Faulty Pacemakers Leave Patients With Risk Of Death From Failure Or Facing Heart Surgery Risks As Well

Faulty Pacemakers Leave Patients With Risk Of Death From Failure Or Facing Heart Surgery Risks As Well

July 27, 2005

PALM BEACH GARDENS, Fla.(July 27, 2005)---Kathy Higginbotham (a resident of Nassau County, Florida) thought that many of her health problems were behind her when her cardiologist prescribed a heart pacemaker to be implanted.  The pacemaker would keep her heart beating at a regular rhythm and her health would be kept under control.  On February 16, 2004, Higginbotham underwent the surgery to implant the device manufactured by Medtronic – and the surgery was successful. 

In April of this year, Medtronic notified Higginbotham that her pacemaker was defective.  After learning that the model DR 7274 was defective and could malfunction at any time, Higginbotham was faced with one of two options – risk death from the malfunction of the pacemaker or undergo major surgery to replace the device.  She chose the latter and has since with reservation had her pacemaker replaced.

David Downes (a resident of Martin County, Florida) was in the identical situation as Higginbotham.  On February 16, 2004, a Medtronic 7274 was implanted, with the company’s representative on hand for the surgical procedure.  In early April of this year he was notified about the faulty device and he was faced with the same choices as Ms. Higginbotham.  Downes too chose a second surgery, however wonders if this device is full proof and reliable.

Most recently Higginbotham and Downes retained consumer advocate attorney, Ted Leopold, a partner in the Palm Beach Gardens law firm of Ricci~Leopold .  Leopold will represent both clients who have filed separate suits in this matter against Medtronic in the 15th Judicial Circuit in Palm Beach County, Florida.  The ten count suit claims negligence, fraud, liability, breach of express and implied warranty, fraud and infliction of emotional distress.

Both Higginbotham and Downes were placed in “Catch 22 situations,” stated Leopold.  “Both of these individuals were faced with either risking death with the real possibility that the device implanted surgically would malfunction or on the flip side of this coin, they could risk a surgery to remove the device and implant a second device manufactured by Medtronic.  Both these individuals now lead lives in hopes that the second device that is now implanted will operate properly.”

Medtronic manufactured, designed and tested for certain heart defibrillators known as implantable cardioverter defibrillators (IC) and cardiac resynchronization therapy defibrillators (CRT-D), under the brand names of InSync III, InSync I/II/III Marquis, Marquis VD/DR and Maximo VD/DR.  These products are installed inside the body surgically.  ICD devices shock or pace the heart into normal rhythm, in the event of the patient suffering a rapid, life-threatening heart rhythm disturbance.  These heart rhythm disturbances can lead to sudden cardiac arrest.  The CRT-D devices provide electrical pulses to the heart in the event of heart failure symptoms. 

The devices are all operated by a battery contained within the unit.  For a period of time, believed to extend from April 2001 – December of 2003, Medtronic placed a defective battery in these products which include those of Higginbotham and Downes.  These batteries are subject to rapid change depletion due to shorting of the battery life, which leads to sudden, unpredictable loss of power without warning to the unit.

“Basically at any given time these two individuals as many other people could have been at work, with family, operating a motor vehicle or even sleeping and the device may have failed.  A failure would cause cardiac arrest,” added Leopold.  “In February of this year Medtronic disclosed to physicians and to the Food and Drug Administration the existence, but not the magnitude of the defective battery.  This is a condition of which they were aware for a long period of time.” 

“Medtronic is basically telling these individuals whichever way you choose to proceed, you risk your life.  Leave the current device and risk the malfunction, or implant another device and risk your life with another surgery.  Beyond that, these individuals have lost confidence in these devices after being assured that they were tested, full proof and warranted to never fail.  This is a life threatening scenario whichever way it plays out, and Medtronic can not simply excuse themselves from putting these faulty devices into commerce and risking a person’s life simply for sheer profits,” he concluded.

The suit seeks no specific monetary damages.  “We are looking for justice for these two individuals and Medtronic accepting responsibility for their negligence.  Human life is at stake here, it’s not like changing a battery in a child’s toy or a flashlight, this is a major surgical procedure that puts two vibrant individuals as well as countless other individuals lives in peril.  Will this happen again?  Can this copy be trusted with the implanted replaces devices?” Leopold asked.

Attorney, Theodore J. Leopold is a partner in the law firm of Ricci~Leopold, P.A. The firm founded in 1982, has five attorneys.  The firm is headquartered in Palm Beach Gardens, Florida, with offices located at 2925 PGA Blvd.  Mr. Leopold can be contacted at 561-684-6500.  Additional information about Ricci~ Leopold, P.A. may be obtained from the firm’s website at www.riccilaw.com . 

Attorney, Theodore J. Leopold is a partner in the law firm of Ricci~Leopold, P.A. The firm founded in 1982, has five attorneys and is headquartered in Palm Beach Gardens, Florida, with offices located at 2925 PGA Blvd.  Mr. Leopold can be contacted at 561-684-6500.