Senators propose bill concerning unsafe medical products
Posted by William D Davis on Monday, February 13, 2012
Under: Health
Reaching out to fellow Republicans and seeking bipartisan support, US Democrats aim to block of medical devices with safety issues, Bloomberg reports. They mentioned injuries from flawed medical products, including those manufactured and distributed by Johnson & Johnson.
In a statement released by the Democrats led by Representative Edward Markey of Massachusetts, he explained that the bill introduced would close a loophole that lets devices win approval on the basis of their similarityt to a product alreadymarketed and sold in the market.
The bill also requires the Food and Drug Administration (FDA) to review previously cleared products to determine whether any have recalls in their device lineage, as was reported by Bloomberg News.
For the bill to become law, it would need to pass the Republican-controlled House and Democratic-led Senate and then win US President Barack Obama’s signature.
Markey’s bill is one of more than a dozen introduced in Congress to overhaul device reviews, in response to consumer advocates who say products need to be safer and industry group spokesmen who say the process is too strict.
Case of Johnson and Johnson’s Recalled Hip Devices
As for Johnson & Johnson’s case in particular, after information was out saying that the devices have defects in one out of eight clients, the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. These devices were manufactured in 2003 by DePuy Orthopaedics Inc., a subsidiary of Johnson& Johnson. There are about 93,000 recipients of these products worldwide, including 40,000 in the US alone.
In November, a legislative panel in Australia issued a report concluding that Johnson & Johnson was possibly well-aware of the serious setbacks of DePuy hip replacement before recalling it in August 2010.
“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian media report said.
Included in the list of the complications that may result from DePuy hip implants are loosening of hip device, additional hip replacement surgery, detachment of hip device from the bone, unexplained hip pain, hip dislocation, metal toxicity (metallosis), pseudotumors, genetic damage (genotoxicty), bone fractures, bone loss, tissue damages and cancer due to the presence of chromium and cobalt in the blood.
Increasing Number of Lawsuits against Johnson and Johnson
As of early October 2011, there were already approximately 3,500 DePuy hip replacement lawsuits that have been filed against Johnson & Johnson in connection with their hip replacement devices. DePuy advises their clients to consult a doctor for the evaluation of their hip replacement device.
References:
- bloomberg.com/news/2012-02-02/
democrats-want-to-let-fda- block-devices-tied-to-safety- recalls.html - arthritistoday.org/news/asr-
depuy-hip-replacement- recall078.php - nursinghomesabuseblog.com/
defective-products/defects- with-depuy-hip-replacement- hardware-may-be-responsible- for-complications-following- hip-surgury/
In : Health
Tags: depuy depuy hip recall hip replacement hip devices health