Guidant Defective Defibrillators: Keeping Pace with the Lawsuits

St. Clair County, MIWhen Boston Scientific merged with Guidant last year, it not only acquired Guidant's product line, but assumed its liabilities as well. That includes a host of individual and class action lawsuits, at least 100 in number, over defective Guidant defibrillator and pacemaker products.

The latest was filed recently by 14 plaintiffs, launching a 39-count product liability lawsuit against the makers of the defective Guidant implants.

The suit was filed June 15th in St. Clair County Michigan, and is the third such lawsuit brought against Guidant Corporation of Indiana, Boston Scientific Corporation of Delaware, and Cardiac Pacemakers of Minnesota by the St. Louis law firm of Brown and Crouppen.

The Guidant story is a sorry example of a corporation seemingly overtaken by greed, growth and a bottom-line mentality at the expense of thousands of Americans believing that their Guidant defibrillator, or pacemaker, would be their ticket to better health, rather than a threat to their well being.

It is alleged that Guidant knew there were problems, all along.

It was in 2005 that the U.S. Food and Drug Administration (FDA) first weighed in on the faulty Guidant Implantable Cardioverter Defibrillator (ICD), suggesting that reports of a seal failure allowing excess moisture into the ICD (thereby causing their malfunction) constituted a concern. Guidant commenced a recall at that time, and has since expanded that recall to include a wider range of products, and problems - the latest, a faulty capacitor which could lead to shortened battery life.

However, it is alleged that Guidant knew as early as 2002 that there were problems with some products in their ICD line, and withheld pertinent information that may have succeeded in casting their products in a poor light. Meantime the company continued actively promoting their defibrillators with a focus to growing their stake in a growing market represented by an aging population in need of intervention to keep the ol' ticker going.

The lawsuit in Michigan alleges that Guidant recalled a number of its pacemaker models between 2002 and 2006 over concerns with seal deterioration and short-circuiting. The plaintiffs also allege that Guidant 'actively concealed' defects in their product line in order to suppress any potential for adverse publicity.

The suit alleges that Guidant ICDs were defective in design and did not conform to federal requirements for those products.

The 14 plaintiffs from various parts of the U.S. are seeking damages for pain, suffering, mental anguish, emotional distress, loss of capacity to enjoy life, lost past and future income, and incurred expense.

ICDs are implanted into patients with congestive heart failure, abnormally fast heart rhythms or irregular heartbeats. According to the American Heart Association, 64,000 implantable defibrillator operations are performed on U.S. patients each year. Approximately 24,000 defective Guidant ICDs have been implanted in U.S. patients, and Guidant has recalled, or issued warnings for over 80,000 units.

Unfortunately, in many cases it cannot be concluded that a product reflected in the list below is actually defective, based on the recall. The latter can only be conclusively determined if a patient suffers any adverse health effects which could be traced to a defective ICD, or an ICD that is explanted (removed) for future study.

Some patients may not be in a position to afford, in monetary or health terms, another surgery in order to replace a potentially defective device. At last word, the manufacturer was covering the cost of unit replacement, but NOT the cost of the explanting of the old, or implanting of the new.

A patient's best recourse is to talk to their doctor, or surgeon. The medical community was provided with a list of recalled ICDs and should have contacted their patients individually. If it is determined that you may have a faulty Guidant defibrillator and could be facing another costly surgery, you may wish to consider seeking legal help, in order to recover those costs.

Here's a list, and the recall classification, of Guidant products.

Class I Guidant Recall: PRIZM 2 DR, CONTAK RENEWAL, CONTAK RENEWAL2
The reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.

Class II Guidant Recall: VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices, CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices
The malfunctioning product may cause temporary, or medically reversible adverse health consequences. These Guidant devices are said to be subject to memory errors.