In late 2014, St. Jude Medical requested the Food and Drug Administration (FDA) to approve a design change to prevent lithium clusters from draining the battery. The company falsely told the FDA that “no serious injury, permanent harm or deaths have been reported associated with this” problem.
However, St. Jude Medical knew at the time that there were two reported serious injuries and one death linked to a premature battery depletion caused by lithium clusters, the government alleged. The company continued to distribute its heart devices despite the adverse health events.
In August 2016, the company informed the FDA that the number of premature battery depletion increase to 729. The problem caused two deaths and 29 health incidents associated with loss of pacing.
In October 2016, St. Jude Medical issued a health advisory regarding the premature battery depletion of its heart devices. The FDA classified the advisory as a Class 1 recall due to a reasonable probability that the Fortify, Fortify Assura, Quadra, and Unify heart devices will cause serious injuries or death. The company stopped selling its older heart devices after the recall. However, thousands of them have been implanted on patients’ chests between November 20. 2014, and October 10, 2016.
Details of the settlement agreement
On July 2, 2021, St. Jude Medical agreed to settle the allegations of the government, which was brought under the qui tam or whistleblower provisions of the False Claims Act by Debbie Burke.
