Senate Investigation Could Prompt DePuy Hip Recall

A committee within the United States Senate held a hearing on the 13th of April regarding the approval process of medical devices, many of which are defective when brought to market. This meeting was prompted in part by the recall of DePuy-brand hip replacement systems, which have been defective and faulty in many cases. The Food and Drug Administration’s approval process for devices such as these are under investigation.
The hearing was held before 21 members of the United States Senate Special Committee on Aging, as most of the people affected by the defective DePuy hip replacement systems are somewhat elderly. Senator Herb Kohl of Wisconsin acted as chairman as the committee discussed the pre-market approval process, part of which allows the Food and Drug Administration to speed devices that are similar to already-approved devices through the approval process. It was through this potential flaw in the process that the DePuy ASR hip replacement system was approved, since it was similar to DePuy’s Pinnacle hip replacement system.
The Food and Drug Administration seems more likely to initiate a recall of of the device in question if the recall process is deemed to be fallible or flawed. Diana Zuckerman, president of the National Research Center for Women and Families, was one of the authors of a report published last year that showed devices that were rushed through the approval process based on similarities with another device were much more likely to be faulty. Ms. Zuckerman presented these findings at the Senate’s hearing.
As many as 67 devices that range from pacemakers to hip joints have been reviewed in the expedited process due to similarities with other devices since the Government Accounting Office called for “immediate steps” to reduce the possibility of risk in January of 2009. The Food and Drug Administration has apparently stepped up its overseeing of products, but is still failing to catch many faulty devices.
It is not yet clear what kind of impact this Senate hearing will have on the future of DePuy hip implant lawsuit cases.