11 more lawsuits for Medtronic on Sprint Fidelis leads

-Finance and Commerce

09/14/2008- Lawsuits involving the recalled implantable Sprint Fidelis leads are piling up for Fridley-based Medtronic.

Just in the last five days, 11 separate lawsuits have been filed in district courts in Texas and Tennessee, pushing the total number of similar lawsuits against Medtronic beyond 300 since the company recalled the leads in October 2007.

On Sept. 9, four individuals brought lawsuits against the medical device company in a Texas district court in connection with the Sprint Fidelis family of leads – wires – that are used in Medtronic’s implantable cardiac defibrillators (ICDs), which monitor an irregular heartbeat.

Medtronic recalled all unimplanted Sprint Fidelis leads on Oct. 15, 2007, citing several deaths related to the leads (patients died when the lead conductor fractured). The company also recommended that implanted Sprint Fidelis leads be monitored.

But in the four separate lawsuits filed Sept. 9, the plaintiffs, all represented by Texas law firm Provost & Umphrey, alleged that, “Medtronic misrepresented the safety of the Sprint Fidelis leads and negligently manufactured, marketed, advertised, promoted, sold, and distributed the leads as safe devices to be used together with ICDs.”

Among other charges, the complaint added that before the leads were recalled, Medtronic knew they were defective. In particular, it alleges that the medical device heavyweight knew that one specific Sprint Fidelis model’s failure rate was 10 times higher than an earlier model that the new family of Sprint Fidelis leads was replacing.

Advertisement The complaint estimates that 129,000 Sprint Fidelis leads remain in service globally.

The recalled Sprint Fidelis leads were the source of seven other lawsuits filed Sept. 11 in a district court in Tennessee. The language of this complaint is very similar to that of the lawsuits filed in Texas. All are individual cases and not class-action lawsuits.

Reached on Friday afternoon, a Medtronic spokesman said it was too soon to comment on the new lawsuits.

“Medtronic has not yet had a chance to review the suits in question, therefore it would be inappropriate for us to comment on them,” said Christopher Garland, a Medtronic spokesman for the cardiac rhythm disease management group, via e-mail. “Medtronic acted responsibly in relation to the Fidelis lead, and we intend to defend ourselves vigorously.”

According to Medtronic, as of August 26, approximately 290 lawsuits regarding the Fidelis leads had been filed, including about 33 possible class-action suits reflecting a total of as many as 760 individual personal injury cases. Medtronic has not yet recorded any expenses related to these lawsuits, according to a Medtronic quarterly earnings report released Sept. 3.

Another lawsuit filed on Sept. 11 in a district court in Oklahoma involves Medtronic’s spine division and two other companies – New Jersey-based Biomedical Tissue Services Ltd. and Regeneration Technologies Inc. of Delaware.

Plaintiff Nancy Pennington alleged that Biomedical Tissue Services “assisted in fraudulent harvesting of human body parts” for a specific tissue – called allograft – that was manufactured by Regeneration Technologies and distributed by Medtronic for use in surgery.

The complaint charged that Medtronic and Regeneration Technologies should have known the allograft tissue they bought from Biomedical Tissue Services was defective and wrongly obtained and could cause life-threatening infectious diseases.

Pennington underwent spine surgery that used the allograft tissue in February 2004 and as a result of the bad tissue had to undergo a slew of tests for HIV, hepatitis and syphilis – and will continue to have to undergo periodic testing.

But Marybeth Thorsgaard, a spokeswoman for Medtronic’s spine and biologics division, said that there have been no “confirmed reports of transmission of infectious diseases through transplantation of allograft bone that has been properly processed.”

She added that after the president of Biomedical Tissue Services – Michael Mastromarino – was charged for harvesting body parts in 2006 (and later convicted), Medtronic offered free testing to patients in line with recommendations by the Centers for Disease Control and Prevention.

“[Biomedical Tissue Services’] actions were unacceptable,” Thorsgaard said. “We take our role as distributors very seriously.”

Ennis & Ennis, P.A. is representing individuals that have been harmed by defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation.