New York, NY - In a front-page story by Barry Meier, the New York Times reports that Guidant failed to disclose to physicians or patients information about a rare but potentially fatal short circuit in its Ventak Prizm 2 Model 1861 ICD [1]. Information about the short circuit began to filter out only after the death of a 21-year-old Minnesota college student.

Guidant says that at least 25 other defibrillators contained the same flaw and that three years ago the company changed its manufacturing process to fix the problem. In the article, Guidant's chief medical officer, Dr Joseph M Smith, explains that "the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because the failure rate was very low and replacing the devices might pose greater patient risks." When Guidant learned that the Times was planning to run the story, however, it issued an advisory to physicians. Smith denies that Guidant's decision to withhold the information was motivated by financial or liability concerns.

The company's decision was challenged by Dr Barry Maron (Abbott Northwestern Hospital, Minneapolis, MN), who treated Joshua Oukrop, the 21-year-old student who died. "It is a statistical argument that has little to do with real people," the article quotes Maron as saying. Along similar lines, Dr David S Cannom (Good Samaritan Hospital, Los Angeles, CA) is quoted: "At the end of the day, you have to come down on the side of full disclosure." Although he agrees that most patients might not need a replacement, the "calculus could shift substantially for high-risk" patients, Cannom told the Times.

Smith told the Times that the ICD model "exceeded company specification both before and after the wiring fix."