Kathleen Margenau is identified in the Massachusetts Medical Devices Journal as the plaintiff in the action against DePuy. The lawsuit claims that the plaintiff received a DePuy ASR acetabular cup in March of 2008 and began experiencing "extreme weakness in her hip and quadriceps" following surgery, according to court documents.
A little more than a year later the plaintiff required hip revision surgery where doctors, following removal of the DePuy hip implant, found that the device had "catastrophically failed." Following the implantation of a competing hip replacement, Margenau was able to return to her active lifestyle.
"During this time, defendant DePuy was aware of a high rate of failures of its ASR cups, but did not provide this information to [Margenau's surgeon]," the lawsuit alleged. "As a result of defendant DePuy failing to provide this crucial information to plaintiff's orthopedic surgeon, [he] had little reason to suspect that the source of plaintiff's ongoing pain and weakness was the result of the failure of the ASR cup."
The device manufacturer formally phased out the DePuy hip implant earlier this spring after analyzing data from the medical device registry in Australia, which suggested a "higher-than-expected" failure rate than with traditional hip replacements, adding that patients with small body builds or those with weak bones were especially prone to such failures.
Traditional hip replacements are expected to last upwards of 15 years.
The DePuy hip replacement that is the center of controversy received US Food and Drug Administration (FDA) approval in 2005, and began to fail soon after. Since 2008, the New York Times reported that the FDA received upwards of 300 complaints regarding the DePuy ASR Cup, and the manufacturer was criticized for reacting too slowly in its eventual decision to remove the device from the US market.
Critics of the DePuy implants claim that the device was prone to a poor design, a suspicion fostered by comments from the co-designer of the product. The New York Times quoted Los Angeles-based orthopedic specialist Dr. Thomas Schmalzried as saying in February—just before the device was pulled—that he and DePuy officials had come to the realization during the last two years that implanting the ASR cup properly was a greater challenge than that required with competing devices.
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While DePuy had issued a brochure to doctors in early 2009 with regard to proper ASR cup positioning, there were no specific concerns about the DePuy ASR outlined until the March, 2010 communiqué, when DePuy emphasized the need to properly position the device. The New York Times reported that several orthopedic specialists have said that the design of the DePuy ASR, which is shallower than competing devices, lay at the heart of alleged design problems. The lawsuit was filed in the United States Federal District Court for Middle District of Florida, Ft. Myers Division.