Coverup of Medical Device Failure

Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. Such devices can fail prematurely for a variety of reasons, but the early replacement rate is typically 1 percent after a year, or 5 percent at five years.  However, the New York Times reported that an internal analysis conducted by Johnson & Johnson in 2011 estimated that the all-metal hip implant device would fail within five years in nearly 40 percent of patients who received. The company’s analysis showed that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it. "Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate."

"The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take."

"About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States. There are two versions of the A.S.R., one used in standard hip implants and the other used in an alternative replacement procedure known as resurfacing. Only the standard implant was sold in the United States. Both versions of the A.S.R., however, used the same metal hip cup as part of their design."

 

Trackbacks (0) Links to blogs that reference this article Trackback URL
http://www.scnursinghomelaw.com/admin/trackback/294520
Comments (0) Read through and enter the discussion with the form at the end
Post A Comment / Question Use this form to add a comment to this entry.







Remember personal info?
Send To A Friend Use this form to send this entry to a friend via email.