Parallel, Not Perfect
Walker v. Medtronic is another new case interpreting Riegel. This time the device failed utterly (given the undisputed evidence that the plaintiff's decedent died when an implantable pain pump delivered a massive overdose). The case hinged on whether the (in)accuracy of the (over)dose administered, in this case the consequence of a complete failure, constituted a variance from a performance standard set out in the pre-market approval (PMA) so that a state tort claim could proceed.
Holding (essentially) that the FDA mandates design/manufacturing process fealty rather than perpetual operational accuracy, the majority recognized that a product made to the FDA's exacting standards may fail nonetheless and that in such circumstances a parallel state claim cannot lie.
The dissent sought to make the performance standards basically a guarantee confusing, we think, accuracy with perfection.
Props to the majority for the Mr. Spock reference: "the benefit to the many ... outweighed the cost to the few..."
