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Prominent EPs oppose Guidant plea deal

This article was originally published in The Gray Sheet

Executive Summary

Doctors who first alerted FDA in 2005 to a heightened risk for some Guidant implantable defibrillators to short circuit have written a Minnesota District Court judge in opposition to a plea agreement between Boston Scientific/Guidant and the U.S. Department of Justice. Judge Donovan Frank has yet to rule on whether to accept the guilty plea to two misdemeanor counts of making false statements and failing to notify FDA on issues related to revisions and malfunctions with two ICDs (1"The Gray Sheet" April 12, 2010). "We are extremely dismayed by the U.S. Attorney General's decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for the egregious act," write cardiologists Robert Hauser and Barry Maron, both of the Minneapolis Heart Institute, in an April 12 2letter. "To allow a repeat offender like Guidant to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety." The doctors treated a 21-year-old patient who died in 2005 after his Prizm 2 failed to deliver a needed shock

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