Federal probe of Stryker ongoing in off-label promotion case

February 27, 2009 by MassDevice staff

Second Stryker sales manager pleads guilty to promoting the combination of a pair of human bone growth products, despite earlier knowledge of problems with the combination

A federal investigation of Hopkinton’s Stryker Biotech is still underway after a second guilty plea by a former Massachusetts sales manager for the Michigan-based Stryker Corp. subsidiary, which develops bone injury repair products, according to news reports.

Two weeks ago, former territory manager Justin Demming admitted to promoting the combined use of a pair of separate bone-healing products, each granted a provisional “humanitarian device exemption” by the FDA, a designation Massachusetts federal attorney Michael Sullivan’s office termed among the “narrowest” of approvals the agency bestows.

Combining the treatments and devices caused “adverse effects” in patients ranging from minor irritations to infections requiring follow-up surgeries, according to the Boston Business Journal, which reported the first Stryker sales manager’s guilty plea in November 2008.

Demming knew about the adverse outcomes when he promoted the products’ off-label use beginning in February 2006, according to his plea agreement — despite the August 2006 recall of one of the bone void-filling products, Calstrux, for what the FDA called a “lack of labeling precautions,” the business journal reported.

Last November, Darnell Martin pleaded guilty to the same 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.

Martin said the company motivated its sales force with bonuses for meeting quotas for clinical trial approvals, according to his plea agreement.