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J&J began phasing out hip implant after FDA safety data request

On Behalf of | Mar 27, 2012 | Product Liability

According to a recently released document, New Jersey company Johnson & Johnson began taking action to phase out the use of its metal-on-metal artificial hips just weeks after the receiving a letter from U.S. Food and Drug Administration. In that letter, the agency reportedly turned down Johnson’s application to sell the medical product in the United States, and told the company to submit additional safety data if it wanted to pursue the application.

Instead of complying with that request, however, Johnson decided to phase out the articular surface replacement devices, or ASRs, manufactured by company unit DePuy Orthopaedics. Just a few weeks later, Johnson began to sell off its inventories of the products for patient use. Although company executives deny having any knowledge of the potential dangers of the ASR devices at that time, Johnson initiated a mass recall of the ASRs less than one year after receiving the FDA letter.

The letter was reportedly received in the fall of 2009, and the ASRs were recalled in August 2010. By that time, about 100,000 people around the world had received the metal-on-metal artificial hips, and many had suffered debilitating pain, injury and illness as a result of the product’s defective design.

Johnson and DePuy executives continue to maintain that they were unaware of the product’s flaws and risks until just before the 2010 recall. However, with every new revelation about the company’s actions regarding the ASR and other products manufactured by Johnson & Johnson, many of which we have detailed in previous personal injury blog posts, that claim becomes more difficult to believe.

If you have suffered an illness or an injury as a result of the DePuy ASR hip replacement product, please contact Breslin & Breslin for a free consultation with an attorney.

Source: The New York Times, “Hip Device Phaseout Followed F.D.A. Data Request,” Barry Meier, Mar. 22, 2012

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