Guidant Medical Device Press Articles

Bloomberg News, "Guidant Gets FDA Warning, Sanctions on Devices Plant"

          Guidant Corp., the object of a bidding war, was barred by U.S. regulators from exporting heart- rhythm devices from its principal plant in St. Paul, Minnesota, because of product flaws. The shares had their biggest decline in more than seven weeks.
          The action resulted from a September inspection report as the Food and Drug Administration probed defibrillator failures linked to at least seven deaths that forced the recall of 109,000 devices. After the recall, Johnson & Johnson cut $4 billion from its $25.4 billion buyout offer, first made a year ago. Boston Scientific Corp. on Dec. 5 bid $25 billion for Indianapolis-based Guidant.
          "We continue to move forward on our due diligence with the goal of reaching a definitive agreement with Guidant," said Boston Scientific spokesman Paul Donovan in a telephone interview from Italy today after Guidant disclosed the FDA action. "I don't think we're going to have anything more to say right now."

Reuters, "Guidant saw some deaths from heart device: report"

          Medical device maker Guidant Corp. projected that some patients might die as result of short circuits in a company heart device, the New York Times reported Saturday, citing company records filed in connection with a lawsuit.
          Guidant did not publicize the flaw because it appeared to have viewed the overall failure rate as acceptable, according to the documents filed Thursday in a Texas state court in connection with a lawsuit involving Guidant's Prizm 2 DR defibrillator.
          A company report also showed that by the middle of 2002 Guidant determined that the consequences of the defibrillator's electrical failure, although rare, could be "life threatening," the newspaper said. Still, Guidant continued to sell the potentially flawed devices and did not notify doctors about the defect until last spring, when the problem was about to reach the public, the Times said.

The Indianapolis Star, " Report: Guidant settles defibrillator case"

         Indianapolis-based Guidant Corp. will settle a lawsuit over the death of a 21-year-old man who used a company-made heart device that failed, Bloomberg News reported today.
          Joshua Oukrop died in Utah on March 14, 2005. The agreement with his family may be the first civil settlement related to Guidant's recall of 109,000 heart defibrillators, lawyers said. Since the recall, Guidant's shares have plunged, state and federal regulators have begun probes and the company agreed to a reduced takeover offer from Johnson & Johnson.

          Guidant faces about 100 lawsuits from patients alleging damages from recalled defibrillators and pacemakers.

          Oukrop used Guidant's Prizm 2, which was bedeviled by a short circuit that could disable the device, so it can't do its job of shocking the heart if the patient suffers cardiac arrest or erratic beating.

Minneapolis Star-Tribune , "Panel combines suits against Guidant"

         To save time and money, class-action lawsuits filed against Guidant Corp. over its string of heart device recalls will be consolidated for discovery and other pretrial motions before a federal judge in Minneapolis.
          A special court called the Judicial Panel on Multi-District Litigation ruled Monday that two cases in Minnesota and one each in California, Florida, Indiana and New York had enough in common to be consolidated. Doing so also would prevent inconsistent pretrial rulings.
          "These actions share allegations that certain implantable defibrillator devices manufactured by Guidant were defective and caused injury, or the threat of injury," the court said in its order. In addition, the panel noted that it had learned of more than 60 "tag-along" actions pending in multiple federal districts.
          The lawsuits began shortly after the company alerted doctors in May about a potential short-circuiting problem in some of its implantable cardioverter defibrillators, or ICDs.

Associated Press, "Guidant Sued by Spitzer as Deadline for J&J Deal Nears"

          New York Atty. Gen. Eliot Spitzer said Thursday that he was suing Guidant, alleging it concealed information about a heart defibrillator's design flaw. Since June, Guidant has recalled or issued warnings on about 88,000 heart defibrillators -- including its top seller, the Contak Renewal 3 -- and almost 200,000 pacemakers because of reported malfunctions. The company faces multiple lawsuits from patients and shareholders, as well as a reported criminal investigation by the Food and Drug Administration.
          U.S. attorneys in Boston and Minneapolis last week issued subpoenas seeking documents about Guidant's devices and its Ventak Prizm 2 and Contak Renewal 1 and 2 defibrillators. Spitzer filed the civil lawsuit Wednesday in state Supreme Court in Manhattan. "We wouldn't permit this type of conduct in connection with the sale of cars or washing machines," Spitzer said. "It is simply unconscionable that it occurred with a critical medical device."

The New York Times, "Guidant to Issue More Data on Device Failures"

          The Guidant Corporation, a maker of defibrillators and pacemakers, said yesterday that it planned to start issuing periodic reports that would highlight for each model the number of confirmed failures that prevented the units from delivering critical patient therapy.
          The move appears to be a significant change because Guidant, like other makers of heart devices, had previously told doctors only about the total number of product malfunctions, rather than separating those that posed high risks from those of lesser concern. More...

The New York Times, "Repeated Defect in Heart Devices Exposes a History of Problems"

          Two months after Joshua Oukrop's death, the Guidant Corporation, the country's second-biggest maker of heart defibrillators, acknowledged that it had not told doctors for three years that one model had short-circuited in about two dozen cases, including the one involving him.
          Guidant, which has said it did nothing wrong, has characterized the student's death as a tragic event. But it turns out that the same type of electrical defect that destroyed Mr. Oukrop's defibrillator also caused another heart device from Guidant to malfunction. More...

Bloomberg News, "Guidant Reports 6 More Defibrillator Failures"

          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 late June.
          The new reports of failures since a previous FDA notice July 14 bring the total worldwide to 21, including three cases in which patients died, the FDA said.

The New York Times, "Guidant Case May Involve Crime Inquiry"

         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.
          Since June, the FDA has been looking into several issues involving Guidant, including whether it properly reported failures of some of its heart devices and manufacturing changes to correct the problems. The agency's Office of Criminal Investigations is often called upon to examine such issues. More...

San Francisco Chronicle, "Guidant Warns on Two Pacemaker Lines"

          Guidant Corp. said Thursday [Sept. 22, 2005] it recalled some of its Insignia and Nexus implantable pacemakers because of failures, including nine cases requiring emergency hospitalization. More...

Star Tribune (Indianapolis),"Diverse panel to probe Guidant"

         A 12-member panel created by medical technology firm Guidant Corp. in the wake of criticism that it withheld important safety information about its products has an unusual array of members with varying specialties. More...

The New York Times, "FDA Expanding Inquiry Into Heart-Device Company"

          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. More...

Los Angeles Times, "Guidant Gets U.S. Approval to Relaunch Heart Failure Device"

          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.
          The medical device maker in June had stopped its Contak Renewal 3 failure product from use in implants and halted distribution after it was found to have defects in a switch component.

The New York Times, "New Report of Problems at Guidant"

          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. More...

Star Tribune (Indianapolis), "Guidant promises openness"

          While defending its actions over a recent spate of recalls of its heart devices, a Guidant Corp. executive acknowledged that the industry is entering a new era of disclosure, with doctors demanding more information on product safety than ever before. More...

Star Tribune (Indianapolis), "FDA gives Guidant recall urgency"

          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. More...

Associated Press, "Guidant revises safety recommendations for some defibrillator models"

          Guidant Corp. said Friday one of its recent recommendations for correcting problems with some of its defibrillators may actually increase the risk of malfunction in three models implanted in about 21,000 heart patients.
          The company said a programming change it suggested to physicians in June may "significantly increase" the risk that a magnetic switch in the Ventak Prizm, Vitality and Contak Renewal devices would become stuck and prevent them from providing treatment.
          The company said Friday it found that a malfunction had occurred in one of the devices after it was reprogrammed. In that instance, the patient was not injured, but had to have the device replaced. Guidant said it is now investigating other instances of malfunction, including a possible injury.

Associated Press, "Guidant issues warning for 28,000 pacemakers; Faulty seal could lead to malfunction, heart failure, manufacturer says"

          Guidant Corp., already under fire for problems with its implantable defibrillators, on Monday warned physicians replacements might be needed for nine pacemaker models made between 1997 and 2000. More...

Associated Press, "Lawsuit blames father's death on defibrillator"

          The family of an elderly man who died when the heart defibrillator implanted in his chest allegedly failed is suing the device's maker and wants to expand the suit to thousands of patients nationwide. More...

Associated Press, "Guidant defibrillator recall becomes more urgent"

          Indianapolis-based Guidant, which has a $25.4 billion acquisition offer pending from New Brunswick, N.J.-based Johnson & Johnson, recalled a series of defibrillators last month. The new FDA action lists three models as Class I recalls, the most serious type — a move that might help doctors in deciding how aggressively to notify and treat their patients.
          The FDA also said it was investigating how Guidant notified the agency and the public of the problem, said Timothy Ulatowski, the FDA's medical device compliance chief.
          Eleven types of defibrillators made by Guidant were the subject of safety warnings issued last month. About 87,600 defibrillators are implanted in patients worldwide.

Associated Press, "FDA gives heart implant recall highest warning -- not urging removal of Guidant devices; patients should contact doctors"

          A malfunction in some of the Guidant Corp. defibrillators recalled last month could cause serious injury or death, the government said Friday [July 1, 2005] in classifying 20,000 of the devices as the most urgent type of recalls.
          The Food and Drug Administration is not urging that the recalled defibrillators be removed. But it used Friday's action to urge patients to contact their doctors to decide appropriate next steps. More...

The Recorder, "Faulty Defibrillator Opens Guidant to Enormous Lawsuits -- Again"

          There's nothing like a short circuit inside thousands of people's chest cavities to jumpstart plaintiff lawyers and shock the heart of a corporate defendant.
          That has become clear over the past month, with a medical-device maker that was already squaring off with several local plaintiff firms suddenly the target of new -- and possibly costly -- litigation by some of the same lawyers. More...

Associated Press, "Patients call doctors after Guidant recall"

          Nervous patients called their doctors Monday to have potentially faulty implanted heart devices checked out after the company offered to replace thousands of them because of flaws.
          For 44-year-old Alan Black, the potential for a short circuit in his defibrillator was enough to convince his doctor to schedule replacement surgery for June 30. The Lock Haven, Pa., resident got his device in 2002. More...

Associated Press, "FDA recalls Guidant heart defibrillators; More than 38,000 implanted devices could malfunction"

          The U.S. Food 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. More...

National Law Journal, "Integrity agreements could spark litigation"

          On July 1, 2003, medical device maker Guidant Corp. pledged its commitment to comply with a tough corporate integrity agreement after it admitted to 10 felonies and paid a record $92 million for covering up thousands of cases in which its aortic stent malfunctioned. More...

The New York Times, "Heart Device Sold Despite Flaw, Data Shows"

          When the Guidant Corporation told doctors last week that a popular implantable heart defibrillator had failed in a small number of cases because of an electrical flaw, it also said that it had fixed the flaw in devices produced after mid-2002.
          But now data provided by Guidant to a Minnesota hospital suggests that the company continued to sell the potentially flawed devices for months after it changed the way it made the device and had begun selling the new ones. More...

The New York Times, "Defibrillator Maker Didn't Reveal Problem"

          The maker of an internal heart defibrillator is acknowledging it waited three years before telling some 24,000 patients and their doctors about an electrical problem that caused a small fraction of the implanted devices to short-circuit. More...

Star Tribune (Minneapolis, MN), "Disclosure defense; Guidant says it handled defibrillator flaw properly"

          Guidant Corp. defended itself Tuesday against charges that it waited too long to disclose that some of its popular implantable defibrillators could short-circuit. An episode in which a young college student died as a result of the faulty device raises questions about when a company is required to go public with the information and to what degree responsibility falls on doctors and as well as the Food and Drug Administration (FDA).
          This isn't the first time Guidant has faced questions over not reporting adverse events with a device. In 2003, the company pleaded guilty to 10 felony counts and agreed to pay a $92.4 million fine to the Justice Department after its Ancure Endograft System was linked to 12 deaths and dozens of emergency surgeries.
          The device was used to treat abdominal aortic aneurysms, a potentially fatal condition that can develop in the wall of the aorta. Federal prosecutors said the company failed to report 2,628 incidents to the FDA involving malfunctions with the Ancure device system.
          Guidant since has closed the California-based division that made the device, EndoVascular Technologies.