The preemption question “comes down to whether the warranty on Medtronic’s website was consistent with assessments made during the approval process, in which case this lawsuit would be preempted as a challenge to the FDA’s determination of safety and effectiveness, or whether the warranty goes beyond what the FDA considered.

“What did the warranty promise?

“Medtronic argues that it equates battery life with device life, which makes ’eminent sense’ because the Device’s primary component is the battery. Medtronic goes on to say that its warranty claimed that battery longevity was the limiting factor to overall longevity and thus battery life was the device life.

“But a plain reading of the warranty is at odds with Medtronic’s interpretation. It repeatedly makes a ‘distinction’ between the battery and the ‘many components’ and focuses on guaranteeing the reliability of the latter. The Statement begins by asserting that although other manufacturers ‘may state that their batteries have a longevity greater than 9 years, it’s important to understand that many other factors and components are involved in determining the overall longevity of an implanted medical device’.  The next sentence states that ‘extensive design and testing … give Medtronic the confidence that our device is reliable for 9 years.’  Why does it have that confidence?  Because ‘Medtronic rigorously verified and validated the many components that impact device longevity, not just the battery.’  By its own terms, the Statement says that longevity of many components other than the battery contributes to the Device’s overall longevity.

“The Statement cannot reasonably be read as anything other than a claim of comparative advantage over competitors that vouch only for the life of their batteries. Medtronic is telling consumers why its product is superior. When the Statement says nine years, it means the many components — in its words, ‘not just the battery’ — are guaranteed to last that long. It cannot have it both ways by claiming that as an advantage over competitors in the marketplace and now contending that only the battery life matters. Nor has Medtronic convinced us that battery life would be the only factor affecting the Device’s longevity. Of course, when the battery dies, the device would cease to function. But it does not follow that the failure of the device would only be attributable to a drained battery. There are other potential points of failure — such as the casing, the connections between the wires and battery, or the embedded computer and software. The Statement says each of the many components were tested in guaranteeing ‘reliable performance’ over the ‘entire period of predicted service.’ So like any number of products — consider a car’s drivability which depends not just on a working battery but also a functioning engine or alternator — Medtronic offered an express warranty on the longevity of the entire Device.

“Whether Wildman can challenge the truthfulness of that Statement thus depends on whether the FDA evaluated the longevity of the ‘many components.’  As we mentioned at the outset, the FDA did test battery life and approved a statement that the Device’s ‘battery life’ was ‘9 years.’ But Medtronic has not identified anything in the administrative record showing that the FDA evaluated the longevity of other components.”

 

Wildman v. Medtronic, No.17-50010, 2017 WL 4926804 (5th Cir. Oct. 31, 2017).