Personal Injury Law

Senate Holds Hearing to Investigate Defective DePuy Hip Implants

News about the defective hip implants given to patients by the DePuy company continues to roll in. This week the U.S. Senate Special Committee on Aging heard testimony on the Depuy recall as well as other medical device problems and complications. Mass Device reports that the hearing was part of a larger investigation by the federal legislative body into the approval process currently available for medical devices and the effect that process has on overall patient safety. As the DePuy hip recall made clear, devices that are rushed to the market and given to unsuspecting medical patients pose huge risks that circumvent the very purpose of the regulatory process.

The hearing put Johnson & Johnson--the parent company of DePuy--in the middle of the federal investigation evaluating that medical device approval process. Besides hearing from those executives, the committee was briefed on the situation by one of the victims of the recall?many Illinois patients found themselves in a similar circumstance to the victim who attended the hearing.

Following the first-hand account of hardship, a national researcher discussed her new data which indicates that there are more recalls of devices that are approved through the 510(k) pre-market notification program. The less stringent alternative process allows devices to reach consumers sooner abrogating many of the usual requirements of the Food and Drug Administration?s more comprehensive PMA protocol.

The subcommittee holding the hearing explained, ?Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved. The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.?

Full post as published by Illinois Injury Lawyer Blog on April 16, 2011 (boomark / email).