Canada-wide lawsuit brought against US-Canada defibrillator manufacturer

May 12, 2017

Two Toronto law firms have launched a Canada-wide class-action lawsuit against the manufacturers of implantable defibrillators that can fail with little or no warning because of potentially defective batteries.

U.S.-based manufacturer St. Jude Medical and subsidiary St. Jude Medical Canada are named as defendants in the multimillion-dollar suit. On October 10, 2016, St. Jude Medical sent notification letters to customers and health care providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices.

Both Health Canada and the U.S. Food and Drug Administration have issued warnings about the St. Jude devices after some of the devices' batteries developed a lithium cluster formation, causing them to short-circuit and their power to rapidly deplete. The allegations in the lawsuit have not yet been tested in court.

Images of a Fortify Assura VR ICD (left) and a Quadra Assura CRT-D.
Credit U.S. Food and Drug Administration

As explained by the FDA, the devices provide pacing for slow heart rhythms, as well as electrical shock or pacing to stop dangerously fast heart rhythms. They are implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need the devices if their heart beat is too slow (bradycardia), too fast (tachycardia) or needs coordination to treat heart failure.

About 8,000 Canadians received the defibrillators with the brand names Fortify, Fortify Assura, Fortify Assura MP, Unify, Unify Assura or Unify Quadra manufactured between January 2010 and May 23, 2015.