October 11, 2012 — An investigation from the Wall Street Journal has uncovered evidence that St. Jude knew about defects with the Riata defibrillator leads as early as October 2005, but waited until December 2011 to issue a recall. In 2005 and 2006, several doctors reported to St. Jude that they treated patients with defective leads. St. Jude said the incidents were isolated. The U.S. Food and Drug Administration (FDA) collected company documents showing that St. Jude had been tracking the issue since 2005.
The St. Jude Riata defibrillator lead is a long, thin wire that connects an external defibrillator to a patient’s heart tissue. If defibrillator detects an arrhythmia, it delivers a high-voltage electrical shock through the lead. Unfortunately, the internal wire can erode through its insulation and become externalized. Once externalized, the wire may or may not be defective — it is nearly impossible to tell until an adverse event occurs. If the lead malfunctions, it may fail to deliver a shock in an emergency, or deliver a shock when there is no emergency. The FDA does not recommend removing the leads because surgery has a high risk of complications.
Journalists from the WSJ reviewed documents from St. Jude that were collected by the FDA. According to their investigation:
“The audit, which had began looking broadly at insulation problems in 2006, included a special section on inside-out abrasion. … The report said 32 of the 246 leads examined were damaged enough to inhibit lifesaving shocks. The company had sold more than 120,000 Riata leads in the U.S. by that time, and the risk of all abrasion-related failures appeared “remote,” the audit said.
St. Jude has been criticized by physicians and medical device safety experts for failing to inform the public and the medical community about this known risk. However, the FDA did not find manufacturing deficits during inspections in 2006 and 2009.
In 2010, St. Jude withdrew the Riata and sent a letter to doctors to inform them of the inside-out abrasion issue. In December 2011, the FDA and St. Jude voluntarily issued a Class 1 recall of the device. Subsequent studies, including one conducted by St. Jude, have found that 19-25% of the leads develop inside-out abrasion.
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