety study that showed the ASR hip implants failed prematurely at higher rates than competitor hip implants. The Australian study showed failure rates that were significantly higher than the safety information DePuy provided to the FDA. The agency was also concerned about toxic metals leaking into a patient, because blood tests from some patients had shown high concentration of metal ions.

The FDA letter concluded by rejecting approval of the devices. A couple weeks later, DePuy Orthopaedics executives decided that they would slowly phase out the hip replacements and sell the devices that remained in stock. Nine months after DePuy received the FDA’s letter, in May 2010, an official wrote “we are almost out of ASR, and the few doctors still using ASR are threatening to leave DePuy anyhow.” By August 2010, stocks of the ASR hip replacement were nearly depleted. DePuy issued the recall.

In the recall, DePuy cited safety concerns such as high premature failure and toxic chemicals leaking into the body — concerns that the FDA had noted one year previously.

The letter, obtained by the Times under the Freedom of Information Act, is proof that DePuy was notified of potential safety concerns long before they decided to issue the recall. During the year’s time between the letter and the recall, people continued to be implanted with the devices.

DePuy executives defended their decision to issue the recall when they did, saying that suggesting that FDA concluded there were safety issues with the ASR was “simply untrue.” The executives claim that the phase-out was prompted by slowing product sales — not due to safety concerns or the Australian study. The executives also say that the internal company safety data showed that their hip replacements were as safe as competitor hip implants, until August 2010, when they issued the recall.

In the eight-year period in which the ASR was used, around 93,000 people were implanted with the device, about one-third in the U.S. However, there is growing concern about all metal-on-metal hip implants. Approximately 500,000 people in the U.S. are implanted with this type of hip replacement. Researchers have found that the design has a higher risk of side effects compared to plastic or ceramic designs, and experts are now calling for a ban of all metal-on-metal hip replacements. This design is being phased out in Europe, but remains popular in the U.S.

When the FDA initially approved the ASR and Pinnacle hip implants, the manufacturers obtained FDA approval without conducting a clinical safety study of the devices, through a loophole that allows “substantially similar” devices to gain approval without conducting expensive studies. The problem with hip replacements is that it often takes many years before safety issues are discovered. By the time problems with the metal-on-metal design were discovered, hundreds of thousands of people had been implanted with the device. The FDA is now facing a whistleblower lawsuit brought by scientists who notified Congress that the FDA might be approving unsafe medical devices, and the FDA put them under surveillance.

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