Boston Scientific has reached a $195 million deal to settle what it terms “a series of product communications” issued by medical devices maker Guidant Corporation during 2005-6, a company it acquired last year in a $27 billion deal.
The agreement was sealed before US magistrate judge Arthur Boylan in Minneapolis and covers around 4,000 claims that were consolidated together in the US District Court for the District of Minnesota in a Multi-District Litigation over faulty heart defibrillators and pacemakers. The court case had been scheduled to start on July 30, but has now been suspended.
"We are pleased by this resolution, which is in the best interest of all involved," said Jim Tobin, president and chief executive of Boston Scientific. "It will better allow us to focus our time and resources on developing innovative products to serve physicians and patients."
Between 2005 and 2006, Guidant was forced to issue a series of safety warnings for or recalled 88,000 of its defibrillators and over 200,000 of its pacemakers after defects were observed, but allegedly continued to sell the devices despite already being aware of the problems.
Last year, an independent inquiry commissioned by Guidant concluded that the firm’s strategy for reporting problems with its products failed to take patient safety into account. “We found overall device reliability to be well within acceptable performance expected of devices of that type, but internal and external communications methods burdened the company’s ability to manage and communicate low frequency malfunctions,” commented panel chair Dr Robert Myerburg, Professor of Medicine and Physiology at the University of Miami.
Boston Scientific had set aside $732 million to cover expenses in the cases as of March 31, it said in a regulatory filing with the US Securities and Exchange Commission. However, an undetermined number of claims still remain to be resolved.