St. Jude likely to receive FDA warning letter following inspection of California manufacturing facility

St. Jude Medical Inc. believes it is likely to face a regulatory warning letter on the heels of a recent Food and Drug Administration inspection of a California manufacturing facility that makes some of its troublesome cardiac defibrillator leads.

According to a Reuters report this week, St. Jude CEO Dan Starks informed shareholders that the company is likely to receive a Food and Drug Administration warning regarding the operation of its production facility in Sylmar, Calif. Though the company is vague on exactly what will prompt the FDA to issue a warning letter to the company, problems with St. Jude’s lines of cardiac defibrillator leads and the agency’s current focus on these defective medical devices means it is likely to involve these products.

The FDA is concluding an inspection of the St. Jude facility in California, one of five the company uses to manufacture cardiac defibrillators leads that connect a defibrillator device to the heart. The agency often issues warning letters following these inspections when it finds fault with any number of steps in the manufacture of medical devices. This could range to unsanitary and unsterile conditions, improper safety protocols, or even poor record-keeping, including the tracking of complications and defects reported to the company.

Late last year, St. Jude and the FDA issued a Class I recall on the company’s line of Riata and Riata ST cardiac defibrillator leads after they were linked to a defect known as “inside-out corrosion”. This defect causes the conductive ends of the Riata leads to break from their protective housing, causing an implanted heart defibrillator to malfunction.

The Riata leads have been linked to more than 20 deaths and tens of thousands of people still rely on these questionable wires to deliver life-saving shocks to their heart, something that isn’t guaranteed if corrosion becomes an issue. After the recall, with these thousands of people left wondering how they should proceed with the faulty lead wires implanted, the FDA determined that patients with the Riata should consult their physicians and be vigilant for signs that their Riata leads were malfunctioning. The agency ruled against telling people to have replacement surgeries to remove the defective leads because that procedure carries its own life-threatening risks.

In response to the failed Riata leads, St. Jude recently released the Durata lead. This new design features a more durable coating on the conductive ends of the devices, known as Optim, but like its predecessor, has also been subject of some adverse event reports during its short time on the market.

New of the impending FDA warning letter sent stock of St. Jude downward this week, dropping more than 6 percent in a day. Reuters also reports that sales revenues for the company have dropped considerably in the last year, likely due to problems with the Riata leads and increased legal pressure the company will soon face.

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