We use products with warranties every day. There are warranties on frying pans, on light bulbs, on computers. We once saw a warranty on a pair of nail clippers that cost $1.49 that allowed the owner to send them in for repair or replacement as long as you included $3.00 for return shipping. What a bustling warranty department that company must have had. Generally speaking, we don't pay much attention to warranties unless they are on big ticket items. If something goes wrong with your car, you're scrambling to see whether it's covered by a warranty. If a light bulb that's supposed to last five years burns out in three, you most likely just toss it out and screw in a new one. You probably forgot how long it's been since you last changed it anyway (speaking for this blogger at least).
Medical devices such as implantable spinal neurostimulators (guess what today's case is about) don't come with warranties of the kind alluded to above. You're not going to see a provision on the labeling that says should this device break or malfunction within 3 years of implant, just send it back for a new one. There are many reasons for this, the most obvious of which is the device is inside someone's body. Returning the device it isn't always an option, because revision surgeries aren't always the best option. Moreover, most product warranties talk about normal wear and tear or under normal conditions. There is no such thing as "normal" or "typical" when you are talking about inside the human body. There are simply too many unknowns for medical device manufacturers to guarantee their products.
But that doesn't stop plaintiffs from including express warranty claims in their complaints. Typically the allegations in express warranty claims in drug and device cases are general statements that the manufacturer's labeling and advertising represented that the product would be safe, effective, fit, proper, etc. When pressed for the actual representations that constitute the express warranty or for proof of reliance on such statements – well, that's when plaintiffs' express warranty claims often fall away. That's because they don't exist. And, that's usually the focus of our discussion on express warranty. Occasionally, however, plaintiffs come armed with a little more specificity.
That was the case in Wildman v. Medtronic, Inc., 2016 WL 7468232 (W.D. Tex. Dec. 22, 2016). Plaintiff had surgery to implant a neurostimulator to aid in pain relief. The device is a Class III, PMA device – so express preemption applies. Approximately one and half years later, the device stopped working and had to be removed. Id. at *1-2. Plaintiff brought only an express warranty claim based on language from the manufacturer's website that reads: "The result of extensive design and testing involved in manufacturing rechargeable neurostimulators give Medtronic the confidence that our device is reliable for 9 years." Id. at *1. Plaintiff argued that by this Medtronic warranted that the device would last for 9 years, which it did not. Medtronic moved for judgement on the pleadings on several grounds, but the court addressed preemption only.
First we should note that plaintiff argued that the court should be guided by the presumption against preemption. Id. at *5. But, Wildman turns out to be, we believe, the first PMA preemption case to directly recognize the elimination of the presumption against preemption in express preemption cases. "[T]he Supreme Court has squarely stated the opposite when the text of a statute plainly contains a preemption clause. See Cuomo v. Clearing House Ass'n, L.L.C., 557 U.S. 519, 554 (2009) ("There should be no presumption against preemption because Congress has expressly preempted state law in this case")." Id.
Moving to the alleged express warranty itself, plaintiffs first argued that it was voluntarily made – that it was not reviewed or approved by the FDA – and therefore should not be considered an FDA requirement that would trigger express preemption. Id. While the exact language on the website may not have been approved, it was based on the language in the device's Implant Manual which provided that the battery life of the device was 9 years. And the Implant Manual was reviewed and approved by the FDA as part of the PMA process. Therefore, defendant could not have stated anything other than that the device's life was 9 years – to do so would have been a deviation from the specific FDA-approved language. The court agreed with defendant. The device was pre-market approved based, in part, on the FDA's review of materials which stated that the battery life was 9 years. Id. at *6. It therefore constitutes part of the federal requirements concerning the marketing and distribution of the device.
The court next examined whether plaintiff had stated a non-preempted parallel violation claim. But, at the heart of a parallel violation claim is a violation. Plaintiff didn't allege that the defendant violated a federal regulation by stating the product had a lifespan of something other than 9 years. Id. at *7. Plaintiff's claim was based on the fact that the device did not last 9 years. But a malfunction is not a violation. Compliance with all of the terms of the PMA process isn't a guarantee that the device won't fail. The PMA process provides a "reasonable assurance" of safety and effectiveness. So, even where a product fails, if the manufacturer complied with the PMA requirements, tort claims based on that failure are preempted. Id.
Finding that the statement was part of the PMA process and therefore a federal requirement, the final question for the court was whether plaintiff's express warranty claim would impose different or additional requirements on the manufacturer. The court found that it would. To find that the defendant breached the warranty, a jury would have to conclude that the device was unsafe and ineffective, which would "directly contravene the FDA's determination that the device was both safe and effective." Id. at *8. Put another way, in deciding an express warranty claim, the jury would have to assess whether the representations made by the defendant were true. But because those representations were approved by the FDA, the state law claim is potentially inconsistent with federal regulations. So, it must be preempted. Id.
As express warranty was the only claim brought by plaintiff, the case was dismissed in its entirety with prejudice. Another great PMA preemption win. But thinking about warranties, if a frying pan warranty excludes damage from "misuse or abuse," does abuse include using it as a hammer? What about just when in need of a hammer in the kitchen? It's really quite effective.
This article is presented for informational purposes only and is not intended to constitute legal advice.
