St. Jude Class Action Lawsuit Filed Over Defibrillator Lead Problems

St. Jude Medical faces a class action lawsuit over allegedly defective defibrillator leads, with investors claiming that the company’s actions violated federal securities laws. 

The St. Jude class action lawsuit (PDF) was filed by the Norfolk County Retirement System in the U.S. District Court for the District of Minnesota on December 10, alleging that the medical device manfacturer made false and misleading statements to investors and federal securities officials by concealing problems with St. Jude defibrillator lead wires, specifically regarding information about the safety, durability and manufacturing processes of the Durata lead.

Defibrillator leads are small wires used to connect implantable cardioverter defibrillators (ICD) to the heart. The lawsuit comes just weeks after the FDA announced that inspections of the manufacturing facility where St. Jude defibrillator leads are made uncovered numerous and serious manufacturing deficiencies.

The St. Jude Durata lead was introduced as a second generation of the recalled Riata leads, which were removed from the market amid reports of problems with the insulation that allowed the small wire to become exposed inside the body. The newer leads featured a redesigned insulating material.

Originally introduced in 2006 as the St. Jude Riata ST Optim, the new generation of leads were subsequently renamed the St. Jude Durata in 2008, as concerns arose with the older Riata models.

Although St. Jude has tried to shield its Durata leads from the fallout surrounding its recall of Riata and Riata ST defibrillator leads, concerns have been raised about the manufacturing processes with the Durata leads and some reports have suggested that the new leads may also be prone to problems where the wire may poke through the insulation, leaving bare electrodes in nearly direct contact with patients’ hearts.

According to the investor lawsuit filed against St. Jude, the company perpetrated fraud and misled investors on the safety of the Durata leads, resulting in inflated stock value.

In October, the company announced it would likely receive a warning letter from the FDA due to problems with the Durata lead, resulting in a series of stock value drops, including the largest, a 12% drop after the FDA issued the expected warning letter.

“Defendants knew that the Company’s previous generation of leads, marketed under the names ‘Riata’ and ‘Quick,’ had suffered from significant design flaws in the composition and construction of their insulation,” the lawsuit states. “Because these flaws created a risk of possibly lethal electric shocks or tissue penetration, St. Jude had stopped marketing those products. The company claimed that these potentially lethal manufacturing defects had been resolved in its new line of Durata Leads by using an improved insulator called ‘Optim,’ a co-polymer of silicone and polyurethane approved by the [FDA] in 2006.”

A growing number of individuals throughout the United States are also pursuing a product liability lawsuit over the St. Jude Riata leads, alleging that manufacturing defects made the insulation weaker at certain points, allowing the wire to penetrate and become exposed inside the body. This could result in unnecessary shocks or cause the defibrillator to fail to provide a life-saving jolt when needed.