The company, former president Mark Philip and three current sales managers were indicted on charges of promoting the off-label combination of two bone growth products and lying to the FDA.
Stryker Biotech, its former president and three current sales managers were slapped with federal charges of promoting the off-label use of a pair of bone-growth products and lying to the Food & Drug Administration.
The Hopkinton, Mass.-based firm and its former president, Mark Philip, along with sales managers David Ard, Jeff Whitaker and William Heppner, were indicted by a grand jury on charges of wire fraud and conspiracy. Stryker and Philip were also charged with making false statements to the FDA.
The indictment alleges that the defendants were part of a scheme to promote the combined use of a pair of separate bone-healing products, each granted a narrow, provisional "humanitarian device exemption" by the FDA.
Combining the treatments and devices — the OP-1 Implant, OP-1 Putty and the bone void filler Calstrux — caused adverse effects in patients ranging from minor irritations to infections requiring follow-up surgeries.
The Indictment also charges that Stryker and Philip lied to the FDA about the number of patients treated each year with OP-1 Putty.
In a prepared statement, Stryker said it is "disappointed" about the indictment and "still hopes to be able to reach a fair and just resolution of this matter."
"Conviction of these charges could result in significant monetary fines and Stryker Biotech's exclusion from participating in federal and state health care programs, which could have a material affect on Stryker Biotech's business," according to the statement. "As a matter of company policy Stryker will not have any further comment on these allegations."
The case began last November, when former Stryker sales rep Darnell Martin (PDF) pleaded guilty to the off-label promotion scheme and to faking clinical trial approval paperwork.
Martin said he learned that Stryker had fired another, unnamed sales manager after it discovered falsification of the same type of approval paperwork, prompting him to send emails to the Hopkinton subsidiary in an attempt to cover his tracks.
The company motivated its sales force with bonuses for meeting quotas for clinical trial approvals, according to Martin's plea agreement.
NeuWave Medical raised more than $25 million in equity financing as it works to advance the market...
ConforMIS files for an initial public offering worth up to $173 million for its customized joint...
Here's a look at some of the top legal news stories for medical device companies this week: PAD:...
Mind-controlled prosthetics allow quadriplegic Erik Sorto to drink his 1st beer in a decade by...