St. Jude Riata Recall Sign of FDA Oversite Problems: Report

A recent editorial published in the New England Journal of Medicine suggests that last year’s recall of St. Jude Riata defibrillator leads highlights ongoing problems with the FDA’s oversight of medical device safety.

The editorial, written by Dr. Robert G. Hauser, points to the recent Class I recall of the Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads as a flashback to the Medtronic Sprint Fidelis lead recall, and said that it serves as an indication that regulation of dangerous medical devices in the United States has not gotten any better over the intervening four years.

In both cases, tens of thousands of people were implanted with supposedly life-saving heart devices that were later found to have significant design problems, which could expose them to a risk of serious injury or death.

In the case of the Riata, approximately 79,000 patients received the now recalled defibrillator leads. Medtronic’s Sprint Fidelis leads were implanted in 268,000 patients before they were pulled from the market in October 2007.

The recalled leads pose a serious health concern, as it is largely impractical for patients to have the ICD leads removed, leaving patients with more frequent medical follow ups and the need to hope that they do not experience any of the problems associated with the small wires that connect their implanted defibrillator to their heart.

Hauser’s editorial suggests that improved FDA oversight and more stringent approval requirements could avoid these situations.

“The problem is that our current passive postmarketing surveillance system fails to detect significant device defects before large patient populations have been exposed,” Hauser writes. “Consequently, we repeatedly find our selves reacting ineffectively, even dangerously, to big problems with devices by subjecting patients to care strategies that are not supported by solid clinical evidence.”

The St. Jude Riata lead recall came in the form of a Physician Advisory Letter sent out by St. Jude Medical, Inc. in late November, where the company warned doctors that there were problems with externalized conductors that poked through the leads’ insulation, potentially causing an electrical hazard to patients with the implants. The FDA reports that there have been at least two patient deaths and one serious injury reported in connection to the externalized conductor problem.

The internal defibrillators are designed to be implanted near a patient’s heart, monitor his or her heart rhythms and give life-saving electrical shocks if necessary. The defibrillator leads, which deliver the electrical charge, are supposed to remain covered by insulation once implanted. However, in some cases it appears that the leads have penetrated the insulation and parts of those leads are bare and uncovered inside patients’ bodies.

St. Jude has told the FDA that it does not fully know the medical risks and complications that could arise from electrically charged leads being exposed in the body. The FDA warns that it could result in failure to deliver appropriate therapy or potentially could deliver a deadly shock when no shock was needed.

In 2007, there were reports that St. Jude Riata leads could puncture holes in the heart instead of laying on the outer skin of the heart as they were designed to do.

A Medtronic Sprint Fidelis recall was issued on October 15, 2007, after it was confirmed that the small wires were prone to fracture or break. If the defibrillator lead fails, it could result in a massive electrical shock or cause a patient’s cardiac defibrillator not to work when it is needed to deliver a life-saving jolt.

Thousands of Medtronic defibrillator lead lawsuits were filed on behalf of individuals who had the leads implanted, including hundreds who have had the lead fracture. However, most of those suits were settled for small values after a 2008 Supreme Court decision.

Despite shortcomings in the oversight of medical device safety, the U.S. Supreme Court ruled in Reigel vs. Medtronic that manufacturers could escape liability for defectively designed products by arguing that their medical device was approved by the FDA.