New documents have revealed that DePuy Orthopaedics, a unit of New Jersey-based Johnson & Johnson, continued to sell faulty hip replacement joints internationally after they were rejected for sale by the U.S. Food and Drug Administration. At the same time, DePuy sold a similar defective product in the U.S. after was approved through the FDA's 501(k) loophole, which we detailed extensively in a previous product liability blog post.
According to a letter from the FDA to Johnson which was just made public, DePuy began selling a version of the articular surface replacement device, or ASR, overseas in the early 2000s. Johnson soon sought approval of that product by the FDA. However, the agency rejected the product after it reportedly determined that the company studies and clinical data submitted by Johnson was not sufficient for approval in the U.S.
The version of the ASR product that was rejected by the FDA involved a process called resurfacing, which is an alternative to a standard hip replacement that spares the existing bones. Because this was a new procedure in the U.S., the FDA instituted additional requirements in order for the product to be approved for sale here.
The FDA reportedly told Johnson that it would need to obtain more clinical data in order for the product to be approved, which was expected to take at least a year. In the meantime, Johnson sought another avenue for its hip replacement, which we will detail in a second blog post later this week.
If you or a loved one has suffered injury as a result of a faulty joint replacement product, please contact Breslin & Breslin for a free consultation.
Source: New York Times, "Hip Implant U.S. Rejected Was Sold Overseas," Barry Meier, Feb. 14, 2012