Prominent Cardiolgists Says Durata Report to FDA Likely CredibleJun 15, 2012 | Parker Waichman LLP
A leading cardiologist tells Reuters news service he is inclined to believe the report that surfaced recently detailing the failure of St. Jude Medical Inc.’s new Durata cardiac defibrillator lead.
According to a report late this week, Dr. Robert Hauser - who had recently sparked imbroglio between he and St. Jude with another article on a previous model of the company’s defibrillator lead - said he believes a report filed with federal regulators which noted how one patient’s new Durata lead had its connective end break free of its silicone insulation housing.
The report broke usual protocol in that it was filed through the Food and Drug Administration’s Maude adverse event database and no report was filed with St. Jude. The medical device company denies the validity of the report but it surfacing has led to a sharp and sudden decline in the company’s value with stocks trading 8 percent below averages.
Hauser, who recently published a report in the journal Heart Rhythm detailing the failings of St. Jude’s previous and withdrawn cardiac defibrillator lead, the Riata, told Reuters the new report on Durata is certainly believable. He said, “it’s concerning, but hardly definitive.”
In his study on Riata, Hauser linked the defective leads to at least 20 deaths, a figure that struck the ire of St. Jude, which questioned the validity of it and even prompted the company to cobble its own quick review of available data in an attempt to refute the prominent cardiologist’s claims. The report sparked a month-long back-and-forth public argument between St. Jude and Hauser.
While St. Jude has removed the Riata due to its link to a high rate of failures in which the connective ends of the leads break free of a housing, exposing the end and putting patients at risk of not receiving a life-saving shock to their heart or the shocks necessary to maintain normal heart rhythm, it had hoped that Durata would correct those issues and allay fears that these newer model of leads were safe and effective.
Durata allegedly uses a stronger and more durable silicone housing to protect the connective ends of the lead, reducing the risk present with the Riata.
Some critics of both the FDA’s reporting system and the database holding them believe this adverse event report has not been properly vetted for accuracy. A spokesperson for the agency told Reuters that reports are posted in the database but whether it has undergone a review by regulators is unknown.
Hauser said he does not believe St. Jude is in denial about the possible problems with its cardiac defibrillator leads but thinks more will come of this report than is initially being suggested. He said several early studies on Durata’s performance are currently underway but are not expected to have any findings available until the end of the year.