Legal Experts Call For Investigation Following Safety Concerns

Specialist defective product lawyers at Irwin Mitchell have called for an investigation into safety standards at medical manufacturer St. Jude Medical Inc. after the firm issued a recall of some of its 400,000 implanted heart devices due to risk of premature battery depletion.

The defibrillators shock abnormal heartbeats back to their normal rhythm and treat heart failure. 

They alert patients that batteries are running low by vibrating and normally they have 90 days to replace the device after receiving the alert, the Food and Drug Administration said. 

But the devices involved in the recall could stop working within 24 hours to a few weeks of patients receiving the low battery alert.

St Jude issued a warning on Tuesday, that a battery malfunction could cause hundreds of thousands of its implanted devices to lose power unexpectedly and stop functioning.

All the devices, called ICDs and CRT-Ds, contain batteries that were manufactured before May 23, 2015.

Two patients died after batteries in their St. Jude-made defibrillators ran down prematurely meaning the devices were unable to provide vital shock therapy according to the FDA. 

They also revealed that 10 patients have reported fainting from devices that didn’t provide pacing because of battery depletion, and 37 patients have reported dizziness. 

St. Jude is telling patients with the devices to monitor them closely and to contact their doctors if the device notifies them of a battery problem. 

Matthew Newbould is a Solicitor and legal expert in Irwin Mitchell’s product liability team who specialises in cases related to defective medical devices.

Expert Opinion

This is the most recent in a series of safety warnings and recalls for St Jude defibrillation products. The Riata and Riata ST, made by St Jude, leads were withdrawn in 2012 because of a greater than expected rate of fracture, leading to failure and unnecessary shocks.

Then in 2014 we saw the Ellipse ICD recalled because of a capacitor issue which, in some cases, meant that it failed to charge and could not administer a potentially lifesaving shock. Again, this was another product from St Jude.

In 2015 St Jude issued a medical device alert relating to a manufacturing problem for Optisure Dual Coil Defibrillation leads.

To the patients who are fitted with these devices their functionality is a matter of life and death and it is a huge concern that issues like this are continuing to occur in products made by St Judes.

We hope that a thorough investigation into safety standards takes place to assess if any measures need to be taken to ensure patients are getting the best quality medical devices and are no longer exposed to the risk of serious injury. Matthew Newbould - Associate Solicitor

View our Defective Medical Device & Medicines Claims page for more information.