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Defective heart devices leave taxpayers with bills

Nov 19, 2005 | Salt Lake Tribune Gregg Gruis remembers how thankful 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.
His first defibrillator gave out in May of 2003 after two years, short of the unit's expected four-to seven-year life span, and a second defibrillator was surgically removed in March after it was found to have flaws. This summer his third device also was recalled. On top of that, because of a labyrinth of hospital charges not unraveled until this week, Gruis has delayed more treatments for the past eight months in the face of tens of thousands of dollars in medical bills.

"Someday I'm not going to wake up," said Gruis, 58, who has undergone 10 shock treatments during the past six years in failed attempts to regulate the beating of his heart. "I didn't want to leave my wife with all these bills."

To make matters worse, Gruis also has been caught up in the largest-ever recall of defibrillators and of pacemakers that keep the heart beating. Since June, more than 200,000 devices made by Guidant Corp. have been recalled, as well as another 80,000 units manufactured by Medtronic Inc. Both companies reportedly knew of defects for at least two years but continued selling the devices until the U.S. Food and Drug Administration removed them from the marketplace this summer. Neither company returned telephone calls for this story.

Although the manufacturers are giving reimbursements to replace some of the recalled devices, it is patients, private insurance companies and ultimately taxpayers who are picking up the tab for hospital and doctor fees in the change-out surgeries.

Medicare, the federally funded program that helps pay health care costs for people with disabilities and those over age 65, is covering much of the costs, as is Medicaid, which provides assistance for the needy, aged, blind and low-income families. Federal officials in Washington, D.C., refused to disclose how much has been paid but said reimbursements are under negotiations with the device manufacturers.

It's probable that because many patients are elderly, the bulk of the change-out surgeries are being paid for by the federally funded insurance plans, said Daron Cowley, spokesman for Intermountain Health Care, or IHC, Utah's largest hospital chain.

For instance, nearly 70 percent of the 72 patients undergoing change-out surgeries at IHC hospitals this year were covered by Medicare or Medicaid. And at the University of Utah hospital, four of five patients were covered by Medicare. At IHC, 18 patients had private insurance, and another five had no insurance and were given charitable care. In all cases, manufacturers issued full rebates for replacement heart devices or donated units to uninsured patients. The IHC charges ranged from $2,800 to $31,000. The average hospital tab was less than $6,000.

Gruis' hospital bill came to nearly $111,000 at Salt Lake Regional Medical Center in March, including a charge of $84,000 to replace his defibrillator, Model 7274 Marquis made by Medtronic Inc. His warranty stated that Medtronic would not cover a replacement device made by another company. Two months later his Guidant unit also was recalled. Bills from the first change-out surgery caused him to postpone more treatments because his IHC insurance paid only $36,000 of the costs, leaving him with a tab of more than $75,000. Medicare paid nothing.

Gruis is a Wall-Mart greeter whose sales career ended in 1997 when an uninsured motorist ran a red light on Bangerter Highway and crashed head-on into his car. He suffered brain damage and then heart problems that worsened with each successive surgery. Finances since the accident have been tight. He pays $500 a month to remain on his wife's IHC policy.

"I've always been an optimistic person," said Gruis, "but there are some days where I just want to give up."

On Wednesday, questions about Gruis' bills were finally unraveled after what he said were repeated calls to his private insurer, Medicare representatives and Salt Lake Regional. Basically, he owes nothing because the hospital had written off more than $75,000 in an adjustment that came after Medicare refused payment.

Dawn Booth, spokesperson for Salt Lake Regional, said it is standard practice for hospitals not to send out zero-balance statements to patients. "It is up to insurance companies and Medicare not hospitals to send out explanations of benefits," she added.
    Conversely at IHC, spokesman Daron Cowley said hospitals in its system routinely mail zero-balance statements to patients.
    Gruis now must schedule a date for a three-day hospital stay to determine if medication may help his weakened heart. His second recalled defibrillator, which remains implanted in his chest, has been turned off so that it no longer regulates the top portion of his heart.
"Why are patients, taxpayers and private insurance companies paying to replace these defective devices?" asked Gruis. "Why aren't the manufacturers responsible?"
Another implant patient, Zina Lewis, 39, of Park City, who faces surgery next week to replace a defective Guidant pacemaker, said patients can go into debt paying insurance deductibles, travel costs and time out of work during hospital stays  along with the worry of reaching insurance caps that range from $1 million to $2 million. Since her teens when her first pacemaker was implanted, she's had medical expenses totaling $750,000.
"I am now under my husband's IHC policy and we have some distance yet before we reach our maximum, but I'm also in my 30s. What happens when that runs out?" she asked. "Why should the private payers, Medicare and the taxpayers, have to pay for marketing and sales of fraudulent devices that are known to be failing at increasing rates?"
Lewis was unable to get information on the reliability of the lead wires that connect her device to her heart until late this month when Guidant issued a statement indicating the leads are more likely to fail than its recalled pacemakers or defibrillators. The report cited 179 cases involving lead wires that failed. By contrast, the company said its heart devices have experienced only five failures.

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