Guidant Fails to Disclose Defibrillator Problem

Although aware of a potential problem for more than three years, Guidant Corp. (Indianapolis) did not tell doctors or patients that one of its defibrillator models contained a flaw that could result in malfunction. The device, the Ventak Prizm 2 Model 1861implantable defibrillator, is now linked to the death of a 21-year-old college student with a genetic heart disease. The young man died while on a bicycle trip in Utah.

Guidant has acknowledged that the patient’s defibrillator had short-circuited. The company said it was aware of 25 other incidents of device failure for the particular model, but no other deaths. Guidant also reported that it had modified the manufacturing process for the device in November 2002, and that malfunctions were limited to devices made before the design change. FDA was advised of the changes in the company’s annual report of August 2003. The company also maintains that each instance of malfunction was reported to the regulatory agency in a timely fashion.

Guidant CMO Smith: Low-risk decision.

Yet, Guidant never issued a “Dear Doctor” advisory letter to physicians, which is a common practice when such incidents occur. The company’s chief medical officer, Joseph Smith, MD, said that the company did not issue an alert since the risk was considered very low and replacing the device—a surgical procedure—could actually pose greater danger, particularly from infection.

According to Guidant, since the product’s introduction, 37,000 of the devices have been implanted in patients around the world. The company says that 24,000 of the units remain implanted, but it has not disclosed how many of them were manufactured prior to the design change. A company press release of May 23 cites a letter to physicians that describes “a rare failure that results in the device’s inability to deliver therapy,” but the letter was not made public. The press release recommended that physicians “continue to monitor patients every three months as described in the labeling.”

The short circuit can occur when the device builds up a charge to deliver the high-energy shock needed in dealing with life-threatening cardiac arrhythmia. In three reported cases, doctors intentionally induced abnormal heart rhythms during routine checkups. The Guidant device failed, requiring doctors to resuscitate the patients with external defibrillators.

Asserting that the overall reliability of the device remains high, Guidant said it “does not recommend early replacement of these devices, which continue to exceed design expectations and rank overall as one of the most reliable ICD (implantable cardioverter defibrillator) products available.” Patients with units were advised to “consult with their physicians, particularly if they’ve sustained a recent defibrillation shock.”

According to a report in the Indianapolis Star, FDA has already begun an investigation of the Utah incident. Agency spokeswoman Kathleen Quinn said FDA wants to find out “all of the elements of this particular situation.” There was no indication of the nature of the investigation or how long it was expected to last.

According to an Indianapolis Star interview, Guidant spokeswoman Annette Ruzicka, said, “We decided we needed to step in and communicate with our physicians. We realized there was an opportunity for confusion.”

The physician advisory also coincided with an article in The New York Times, which was first to break the story.

Guidant cites the fact that of a total of 37,000 devices manufactured, only 26 patients have experienced problems, an overall failure rate of 0.07%. Industry analysts and medical reporters were quick to compare Guidant’s response with that of rival medical device maker Medtronic Inc. (Minneapolis). Just three months ago Medtronic rapidly began to notify physicians when the company discovered that the batteries in one of its ICD models were draining faster than expected and should be immediately replaced.

Physician notification was swift and initiated after just nine reported instances of battery problems in the Medtronic device in spite of there being more than 87,000 in use—a failure rate of 0.01%.

Many medtech analysts were left shaking their heads as to why a “first-rate,” “premier,” and highly regarded medical device maker would make the kind of decisions that Guidant made in this case. Yet, many recalled that it was just two years ago that Guidant was hit with a $92-million fine for covering up thousands of medical problems related to its aortic graft device. It remains the largest fine ever levied against a medtech firm.

The situation was apparently alarming enough for Johnson & Johnson (New Brunswick, NJ) to step into the fray and reassure investors that its $25.4-billion acquisition of Guidant remained on target. J&J’s handling of the infamous Tylenol-tampering scare in the early 1980s is generally considered the classic model for how to develop a consistent, coherent, and effective response to a corporate crisis. In a statement, J&J said it “continues to be confident in its decision to acquire Guidant Corp. and anticipates a closing of the transaction in the third quarter of 2005.”

Almost half of Guidant’s 2004 revenues of $3.8 billion come from implantable defibrillators.

© 2005 Canon Communications LLC

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