Healthcare titan Johnson & Johnson (J&J; New Brunswick, New Jersey) yesterday issued a terse, one-sentence statement saying that it “continues to be confident” in its plan to buy cardiovascular device manufacturer Guidant (Indianapolis).
Prompting the brief statement was a New York Times article yesterday disclosing that Guidant had delayed, for three years, notice to doctors and patients that one of its implantable cardiac defibrillators (ICDs) had a design flaw that could cause the units to short-circuit and malfunction.
At the core of the Times story was its reporting on the death of a Minnesota resident, Joshua Oukrop, a 31-year-old college student.
Oukrop was implanted with one of the devices, a Ventak Prizm 2 Model 1861, because of a genetic heart defect. He was reportedly on a bicycle trip in Utah, and had first complained of being very tired and then died of cardiac arrest.
The Times reported that the ICD has been implanted in 24,000 people and that the devices were produced from 2000 to 2002. Oukrop’s death from the defect is the only one thus far disclosed.
Various news stories have indicated that Guidant has acknowledged the defect and that it has sent advisories to doctors that implanted the devices but, as of yesterday, the company had posted no statement concerning the advisory on its corporate web site. The physician advisory did not recommend replacement of the device.
The advisory apparently was issued – as was J&J’s press release – in response to the Times article.
Calls to Guidant’s media communications department by Medical Device Daily were not returned.
The company’s shares were down 48 cents yesterday to $73.75 at the close of the market.
Guidant said that it reported a change in production of the ICD to improve its safety in its 2002 annual report, as required by regulations, though it is not clear if it had detailed the particular need for the change.
The company reportedly disclosed the flaw in its Ventak Prizm 2 Model 1861 to Oukrop’s doctors, after his death, following an inspection of the failed device, and told them of about 25 other cases in which the defibrillator had malfunctioned.
It did not, however, issue an alert to physicians until it learned the newspaper was preparing a story on the ICD, which appeared yesterday.
According to the Times report, Oukrop’s father, Lee Oukrop, has the same genetic disease as his son and was implanted with the same ICD device. After his son’s death, he was implanted with a replacement.
In the brief statement it issued yesterday, J&J said it still expected the $25.4 billion acquisition of Guidant to be completed during the third quarter of this year.
Guidant reported FDA approval of the Ventak Pixm ICD in 2001, at the time billing it as “the world’s smallest dual-chamber implantable defibrillator.” It cited its “small, physiologic shape,” its “longevity” between replacement times and overall simplicity of use (Medical Device Daily, Jan. 27, 2001).
Later that year, the company said it sent information to physicians warning them that some first-generation Ventak Prizm and Ventak Prizm HE ICDs unexpectedly switched to a built-in safe mode. It said 44 ICDs representing 0.3% of those made, switched to safety mode because of what it called “a rare interaction” between the device and a specific memory component (MDD, April 25, 2001).