FDA questions another St. Jude 'lead'by Jon Collins, Minnesota Public Radio
ST. PAUL, Minn. — St. Jude Medical's stock fell as much as 15 percent Wednesday, the day after the Food and Drug Administration released a report that again raised concerns about a key component the Little Canada-based medical device company produces.
The FDA report criticized St. Jude's testing of the Durata line of "leads," the industry term for wires that connect an implanted device such as a defibrillator to the heart.
St. Jude Medical spokeswoman Amy Jo Meyer said in a statement that company communications with regulatory agencies are typically confidential, but that the FDA report hadn't "identified a specific issue regarding the clinical or field performance of any of our products."
In August, Dr. Robert Hauser of the Minneapolis Heart Institute advised heart surgeons to avoid the Durata lead until its long-term safety is more closely examined.
St. Jude recalled an earlier lead product called Riata in November 2011 because the wire's insulation could deteriorate more quickly than expected, and cause shocks or device failure.
The FDA report led Wells Fargo securities analysts to downgrade their rating of St. Jude Medical's stock, saying the "very concerning" findings would likely increase physician concerns about the product. The note to investors said, "It's becoming increasingly difficult to defend Durata."
In October, the company released a copy of the FDA report that had been redacted based on what the company said was its "good faith interpretation of Freedom of Information Act exemption which protects confidential and proprietary information from disclosure."
The company blacked out part of the report that referred to Durata. But the version the FDA released had fewer redactions.
But Piper Jaffray analyst Thom Gunderson said Wall Street overreacted.
"This is just a normal course of business for most medical companies," Gunderson said. "The FDA comes in, does inspections periodically. They see some things that are off a little. They write up a report and say, 'Here, we want you to fix, this, this and this.' That's fairly common."