A report in the Salt Lake Tribune concerns 50 Utah women who have joined thousands of plaintiffs nationwide in lawsuits against vaginal mesh manufacturers.
The report includes an interview with an unnamed Utah woman in her 50s who had the device implanted in order to treat a leaky bladder. Not only did the device fail to cure problems, but it also caused her constant pain in addition ...
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Johnson & Johnson will reportedly pay a settlement in the neighborhood of $2 billion to settle federal charges that the company used illegal tactics in marketing its antipsychotic drug Risperdal.
The federal probe prompting that settlement included investigations into the company’s alleged kickbacks to Omnicare Inc., a company that dispenses drugs at nursing homes, to boost sales of certain medicines.
In light of Johnson & Johnson’s enormous profits, some observers have questioned ...
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The federal Food and Drug Administration has unveiled a plan to track high-risk medical devices.
A Wall Street Journal report on the policy says that it would require the high-risk devices to carry identification numbers. Jeffrey Shuren, director of the FDA’s medical-device center, described the plan as “a major game-changer” and said the agency plans to ramp up efforts to identify malfunctioning medical devices early.
For a long time, public safety advocates ...
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Members of a U.S. Food and Drug Administration panel that recently discussed metal-on-metal artificial hip implants said they wouldn’t recommend that patients get them, although the FDA as a whole has so far stopped short of an official ruling on the devices.
Still, the FDA Website has a section advising orthopedic surgeons who are performing metal-on-metal hip implantation surgery. And the FDA’s recommendations clearly reflect concerns about the devices shedding toxic ...
continue reading...According to Bloomberg, Johnson & Johnson continued selling a vaginal mesh implant for nine months after the U.S. Food and Drug Administration ordered the company to stop.
In a letter from August, 2007, the FDA told Johnson & Johnson to halt sales of Gynecare Prolift until the agency decided whether the device was “substantially equivalent” to other products on the market. The letter cited the “potential high risk for organ perforation” ...
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