The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called " the best Wisconsin law decision we have ever seen." What was the reason for our unusually unbridled enthusiasm? The district judge debunked the idea that the learned intermediary rule does not apply in Wisconsin. We have often heard that refrain, but we have always been skeptical. The truth is that Wisconsin's appellate courts have not addressed the issue, and the In re Zimmer Nexgen judge predicted that Wisconsin's Supreme Court would adopt the learned intermediary rule if given the opportunity.
The Seventh Circuit has affirmed that order, so its opinion now inherits the mantle of "Best Wisconsin Law Decision We've Ever Seen." That title is cemented not only by the adoption of the learned intermediary doctrine, but also the rejection of a heeding presumption, which is also very helpful. We note that the three judges who issued this opinion have spent a combined 83 years on the Court of Appeals and that the author of the opinion spent five years on the Wisconsin Supreme Court. Maybe the latter fact was considered when assigning the opinion; maybe it was not. Regardless, it is a clear-minded and well-reasoned opinion that we commend to anyone who has grappled with warnings claims in Wisconsin.
Here is what happened. The plaintiff sued a knee implant manufacturer alleging design, manufacturing, and failure-to-warn claims after his prosthetic knee replacement loosened, which is a known complication of all joint replacement procedures. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 16-3957, — F.3d –, 2018 WL 1193431, at *1 (7th Cir. Mar. 8, 2018). Following summary judgment, the plaintiff raised only the warnings claims on appeal and argued that the manufacturer failed adequately to warn both the plaintiff and his surgeon.
Of course, an alleged failure to warn the plaintiff raises the application of the learned intermediary rule, which "holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product's risk by informing the prescribing physician." Id. at *2. Because neither the Wisconsin Supreme Court nor the state's intermediate appellate courts have addressed the rule, the Seventh Circuit undertook an Erie analysis. Id. at *3.
Although we would like to believe that the Seventh Circuit reviewed our frequently updated 50-state survey on the learned intermediary rule, it is more likely the court did its own research or relied on that provided by the manufacturer. What it found was one Wisconsin trial court opinion applying the doctrine and noting its widespread acceptance. Id. at *3 (citing Staub v. Berg, No. 00-cv-0117, 2003 WL 26468454 (Wis. Cir. Ct. Jan. 6, 2003)). The Court also found three federal district court opinions invoking the learned intermediary doctrine under Wisconsin law, and one case called Maynard v. Abbott Labs observing that "Wisconsin does not apply the learned intermediary doctrine." Id. On this last point, the Seventh Circuit was particularly blunt: "That statement is incorrect—the Wisconsin Supreme Court has never weighed in on the topic [and] Maynard itself is bereft of any analysis on the point." Id.
The Seventh Circuit also relied on the learned intermediary doctrine's "broad support in other jurisdictions," including 48 states where the highest court or the intermediate appellate courts have adopted the doctrine in some form. Id. Finally, the rationale for the learned intermediary rule applies even more forcefully in cases involving surgical implants because "it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician." Id. Amen.
The following holding and the reasoning upon which it is based are what make In re Zimmer Nexgen the Best Wisconsin Law Opinion We've Ever Seen:
In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so. Accordingly, to the extent that [the plaintiff's] defective-warnings claim is based on [the manufacturer's] duty to warn him, it is foreclosed by the learned-intermediary doctrine.
Id. at *4. For good measure, the Seventh Circuit held that the plaintiff's direct warnings claim failed also because the plaintiff did not identify any danger about which that the manufacturer should have warned him and because he had no evidence of causation. Even if the plaintiff would have heeded a different warning, "[he] didn't select the NexGen Flex implant." His surgeon did. Id.
The Seventh Circuit likewise rejected the plaintiffs' argument that the manufacturer failed adequately to warn the surgeon. The plaintiff cited the defense expert's testimony that he would have used more cement to place the implant and argued that the manufacturer failed to warn about the amount of cement needed. Id. at *4. But that was not sufficient because "no evidence supports [the plaintiff's] contention that it was [the manufacturer's] responsibility to instruct surgeons about the amount of cement they should use." Id. at *5. This surgeon relied exclusively on his education and training, not on any materials from the manufacturer, and the plaintiff offered no expert opinion that the warnings were inadequate in any event. Id.
Finally, the Seventh Circuit rejected the warnings claims on causation. The surgeon did not read the instructions for use and could not been affected by a different warning. Id. at **5-6. The plaintiff urged the Seventh Circuit to apply a "heeding presumption," i.e., a presumption in the absence of proof that the surgeon would have read and heeded a proper warning. Id. at *5. But Wisconsin law squarely places the burden of proving causation on the plaintiff. As the Seventh Circuit held,
Here again, the state appellate courts have not addressed this doctrine [the heeding presumption]. We seriously doubt that they would adopt it in this context. [¶] To the contrary, as we've already noted, the state court of appeals has recently held that "[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury."
Id. (citing Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. Ct. App. 2004)). In other words, since Wisconsin law already places the burden of proving causation on the plaintiff, the Seventh Circuit would not alter that law by creating a presumption.
The plaintiff's last request was to certify questions to the Wisconsin Supreme Court, which the Seventh Circuit rejected because "[n]o genuine uncertainty exists here." We could not agree more and would not be surprised to see this opinion on our Ten Best list at year end.
This article is presented for informational purposes only and is not intended to constitute legal advice.
