Guidant Agrees to Bolster Reporting
From Reuters
Guidant Corp. said it agreed to strengthen its reporting of product malfunctions, bringing closure to a federal investigation of a vascular device linked to 28 deaths.
The Indianapolis-based company said it reached an accord with the inspector general’s office in the Department of Health and Human Services, the final step in a settlement between a Menlo Park, Calif.-based subsidiary and the Justice Department.
That settlement, announced June 12, included a $92.4-million fine and a guilty plea to 10 felonies for shipping misbranded products and for false statements by an employee.
On June 16, Guidant said it would stop making the device used for treating abdominal aortic aneurysms.
