Medtronic Sprint Fidelis Leads Class Action

UPDATE

July 15, 2011
– The notice of certification has now been mailed to all class members. The notice may be viewed by clicking HERE.

Veuillez cliquer ICI pour voir l'avis concernant l'autorisation du recours collectif en français.

Canadians who have been implanted with one of the following Medtronic Sprint Fidelis leads – models 6949, 6948, 6931 and 6930 (the "Leads") are automatically included in the class.

You are not required to do anything further to participate in the class action. If you do not wish to participate, you must send a written notice to Kim Orr Barristers P.C. by September 12, 2011.

To view a list of frequently asked questions and answers, please click HERE.

The next step in this action is for the parties to engage in documentary production. It is expected that the documentary production will be voluminous.

There is no cost to you to participate in the Sprint Fidelis class action.

BACKGROUND

On October 20, 2009, the Ontario Superior Court of Justice certified a national class action on behalf of Canadians who have been implanted with one of the following Medtronic Sprint Fidelis leads – models 6949, 6948, 6931 and 6930 (the "Leads"), and their families.

A copy of the certification decision may be viewed by clicking HERE.

The Leads are small, insulated wires implanted in the heart and attached to implantable defibrillators or pacemakers. A defibrillator and its leads are designed to detect and correct arrhythmia. When an irregular heart rhythm is detected, the function of the defibrillator or pacemaker is to deliver corrective electrical energy (or shock) through the leads to the heart.

The lawsuit follows a recall of the Leads by Medtronic, the world's leading manufacturer and seller of heart devices, in October, 2007. In a letter to physicians dated October 15, 2007, Medtronic advised that it would be voluntarily suspending the sales of the Leads because the devices were prone to fracture, which could cause a defibrillator to deliver unnecessary shocks to patients or fail to provide life-saving therapy to patients when needed. The FDA classified the suspension of sales of the Leads as a "Class I Recall", the most serious type of recall, a designation reserved for situations in which there is a reasonable probability that use of the product will cause serious injury or death.

It is estimated that approximately 270,000 patients have been implanted with the Leads worldwide, with approximately 6,000 being implanted in Canada.

  1. Medtronic knew of Lead failures as early as July 2005 but failed to report them to the regulators;

  2. Medtronic failed to warn class members of the risks of Lead failure even after several failure modes were identified;

  3. Medtronic implemented design and manufacturing changes to correct the defects to the Leads yet continued to sell its inventory of defective Leads.

The Court certified common issues in negligence and waiver of tort, and ordered that the Plaintiffs amend the Statement of Claim with respect to claims of conspiracy. The Court ordered that the issue of damages for the waiver of tort claim will be bifurcated and heard following the trial of the common issues. The Court declined to certify a common issue with respect to punitive damages.

The Plaintiffs are seeking to appeal the aspects of the decision involving the bifurcation of the waiver of tort claim and the punitive damages claim.

The allegations raised in the claim have not yet been proven in court.  The plaintiff and the class members are represented by the firms Kim Orr Barristers P.C. and Rochon Genova LLP.  For more information, please contact Aris Gyamfi at ag@kimorr.ca or Joel Rochon at (416) 363-1867 or jrochon@rochongenova.com.