Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).
Here’s why ZNKI is favorable on Wisconsin legal issues.
First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule. Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding. What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule. Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:
[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability. The vast majority of states, however, do employ some version of the doctrine. In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.
In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . . Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.
ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted). As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.
But as ZNKI discussed, other Wisconsin law decisions have followed learned intermediary principles, so what else is there?
Second, ZNKI is the first Wisconsin law case to hold proximate causation is defeated, in an inadequate warning case, by the actor’s (here, the implanting surgeon’s) not reading the warnings in question. The implanter “admit[ed] that he has never read the package insert that accompanied [the] implant and that he still had not read the insert as of the day he was deposed.” Id. at *20. The court quite reasonably concluded that the inadequacy of an unread warning could not be causal. “Because [the implanter] did not read or rely upon the warnings [defendant] actually provided, Plaintiffs cannot prove that an improved warning − whether about the risks . . . or about proper surgical technique − would have led to a different outcome.” Id. ZNKI distinguished prior Wisconsin precedent, not involving prescription medical products, because there is no alternative to the prescriber in learned intermediary cases.
In [that ordinary case], the plaintiff’s failure to read the product’s warning label was not fatal to his failure-to-warn claim because the fact-finder could assume that other users would have read the warning, which could have prevented his injury. . . . There is no such argument in this case − that is, no contention that an improved warning would have prevented [the] injury because someone other than [the implanting surgeon] would have read it.
Id. (citation omitted). Thus, ZNKI necessitated us updating our failure to read 50-state survey as well.
Third, Wisconsin relatively recently passed thorough-going tort reform. Among other things, the new statute mandated that plaintiffs establish an alternative design for all design defect claims. Wis. Stat. §895.047(1)(a). ZNKI refused to water down the will of the Wisconsin legislature by letting in the rejected “consumer expectation” standard through the back door. A comment to a “pattern jury instruction” did not suggest retention of consumer expectations. 2016 WL 6135685, at *16. Nor did plaintiffs’ claim that the statute in effect adopted the Third Restatement of Torts, Product Liability, and thus a comment favorable to consumer expectations:
This court is uncertain that this comment in the Restatement (Third) is an accurate statement of the law in Wisconsin. Even if it is, the comment provides only that consumer expectations are a factor to be considered. . . . Whether or not consumer expectations are an appropriate factor to consider in judging the defectiveness of a product’s design, the statutory language makes clear that a plaintiff bringing a design defect claim in Wisconsin must propose a reasonable alternative design.
Id. Plaintiffs, of course, did not produce evidence of the requisite alternative design, “the omission of which renders the product not reasonably safe.” Id.
The alternative design upon which Plaintiffs appear to rely primarily − and the design they pointed to at oral argument − is the one proposed by [their expert]. . . . Significantly, however, [he did] not offer any opinion − or any analysis in support of an opinion − that [this] proposed design would be safer than that of the [product]. Indeed, he does not discuss what the proposed design modification was, what made it “biomechanically reasonable,” or how it would have reduced any of the risks he identified with the [product] design.
Id. at *21. This enforcement of the Wisconsin statutory alternative design requirement is also one of the first, we believe, in design defect litigation involving prescription medical products. Cf. Yakich v. C.R. Bard, 2016 WL 743476, at *11 (New Jersey Super. Law Div. Feb. 19, 2016) (much more cursory holding) (applying Wisconsin law).
Plaintiffs’ negligent design claim also failed, first for lack of alternative design, because “in the negligence context, the reasonableness of a product’s design turns essentially on whether the seller could have come up with a less dangerous design. ZNKI, 2016 WL 6135685, at *18 (citation and quotation marks omitted). Nor could plaintiffs pursue negligent testing as an aspect of negligent design – and the burden of proof remained where it belonged:
Plaintiffs fail to produce any evidence to establish what such testing would have shown had [defendant] actually conducted it. Plaintiffs suggest that because it was [defendant’s] duty to conduct the required testing and it failed to do so, it is [defendant] who carries the burden of demonstrating what such testing would or would not have shown. Plaintiffs offer no support for this burden-shifting approach, and the court sees no reason to adopt it. Plaintiffs are the ones asserting that [a] failure to test constituted negligence and that the lack of testing had some causal relationship with [the] injury; it is their burden to produce evidence to support such a claim.
Id. (footnote omitted).
There’s even more. ZNKI includes some good Daubert rulings that exclude a shoddy “differential etiology” and other aspects of plaintiffs’ experts’ opinions. 2016 WL 6135685, at *3-4, 9-14 (the expert “does not even explain to the court what his reasoning is, how the sources he reviewed inform his conclusion, or why he applies the methods that he does. These problems render the etiology unreliable”). The critique of the inadequate methodology is quite detailed, so readers interested in Daubert issues would be well-advised to review it. But to us, the expert rulings are far less important than the decision’s tour de force concerning Wisconsin law.