On June 17, 2005, Guidant Corp. announced the first of several recalls involving heart devices manufactured by the company. At the time of the recall, Guidant was aware of at least 45 occasions where the various defibrillator models had failed.
Internal company documents indicate the company was aware of internal problems with the devices in February 2002, but nonetheless continued selling defective devices. Further, the company failed to warned existing patients of the potential problems with their defibrillators.
January 30, 2006—Martin & Jones has filed more than 30 individual lawsuits on behalf of people harmed by defective Guidant heart devices. The lawsuits were filed in federal court in the District of Minnesota. Pre-trial discovery has been consolidated in Minnesota under Multi-District Litigation procedures.
The company presently faces about 145 individual lawsuits involving its defective defibrillator and pacemaker devices, and an additional 60 class action lawsuits. It is likely the company will face several thousand additional lawsuits over the next several years.
Martin & Jones filed a lawsuit in the Central District of California on behalf of a client who suffered injuries after a defect in her internal Guidant defibrillator required a replacement.
This lawsuit is one of more than 30 that our law firm has filed against the Guidant Corp. alleging injuries from defective defibrillator and pacemaker devices.
The New York times reported that the FDA is investigating the circumstances surrounding the recall of heart devices manufactured by Guidant Corp. Specifically, the federal agency is questioning whether Guidant Corp. delayed in disclosing dangers with various defibrillator devices. It is likely the FDA is also looking at the sufficiency of the warnings issued by Guidant Corp. in May and June 2005.
In May 2005, the company acknowledged it waited three years before notifying physicians of a serious product flaw that could result in injury or death in implanted patients. The company defended its decision to withhold the information from doctors because it classified the risk as insignificant.
The company recalled or issued alerts on 10 different models in June 2005. A number of the device recalls were classified by FDA as falling under the Class I ("highest priority") classification. In a Class I recall, there is a reasonable probability that a malfunctioning medical device will cause serious health consequences or death.
The FDA has a number of options available to it should the agency conclude Guidant Corp. acted unreasonably. FDA investigations can conclude with consent orders, fines or even criminal investigations. The agency has indicated it will complete the review quickly—perhaps within just a few months.
Boston Scientific Filing: 550 Lawsuits from Guidant Recalls 
Boston Business Journal
August 11, 2006
Boston Scientific Recalls More Guidant Heart Devices
The Boston Globe
June 26, 2006
Boston Scientific Warns of Flaw in Heart Aids
The Boston Globe
May 16, 2006
Inquiry Arranged by Guidant May Aid Lawsuits and Critics
The New York Times
March 22, 2006