Birnbaum & Associates P.C. presents the article: "Woman: Failed Defibrillator Killed Spouse"

By AMY FORLITI Associated Press Writer

(AP) - MINNEAPOLIS-As she paid her last respects to her husband, Kathleen Gohde was shocked to hear a beeping sound coming from his chest when she leaned down to give him a final goodbye hug and kiss.

The sound indicated something had gone wrong with the defibrillator that was supposed to keep Allan Gohde's heart beating at a normal rhythm, according to a wrongful death and product liability lawsuit filed against Guidant Corp.

"It was a horrifying experience for Mrs. Gohde that she will carry with her for the rest of her life," Tara Sutton, a Minneapolis attorney for Gohde, said Thursday. Kathleen Gohde noticed the beeping during a private viewing session for family at the funeral home before his cremation.

The lawsuit, filed this week in Ramsey County District Court in St. Paul, claims Allan Gohde's defibrillator short-circuited, and that he died as a direct result.

The lawsuit names as defendants Indianapolis-based Guidant and its subsidiary in Arden Hills, Minn., where the defibrillators are made. The claim is one of several filed against Guidant in recent months after the company recalled thousands of the devices.

According to the lawsuit, Allan Gohde, 53, died of sudden cardiac arrest at his Birchwood, Wis., home on July 28, 2005, more than a month after Guidant recalled its Ventak Prizm 2 DR Model 1861 defibrillator. Gohde had received the device in February 2002.

At the time of the recall, Guidant did not recommend the devices be removed, noting that failure was rare while invasive surgery was risky. The company advised doctors to monitor patients every three months.

The lawsuit also asserts Guidant knew that the model, manufactured before April 2002, had a defect for more than three years before announcing it to the public, and that Guidant issued an advisory only after the company learned The New York Times was writing a report about the defect and the death of a 21-year-old Minnesotan.

The lawsuit also claims that Guidant continued to sell the defective products, "with deliberate disregard for patient safety."

On the morning Gohde died, his defibrillator detected an arrhythmia that should have prompted the device to shock the heart back to a normal beat, according to the lawsuit. Three seconds later, when the device tried to do so, it failed.

Gohde's wife was with him when he collapsed, but the beeping sound, which may indicate a malfunction, was not noticed until later that day at the funeral home. Before Gohde's body was cremated, the funeral director removed the defibrillator and it was sent to Guidant for analysis.

Steve Tragash, a Guidant spokesman, said in an e-mail that Guidant does not comment on litigation.

According to a document filed with the lawsuit, the company's analysis on Sept. 23 concluded that on the morning of Gohde's death "a shock was attempted and the device became non-responsive at this time."

The document, an adverse event reporting form, was filed with the Food and Drug Administration. On it, Guidant concluded that the "device failure directly contributed to event," and the event checked off on the form is "death."

No autopsy was done, said Sutton.

She said Kathleen Gohde was not conducting interviews.

"Of course it's been a very traumatic experience for Mrs. Gohde," Sutton said. "She has a hard time talking about any of it."

The lawsuit seeks more than $50,000 in damages.

Since June, Guidant has recalled or issued safety advisories for about 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices.

Last March, a 21-year-old Minnesota man died after collapsing while mountain biking in Utah, after his defibrillator - the same model implanted in Gohde - apparently short-circuited. Guidant agreed in November to an undisclosed settlement with Joshua Oukrop's family.

According to the Gohde lawsuit, a properly functioning defibrillator detects abnormally fast and life-threatening heart rhythms and delivers an electric shock to the heart muscle, causing it to return to a normal rhythm.

Thom Gunderson, a medical technology analyst at Piper Jaffray, said the Gohde lawsuit is one of several product liability lawsuits against Guidant.

"I expect that these will trickle out into the media and into the courts for the next several months," Gunderson said. "Wall Street ... is aware that this is going to happen and it's just not an if, it's a when, you (will) see the next story."

The defendants have 20 days to file an answer to the complaint.

Boston Scientific Corp. is acquiring Guidant for $27 billion.

2006-03-24T00:02:04Z

Title: Woman: Failed Defibrillator Killed Spouse	Article has been viewed : 463 times	Date: 3/31/2006 2:44:49 PM
By AMY FORLITI Associated Press Writer (AP) - MINNEAPOLIS-As she paid her last respects to her husband, Kathleen Gohde was shocked to hear a beeping sound coming from his chest when she leaned down to give him a final goodbye hug and kiss. The sound indicated something had gone wrong with the defibrillator that was supposed to keep Allan Gohde's heart beating at a normal rhythm, according to a wrongful death and product liability lawsuit filed against Guidant Corp. "It was a horrifying experience for Mrs. Gohde that she will carry with her for the rest of her life," Tara Sutton, a Minneapolis attorney for Gohde, said Thursday. Kathleen Gohde noticed the beeping during a private viewing session for family at the funeral home before his cremation. The lawsuit, filed this week in Ramsey County District Court in St. Paul, claims Allan Gohde's defibrillator short-circuited, and that he died as a direct result. The lawsuit names as defendants Indianapolis-based Guidant and its subsidiary in Arden Hills, Minn., where the defibrillators are made. The claim is one of several filed against Guidant in recent months after the company recalled thousands of the devices. According to the lawsuit, Allan Gohde, 53, died of sudden cardiac arrest at his Birchwood, Wis., home on July 28, 2005, more than a month after Guidant recalled its Ventak Prizm 2 DR Model 1861 defibrillator. Gohde had received the device in February 2002. At the time of the recall, Guidant did not recommend the devices be removed, noting that failure was rare while invasive surgery was risky. The company advised doctors to monitor patients every three months. The lawsuit also asserts Guidant knew that the model, manufactured before April 2002, had a defect for more than three years before announcing it to the public, and that Guidant issued an advisory only after the company learned The New York Times was writing a report about the defect and the death of a 21-year-old Minnesotan. The lawsuit also claims that Guidant continued to sell the defective products, "with deliberate disregard for patient safety." On the morning Gohde died, his defibrillator detected an arrhythmia that should have prompted the device to shock the heart back to a normal beat, according to the lawsuit. Three seconds later, when the device tried to do so, it failed. Gohde's wife was with him when he collapsed, but the beeping sound, which may indicate a malfunction, was not noticed until later that day at the funeral home. Before Gohde's body was cremated, the funeral director removed the defibrillator and it was sent to Guidant for analysis. Steve Tragash, a Guidant spokesman, said in an e-mail that Guidant does not comment on litigation. According to a document filed with the lawsuit, the company's analysis on Sept. 23 concluded that on the morning of Gohde's death "a shock was attempted and the device became non-responsive at this time." The document, an adverse event reporting form, was filed with the Food and Drug Administration. On it, Guidant concluded that the "device failure directly contributed to event," and the event checked off on the form is "death." No autopsy was done, said Sutton. She said Kathleen Gohde was not conducting interviews. "Of course it's been a very traumatic experience for Mrs. Gohde," Sutton said. "She has a hard time talking about any of it." The lawsuit seeks more than $50,000 in damages. Since June, Guidant has recalled or issued safety advisories for about 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices. Last March, a 21-year-old Minnesota man died after collapsing while mountain biking in Utah, after his defibrillator - the same model implanted in Gohde - apparently short-circuited. Guidant agreed in November to an undisclosed settlement with Joshua Oukrop's family. According to the Gohde lawsuit, a properly functioning defibrillator detects abnormally fast and life-threatening heart rhythms and delivers an electric shock to the heart muscle, causing it to return to a normal rhythm. Thom Gunderson, a medical technology analyst at Piper Jaffray, said the Gohde lawsuit is one of several product liability lawsuits against Guidant. "I expect that these will trickle out into the media and into the courts for the next several months," Gunderson said. "Wall Street ... is aware that this is going to happen and it's just not an if, it's a when, you (will) see the next story." The defendants have 20 days to file an answer to the complaint. Boston Scientific Corp. is acquiring Guidant for $27 billion. 2006-03-24T00:02:04Z Copyright 2006 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.