FDA Enforcement Report involves Guidant Corp.
October 7, 2005 10:09

Guidant Corp. shares dropped more than $2 a share Thursday after a New York Times report that criminal investigators for the U.S. Food and Drug Administration questioned two former employees of the medical device maker.

But given the attention the Guidant recalls have received over the past few months, Gunderson expects that the FDA is conducting an extremely thorough investigation before giving the company a clean bill of health so as not to be subject to criticism later.

http://www.rednova.com/news/health/256099/guidant_shares_drop_after_report_of_fda_investigation/index.html?source=r_health

It was March in the high desert West but the day felt more like early summer as the young couple rode out on rented mountain bikes along a trail that ran through the red rock canyons outside Moab, Utah. The two college students met only a few months earlier, in late 2004. But the couple, Jessica Lemieux and Joshua Oukrop, had talked in recent days about their lives together and marriage. From behind, where Mr. Oukrop was riding, she heard him call out, "Hold on, I need to..." When she turned, he was already falling backward, the bike tumbling on top of him. She pulled off his helmet. He gasped once, and then he stopped breathing. Mr. Oukrop, a 21-year-old student who suffered from a genetic heart disease, died of sudden cardiac arrest even though a medical device known as a defibrillator had been implanted in his chest to protect him from potentially fatal heart rhythms. His death set off a series of events that would expose flaws in how producers of critical heart devices disclose defects to doctors and patients. It also would reveal that the Food and Drug Administration's oversight of the fast-growing heart device industry is, at best, loose. Two months after Mr. Oukrop's death, the Guidant Corporation, the country's second-biggest maker of heart defibrillators, acknowledged that it had not told doctors for three years that one model had short-circuited in about two dozen cases, including the one involving him. It turns out that the same type of electrical defect that destroyed Mr. Oukrop's defibrillator also caused another heart device from Guidant to malfunction. Short circuits involving that device, an advanced pacemaker that also contains a defibrillator, have been associated with the deaths of three patients. Guidant said recently that it was aware of 49 short-circuit reports involving both devices, out of a total of 42,000 units produced, a malfunction rate that the company has characterized as low.

Barry Meier, The New York Times.