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Home » Third Stryker Biotech rep cops plea in off-label promotion case

Third Stryker Biotech rep cops plea in off-label promotion case

April 15, 2009 By MassDevice staff

U.S. Attorney Michael Sullivan is making his last week on the job a busy one.

Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.

Winchester’s Shane Doyle, 32, a former territory manager for Stryker, pled guilty to a single felony misbranding count. He faces up to three years in prison and a $250,000 fine from Judge Douglas Woodlock when he’s sentenced July 23, followed by a year of supervised release.

Doyle is the third former rep from Hopkinton-based Stryker to plead guilty in the case, in which the reps admitted to promoting 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 caused adverse effects in patients ranging from minor irritations to infections requiring follow-up surgeries.

It will be one of Sullivan’s last successes as Boston’s top prosecutor, Lawyers Weekly reported, as his last day on the job is set for April 19. Sullivan was appointed in 2001 by President George Bush.

His top deputy, Michael Loucks, is expected to get the nod to replace Sullivan, who’ll cross to the other side of the legal world as a defense attorney for a prominent Boston law firm.

The Stryker case began last November, when Darnell Martin (PDF) pleaded guilty to the off-label promotion scheme and to faking clinical trial approval paperwork for a third Stryker product.

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 that attempted 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.

In February, the second former rep, Justin Demming (PDF), admitted to participating in the off-label scheme.

Filed Under: Biotech, Business/Financial News, Orthopedics

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