St. Jude Under Fire for Blacking Out References to Durata Lead in FDA Report


St. Jude Under Fire for Blacking Out References to Durata Lead in FDA ReportOverview: Patients and healthcare professionals are left wondering whether St. Jude Medical has something to hide, as the company has redacted, or blacked out, a number of references to its Durata defibrillator lead in a U.S. Food and Drug Administration (FDA) report. The company’s actions are only the latest in a series of event that has brought St. Jude under scrutiny over the safety of its leads, or wires that connect to implantable cardiac defibrillators.

  • St. Jude blacks out all 20 references to Durata in filing an FDA report with the Securities and Exchange Commission
  • The redaction only fuels suspicions that the Durata is defective and similar to the recalled Riata
  • A recent Medtronic-funded study found that the insulation surrounding Durata lost substantial strength when exposed to a series of tests

Product: Durata defibrillator lead wire

Manufacturer: St. Jude Medical

Side Effects & Complications

  • Electrical short-circuit
  • Software problems
  • Increased pacing rate

Durata Redacted in FDA Report

According to an article in the New York Times, St. Jude blocked out all 20 references to its Durata defibrillator lead in an FDA report filed with the Securities and Exchange Commission. The company claims that Durata was redacted in “good faith”, claiming that their actions were an interpretation of what the FDA would have done if the report were released under the Freedom of Information Act. FDA spokesperson Mary Long disagreed, saying that the agency does not consider the names of approved products to be confidential information.

The FDA report had found a number of issues with the oversight and testing of Durata. Following the report, St. Jude’s stock plummeted 12 percent to a three-year low of $31.37.

St. Jude Reputation at Risk

The report, and the way St. Jude has handled it, could have significant repercussions for the company, healthcare professionals and patients who have the Durata. Reports have already raised safety concerns over whether or not Durata has the same problem as the Riata, a defibrillator lead that was recalled last year due to exposed wire. A recent study, funded by Medtronic, only fueled these suspicions when researchers found that Optim (the insulating material coating Durata) failed in strength following a series of environmental tests. Failed insulation is a concern for patients with defibrillators because when the wires become exposed, the device may fail to function. The issue has become a dilemma for these patients, as well as their doctors, because the surgery to remove the device can be risky as well.