Legal documents released in Johnson & Johnson’s trial regarding all-metal hip implants reveal that the company was aware of problems with the devices in 2008 – two years before recalling them, the Wall Street Journal reports.
For example, the company was in possession of clinical data showing “extreme” levels of metal ions in patients who received the devices, compared to patients who received a product from a rival company. The all-metal ...
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The U.S. Food and Drug Administration has sent a warning letter to medical device manufacturer St. Jude Medical, warning of problems with manufacturing and quality control at the California plant where the company makes implantable heart defibrillators.
A story in the New York Times notes that the St. Paul-based company has been struggling to deal with problems involving wires that are used to attach the defibrillator to the heart. The wires ...
continue reading...The U.S. Food and Drug Administration is proposing a policy that could prevent manufacturers from selling dangerous metal-on-metal hip implants, according to a story in the New York Times.
The story says all-metal hips – which have both a ball and a socket coated with a combination of cobalt and chromium – have been plagued by high early failure rates.
Traditional hip ...
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The U.S. Food and Drug Administration says metal-on-metal hip implants, which feature both a ball and a socket coated in a mixture of cobalt and chromium, can cause soft-tissue damage. According to a Reuters story, the agency warns that the implant defects can make further surgery necessary.
The problem, according to the FDA, is that the implants can shed metal debris when the ball and socket slide against each other during ...
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During a trial over vaginal mesh implants, a Johnson & Johnson official testified that the company was well aware the medical devices were dangerous before putting them on the market in 2005.
In the first of 1,800 such lawsuits to go to trial, a 47-year-old South Dakota woman named Linda Gross is suing over allegations that the health care giant failed to adequately test the devices or warn patients of their ...
continue reading...A CNN story concerns a congressional investigation into pharmaceutical giant Johnson & Johnson, based on reports that the company tried to mislead the public about defective products.
Specifically, the story focuses on an alleged “phantom recall” of painkiller Motrin. According to the story, the U.S. Food and Drug Administration eventually initiated a nationwide recall of more than 88,000 Motrin tablets because of a problem with the way the drug dissolved.
But the ...
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