A Medical Device Daily

Wolf Popper, a New York law firm, is the latest to file a lawsuit against Medtronic (Minneapolis) regarding the company’s recently recalled Sprint Fidelis defibrillation leads and the company voluntarily suspended distribution (Medical Device Daily, Oct. 16, 2007).

The class action lawsuit was filed in the U.S. District Court for the District of Minnesota, on behalf of investors who purchased Medtronic common stock from June 25, 2007, through Oct. 15, 2007.

The complaint charges that during the class period Medtronic misrepresented the facts concerning the Sprint Fidelis defibrillation leads and that the actual facts were only disseminated to investors on Oct. 15, 2007, when the company disclosed the voluntary recall.

The suit charges that the company’s disclosure lagged far behind the reports made to the company concerning lead failures. It says that as of January 2007 it had received 679 notices of injuries caused by fractures in the defibrillation leads.

The FDA approved the Fidelis defibrillation leads in September 2004 (MDD, Sept. 3, 2004). At 6.6 Fr in size, the leads were the world’s smallest right ventricular defibrillation leads, allowing for compatibility with 7 Fr introducers, according to Medtronic. The small size of the leads was intended to help improve passage into a patient’s venous system for an easier implant, and minimize venous obstruction.

The lawsuit filing claims that in a meeting with Robert Hauser, MD of the Minneapolis Heart Institute in February 2007, Medtronic was informed specifically that the institute would cease using the Fidelis leads in operations and would use Medtronic’s earlier generation Sprint Quattro leads.

The reports of lead failures led Medtronic to send a letter dated March 21, 2007, to physicians treating patients with the Sprint Fidelis leads describing the nature of the failures and attributing those failures to physician error, or “variables within the implant procedure.” The suit says that Medtronic continued to receive reports of lead failure after to March 21 and that the number of lead failures grew from 795 injuries reported by April 30, 2007. to a total of 1,053 injuries reported by June 30, 2007.

The company further admitted that it had “identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.” Upon the release of this information into the market, Medtronic’s stock dropped $6.33 per share or 11.2% on volume of approximately 62.9 million shares.

To date, multiple lawsuits have been filed against the med-tech giant regarding the Sprint Fidelis defibrilation leads — those implanted with the leads claiming injuries received as a result — just days after the recall (MDD Oct. 17, 2007).