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Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA
Date:2/25/2010

ning the FDA's role to guard the American public against potentially dangerous medical devices," said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. "Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law."

"The community has the right to expect that companies that violate federal law by submitting false or misleading information to the FDA will be held accountable, particularly when that information relates to lifesaving devices, such as defibrillators," said Frank J. Magill, Acting U.S. Attorney for the District of Minnesota on this case. "I want to thank the prosecutors and investigators responsible for this challenging investigation that resulted in these charges being filed. For that, we all can be very thankful."

"This investigation highlights the commitment by FDA's Office of Criminal Investigations to pursue those who seek to circumvent FDA's regulatory authority," said Thomas P. Doyle, Special Agent in Charge of the FDA/OCI Washington Field Office. "The FDA relies on information submitted by regulated entities to fulfill our mission of protecting the public health. Device manufacturers are required to be honest and forthright in all dealings with the FDA, including the submission of post-approval reports and notification of corrective actions. Guidant put patients at risk by modifying f
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SOURCE U.S. Department of Justice
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