This blog has noted several times that DePuy knew of the likely failure rates of its ASR hip implants several years before the medical device manufacturer issued its 2010 recall of the product. In light of this knowledge, DePuy nevertheless waited years before it decided to remedy the dangerous situation caused by its defective hip implants. Instead, it chose to shift the blame for reported problems elsewhere before finally initiating the recall.
New evidence has been uncovered showing that DePuy had received credible notification of its ASR hip implant failure rates as far back as 2007. According to The Independent, the Australian joint registry, the second largest registry of its kind in the world, informed DePuy of identified problems in seven separate reports. One of the most striking findings made by the registry was the higher than usual amount of revision surgeries needed to replace previously-implanted ASR hip units. DePuy sat on this knowledge until 2009, when the company finally withdrew the ASR hip implants from the Australian marketplace, citing “commercial reasons.” DePuy initially blamed the Australian joint registry findings on “imprecise surgical techniques” by doctors, but was forced to retreat from that position in response to the multiple reports of problems sent the company’s way.
Director of the Australian joint registry, Stephen Graves, has since stated DePuy behaved “irresponsibly and very badly.” Graves warns, “This is why regulators should not rely so heavily on manufacturer data. It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”
British officials have also noted that the ASR hip implant recall is not the first time DePuy has recalled one of its products. In 2003, the company had to issue a recall for its Hylamer hip and shoulder components in British markets. Similarly, during the summer of 2009, DePuy-manufactured knee components were withdrawn because of aluminum leakage into the bodily tissue of British patients.
In the United States, DePuy began issuing letters to physicians in March 2010, notifying them of the high failure rate of its hip implants. Nevertheless, the implants remained in the American marketplace for nearly half a year until the American recall was announced in August 2010. Moreover, by March 2010, DePuy was aware that patients with smaller bones were the highest at risk for failures, yet the company continued to market the hip implants to those very patients until the recall.
Based on the reports cited above, it is apparent DePuy had scientifically-backed data illustrating the propensity of its ASR hip implants to fail. Furthermore, the company’s track record of recalling other implant products elsewhere shows DePuy has a tendency to forego consumer safety in exchange for maintaining its profit margins. Had DePuy acted responsibly in 2007, and removed the defective hip implants from the marketplace, thousands of patients would have been spared the pain, suffering, and economic damages they’ve experienced as a result of the medical problems the ASR implants create.
The attorneys at Berniard Law Firm will continue to make efforts to uncover reports DePuy ignored when it continued to market the hip implants to the American public. If you have received a hip implant since 2003 and are interested in knowing whether your legal rights have been impacted, feel free to contact Berniard Law Firm today.