The U.S. Food & Drug Administration just issued another, stronger warning to St. Jude Medical about its Durata electrical heart lead.
The warning letter discussed either imposing a fine or other, serious, actions against the medical provider for not responding to the agency’s concerns about the heart device, said The New York Times.
St. Jude issued a Class I recall on its Riata and Riata ST cardiac defibrillator leads when it was found that the devices were linked to a defect known as “inside-out corrosion.” This so-called “inside-out corrosion” causes the conductive ends on the Riata leads’ to fracture from their protective housing, which can cause a malfunction of an implanted heart defibrillator.
The Riata leads have been linked to more than 20 deaths and tens of thousands of people still rely on these controversial wires to deliver life-saving shocks to their heart, something that cannot be guaranteed in the event the wires corrode. The recall has left these patients wondering how they should proceed with the faulty lead wires. The agency determined that patients implanted with the Riata consult their physicians and be attentive for signs that their Riata leads were malfunctioning and also ruled against advising patients to undergo replacement surgery to remove the defective leads as that procedure carries its own 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 adverse event reports in the short time it has been on the market.
An emerging The New York Times report indicates that the FDA’s letter indicated that St. Jude never addressed a issues concerning the component that were discovered during an FDA inspection of the company’s California factory late last year. St. Jude disclosed that it had received the FDA letter in a filing this week made to the Securities and Exchange Commission (SEC) and also stated that the federal regulator advised St. Jude that it would not approve applications for complex medical devices, “among other things,” until the firm resolves the discovered issues, said The Times.
In its filing, St. Jude said it would be “giving the highest priority to fully remediating these concerns”, said The Times; the FDA letter stated that the agency was losing patience with the device maker. The FDA also stated that St. Jude may have neglected to respond to its inspection report claims and had not supplied “evidence” of any corrective steps it had taken, said The Times.
St. Jude spokeswoman, Amy Jo Meyer, told The Times that complaint reports did not involve defibrillator wires implanted in patients, that St. Jude was working on responding to the agency’s concerns, and that it would continue to ship products from the California plant mentioned in the inspection report. The FDA said that if St. Jude continues to delay responding, the firm could be subject to civil penalties as well as notification to federal health care agencies that purchase from St. Jude, said The Times.
The report in question revealed serious flaws in St. Jude’s testing and its oversight of what The Times previously described as a “controversial heart device component.” The report also highlighted issues with how executives at St. Jude portrayed the inspection’s contents to its investors and other concerned parties and entities. Last October, St. Jude filed an iteration of the inspection report with the SEC with several blacked out portions that referred to the Durata. The firm said it redacted the report due to what it said was its “good faith interpretation” of how the FDA would respond when it released the document in compliance with a Freedom of Information Act request, The Times then noted. The FDA report focused on the way in which St. Jude tested the Durata; the inspection revealed that St. Jude did not appropriately evaluate some study results and concluded that the firm did not correctly follow up on issues it identified during manufacturing and did not appropriately investigate complaints involving the Durata.