The New York Times, "Guidant Case May Involve Crime Inquiry"

         Criminal investigators at the Food and Drug Administration have apparently become involved in the agency's inquiry into how the Guidant Corporation handled problems with its heart devices, said two people contacted by the investigators.
          Since June, the F.D.A. has been looking into several issues involving Guidant, including whether it properly reported failures of some of its heart devices and manufacturing changes to correct the problems. The agency's Office of Criminal Investigations is often called upon to examine such issues.
          The disclosure comes as a pending $25.4 billion takeover by Johnson & Johnson of Guidant, the nation's second-biggest heart device maker, nears completion.
          A spokeswoman for the F.D.A., Julie Zawisza, said the agency, as a matter of policy, did not confirm or deny the existence of a criminal investigation. In a statement, a spokesman for Guidant, Steven Tragash, said he was not aware that the company had been contacted.
          In that statement, however, he added, "We are aware that former employees have been interviewed by the F.D.A. in connection with their activities when they were with Guidant." He did not elaborate.
          In separate interviews, the two people said F.D.A. officials who had identified themselves as criminal investigators had contacted them in recent weeks. Both people, citing the potential sensitivity of the investigation, spoke on the condition of anonymity.
          Neither the direction of the agency's inquiry nor its progress is clear. But one federal prosecutor said that it was not unusual for the agency's criminal investigators to get involved if there were indications that a company might not have complied with the agency's reporting requirements.