MINNEAPOLIS -- (Mealey's) Medtronic Inc. on Oct. 14 said it has agreed to pay $268 million to settle about 3,700 lawsuits and claims in the United States related to the recall of its Sprint Fidelis implantable cardiac defibrillator leads.
In its most recent Form 10-Q report filed with the U.S. Securities and Exchange Commission, it said that as of Sept. 1, about 3,700 Sprint Fidelis lawsuits were filed against the company.
In a press release, Medtronic said it has entered into an agreement to settle lawsuits and claims pending as of Oct. 15. It said the $268 million includes an amount for attorney fees and expenses and said plaintiffs and claimants are responsible for subrogation claims for Medicare or Medicaid. "No additional sums for these cases will be paid by Medtronic for third-party claims or attorneys' fees," the company said.
Medtronic said it and parties in the Sprint Fidelis multidistrict litigation in the U.S. District Court for the District of Minnesota (In Re: Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, MDL Docket No. 1905, No. 08-md-1905, D. Minn.) and in Minnesota state court will file joint requests to terminate those litigations. In addition, it said they will move to dismiss an appeal pending in the Eighth Circuit U.S. Court of Appeals (Anna Bryant v. Medtronic, Inc., No. 09-2290, 8th Cir.) and an appeal in the Minnesota Court of Appeals.
Also, Medtronic said the parties will "request dismissal of other Fidelis-related cases throughout the country."
Medtronic said the agreement allows the company to cancel the agreement if certain conditions are not met and either party can cancel it if the MDL proceedings are not terminated. Medtronic did not specify what conditions must be met to keep the agreement alive.
On Oct. 15, 2007, Medtronic issued a field action voluntarily suspending distribution of its Sprint Fidelis leads because of the potential for fracture, which can cause unnecessary shocks or failure, resulting in serious injury or death. Leads are wires that carry electrical impulses through blood vessels to the heart to regulate abnormal heartbeats. They are used mostly in conjunction with implantable cardiodefibrillators.
The Food and Drug Administration subsequently classified Medtronic's action as a Class 1 recall, meaning the problem carried the greatest risk of serious injury or death.
[Editor's Note: Full coverage will be in the October issue of Mealey's Litigation Report: Heart Drugs & Devices. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
For more information, call editor Dylan McGuire at 610-205-1114, or e-mail him at Dylan.McGuire@lexisnexis.com.