The risk of surgery from taking out the device might be riskier than device failure. When countless Southwest Florida heart patients received a letter last year informing them that their Guidant defibrillators were defective, they rushed to their doctors hoping for a replacement.
But, they’ve learned that changing the devices can be even more dangerous.
“When you are talking about changing out devices, patients undergo significant risk,” said Dr. Erick Burton, a Lee Memorial Health System cardiac electrophysiologist, who’s removed 20 to 40 defective defibrillators. “The risk of surgery from taking out the device might be riskier than device failure.”
Now these patients require a lifetime of close monitoring by doctors, which is hitting health insurance companies hard as they pay for that care.
Blue Cross and Blue Shield’s 38 plans nationwide have filed a lawsuit against Guidant Corp
To recoup some of those losses, 20 of Blue Cross and Blue Shield’s 38 plans nationwide have filed a lawsuit against Guidant Corp. for an undisclosed amount. Blue Cross and Blue Shield of Florida is one of the plaintiffs.
“It is just a matter of protecting the company,” said Valerie Rubin, spokeswoman with Blue Cross and Blue Shield of Florida.
The lawsuit alleges that Guidant, based in St. Paul, Minn., knew the defibrillators were defective as early as 2002 but did not issue the recall until 2005. During those years, the company continued to sell, manufacture and market the devices. About 24,000 defective Guidant defibrillators were used.
The devices are implanted in patients with congestive heart failure, abnormally fast heart rhythms or irregular heartbeats to shock their hearts into a regular rhythm.
short circuiting, causing the devices to stop functioning entirely for a period of time
“The subject devices are defective in a number of ways, including short circuiting, causing the devices to stop functioning entirely for a period of time up to 24 hours,” the lawsuit states. “When subject devices resume working after this period, if at all, all of their computer memory has been erased so the malfunctions are not detectable by physicians, hospitals, medical practitioners or patients.”
There have been 26 documented failures, the lawsuit alleges, and contends countless others that went undetected.
Each year, about 64,000 defibrillators are inserted into patients, according to the American Heart Association.
Insurance companies suing Guidant Corp.
- Blue Cross and Blue Shield Association in Illinois
- Blue Cross and Blue Shield of Alabama
- Blue Cross and Blue Shield of Florida
- Blue Cross of Idaho Health Service, Inc.
- Blue Cross and Blue Shield of Michigan
- Blue Cross and Blue Shield of Rhode Island
- Blue Cross and Blue Shield of Tennessee
- California Physicians’ Services Blue Shield of California
- Excellus Health Plan of New York
- Health Care Service Corporation, which covers part of Illinois
- Health Care Service Corporation in New Mexico
- Health Care Service Corporation in Texas
- Health Care Service Corporation in Oklahoma
- Horizon Blue Cross and Blue Shield of New Jersey
- Louisiana Health Service and Indemnity Company Blue Cross and Blue Shield of Louisiana
- Premera Blue Cross of Washington
- The Regence Group of Oregon
- Wellmark Blue Cross and Blue Shield in Iowa
- Wellmark Blue Cross and Blue Shield in South Dakota