The federal criminal trial of Stryker, a medical device manufacturer, has begun in Boston, according to a Bloomberg News report.
The company, based in Hopkinton, Mass., is charged with allegedly misbranding products and its sales force with conspiring to defraud surgeons. The sales force team allegedly told surgeons to combine the company's OP-1 and OP-1 Putty with the bone filler Calstrux. A defense attorney said the company tracked 63 adverse events in more than 10,000 procedures.
At the start of the trial, a prosecutor said a unit of Stryker and three former sales managers put patients at risk by marketing an unapproved mixture of products for strengthening human bone growth, according to the report. The putties were cleared under the humanitarian exemption, but the company had no FDA approval to mix in Calstrux.
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The company, based in Hopkinton, Mass., is charged with allegedly misbranding products and its sales force with conspiring to defraud surgeons. The sales force team allegedly told surgeons to combine the company's OP-1 and OP-1 Putty with the bone filler Calstrux. A defense attorney said the company tracked 63 adverse events in more than 10,000 procedures.
At the start of the trial, a prosecutor said a unit of Stryker and three former sales managers put patients at risk by marketing an unapproved mixture of products for strengthening human bone growth, according to the report. The putties were cleared under the humanitarian exemption, but the company had no FDA approval to mix in Calstrux.
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Samsung Open to Partnering with Olympus on Medical Devices
Covidien Looking to Acquire Companies With Annual Sales of $20-120M
Three-Quarters of California Biomedical Companies Delayed Research or Development Last Year