(NaturalNews) The federal government has indicted a Swiss medical device company and four of its top executives on charges of illegally marketing two experimental spinal cements without FDA approval.
While U.S. law allows medical professionals prescribe or use any treatment that they think would be effective, it prohibits manufacturers from actively marketing any product for a nonapproved ("off-label") use.
"It's not proper for companies to do that without getting approval from the FDA," U.S. Attorney Mark Levy said.
The indictment alleges that Synthes Inc. marketed two kinds of
bone cement, SRS and CRS, to
doctors without FDA approval, leading to 200
patients being treated with the
products off-label.
Synthes and its U.S. subsidiary Norian stand accused of 97 criminal counts, including impairing the functions of
the FDA, shipping a misbranded product across state lines, and deliberately making false statements to the
FDA in order to cover up its illegal, off-label
marketing practices. If convicted, Synthes could be punished with a fine of up to $8.8 million, while Norian could be fined up to $26 million. Indicted executives Richard Bohner, Thomas Higgins, Michael Huggins and John Walsh are facing up to a year in prison and fines of up to $100,000 each.
Three patients died between 2002 and 2004 from rapid
blood pressure drops while undergoing spinal surgery in unauthorized clinical trials of the products. Synthes ceased marketing CRS and SRS after the third patient's death.
Federal prosecutors claim that even before the unauthorized trials had begun, the company possessed preliminary data showing that CRS and SRS could produce
blood clots. Neither the company nor its executives are charged with the deaths of the patients, since doctors are unable to prove a direct connection between the bone cements and the drops in blood pressure.
Company spokespeople have declined to comment on the case.
Sources for this story include:
www.reuters.com.
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