November 4, 2005 |
With one day left for Johnson & Johnson to seal the deal on its $25.4-billion acquisition of Guidant Corp., New York Atty. Gen. Eliot Spitzer said Thursday that he was suing Guidant, alleging it concealed information about a heart defibrillator's design flaw. Shares of the Indianapolis-based maker of medical devices fell 4.7%, or $2.83, to $57.57. J&J lost 10 cents to $61.20.
November 3, 2005 |
Johnson & Johnson warned Wednesday that it might pull out of a $25.4-billion deal to buy Guidant Corp. because of potential liability arising from the medical device maker's sweeping product recalls and a regulatory investigation. But Guidant executives said J&J was legally bound to go through with the deal. "Recent product and communications issues have certainly had an impact on our business in the near term," Guidant Chief Executive Ronald W. Dollens said.
October 14, 2005 |
Guidant Corp. told U.S. regulators that it learned of six additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms. The failures occurred in the Contak Renewal and Renewal 2 brand of devices, the Food and Drug Administration said. The two devices were among models included in warnings Guidant sent to doctors in June.
September 23, 2005 |
Guidant Corp. issued recalls or safety advisories for almost 170,000 of its top-selling pacemakers Thursday after a two-week federal inspection of its cardiac unit. Since June, Indianapolis-based Guidant has recalled or issued warnings for about 88,000 implanted defibrillators -- including its leading seller, the Contak Renewal 3 -- and almost 200,000 pacemakers because of reported malfunctions.
August 2, 2005 |
Guidant Corp. said Monday that it had received U.S. approval to relaunch its top-selling implantable heart failure devices after a recall and that sales would resume as early as midweek. The approval by the Food and Drug Administration for the Contak Renewal 3 device in the United States means Guidant soon will have a complete product line on the market again. This should help dispel lingering doubts that its deal to be acquired by Johnson & Johnson for $25.4 billion is in peril, analysts said.
July 23, 2005 |
A recall by Guidant Corp. of certain heart pacemakers has been classified as the most serious type of recall, the Food and Drug Administration said. Guidant's action, announced July 18, was deemed a Class 1 recall, reserved for when there is "a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death."
July 21, 2005 |
Guidant Corp. won a ruling that upholds a patent related to implantable pacemakers and defibrillators, a victory in its bid for royalties from Medtronic Inc., a rival medical device maker. U.S. District Judge Sue Robinson in Wilmington, Del., upheld the validity of the patent. Medtronic filed suit in August 2003 to have the patent invalidated.
June 25, 2005 |
A second safety warning from Guidant Corp., one of the nation's largest medical device manufacturers, urged doctors to stop using five defibrillator models because they could malfunction and may have to be recalled. Indianapolis-based Guidant announced its second worldwide safety advisory in a week Friday, after voluntarily recalling seven defibrillator models last week. The pager-sized, implantable devices sense an irregular heart rhythm and shock the heart back into correct beating.
June 18, 2005 |
Under pressure after malfunctions in at least 45 implanted defibrillators, including two that are suspected in patient deaths, Guidant Corp. on Friday recalled nearly 50,000 of the devices worldwide. For the Indianapolis-based company -- its stock price dropped nearly 2% on the news -- the recall means a financial blow as it prepares to be acquired by health giant Johnson & Johnson. For many patients, it means surgery to replace suspect devices.
June 3, 2005 |
Medical device maker Guidant Corp. on Thursday stood by its decision to continue selling an implantable heart defibrillator for months after a potential flaw prompted a redesign, saying the original device was still reliable. "The reliability data showed that the original Ventak Prizm 2 DR, like the enhanced version, was a highly reliable lifesaving product," said Steve Tragash, Guidant's director of corporate communications. "Current data continues to support the reliability of this product."