Questions raised on whether medical device industry embraced safety reforms

April 19, 2012

The New York Times (4/19, B1, Meier, Thomas, Subscription Publication) reports, “As doctors scramble to understand the risks posed by a flawed heart device component made by St. Jude Medical, the episode is raising a bigger question — whether the $10 billion heart device industry has fully embraced promised safety reforms.” In 2005, “the industry was shaken in 2005 by disclosures that a major maker of heart defibrillators, Guidant, had not warned doctors about a potentially fatal flaw in its products,” and “now the same issues that dogged device makers seven years ago are resurfacing amid a controversy over how St. Jude Medical has handled disclosures about a problem component, a wire — or lead — that connects a defibrillator to a patient’s heart.”

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