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Originally Published MX March/April 2008 BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT
Corporate Conduct amid Recalls
In recent years, both the pharmaceutical and medical device industries have been hit by many high-profile product recalls, the effect of which has been to undermine the nation’s confidence in nearly every segment of the healthcare sector.
In particular, product recalls by cardiovascular product manufacturer Guidant Corp., now part of Boston Scientific Corp. (Natick, MA), have garnered significant attention both in the media and in courtrooms. During 2005 and 2006, the company recalled hundreds of thousands of its implantable cardioverter-defibrillators (ICDs) and pacemakers due to the possibility for malfunction.
Although recalls are not unusual among medtech manufacturers, the debate surrounding Guidant intensified after The New York Times reported that the company failed to properly inform physicians and patients about a potentially fatal flaw in its devices. Company executives defended the decision to limit notification by asserting that the devices met engineering standards and that the risk involved in surgery to remove the devices was greater than the risk associated with leaving the device implanted.
As Guidant’s acquirer, Boston Scientific currently faces numerous class-action and individual lawsuits nationwide. Of greater importance to medical device manufacturers outside of Boston Scientific–Guidant is the attention and reaction that company’s woes have drawn, not only from the public and media outlets, but also from industry leaders and regulatory agencies.
Copyright ©2008 MX
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