By Thomas M. Burton
Federal authorities reached a tentative consent agreement with
medical device maker Medtronic Inc. over flaws in its SynchroMed
infusion pump for cancer and pain medicine, which has been linked
to serious injuries and deaths.
The Justice Department, working with the federal Food and Drug
Administration, filed the consent decree along with a legal
complaint alleging that Medtronic, its chief executive officer, S.
Omar Ishrak, and its senior vice president, Thomas M. Tefft, have
distributed "adulterated" devices because they weren't manufactured
in accordance with current good manufacturing processes.
Under the proposed decree, Medtronic has agreed to stop
manufacturing and distributing new versions of the SynchroMed II
pump except in extraordinary cases such as when a treating
physician certifies that the pump is medically necessary.
Medtronic didn't immediately respond to a request for
comment.
Write to Tom Burton at tom.burton@wsj.com
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