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Boston Scientific Filing: 550 Lawsuits from Guidant Recalls Boston Business Journal \| August 11, 2006	February 2002 Guidant was aware that its defibrillators were short-circuiting at the rate of about one per month. April 16, 2002 The company made changes to the devices to attempt to correct the malfunction. In spite of the fact that the company had substantially modified the device, it continued selling the older, defective devices until May 23, 2005. March 14, 2005 Joshua Oukrop, a 21-year-old college student, collapsed and died during a bicycle ride with his girlfriend. His Guidant defibrillator short-circuited, leading to his death. May 23, 2005 Guidant first admits publicly the flaw with their heart devices after learning the New York Times was preparing to publish an article exposing problems with the Ventak Prizm 2 DR. June 17, 2005 Guidant announced the first of several recalls.
Boston Scientific Corp. has almost 550 individual and class action lawsuits pending due to problems with heard devices made by Guidant Corp., the device maker acquired in April. In a Bloomberg News report, Boston Scientific said there are 477 individual lawsuits and 72 product liability class action lawsuits related to Guidant's implantable defibrillators, Natick, Mass.-based Boston Scientific said in an August 9th filing with the U.S. Securities and Exchange Commission.
Boston Scientific Recalls More Guidant Heart Devices The Boston Globe \| June 26, 2006
Boston Scientific Corp. on Monday said it is recalling some defibrillator and pacemaker models that could fail because of an electrical flaw, the latest in a string of product problems Boston Scientific inherited when it bought Guidant Corp. in April for $27 billion.
Boston Scientific Warns of Flaw in Heart Aids The Boston Globe \| May 16, 2006
Boston Scientific Corp. yesterday said a batch of defibrillators from its newly acquired Guidant Corp. unit may stop working prematurely because of an electronic defect that causes the batteries to fail. The problems, disclosed in a warning letter to doctors, affect 996 defibrillators made by Guidant. No deaths or injuries have been linked to the defect, Boston Scientific said, but the battery failures could prevent the defibrillators from functioning properly and restarting a recipient's heart. The devices were not recalled.
Inquiry Arranged by Guidant May Aid Lawsuits and Critics The New York Times \| March 22, 2006
The Guidant Corporation may have gotten more than it bargained for when it appointed a panel last year to look into its practices after it came under scrutiny for its failure to publicize flaws in its heart devices. The 12-member panel not only urged the company to overhaul its disclosure process, but its full report, released yesterday, may provide plaintiffs' lawyers suing Guidant with a road map and may also help government agencies that are investigating the device maker.
Deposition Sheds Light on Guidant Defibrillator Case The Indianapolis Star \| February 22, 2006
The Guidant Corporation may have gotten more than it bargained for when it appointed a panel last year to look into its practices after it came under scrutiny for its failure to publicize flaws in its heart devices. The 12-member panel not only urged the company to overhaul its disclosure process, but its full report, released yesterday, may provide plaintiffs' lawyers suing Guidant with a road map and may also help government agencies that are investigating the device maker.
Guidant Discloses Lawsuit Tally, Says Many More Possible MarketWatch \| February 22, 2006
Medical device maker Guidant Corp. is facing about 145 individual lawsuits, around 60 class action suits, and could face thousands of additional suits down the road over problems with heart devices that became public last year, according to a regulatory filing made Wednesday.
Recalls, Lawsuits Make Guidant Merger Hairy USA Today \| February 15, 2006
Boston Scientific triumphed last month in the fierce merger war for Guidant, outlasting Johnson & Johnson with a $27 billion offer. But now Boston Scientific and Guidant, leading heart-device makers in the growing $250 billion market for medical devices and supplies, must ride out a legal and regulatory storm that could slow their deal and lead to costly court judgments and government penalties. The companies face investigations, product-liability lawsuits and warnings from the Food and Drug Administration to correct problems at their manufacturing sites.
Feds Seek Guidant Documents About Malfunctions The Indianapolis Star \| January 30, 2006
The Justice Department has ordered an attorney to turn over documents indicating Guidant Corp. continued selling some of its heart defibrillator models after knowing the devices could malfunction. The subpoena, part of the federal government's investigation into the Indianapolis-based company, requires Texas attorney Bob Hilliard to turn over handwritten notes and PowerPoint slides. He obtained them from the company during preparations for a product liability case in Texas state court.
Judge Releases Guidant Defibrillator Documents The Boston Globe \| January 26, 2006
The New York Times and two Texas plaintiffs won access yesterday to documents they say show Guidant Corp. continued selling some models of its heart defibrillators after knowing the devices could malfunction.
Guidant Lax on Quality and Records, FDA Finds The Minneapolis Star Tribune \| October 28, 2005
Guidant Corp. managers did not ensure the quality of heart-implant devices during manufacturing and didn't quickly warn doctors about software glitches that caused some pacemakers to quit, federal regulators said. Guidant released a 79-page document Thursday that it filed with the Food and Drug Administration that outlines problems found by the agency in an August inspection of the company's plant in Arden Hills. The FDA said that Guidant lacked an effective quality-control system at all levels and that its record-keeping was poor, with little accountability for errors.
Guidant Case May Involve Crime Inquiry The New York Times \| September 29, 2005
Criminal investigators at the Food and Drug Administration have apparently become involved in the agency's inquiry into how the Guidant Corporation handled problems with its heart devices, said two people contacted by the investigators.
FDA Expanding Inquiry Into Heart-Device Company The New York Times \| August 25, 2005
The Food and Drug Administration said yesterday that it would conduct an extensive inspection of the manufacturing facilities of the Guidant Corporation, a maker of implantable heart devices that is under scrutiny for the way it disclosed product problems.
FDA Will Not Release Some Data on Heart Devices The New York Times \| August 6, 2005
The Food and Drug Administration said yesterday that it would not release information that it receives annually from the makers of heart devices detailing how often and why products fail. The agency called such data a corporate trade secret.
New Report of Problems at Guidant The New York Times \| July 30, 2005
About two weeks before a college student with a flawed heart device died in March, another heart patient implanted with the same model that also failed almost died, according to a government filing by the device's maker, the Guidant Corporation.
FDA Gives Guidant Recall Urgency Star Tribune \| July 23, 2005
The Food and Drug Administration said late Friday it has given a pacemaker safety advisory issued last week by Guidant Corp. its most serious classification as a product recall.
Guidant Issues Warning on 28,000 Pacemakers BusinessWeek Online \| July 18, 2005
Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide.
Guidant Faces Legal Battles After Recalls The New York Times \| July 7, 2005
Guidant Corp., which has recalled 87,600 implantable cardiac defibrillators in three weeks, is facing mounting legal pressure from angry shareholders and frightened patients.
FDA Says Flaws in Heart Devices Pose High Risks The New York Times \| July 2, 2005
The Food and Drug Administration said yesterday that potential electrical flaws in some heart devices made by the Guidant Corporation, including one flaw that the company did not tell doctors about for years, posed a risk of serious injury or death to patients.
FDA Recalls Guidant Defibrillators CBS News \| June 17, 2005
The U.S. Good and Drug Administration will recall more than 38,000 faulty cardiac defibrillators implanted in patients because of potential malfunctions in the devices, the manufacturer Guidant Corp. said Friday.
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