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US biotech Stryker fined $15m for improper marketing

Boston-based firm promoted an unapproved mixture of human bone growth products

Stryker Biotech has been fined $15m after pleading guilty to misbranding and marketing an unapproved mixture of human bone growth products.

The Boston-based company, which is part of medical device manufacturer Stryker Corp, was marketing a combination of its OP-1 and OP-1 Putty products with the bone filler Calstrux.

In March 2009 the US Attorney's Office for the District of Massachusetts filed a grand jury indictment over the illegal marketing scheme.

This included 13 felony charges against Stryker and three of its former sales managers.

OP-1 products had been approved under a narrow humanitarian device exemption (HDE) since 2004, and could only be used in the treatment of one rare condition (in patients who have had a failed posterolateral spinal fusion).

The products were also not licensed to be sold for profit. Stryker is alleged to have made $12.5m by marketing the mixture, which had never been studied clinically in human beings, had no FDA approval and was later withdrawn from the market, to surgeons to promote bone growth in the spine.

The company tracked 63 adverse events from more than 10,000 procedures using the mixtures (less than 1 per cent of treated patients), which in some cases meant that patients suffered “serious medical problems” or were required to undergo further surgery, said the US Justice Department.

The court case also saw a number of Stryker personal charged with wrongdoing, including former sales managers David Ard, William Heppner and Jeffrey Whitaker, who were on trial for conspiracy to defraud.

The charges against Ard have now been dropped and Heppner and Whitaker's legal representatives asked the judge to declare a mistrial.

Meanwhile, Stryker company president Stephen MacMillan will no longer be called to testify in connection with current or future trial proceedings, but former CEO Mark Philip is still scheduled to go on trial in connection with the case later this year.

Stryker, which was facing a maximum fine of $25m, said it had reached an "appropriate resolution" to the case.

20th January 2012

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