Medtronic Inc. has agreed to pay $268 million to settle thousands of lawsuits involving its defective Sprint Fidelis defibrillator leads. The Sprint Fidelis lead was recalled in October 2007 after it was determined to have a higher than normal fracture, or breakage rate. Sprint Fidelis lead fractures have been implicated in at least 13 deaths.
A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.
Before the 2007 recall, Sprint Fidelis leads had been implanted with 90 percent of Medtronicâ€™s defibrillators. When the Sprint Fidelis recall was issued, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests.
At the time of the recall, Sprint Fidelis recipients were advised to leave the leads in place if they were functioning properly, as surgical removal of the tiny wires can lead to serious complications. In fact, it is believed that 4 of the 13 deaths were linked to removal attempts.
Since the announcement of the Sprint Fidelis recall, more than 8,000 product liability lawsuits have been filed against the company. As per the new settlement, Medtronic will not be admitting any liability, nor will plaintiffs’ attorneys be admitting that the device maker has a valid defense.
Plaintiffs’ attorneys will decide how the settlement money will be divided among claimants, and have three months to decide if they will participate for their clients. A committee of plaintiffs’ attorneys then will meet and decide the compensation value of the cases. The largest amounts will likely go to settle claims filed on behalf of people who died, or suffered major complications. On average, plaintiffs will receive about $33,000 each, according to a New York Times report.
The settlement does not need court approval. Those plaintiffs who don’t participate won’t be prejudiced by this settlement, and can still decide to continue their lawsuits.