DOJ Settles Defective Device Claims
Defibrillator manufacturer violated FDCA by withholding information.
April 05, 2010 at 08:00 PM
2 minute read
The original version of this story was published on Law.com
The Department of Justice announced April 5 that Guidant LLC, a unit of Boston Scientific, will pay criminal penalties of more than $296 million to settle charges related to short-circuiting failures in implantable heart defibrillators. The proposed resolution would be the largest criminal penalty ever imposed on a device maker for violating the Federal Food Drug and Cosmetic Act (FDCA).
Guidant was charged Feb. 25 in U.S. District Court for the District of Minnesota and pleaded guilty Monday to criminal violations of the FDCA. It admitted to withholding information from the Food and Drug Administration regarding “catastrophic failures” in some of the devices.
“The guilty plea today should serve as a reminder and deterrent to those who would break the laws requiring honesty and cooperation with government regulators whose mission is to protect the health and safety of the public,” said Frank J. Magill, U.S. Attorney for the District of Minnesota, in a statement.
To read the DOJ press release, click here: http://www.justice.gov/usao/mn/econ/econ0411.pdf
The Department of Justice announced April 5 that
Guidant was charged Feb. 25 in U.S. District Court for the District of Minnesota and pleaded guilty Monday to criminal violations of the FDCA. It admitted to withholding information from the Food and Drug Administration regarding “catastrophic failures” in some of the devices.
“The guilty plea today should serve as a reminder and deterrent to those who would break the laws requiring honesty and cooperation with government regulators whose mission is to protect the health and safety of the public,” said Frank J. Magill, U.S. Attorney for the District of Minnesota, in a statement.
To read the DOJ press release, click here: http://www.justice.gov/usao/mn/econ/econ0411.pdf
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