October 11, 2012 — The Wall Street Journal is reporting that St. Jude Medical Inc. knew about defects with the Riata defibrillator leads as early as 2005, but waited six more years to issue a recall.
After several doctors treated patients with defective devices, they notified St. Jude, who told them the incidents were isolated. Company documents collected by the U.S. Food and Drug Administration (FDA) revealed that St. Jude had been tracking the problem since at least October 2005.
The problem with the St. Jude Riata defibrillator leads is that the inner wires can wear through their insulation and become externalized. Even without insulation, the wires can still transmit a high-voltage electrical shock in the event of an emergency. However, in some cases, the externalized leads can malfunction — either delivering an unnecessary shock, or failing to administer a shock in an emergency. It is difficult to determine whether the lead is defective until an adverse event occurs. Removing the lead is not recommended by the FDA, because the surgery has a serious risk of complications.
According to the WSJ 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 is not accused of any wrongdoing in the way they handled the situation. The FDA inspected manufacturing facilities in 2006 and 2009 and did not find manufacturing problems. However, many physicians and medical device safety experts have criticized the company for failing to warn the public, government regulators, and physicians about known safety issues with the Riata.
In 2010, St. Jude issued a warning to doctors to look for signs of inside-out abrasion with the Riata defibrillator leads, and they pulled the product from the market. In 2011, St. Jude officially issued a Class 1 recall of the device. In 2012, St. Jude researchers published a study finding that 19% of the Riata leads showed inside-out abrasion.
The U.S. lacks an effective tracking system for medical devices, which makes it difficult to determine when certain devices are failing more often than usual. This deficiency has been highlighted in several high-profile recalls involving hip implants, brain stents, vaginal mesh, and defibrillator leads.