St. Jude hit with FDA warning letter over Durata plant

St. Jude Medical says its latest warning letter doesn't call into question the safety of its Durata ICD leads--courtesy of St. Jude Medical

Back in October, St. Jude Medical ($STJ) CEO Dan Starks said the company might get an FDA warning letter over how it manufactures Durata leads, and now the other shoe has dropped. The FDA has served up the expected letter, saying it won't approve PMAs or export requests for devices from the facility until St. Jude rectifies the problems.

The devicemaker disclosed its receipt in an SEC filing, saying the FDA cited the same issues with its Implantable Electronic Systems Division's Sylmar, CA, facility in an October Form 483 that chided the company over its device design protocol, personnel training and handling of complaints, among other things. While St. Jude disclosed the FDA's note, it redacted any and all mentions of the Durata leads manufactured there, leading to investor ire (and litigation) once the facts came out a month later.

Now, the company avers that Durata leads are safe and safely on the market, pointing out that the warning letter does not impact or question any commercialized device that was produced at the facility in question. St. Jude is taking the FDA's concerns seriously, the company said, and it will work to fix each of the agency's issues without delaying customer orders from the plant.

The FDA is generally slow to post warning letters on its website and hasn't uploaded St. Jude's (or any others in 2013, for that matter).

The warning letter is bad but expected news for the devicemaker, which saw a glimmer of positivity last month when it was able to settle a legal dispute with AorTech, the company that supplies Durata's polymer insulation--which is the very ingredient that reputedly keeps the leads from eroding like the now-recalled Riata.

Now St. Jude has to beat back analyst rumors that Durata will get yanked off the market this year, dispute a Medtronic ($MDT)-sponsored study suggesting that that much-hyped polymer could break up in the body within 6 years, and, of course, argue against shareholder lawsuits claiming the company willfully withheld safety information about the leads.

- here's St. Jude's filing