GRASSLEY INVESTIGATES GUIDANT MANUFACTURING PRACTICES
Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, is investigating Guidant's manufacturing practices to determine if the company has violated agreements it reached with the federal government in light of past problems with its heart devices. In a Sept. 22 letter, Grassley, whose committee has jurisdiction over the Medicare and Medicaid programs, asked Guidant for a variety of documents to help determine whether the company violated a Corporate Integrity Agreement it entered with the HHS' Office of Inspector General in 2003. The agreement required the company to alert the government to problems with its products.
"Taxpayers spend a lot of money through the Medicare and Medicaid programs for medical devices, so I have a responsibility to make sure these products are safe and that the federal agency charged with reviewing their safety is doing its job," Grassley said. "National health care programs shouldn't have to rely on a three strikes and you're out program when lives are at stake."
The senator's request comes a day after the company announced another round of recalls of its heart devices. This announcement comes on the heels of controversy over flaws in Guidant's implantable cardioverter defibrillators, which have been blamed for at least one death.