Depuy allegedly marketed a line of metal-on-metal artificial hips that were prone to failure. The Oregon Department of Justice reached a $4-million settlement with DePuy Orthopaedics Inc. over allegations that DePuy knowingly marketed a line of metal-on-metal artificial hips that were prone to failure.
The metal-on-metal devices tend to deteriorate leaving behind metal debris and sometimes damaging muscle and bone and requiring follow-up surgeries, Oregonlive.com reports. DePuy, a subsidiary of Johnson & Johnson, used a streamlined Food and Drug Administration (FDA) device approval process that critics say has insufficient safeguards. The 510(k) process requires little clinical testing for a device that is “substantially similar” to another product already on the market. Because of concerns about metal-on-metal hips and other medical devices, the FDA is considering changing the process. In Oregon, 432 DePuy hips were sold.
Recipients of DePuy hips have reported injuries including pain, loosening of the joint, difficulty walking, cysts around the joint, and elevated chromium and cobalt in the blood. Though hip implants generally last for about 15 years, many DePuy recipients have undergone additional surgery within a few years of implantation.
DePuy has settled thousands of lawsuits over the ASR XL hip, which was recalled in 2010
DePuy has settled thousands of lawsuits over the ASR XL hip, which was recalled in 2010. In the Unfair Act settlement, filed in Multnomah County Circuit Court, DePuy admits no wrongdoing but the firm agrees not to engage in deceptive marketing again, according to Oregonlive.
Oregon Attorney General Ellen Rosenblum says, “Oregonians in need of a hip replacement deserve to know that the artificial hip they are contemplating in fact has the qualities, and benefits, that a company advertises,” and doctors “need to know that the products they suggest to their patients meet certain standards; and no company should be permitted to exploit that basic tenet,” Oregonlive reports.