Integrity Matters
June 22, 2005

Patients must also be smart consumers

Question: (E-192)

Dear Jim:

How can Guidant Health Systems remain in business while delivering pacemakers that kill people? What can I do to make sure I don't die because of a faulty product?


Guidant has a history of irresponsible leadership and inconsistent product quality. This column addressed their malfeasance in July 2003 when I wrote: "Greed, whether for power or money (or both), is at the heart of this problem. Compromising health and life cannot be tolerated. Fortunately, such reckless endangerment seems to be the exception..."

Problems with Guidant's popular heart defibrillator have led federal regulators to start an inquiry into whether the company violated a corporate integrity agreement it signed in 2003. Indianapolis-based Guidant had signed the integrity agreement after a former Guidant subsidiary, Endovascular Technologies Inc., pleaded guilty to 10 felonies and paid $92.4 million to settle criminal and civil charges in a case involving a device meant to treat abdominal aortic aneurysms. The U.S. Justice Department contended that Guidant covered up thousands of Ancure incidents in which the delivery system of the device had malfunctioned, including 12 deaths.

More recently, Guidant reported yet another malfunction to the U.S. Food and Drug Administration, but it did not inform patients and doctors for three years, until physicians at Abbott Northwestern Hospital in Minneapolis publicly questioned the company's conduct. Guidant contends that the device is highly reliable. Under federal law, a company must report any incident to the FDA in which its medical device might have caused or contributed to a death or serious injury, or if the malfunction is likely to recur. Guidant's reputation erodes confidence in the integrity of health care. This cannot be allowed. So, before accepting potentially-risky health treatment, here are some recommendations:

  • Ask questions. Get second opinions.
  • Demand current information that confirms the quality and reliability of any treatments, including technologies, you elect.
  • Utilize this toll-free hot line, (888) 463-6332, which will connect you with the FDA. The FDA also can be reached online at, where the agency addresses many concerns about technology, toxicology and health safety.
  • Research current news regarding issues related to medical devices and radiological health. Learn what products and services are working well and which ones are causing problems:

Forward additional health hotline suggestions directly to us at so we might pass along helpful resources and strengthen the integrity of health-care delivery. Restoring confidence in health care's integrity is a must.

Letter to the Editor, published November 8, 2005:

When the Tylenol scare occurred years back, McNeil Labs stepped up, admitted the problem, pulled the product off the shelf and quickly communicated with customers.

The result was that Tylenol customers continued to hold the company in high esteem and sales increased rather than decreased.

This process was based on responsible management with a high regard for its customers as well as its own profitabilsity. This proved that integrity matters.

I happened to see the June 22 "Integrity Matters" by Jim Bracher. A reader asked a pertinent question: "What can I do to make sure I don't die because of a faulty product?" I was wondering the same thing.

The concept of integrity has its roots in the relationship one has with family, friends and, yes, especially with customers. Integrity does matter. It is the cornerstone of trust. Will I trust a new device from Guidant, if one is offered?

I am the CEO of a Strategy Consulting firm that deals with corporate growth and profitability. I advise companies on how to be "customer centric" as a balance to internal financial/operational issues, as well as being the not-so- proud owner of an implanted Guidant cardiac defibrillator.

Your publication should be commended for printing Bracher's column.

Pete Bogda, CEO, ABA Consulting Inc.

Dallas, Texas

Home Page | About Us | Ask Bracher | Services | Resources | Contact Us

©Bracher Center for Integrity in Leadership. All Rights Reserved.
1400 Munras Avenue ~ Monterey, California 93940