FDA Issues Stronger St. Jude Durata WarningJan 16, 2013
Food & Drug Administration threatened to either impose a fine or take other actions against St. Jude Medical for neglecting to respond to the federal regulator’s concerns about the heart device, said The New York Times.
In 2011, St. Jude issued a Class I recall on its Riata and Riata ST cardiac defibrillator leads after they were associated with a defect known as “inside-out corrosion,” which causes the Riata leads’ conductive ends to break from their protective housing, causing an implanted heart defibrillator to malfunction. Although the Riata leads have been linked to more than 20 deaths, tens of thousands of people still rely on these questionable wires to deliver life-saving shocks to their heart, something that cannot be guaranteed should corrosion occur.
After the recall, with thousands of people left wondering how they should proceed with the faulty implanted lead wires, the FDA determined that patients with the Riata should consult their physicians and be vigilant for signs that their Riata leads were malfunctioning. The agency ruled against telling people to have replacement surgeries to remove the defective leads because that procedure carries life-threatening risks.
In response to the failed Riata leads, St. Jude recently released the Durata lead with the Optim component; however, like its predecessor, the Durata has also been the subject of some adverse event reports during its short time on the market.
According to The Times, the agency letter stated that St. Jude did not address a number of issues concerning the component that were found during an FDA inspection of the company’s factory last autumn.
St. Jude disclosed it was in receipt of the federal regulator’s letter in its filing this week to the Securities and Exchange Commission (SEC) and also stated that the federal regulator had advised St. Jude that it would not approve applications for complex medical devices, “among other things,” until the issues discovered during the inspection are resolved, according to The Times.
St. Jude said would be “giving the highest priority to fully remediating these concerns” in its SEC filing, said The Times, which noted that the FDA letter indicated that the agency was running out of patience with St. Jude. The FDA also stated that, although St. Jude did respond to the agency’s inspection report claims, it had not supplied “evidence” of the steps it had taken to correct issues, said The Times.
St. Jude spokeswoman, Amy Jo Meyer, told The Times that the complaint reports were over defibrillator wires that were not implanted in patients, that St. Jude was working on responding to the FDA’s concerns, and the firm would still be shipping products from the California plant discussed in the inspection report. The FDA said that if St. Jude continues to delay responding to its requests, the firm could be subject to both civil penalties and notification to those federal health care agencies that purchase products from St. Jude, said The Times.