Photo of Bexis

This just in:
Earlier today, Judge Rosenbaum granted Medtronic’s motion for summary judgment in Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 (D. Minn. 2008) (here’s the slip opinion).
In a nutshell, the implantable cardioverter-defibrillator is a Class III PMA device, so you would expect plaintiff’s claims to be preempted under Riegel.
Medtronic moved for summary judgment on the ground of preemption; plaintiff asserted that Medtronic had not complied with the requirements imposed by the PMA. Plaintiff relied on the doctrine of res ipsa loquitur, saying that a device manufactured in compliance with the PMA requirements would have been problem-free.
Judge Rosenbaum disagreed: “Plaintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe. . . [T]he premarket approval process is ultimately a cost-benefit analysis in which the potential health benefits are weighed against the potential risks.” Id. at 9.
Plaintiff also claimed that Medtronic didn’t tell the FDA about the risk (T-wave oversensing) that manifested itself in the plaintiff. Again, Judge Rosenbaum rejected the argument. First, “[T]he FDA was fully informed of this risk. The device’s FDA-approved manual includes warnings about T-wave oversensing.” Id. at 10.
Second, the Federal Food, Drug, and Cosmetic Act does not create a private right of action. Thus, “plaintiff would not be able to raise this claim even if it were supported by the facts.” Id.