The filing of lawsuits over St Jude Medical’s recalled Riata pacemaker leads could have dire consequences for the Minnesota company not only in terms of court-ordered payouts but also in their implications for the leads it is currently selling. There is some debate over whether the Durata family of wires, currently on the market, suffers the same flaw as the Riata leads.
An FDA-mandated 2,500-patient postmarketing study of the Durata product line kicked off last week with the aim of settling the question. However, in 2007, three years before the Riata devices were withdrawn, St Jude was able to point to postmarketing safety studies in 5,800 patients that it said proved that the Riata leads were safe. If trials in nearly 6,000 patients could not pick up the signals on Riata, a study of Durata less than half the size will struggle to convince.
The problems with Riata are related to the lead insulation, which St Jude calls Optim and which has been shown in some cases to wear off, exposing the wire and resulting in inappropriate shocks to patients. The lead failures have been linked with over 20 deaths and many cases of injury (St Jude banks on innovation to see it through tough times for medtech, October 1, 2012). A victory for Riata plaintiffs could have important repercussions for Durata since Optim is used in both product lines.
The legal cases, both filed in California, allege that St Jude did not report the flaws with the Riata leads to the FDA as is legally required, and call St Jude’s manufacturing processes into question.
This last point is particularly interesting in light of an FDA inspection of the facility in which Durata wires are manufactured that questioned St Jude’s quality control (St Jude’s Portico valve reaches Europe, but lead worries intensify, November 22, 2012).
If St Jude is to avoid similar lawsuits over its more recent leads, its best bet is to prove that they pose no risk to patients’ safety. The St Jude Medical cardiac lead assessment study (SJM CLAS) will compare all of St Jude’s lead franchises: Riata, Durata, Quicksite and Quickflex. Primary endpoints include both the prevalence and annual hazard rates of exposed conductors, electrical dysfunction and other lead anomalies including fractures, kinking and crushing.
Full results are not expected until the end of 2016 and even interim data will not arrive before mid-2014, according to analysts from JP Morgan. Bob Hopkins, an analyst at Bank of America Merrill Lynch, said that the study would be the most comprehensive look at Durata safety to date, but disagreed about the timing of the readout, saying that there was potential for an important update on Durata safety within the next 6-12 months.
If either one of these investigations goes against St Jude the company will suffer. But proof that the Durata leads are unsafe, coupled with victory for the plaintiffs in the court cases and therefore the promise of legal success should Durata recipients file suit, will leave St Jude very vulnerable indeed.
|St.Jude Medical Cardiac Lead Assessment Study