Envisioning 2.0

An article by Barry Meier of the New York Times appeared today that provides intriguing details about how medical device maker Guidant responded to a crisis involving one of its products.

Last year, the company considered sending physicians a “Dear Doctor” letter highlighting safety concerns about two models of its implantable defibrillators. According to the Times “at least” seven patients died after the defibrillator failed to work because of an electrical defect. After an internal debate, Guidant decided not to send the letter.

Guidant commissioned an independent investigation of its actions relating to the defective defibrillators. The panel concluded that Guidant’s decision to continue allowing physicians to implant the devices while stopping production was “inconsistent.”

Guidant has admitted that it did not handle the situation appropriately. In a statement, Paul Donovan, a spokesman for Boston Scientific (which recently acquired Guidant), said that the company “understands” that it needs to communicate with patients and physicians in a more “timely and transparent fashion.”

The Decision: Weighing the Benefits Versus Drawbacks Of An Announcement

The Guidant issue highlights the fact that there are no simple answers when healthcare companies are trying to determine how best to address safety concerns relating to a product. In making its decision, Guidant appeared to be weighing three issues:

I - Consequences For Patients: Company documents reveal that Guidant was concerned that patients would have to undergo unnecessary surgeries to remove devices unnecessarily.

II - Financial Implications: The company estimated that it would cost $9 million to destroy its inventory of parts and completed devices.

III - The Technical Assessment: Guidant had its engineers assess the problem. They concluded that the number of deaths associated with the devices was likely low enough to justify continuing to sell them.

Guidant had to make a decision. Do the benefits of full disclosure outweigh the consequences of going public about safety concerns? How big is the problem? Is it significant enough to issue a recall?

The Aftermath: Guidant Facing Legal Scrutiny

An independent panel and the Food and Drug Administration have concluded that Guidant made the wrong decision. In addition, the Minneapolis US Attorney is investigating the company. Clearly, Guidant is facing severe consequences because of its decision.

My point is not to point fingers at Guidant. Rather, I’m interested in what the Times article reveals about the company’s decision-making process.

Dear readers: What do you think motivated Guidant’s decision? If you were providing communications counsel to Guidant what would you have recommended?

This entry was posted on June 7, 2006 at 4:56 pm and is filed under Healthcare Industry, Marketing Communications. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.