WEST VIRGINIA RECORD

CLARKSBURG – Medtronic denies a Morgantown woman's allegations that she was repeatedly shocked because of a faulty heart device.

In its response to a lawsuit Betty L. Bishop filed Dec. 23 in U.S. District Court for the Northern District of West Virginia, Medtronic claims the shocks are a well-publicized risk associated with the device.

According to her complaint, Bishop had an implantable cardioverter defibrillator inserted into her heart. The device is connected to leads positioned inside the heart that deliver electrical shocks, sense the heart's rhythm and pace the heart when needed.

On Dec. 25, 2007, at about 4:30 a.m., Bishop claims her ICD began to shock her repeatedly with 800 volts, so an ambulance took her to Monongalia General Hospital in Morgantown.

At the hospital, after doctors evaluated the defibrillator, Bishop was taken into surgery where doctors revised the oversensing right ventricular lead. In addition, they revised the pulse generator battery in the ICD, the suit states.

On Dec. 27, 2007, doctors released Bishop from the hospital, but she had to return the following day because she couldn't get up or walk, the complaint says.

"The Emergency Room Doctor said it was from the trauma my body had sustained from being shocked numerous times," Bishop wrote in her lawsuit. "I can't do much of anything that requires using my left arm or shoulder, and have constant pain in my shoulder and left arm."

Following the incident, Bishop claims she attempted to mediate her claim out of court to no avail.

"I find it necessary to file this Medical Lawsuit against Medtronic Incorporated due to the pain, suffering and permanent injury caused by the faulty medical device provided by Medtronic Incorporated, even though Medtronic Incorporated had informed me that my medical device was fine and not affected by their recall of other defibrillator leads," Bishop wrote.

In fact, in its response to Bishop's complaint, Medtronic contends the device was not faulty and that oversensing is a recognized risk associated with the device.

"To the extent Plaintiff experienced 'inappropriate shock therapy' caused by a 'fractured right ventricular lead,' as described in Exhibit A to Plaintiff's Complaint, both the fact that a lead can experience 'fracture' and result in ' inappropriate shock therapy' are anticipated adverse events which are specifically set forth in the FDA-approved labeling for the devices in question," Medtronic responded. "By way of further response, and upon information and belief, the allegedly 'fractured right ventricular lead' was not the subject of any recall."

Medtronic also denies Bishop's claim that she was shocked with 800 volts.

It says Bishop's allegations should not be permitted in federal court.

"Plaintiff's claims are barred by the principles of medical assumption of risk and medically informed consent," Medtronic's response states. "The claims asserted in Plaintiff's Complaint are barred because the risks associated with the use of the medical device at issue, if any, are outweighed by the utility and benefits such device provides."

Medtronic is asking the court to award Bishop no damages and to enter a judgment in its favor. It is also seeking costs and other relief the court deems just.

Bishop will be representing herself.

Paula L. Durst of Spilman, Thomas and Battle in Charleston will be representing Medtronic.

U.S. District Court case number: 1:09-cv-171