Rejected DePuy Hip Sold Abroad, Times Reports

The DePuy ASR hip recall occurred because artificial joint databases determined that the ASR XL Acetabular Hip System and ASR Hip Resurfacing System failed at higher-than-normal rates compared to devices designed with other components. The recall led many to ask how such a defective device could have received U.S. Food and Drug Administration (FDA) approval. It turns out that one of the two recalled devices, the ASR Hip Resurfacing System, never received U.S. approval at all, and in fact, the FDA sent DePuy Orhopaedics a “nonapproval letter” in 2009, just before DePuy began phasing out the ASR implants. Nevertheless, the New York Times reports DePuy continued to sell the device overseas.

‘No Suggestion’ DePuy Broke the Law

The ASR XL Acetabular System received FDA approval via the 510(k) premarket approval process, which allows manufacturers to forgo clinical trials by claiming  that their devices are “substantially equivalent” to those already on the market, even if the predecessor device itself obtained approval through the same process. DePuy obtained approval for this device even though its metal-on-metal hip design was novel and untested.

By contrast, the ASR Hip Resurfacing System, which is merely the hip cup and a metal femoral head rather than a total hip replacement, did not receive FDA approval. Even after the rejected DePuy hip received notice from the FDA, DePuy continued to sell the device overseas, where, according to the Times, regulations are even more lax than in the United States. For example, the British Medicines and Healthcare Products Regulatory Agency does not require companies to notify it when their devices fail to obtain approval elsewhere. As a result, the Times writes, “There is no suggestion that Johnson & Johnson [DePuy's parent company] broke the law.”

‘Nonapproval Letter’ Withheld from Patients, Physicians, and Shareholders

The FDA’s approval process is confidential, meaning manufacturers seeking device approval are not required to publically disclose that their devices did not obtain it. Moreover, there are disincentives to informing the public that the FDA declined to allow them to sell their devices. For instance, patients might not trust their brand name, physicians in other countries where they’ve been approved, will not use the device, and shareholders might believe that the company isn’t making effective products. The nonapproval letter, totaling 13 pages, coincides with DePuy’s decision to wind down sales of the ASR, which occurred three months later.

RLG Represents Those Injured by All-Metal Implants

Unless the nonapproval letter comes to light, no one will know whether DePuy realized that its implants failed at abnormally high rates. Obviously, for those who received an ASR device subsequently, it could provide crucial evidence of DePuy’s liability. In the meantime, if you or a loved one received a recalled ASR hip, it’s important to know that the amount of compensation from a hip replacement lawsuit might be greater than what DePuy will give you via its recall compensation program. A lawsuit can allow a plaintiff to recover full medical expenses, lost income, transportation expenses, and damages for pain and suffering. If you are interested in filing a hip replacement lawsuit, click on this link or call 1-877-619-5087 and a hip replacement lawyer from the Rottenstein Law Group will reach out to you as soon as possible.

For more information on filing a hip replacement lawsuit, download this free DePuy ASR brochure.