For the last few months, Guidant Corporation has been justifiably pilloried in the media for continuing to market a model of heart defibrillator three years after discovering a potential defect in it. Only in May, when the New York Times broke the story of a 21-year-old Minnesota man whose Guidant Ventak Prism 2 short-circuited and caused a fatal cardiac arrest, did the company reluctantly issue a recall of the devices. Subsequently, another death and at least 45 non-fatal failures of the devices have been reported.
Now comes the news that the Food and Drug Administration knew about the defective defibrillators months before issuing its recall notice. At least one person has died and thousands more are at risk on account of an unrepentant company, aided and abetted by an irrational federal agency whose ostensible mission is to protect the public. While the FDA received a report from Guidant disclosing the potential flaw in February, the agency did not make it public because such information is treated as confidential. The FDA’s spokesman told the Times that it would consume too many resources for the agency to review which filings should be released and which should not.
If there is a monument to irresponsibility that rivals FEMA, this is it. Twenty four thousand of these devices, any one of which could short circuit at any moment, have belatedly been recalled. This is inexcusable to the point of criminality. We cannot trust the government to do the right thing when it comes to protecting our basic health, welfare and security in the face of a natural disaster, and now we discover that it withholds vital information because it’s too busy.
"That’s our policy" has been policy for too long. It’s no excuse when people die. Have government bureaucrats become so insulated and callous that accountability is a foreign concept to them?