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Stryker Biotech probe continues

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Health Care

A federal investigation into the marketing of a bone-healing product made by Hopkinton, Mass.-based Stryker Biotech is moving forward after prosecutors secured guilty pleas from two former salesmen.

Those pleas include an acknowledgement by the former salesmen that they promoted the use of the products in a way the company knew had created problems in the past under some circumstances.

A spokesman for Stryker Biotech’s parent Stryker Corp., Patrick Anderson, declined in an interview late Friday morning to comment on the investigation other than to say, “We’re in the process of responding to the Department of Justice.”

Stryker is a Michigan company with nearly $7 billion in annual sales.

Before the first guilty plea in the case in November 2008, Stryker Corp. (NYSE: SYK) already had been criticized by the U.S. Food and Drug Administration for failing to adequately monitor reports of problems with some products. Then in November and February of this year, U.S. Attorney Michael Sullivan’s office entered into plea arrangements with the former sales representatives.

Darnell Martin of Chicago and Justin Demming of Ohio signed agreements acknowledging they had encouraged medical professionals to combine Stryker’s bone products, even though the sales representatives knew doing so was not approved by the FDA and had produced “adverse events in some patients.”

Demming’s lawyer, Robert A. Griffith of Boston, declined Friday morning to comment.

Martin’s lawyer, Kathy B. Weinman of Boston, did not immediately return a telephone call Friday morning. In November, she declined to comment on her client’s guilty plea.

According to prosecutors, various Stryker employees distributed brochures giving instructions for mixing bone products in ways not approved by the FDA.

Court records do not elaborate on the “adverse effects,” but an FDA database of complaints shows there were at least several episodes of problems. Some of the events were reported by doctors.

As early as 2006, according to filings Stryker made with the FDA, the company had been made aware of problems among patients in whom the bone products had been mixed. Those problems ranged from minor irritation to infections that required follow-up surgeries.

Health Care