St. Jude Knew About Riata Problems in 2005: Report

A new report suggests that problems with the St. Jude Riata defibrillator lead were known by the manufacturer at least five years before they issued a warning to inform doctors about the risk that the wire may penetrate through the insulation, resulting in a risk of serious and potentially life-threatening injury.

The Wall Street Journal indicates that at least three doctors contacted St. Jude Medical in 2006, when they noticed that Riata defibrillator leads were failing in patients after protruding from the protective insulation inside patient’s bodies.

The report indicates that the company told the doctors that it was aware of the problem and that the incidents were isolated. The Wall Street Journal found that the company noted the problem in FDA documents dating back to at least October 2005.

The St. Jude Riata and Riata ST leads are small wires that are used to connect an implantable cardiac defibrillator (ICD) to the heart. The leads monitor the heart rhythms and are designed to deliver a life-saving shock if needed to restore the heart to normal rhythm.

After halting sales for the Riata lead in 2010, St. Jude sent a letter to physicians warning abotu the risk of the wires poking through the protective insulation in November 2011. The FDA classified the action as a St. Jude Riata recall, categorizing it as a Class I recall, which is used for products that pose a substantial risk of serious injury or death.

Doctors, FDA Saw St. Jude Riata Problems in 2006

According to the Wall Street Journal investigation, the doctors who contacted St. Jude included Dr. Alan Cheng, director of Johns Hopkins Medicine’s arrhythmia service; Samir Saba, University of Pittsburgh Medical Center’s chief of electrophysiology; and Dr. Ernest Lau from Ireland’s Royal Victoria Hospital in Belfast. All of them had noticed the problems in their own work.

The FDA reviewed the issues in 2006 and 2009, but found no manufacturing problems. However, the investigators did not look for design flaws. Other doctors also thought the problem was isolated, and because they did not report them or communicate, the growing number of incidents went unnoticed.

The St. Jude Riata problems finally came to light when some doctors wrote case studies about the defective leads.

In August 2012, the FDA recommended that any individuals who received a St. Jude Riata or Riata ST lead obtain an x-ray or other imaging exam to check the condition of the leads.  The agency also recommended that doctors consider remote monitoring of patients with the recalled leads to quickly catch any electrical problems.

St. Jude was also ordered by the FDA to conduct new clinical studies on other defibrillator leads, including the newer St. Jude Riata ST Optim and St. Jude Durata leads.

Approximately 227,000 of the small St. Jude Riata wires were implanted in patients worldwide before it was removed from the market. Despite the risk of problems, an estimated 79,000 people still have the leads running through their arteries to connect an ICD to their heart, because it is extremely risky to attempt to remove the defective leads.

A growing number of individuals throughout the United States who experienced problems that resulted in the need to have their lead replaced are now pursuing a St. Jude Riata lawsuit.