Minneapolis-based medical technology company Medtronic, Inc. was recently sued in federal court shortly after announcing a global recall of defibrillator leads. Luisi et al. v. Medtronic Inc. et al., No. 047-cv-4250 (D. Minn. 2007). According to the U.S. Food and Drug Administration (FDA), the recall of Medtronic’s Sprint Fidelis defibrillator leads is due to a chance of fracture in the leads that may cause inappropriate shocks or result in the loss of therapeutic pacing or shocking. In a letter to doctors, Medtronic described the fracture rate as “higher than expected.”
The lawsuit alleges that Medtronic misrepresented the safety of the Sprint Fidelis leads by comparing them to an earlier model, which had a lower failure rate. The lawsuit further alleges that Medtronic negligently concealed problems with the leads from the public and the medical community by waiting until March 2007 to warn doctors of the lead fracture rate. The plaintiffs are seeking class certification.