Stryker indicted

Stryker Corporation learned today that a federal grand jury in the District of Massachusetts has returned an indictment charging Stryker Biotech LLC and certain current and former employees of Stryker Biotech with wire fraud, conspiracy to defraud the U.S. Food and Drug Administration (FDA), distribution of a misbranded device and false statements to the FDA. The Company disclosed in March of this year that its Biotech division was the target of a federal grand jury investigation being conducted by the U.S. Attorney's Office for the District of Massachusetts.

Specifically, the indictment accused Stryker Biotech LLC of promoting the use of two devices made for spinal and long bone surgeries for applications that had not been approved by the US Food and Drug Administration.

The Stryker products, called the OP-1 Implant and OP-1 Putty, have only been approved for rare cases. But prosecutors said the company encouraged doctors to use the devices, which were designed to stimulate bone growth, more broadly in combination with a bone void filler, called Calstrux, which has never been formally tested in humans or approved by federal regulators. Prosecutors said some patients who received the combination suffered serious medical problems.

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