Topics:

St. Jude's Durata ICD leads faulted in FDA plant inspection

Tools

St. Jude Medical's ($STJ) ongoing problems with ICD leads are getting increasingly dicey. The FDA released a report that reveals regulators have taken issue, in part, with how the company makes its ICD Durata leads, which replaced the tainted Riata leads recalled last year after major safety concerns. But it gets worse: The beleaguered company disclosed a heavily-redacted version of the document as part of an SEC filing a few weeks ago that blotted out the Durata name.

As The New York Times reports, the discrepancy may raise some concerns about how St. Jude presented the issue when discussing its financials with investors and reporters.

Durata, as readers may remember, is intended to be a safer, better lead for the company's implantable cardioverter defibrillators than St. Jude's Riata line, which faced a massive recall in 2011 over serious safety concerns. But Durata is insulated with a material dubbed "Optim," the NYT story notes, and Optim's long-term viability is coming under increased scrutiny.

The FDA's Form 483 report, which is not an official warning letter, knocked St. Jude for testing and quality control measures at the Sylma, CA, facility that manufactures the Durata leads (the plant also manufactures cardiac rhythm devices).  Many details are blotted out, the story notes, but Durata is named and the remaining information seems to focus on how St. Jude tested Durata and evaluated those results. The report also points out that St. Jude has pledged to address all the issues focused on by regulators.

It's not as if St. Jude has entirely avoided the issue. When the company disclosed its fiscal 2012 third-quarter numbers in mid-October, CEO Dan Sparks revealed during St. Jude's earnings call that an FDA warning letter was likely regarding the plant, and disclosed that it made high voltage leads, but said no further details. No warning letter has followed as of yet. But St. Jude released its own version of the heavily redacted document filed with its earnings, which said little else, without mentioning Durata.

So why wouldn't St. Jude disclose the report's focus on Durata? St. Jude spokeswoman Amy Jo Meyer is quoted as saying that the inspection report did not include anything involving "a specific issue regarding the clinical or field performance of any of our products." And when the company released the redacted document, St. Jude explained at the time, according to the story, that it it tried to follow what the FDA itself would do to address a Freedom of Information Act request. But while the FDA also redacted parts of the document, regulators chose to reveal the Durata name. And St. Jude's aggressive push to defend Durata continues.

- read the NYT story (sub. req.)
- here's the FDA's newly-released redacted report

Related Articles:
FDA chides St. Jude over CRM plant
St. Jude Medical's financials disappoint; CEO warns about warning letter