Claims in Pacemaker Action Preempted Despite Lack of FDA Approval of Device, Ill. Federal Judge Rules

CHICAGO — Strict liability and negligence claims asserted in a Medtronic pacemaker action are preempted by the Medical Device Amendments, despite the fact that the device was not FDA-approved at the time of the surgery, an Illinois federal judge has ruled.

In a Dec. 20 order, Judge Manish S. Shah of the U.S. District Court for the Northern District of Illinois explained that because the FDA granted premarket approval to an earlier version of the lead and multiple supplemental premarket approvals as Medtronic modified the lead throughout the year, the device was subject to FDA regulations.

On Feb. 12, 2004, …