The New York Times reports that Johnson & Johnson, the maker of many medical devices and products including artificial hips, continued to marked a metal-on-metal hip overseas even though the Food and Drug Administration (FDA) had prohibited its sale in the United States based on a review of the company's own safety studies. To read the entire article, click here.
According to the article, the FDA decided in 2009 not to approve the all-metal device known as the DePuy ASR Hip Resurfacing System, however, through a regulatory loophole in the FDA approval process, a similar DePuy ASR metal-on-metal hip was approved for sale in this country without undergoing a similar safety review. The difference between the two devices is that the former was to be used for a hip replacement procedure known as resurfacing, while the latter was for traditional joint replacement surgery. Because the resurfacing procedure was new, the FDA required clinical trials for the DePuy ASR Hip Resurfacing System prior to approval, while the DePuy ASR XL Acetabular System was to be used in traditional joint replacement surgery, and therefore did not require clinical tests under FDA rules because it resembled hip implants already on the market.
The Times reports that the FDA informed Johnson & Johnson that of is disapproval in a confidential letter in August 2009, but continued to market and sell the product abroad. That letter was reportedly at least 13 pages long and very detailed. Johnson & Johnson has yet to disclose the letter, although medical device makers will typically do so if such a letter will have an impact on the company's finances. In that respect, there are an estimated 5,000 lawsuits pending regarding the DePuy ASR, and several hundred regarding a similar metal-on-metal Pinnacle hip.
DePuy's metal-on-metal hips have been linked in studies to myriad problems including, loosening, the need for revision surgery, metalosis, and tissue damage caused by the release of microscopic metallic particles from the hip systems.
Dreyer Boyajian LLP is representing persons in Upstate New York and elsewhere that have been harmed by these defective products. If you or someone you know has been so harmed, contact our offices for a free consultation.