Boston Scientific Has Loss on Legal Expenses, Cuts

-Bloomberg

02/04/2008 - Boston Scientific Corp., the world's second-largest maker of heart devices, posted a loss on costs for legal expenses and job cuts. Sales rose more than analysts' estimated, boosting the shares in extended trading. More>>>

Boston Scientific posts Q4 net loss on charges

-Reuters

02/04/2008 - Medical device maker Boston Scientific Corp posted a fourth-quarter net loss on Monday as it took charges for restructuring operations, divesting assets and patent litigation. The company, which has focused on reducing costs and shedding non-core assets as it copes with downturns in its two key heart device markets, said the net loss was $458 million, or 31 cents a share. More>>>

Boston Scientific amends Guidant settlement, to pay $240 mln

-Reuters

11/19/2007 - Medical device maker Boston Scientific Corp said it would pay up to $240 million to settle numerous legal claims related to the recall of implantable heart defibrillators made by Guidant Corp, which it acquired last year. More>>>

Boston Scientific reaches amended agreement to settle Guidant product claims

-CNN

11/19/2007 - Boston Scientific (NYSE:BSX) Corp. Monday said it reached an amended agreement to settle for $240 million claims related to product communications issued by Guidant Corp. in 2005 and 2006. More>>>

Boston Scientific Ups Settlement

-wbur.org

11/19/2007 - Boston Scientific is agreeing to pay another $45 million as part of a major settlement with thousands of heart patients over potentially faulty defibrillators. More>>>

Guidant Adds $45 Million to Defibrillator Settlement

-Bloomberg

10/31/2007 - Boston Scientific Corp.'s Guidant unit agreed to pay at least $240 million to settle claims it hid defects in its heart defibrillators, $45 million more than a settlement proposed in July, people with direct knowledge of the accord said. More>>>

Ohio settles with medical manufacturer for $390K

- Columbus Business Journal

09/10/2007 - Ohio has been awarded $390,000 in a multistate, million-dollar settlement with a cardiac defribrillator manufacturer. More>>>

Court sides with locals in Guidant suit

-Indianapolis Business Journal

09/21/2007 - The state's second-highest appeals court is allowing a class-action lawsuit involving Guidant Corp. defibrillators to proceed in Marion County, though the ruling won't affect similar federal or state suits. More>>>

Boston Scientific Will Settle

- Wall Street Journal

08/31/2007 - Boston Scientific Corp. agreed to pay $16.8 million to 35 states and the District of Columbia over allegations that its Guidant unit concealed flaws in its defibrillators. More>>>

Guidant's defibrillator complaints get settled

- The Star Ledger

08/31/2007 - Boston Scientific yesterday agreed to pay $16.7 million to 35 states, including New Jersey, to resolve allegations physicians and patients were not properly notified about wiring problems with an implantable heart defibrillator. More>>>

Guidant settles with states over faulty defibrillators

- Tampa Bay Business News

08/31/2007 - Florida is one of 35 states that have reached a settlement with Guidant Corp. over defective implantable defibrillators. Guidant will pay $16.75 million to the states for consumer education and will implement safety programs and report any future problems with the devices.

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Washington Attorney General Announces $17 Million Settlement With Heart Defibrillator Manufacturer Guidant Corp.
08/30/2007 - Washington Attorney General Rob McKenna today announced a $16.75 million multistate settlement with Guidant Corporation that extends a replacement program for certain heart defibrillators built prior to November 2002. More>>>

Boston Scientific Fails to Have Punitive Charges Dismissed
06/13/2007 - A federal court Tuesday ruled against Boston Scientific's attempts to have litigation over faulty defibrillators thrown out of court. More >>>

Study: Defibrillators Iffy 10 Years After Implant
05/01/2007 - One in five implanted devices used to shock hearts back into a normal rhythm fails to work properly after 10 years, a study has found. More >>>

Thousands of Devices For Hearts Are Recalled
-NY Times
06/27/2006 - Boston Scientific said yesterday that it was recalling 23,000 heart pacemakers and defibrillators and recommended that 27,000 patients who already have the devices in their chests consult their doctors.

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Boston Scientific Feels Guidant's Pain
06/27/2006 - Boston Scientific (BSX:NYSE) is recalling a group of pacemakers and defibrillators, all of which were made by the business that used to be the stand-alone company Guidant, because the devices could fail.The recall covers the Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac re synchronization pacemakers and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators. The products are made by Boston Scientific's cardiac rhythm management group that was formerly part of Guidant. More >>>

Guidant Pacemakers and Implantable Cardiac Difibrillators Malfunction
- FDA
Guidant INSIGNIA and NEXUS Pacemakers
Guidant CONTAK RENEWAL TR/TR2 Cardiac Re synchronization Therapy Pacemakers
Guidant VENTAK PRIZM 2, VITALITY and VITALITY 2 Implantable Cardioverter Defibrillators
Audience: Cardiac healthcare professionals, risk managers and biomedical engineers
[Posted 06/26/2006] Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac re synchronization therapy pacemakers and implantable cardioverter defibrillators [ICD's] is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry or premature battery depletion. Patients with affected ICD's may experience inappropriate sensing or premature battery depletion. Physicians are asked to perform an exam as soon as possible to assess device function for all patients with implanted devices from this subset.

[June 26, 2006 – Press Release – Boston Scientific/Guidant]
[June 23, 2006 – Letter to Physicians – Guidant]
[June 23, 2006 – Letter to Patients – Guidant]

Guidant Never Sent Letter Warning About Devices
- NY Times
06/07/2006 - - Newly released records show that Guidant Corp. drafted a letter last year to tell doctors about significant defects in the company's heart devices but never sent it, a report said on Wednesday. More >>>

Boston Scientific Warns About Faulty Guidant Defibrillators
-Business Journal
05/17/2006 - Boston Scientific Corp. has warned physicians that 996 defibrillators made by its Guidant unit may quit prematurely, leaving heart-failure patients without protection against sudden cardiac death. More >>>

Panel cites Guidant patient-safety lapses - NYT
-Reuters
03/21/2006 - A panel chosen by Guidant Corp to review its handling of heart-device flaws has found the company systemically failed to fully assess patient safety in deciding whether to publicize product failures, the New York Times said on Tuesday. More >>>

Guidant warns about voltage problem with defibrillators
-Reuters
03/14/2006 - Guidant Corp. cautioned doctors Monday to check the voltage on certain implantable defibrillators after the company received several reports of defective devices. More >>>

Deaths no higher with recalled heart devices-stud
-Reuters
03/13/2006 - Patients with implanted heart devices that were subject to U.S. recalls or safety warnings do not have higher death rates than those who had devices that were not linked to such problems, a study released on Monday said. More >>>

Internal Turmoil at Device Maker as Inquiry Grew
-NY Times
02/28/2006 - As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were overblown, it said, and perhaps even irresponsible. More >>>

2500 May Seek Damages
-Indianapolis Star
02/23/2006 - Guidant Corp. said as many as 2,500 patients may seek damages following last year's recall of 109,000 implantable defibrillators linked to at least seven deaths. Guidant, the second-largest maker of the devices that correct abnormal heart rhythms, said in a filing Wednesday that it learned last month of about 1,700 claims and expects more. Those claims are distinct from patients already participating in 211 individual and class-action lawsuits in the U.S. and Canada, the company said. More >>>

Deposition sheds light on Guidant defibrillator case
-Indy Star
02/22/2006 - After a Guidant Corp. defibrillator failed to jolt a Minnesota student's heart back to life during cardiac arrest last year, the victim's doctors demanded an explanation from the Indianapolis medical device maker. More >>>

Guidant Issues Warning on Pacemakers
-Bloomberg News
01/24/2006 - The Guidant Corporation, the object of a bidding war between Johnson & Johnson and Boston Scientific, said yesterday that doctors should consider replacing cardiac pacemakers implanted in about 19,300 patients worldwide. More >>>

Ex-worker says Guidant pushed speed over quality
-Bloomberg News - Avran Goldstein
01/14/2006 - Ex Guidant employee claims troubled Arden Hills plant cut training, pressed for "unrealistic" production goals. More >>>

More Deaths Are Linked to Device
NY Times - Barry Meier
12/14/05 - The Food and Drug Administration has received from the Guidant Corporation several new reports about recent patient deaths associated with short circuits in company heart devices, agency records show. More >>>

Guidant Lawsuit Settlement May Be First Tied to Defibrillators
Bloomberg -11/22/05 - Guidant Corp., the second-largest maker of defibrillators, agreed to settle a lawsuit over the death of a 21-year-old man who used a company-made heart device that failed, said a lawyer representing the man's family. More >>>

Defective heart devices leave taxpayers with bills
Salt Lake Tribune - Dawn House
11/19/2005 - Gregg Gruis remembers howthankful he was to be alive after doctors implanted a defibrillator in his chest to shock his weakened heart into beating but now he sometimes feels like giving up. More >>>

Feds Probing Heart Device Firms
www.twincities.com
10/26/2005 - The Justice Department has started a broud investigation into whether makers of implantable heart devices have offered payments or other inducements todoctors or others as a means of promoting use of their products, a major manufacturer said late Tuesday. More >>>.

Guidant Reports Six More Cases of Heart Device Failures
Star Tribune -
10/14/05 - 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 regulatecardiac rhythms. More >>>

FDA Knew of Guidant Heart Device Failures
Reuters -
09/12/05 - Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corp. heart devices, a company report to the agency showed that some of those units were short-circuiting, The New York Times reported on Monday. More >>>

Guidant May Face Senate Scrutiny
Star Tribune - Janet Moore
07/31/05 - At first blush, it might seem a bitunusual that the chairman of the Senate Finance Committee has taken a sudden interest in a series of heart device recalls by Guidant Corp. More >>>

Guidant Says Defibrillator Fix May Make Things Worse
Star Tribune - Dan Browning
07/23/05 - Guidant Corp. issued an urgent warning to doctors today saying a recommendation it issued just last month tofix a problem in three of its implantable defibrillators may actually make matters worse. More >>>

FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators
www.fda.gov -
07/14/05 - This is to provide clinicians with current information and guidance concerning malfunctions occurring with Guidant’s PRIZM 2 and CONTAK RENEWAL implantable cardioverter defibrillator (ICD) devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. More >>>

FDA Puts Guidant Recall In Class 1
Star Tribune - David Phelps,
07/02/05 - Guidant Corp. can't seem to get out of the bad-news column. More >>>

Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Implantable Cardiac Defibrillators
www.fda.gov -
06/24/05 - Guidant Corporation said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below. Guidant will continue its evaluation and communicate further as more information is learned. More >>>

FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Re synchronization Therapy Defibrillators
www.fda.gov -
06/17/05 - FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac re synchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. More >>>

Ennis & Ennis, P.A. is representing individuals that have been harmed defective medical devices such as the Guidant defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Guidant pacemaker or defibrillator or if you need more information about the Guidant recall or class action lawsuit click here for a free, confidential case evaluation.