Posted by Del on November 28, 1999 at 13:10:55:
Here's a few paragraphs of the article.The lawsuit alleges that the Buckman Company, a consultant for medical device manufacturers, used misrepresentations to get the Food and Drug Administration's go-ahead in 1986 for marketing a device known as the Variable Screw Placement Spinal Plate Fixation System.
The FDA had rejected Buckman's two previous applications, made on behalf of AcroMed, for marketing the device. But a third application, which separated the device into its component parts and indicated that the screw would be used in arm and leg bones rather than in the spine, was approved.
Thousands of people who contend they were injured after the bone screws were implanted into their spines sued Buckman, alleging that it had perpetrated a fraud against the FDA. The lawsuits, eventually consolidated into one massive case, sought monetary damages.
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