Guidance for the Postmarket World 4020

Originally Published MX May/June 2006

GOVERNMENTAL AND LEGAL AFFAIRS

With the court of public opinion watching, industry stakeholders are struggling to address patient safety issues that arise in products already on the market.

Lori Luechtefeld

Product liability lawsuits are nothing new for medical device manufacturers. In fact, most medtech executives acknowledge that such suits do and always will come with the territory of manufacturing complex, high-technology products. However, the public spotlight on product liability issues surrounding medical device defects has arguably never been as bright as it has become over the past year. And at the heart of the controversy stands cardiovascular product manufacturer Guidant Corp. (Indianapolis).

Over the past year, the company has 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.¹ 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.