Uncertainty Surrounds St. Jude Riata Lead Replacement Expenses, Safety

Patients implanted with recalled St. Jude Riata defibrillator leads could face significant costs and uncertainty in having the wires removed and replaced, especially if they elect to have the lead replaced under the warranty provided by the manufacturer.  

Since a St. Jude Riata lead recall was issued last year for the small wires used to connect implantable defibrillators to the heart, doctors and patients have faced a tough decision about whether they should have the leads removed or leave them in place, as the replacement surgery can be very risky and expensive.

The St. Jude Riata was recalled after it was discovered that the lead wires may poke through the insulation, potentially resulting in unnecessary electrical shocks or causing the defibrillator to fail to work when it is needed to return the heart to a normal rhythm.

Earlier this month, the FDA indicated that individuals who still have one of these defective leads implanted should obtain x-rays or other imaging exams to check for problems with their Riata leads. Despite the risks associated with removing the lead, a growing number of patients are opting to have their St. Jude Riata lead replaced with a different lead.

According to a recent report in the Wall Street Journal, St. Jude Medical is agreeing to honor the 5-year warranty on the Riata leads, paying $600 for each lead removed, plus providing a free St. Jude Durata defibrillator lead as a replacement. However, it appears that individuals must elect to receive this newer St. Jude lead to qualify for the warranty, which is causing concerns for many.

Concerns About Safety of Newer St. Jude Durata and Riata ST Optim Leads

The newer St. Jude defibrillator leads feature a redesigned insulating material, with a mix of silicone and polyurethane, which the manufacturer calls “Optim”. However, concerns have surfaced that the St. Jude Durata lead and Riata ST Optim, which feature this new insulating material, may be at risk of suffering similar problems where the lead conductors may become externalized.

According to a study published last week in the medical journal Europace, researchers indicated that similar insulation problems may impact these newer St. Jude defibrillator leads as well. Researchers identified at least 52 reports of problems with St. Jude Durata and Riata ST Optim leads in the FDA’s Manufacturers and User Device Experience (MAUDE) database, including at least one death attributed to the insulation problems with the new St. Jude defibrillator leads.

In an FDA safety communication issued August 16, the federal regulatory agency indicated that St. Jude had been ordered to conduct a battery of new clinical studies to help the agency truly assess the insulation problems. The manufacturer has been ordered to conduct a three-year postmarket surveillance study to look at the risk of premature insulation failure not only on the recalled leads, but also on the newer St. Jude Durata and Riata ST Optim leads.

As a result of the problems, many doctors are recommending patients replace St. Jude Riata leads with defibrillator leads made by different companies, such as Boston Scientific. However, according to the Wall Street Journal, this would void the terms of the warranty provided with the recalled Riata leads.

Compensation and Settlements for Replacement of St. Jude Riata Defibrillator Leads

It has been reported the St. Jude is considering individual settlements and reimbursements for Riata lead replacements above the warranty cost on a case-by-case basis. However, few details have been provided about what they are voluntarily agreeing to pay, and there is no indication that the company is willing to pay any non-economic damages, such as pain and suffering associated with a St. Jude Riata replacement.

A number of individuals who received the recalled leads are now consulting with product liability lawyers investigating St. Jude Riata claims to make sure they obtain all of the compensation they may be entitled to.

In recent months, a number of St. Jude Riata lead lawsuits have been filed by individuals who experienced problems with insulation on their lead, seeking compensation through the court system. The complaints allege that St. Jude failed to manufacture the leads consistent with the FDA approved processes, which may cause the insulation to wear thinner at certain parts due to friction and abrasion.