Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting—at least to us. We lamented just yesterday that many judges reflexively deny motions to dismiss on preemption, but others see the light from the get go. Take for example Shawver v. Zimmer Biomet Spine, Inc., No. 3:24-cv-00454-JGC, 2024 WL 4458261 (N.D. Ohio Oct. 10, 2024). In Shawver, a federal judge in Ohio granted a motion to dismiss because federal law preempted state-law claims premised on the implantation of a pre-market approved, Class III medical device. That was the correct result.
The plaintiff in Shawver was treated with the defendant's cervical disk replacement device and later experienced alleged symptoms that included numbness, tingling, and weakness—resulting in a second surgery and a lawsuit claiming personal injury. The district court, however, made short shrift of the plaintiffs' claims. As mentioned, the implant was a Class III medical device that has undergone the "rigorous regime" of premarket approval ("PMA"). As the district court observed, that process involves FDA review of "any probable benefit to health from the use of the device against any probable risk or injury or illness," and PMA-approved devices are subject to continuing FDA oversight. Id. at *1-*2.
Most importantly, the Medical Device Amendments to the FDCA include an express preemption provision, which mandates that no state may impose any safety-related or efficacy-related requirement that "is different from or in addition to" any federal requirement. Id. at *6. As we have written more times than we can count, this provision preempts state-law tort claims seeking to impose standards different from or in addition to federal requirements governing PMA-approved devices.
How then did this district court get to its order dismissing the plaintiffs' claims? The district court first rejected the defendant's argument that the Ohio Products Liability Act abrogated the plaintiffs' express warranty and fraud claims, although it dismissed those claims anyway on other bases (we will come back to that). The OPLA creates a cause of action for design defect, manufacturing defect, and inadequate warnings, among other things. But, it also expressly abrogates "all common law product liability claims or causes of action." According to the court, the plaintiffs had sufficiently pleaded fraud claims outside the OPLA because their allegations "might relate to instances of active misrepresentation," as opposed to a failure to warn. Id. at *5. Express warranty escaped OPLA abrogation because it was a statutory claim, not common law. Id. at *3 n.6.
The marquee holding though was on express preemption. The district court set forth the usual two-step analysis: (1) Has the federal government established requirements applicable to the device?; and (2) if so, will state law impose requirements for that device that are different from or in addition to federal requirements on safety and effectiveness? The court also, however, acknowledged the often-cited and poorly understood "parallel claim" exception, under which the MDA purportedly does not preempt a state from providing a damages remedy for claims premised on violations of FDA regulations. Id. at *6.
Whether you embrace the parallel claim exception or not (we do not), it did not help these plaintiffs. The complaint alleged no way in which the device deviated from its specifications, and it was not sufficient for the plaintiffs to assert blithely that "discovery will uncover further details." Id. at *7. The complaint similarly failed to allege any way in which the device had deviated from the FDA-approved design. Somewhat quizzically, the plaintiffs argued that their claim would be "parallel" to federal claim if the device had deviated from the approved design. But they alleged no such deviation. The plaintiffs further alleged that the defendant failed to provide information about "comparative safety and efficacy; failed to perform adequate testing; and failed to warn adequately of "enhanced risk compared to other options." Id. at *8
These allegations did not state a claim for manufacturing defect, and the MDA preempted the design defect and warnings claims. The FDA granted this device premarket approval under a process that required the FDA to conduct its own risk-benefit analysis. The plaintiffs' design defect claim thus was "a frontal attack[ ] on the risk/benefit analysis that led to the FDA to approve the device." Id. at *7 (citations omitted). The warnings claims similarly threatened state requirements different from or in addition to federal requirements because the plaintiffs did not allege that the defendant had issued anything other than the FDA-approved warnings. Id. at *8. These are classic applications of MDA express preemption, as these plaintiffs were plainly trying to hold defendants to standards different from federal mandates.
The plaintiffs' express warranty claim fared no better. The court expressed the view that a claim for breach of express warranty can avoid preemption where it alleges violations of federal requirements and where it "rest[s] on the defendant's voluntary statements made separately from the FDA's regulatory process." Id. at *9-*10. We're not totally sure what that latter part means, but it doesn't matter. These plaintiffs did not allege any details and did "not describe in any fashion what the express warranty made by Defendant[ ] was and how that express warranty could be enforced by Ohio law in a parallel fashion." Id. at *10 (citations omitted). The claim for negligent misrepresentation was likewise "far too general to survive preemption under the MDA." Id.
Plaintiffs received leave to amend for many of their claims, but not all. We frankly are not sure what they can do with that dispensation, since they pleaded directly into preemption in the first place. We will see.
This article is presented for informational purposes only and is not intended to constitute legal advice.
