Guidant Corporation

In todays NYT there is a story about how Guidant continued to sell heart devices that were known to short-circuit. They did notify the FDA of these failures. Did Guidant act ethically in this case? Was this a government failure, the company's failure, or no failure at all?

The agency's inquiry into Guidant began after The Times reported in late
May that the company had not told doctors about flaws in the Prizm 2 DR and kept
selling older versions of the model after developing an improved one in
2002.

Guidant has said it knows of 28 units that have short-circuited out of
26,000 made before the modification.

Dr. Schultz said he was not familiar with the February report from Guidant that broke out the short circuit figures. He said he did not have information about what percentage of reports were reviewed within 90 days.

Told of Dr. Schultz's comments about the agency's disclosure policies, Dr. Douglas P. Zipes, a professor at the Indiana University School of Medicine, said he took exception to them, saying he believed that the Guidant episode had highlighted gaps in how the F.D.A. oversaw the safety of heart devices. Dr. Zipes added that both the agency and manufacturers needed to provide doctors with more data about product failures.