This week isn’t going to get any better for DePuy Inc., as the Johnson & Johnson (NYSE:JNJ) subsidiary is set to have its dirty laundry aired in front of a Senate panel tomorrow.
The U.S. Senate’s Special Committee on Aging announced that the Warsaw, Ind.-based company’s massive hip replacement system recall will be front and center during its examination of the FDA and its role in “protecting patient safety as part of the medical device approval process,” according to a prepared release.
DePuy is already at the center of a $70 million deferred prosecution agreement J&J signed late last week to settle a federal bribery beef.
The Senate committee will hear from a patient affected by the recall, as well as some leading patient safety advocates, including Diana Zuckerman, the president of the National Research Center for Women and Families. Zuckerman was a co-author of a February 2010 report that claiming that recalls are more common in devices that went through the 510(k) pre-market notification program that for the FDA’s more-stringent PMA protocol.
Other witnesses include Dr. William Maisel, chief science officer for the FDA’s Center for Devices & Radiological Health; Ralph Hall, a professor at the University of Minnesota Law School; and David Nexon of the Advanced Medical Technology Assn.
“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 committee wrote. “The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”
DePuy Orthopaedics Inc. announced in August 2010 that it was voluntarily recalling its ASR hip replacement system after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants. The company said it was pulling the ASR XL Acetabular and ASR Hip Resurfacing systems from the market “due to the number of patients who required a second hip replacement procedure, called a revision surgery.”
Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. DePuy, which introduced the ASR in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits.
DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a “higher-than-expected” failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.
The Senate committee hearing will be followed by a hearing in the House Thursday, which has a much more industry-friendly tone. The House Oversight & Government Reform Subcommittee on Health Care
is scheduled to hold its “Pathway to FDA Medical Device Approval: Is there a Better Way?” hearing April 14, to “study the FDA’s inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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