Chris Kirchmer

Three weeks ago, Provost Umphrey attorney Christopher Kirchmer filed 16 medical products liability suits against GlaxoSmithKline. This week, Kirchmer is again taking on a medical products maker with four suits on behalf of patients who allegedly died because of defects in implantable cardiac defibrillators made by Medtronic.

Kirchmer filed four suits against Medtronic and its Puerto Rican operations on Sept. 9 in the Beaumont Division of the Eastern District of Texas. The plaintiffs are acting individually and on behalf of the estates of deceased family members.

The plaintiffs are Brenda Arisco for Joseph Arisco, Joni Comeaux for Percy Villemez, Candylou Douget for Charles Conklin and Martha Tucker for Gordon Tucker. The plaintiffs reside in Jefferson and Orange counties.

According to the identical complaints, Medtronic designs, makes and sells products used to treat cardiac arrhythmia, heart failure and coronary and peripheral vascular disease.

Implantable cardiac defibrillators can correct both fast and slow heart rates in patients who have irregular heartbeats that are considered life threatening. ICDs are implanted under the skin of the chest wall and wires called leads are inserted through a major vein and attached directly to the muscle on the inside of the heart.

"If an implanted ICD and lead operate properly, the system can save a patient's life," the complaints state. "If either fails to operate, the patient may die within minutes."

The deceased plaintiffs were implanted with models of Sprint Fidelis leads that have been recalled by Medtronic.

The Sprint Fidelis leads were approved for sale by the U.S. Food and Drug Administration in September 2004 and have been implanted in more than 160,000 patients worldwide, the suits say.

"Since the Sprint Fidelis leads were introduced to the market, it has become evident that a significant portion of the leads have potentially fatal defects," Kirchmer writes.

He cites a 2007 study in which the Minneapolis Heart Institute reported that September 2004 to February 2007, six patients out of 583 implanted with Sprint Fidelis leads experienced lead failures.

Kirchmer claims the 1-2 percent failure rate of the Sprint Fidelis lead during the first two years was 10 times the failure rate for Medtronic's previous product, the Sprint Quattro Secure.

He also cites several other studies, one showing 17 percent failure and one with a 62 percent failure incidence.

"Medtronic has not disclosed the precise mechanism of the Sprint Fidelis lead fracture failures," Kirchmer writes, but says it appears the defect may be attributable to the small diameter of the coil and conductors which become overstressed.

In March 2007, the suits state that Medtronic issued a letter to physicians that advised of higher than expected conductor fracture rates in the Sprint Fidelis leads, but that the leads were still performing up to standards.

The suits state that Medtronic recalled all unimplanted Sprint Fidelis leads on Oct. 15, 2007, citing several deaths related to the leads.

"At all times relevant ... Medtronic knew, or had reason to know, that the Sprint Fidelis leads were not safe for the patients for whom they were prescribed or intended," the suits allege.

The company also concealed information about the danger of the leads which prevented the plaintiffs and physicians from making informed choices about the selection of leads for implantation, the suits allege.

Plaintiffs are seeking damages for: