Guidant Defibrillators: Some Shocking Allegations

St. Paul, MNLate last year Boston Scientific, new owner of Guidant and newly responsible for defective Guidant defibrillators, quietly raised its claims purse to $732 million, up from $485 million. According to the Boston Globe, the money is being set aside for potential claims emerging from lawsuits over the defective implants.

The Guidant Defibrillator debacle is now Boston Scientifics' headache, and it's bound to cost them. There are hundreds of product liability lawsuits in the pipeline. Some say lawsuits are accumulating at the rate of three per day.

At issue, according to sources, is the allegation that Guidant continued to market and sell defective implantable defibrillators, even after it learned of the defect.

It was two years ago that Guidant Corp. recalled certain models of its line of implantable Cardioverter defibrillators (ICD) after a manufacturing defect was found to cause some units to short-circuit and fail. At first, only one model in particular was given the hook: the Ventak Prizm 2DR model 1861, manufactured on or before April 16th, 2002.

Since that time, however, the recall has been expanded to include several models of Contak Renewal, Vitality, and Renewal. A combination of both Class 1 (more serious), and Class 2 (less serious) recalls has succeeded in identifying upwards of 80,000 potentially defective units.

ICD technology is used in patients suffering from congestive heart failure, abnormally rapid heart rhythms, or irregular heartbeats. The defibrillator shocks the faltering heart, and helps to keep the life-sustaining rhythm in check. There are approximately 64,000 new ICDs implanted into U.S. patients each year.

While it was in 2005 that Guidant Corp recalled or issued warnings with the blessing of the U.S. Food and Drug Administration (FDA), it is alleged that Guidant knew about the defects upwards of three years prior, in 2002 - and yet continued to aggressively promote and market the products worldwide.

According to court documents filed in Minnesota earlier this month, Guidant officials are said to have been "money-hungry" in the aggressive pursuit of sales of its ICD, which carries a $30,000 price tag. It is alleged that Guidant failed to inform the medical, and regulatory communities for three years after it knew about problems with one of its units, in an effort to further sales of their device. While Guidant claims that their ICD is one of the most reliable on the market, lawyers for the plaintiff point to the insulation used in the device. Polyimide, according to studies conducted in the 1970's, does not stand up well to heat and humidity. Given that the ICD is implanted into the human body - a constant source of moisture and warmth - a breakdown of insulation prone to failure in those conditions, and the ultimate malfunction of internal circuitry, is a recipe for disaster.


Several class action lawsuits have been filed, and hundreds of personal claims. The Minnesota case combines most of 1400 claimants into one lawsuit, which will probably go to trial in July.

Boston Scientific is facing other hurdles, including slipping sales of its' drug-coated stents, due to safety concerns. Even so, a spokesperson for the company maintains that Boston Scientific has no plans to abandon its' core business, which includes the stents and the Guidant implantable heart regulators. Instead, the company is talking of selling off parts of the company, and trimming its' workforce to help pay down an accumulated U.S. $7.2 billion in debt.

With the age wave starting to crash into the demographic beach, and baby boomer hearts starting to sputter, there's little surprise that Boston Scientific would not want to abandon an area where it sees a lot of growth: implantable defibrillators.

So far, the only growth appears to be in the legal defence fund.