Serono employee pleads guilty to software charge

A medical director for Serono Laboratories Inc., Norma Muurahainen, pleaded guilty in federal court today to helping distribute medical software to diagnose AIDS wasting, without first winning approval from the Food and Drug Administration.

Though other employees were involved, the US Justice Department argued that Muurahainen had the power to stop the shipments, but declined to do so.

Serono already agreed to pay $704 million to resolve criminal charges that it was involved in several illegal schemes to promote its drug, Serostim, which is used to treat AIDS wasting. A medical manufacturer, RJL Sciences Inc., and its president are awaiting sentencing for conspiring with Serono Labs to distribute the unapproved software.

Muurahainen, 56, of Hull faces up to 3 years in prison and a $300,000 fine. Sentencing is scheduled for Oct. 29.
(By Todd Wallack, Globe staff)