Here's yet another story about how health care executives can hide bad news which might have slowed their cash flow, and then delay taking any responsibility for their actions.
Based on an ongoing grand jury investigation, The Boston Globe reported how Boston Scientific Corporation continued to ship coronary artery stents in 1998 even though its leaders knew that internal testing showed that 10% of the balloons used to insert the stents were failing. During a conference call, the Boston Scientific CEO admitted "we're shipping adulterated product, and we cannot do that." Instead of halting shipments, and recalling stents already shipped, however, Boston Scientific executives decided to "engage" with the FDA to delay a recall. The company also sent a "Dear Doctor" letter reminding physicians to insert the stents using proper procedures, which implied that stent failures were due to incorrect placement procedures. There was no evidence that this was the case. The letter failed to mention the balloons' 10% failure rate, or that Boston Scientific had made changes to the stent manufacturing process that the FDA had not approved. Meanwhile, Boston Scientific was shipping stents worth about $1.5 million a day, and physicians, unaware of these issues, were continuing to insert apparently defective stents from existing stocks.
The criminal investigation of Boston Scientific has gone on for six years without any clear results. The CEO of Boston Scientific, in fact, had predicted that it would be a long time before the company paid any penalty for its actions, "another three or four years and ... Boston Scientific would then settle with a consent decree and a fine."
Club 329: Part 4 - Editorial Note: This post perhaps should be called: There’s Something about Leonie. The image above is of a Rapid Response she submitted to a BMJ editoria...
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