Because of Reed Smith’s involvement in this litigation, this post is from the Dechert side of the blog only.
We love to bring you the slam dunks, the grand slams, the holes in one – well, at least the ones that go in defendants’ favor. And, while we dislike having to deal with the air balls, the strike outs, and the shanks into the rough, we do it. Usually with less gusto but then we’ve always been honest that this is a defense oriented blog. We examine the rulings that go against us to be forewarned, to develop new strategy, and we hope in some small way to contribute to changing the law. But, as practitioners we know that more often the course of a lawsuit is filled with small victories and minor defeats as the game inches toward completion – whether trial, settlement or dismissal.
That brings us to today’s case – mostly sweet, with a hint of a sour after taste. Cisson v. C.R. Bard, Inc., 2013 WL 3821280 (S.D. W. Va. Jul. 23, 2013) is another decision out of the Pelvic Mesh MDL and it applies Georgia law. The decision is actually clarifying the court’s earlier evidentiary ruling regarding evidence of defendant’s alleged failure to test.
First, the court makes clear that under Georgia law, there is no separate cause of action for failure to test. Id. at *4 (“there is no claim for failure to test under Georgia law”). That’s no shocker; the list of courts reaching the same conclusion is quite lengthy. But this wasn’t a motion to dismiss, rather a motion in limine. And, because the “duty to test is subsumed within the plaintiffs’ design defect and failure to warn claims,” id. at *5, the court was called upon to determine what testing evidence would be admissible at trial.
Which leads us to our second and third favorable aspects of this decision – adoption of a fairly stringent foundational requirement and adherence to the state-of-the-art.
Defendant has a duty to warn of risks about which it knew or “should have known.” That’s plaintiff’s failure to warn claim. Plaintiff argued that evidence of failure to test goes to what the defendant should have known. To which the court gave the answer parents have been giving disappointed children for centuries: “Yes, But. . . .” And here’s the but: Before plaintiff is allowed to admit evidence regarding defendant’s alleged lack of testing, she must lay a foundation by presenting evidence regarding:
1) what results [a] study would have shown; 2) whether the results constituted information of a new risk or defect; and 3) whether the newly identified risk or defect is causally related to the injuries alleged.
Id. at *2. It makes logical sense. Studies that weren’t conducted really tell us nothing about defendant’s knowledge, unless there is evidence of what the results would have been. As the court explained:
First, without evidence as to what the study would have shown, the failure to test is merely speculative of what [defendant] “should have known.” Second, if the results would not have shown a new risk or defect, the failure to test would not be relevant to what [defendant] “should have known.”
Id. Further, simply because proposed studies proposed to examine certain proposed adverse events or reactions “do[es] not answer the question of whether the studies, if actually conducted, would have revealed the adverse reactions.” Id. at *3 (emphasis in original).
Plaintiff attempted to meet her foundational burden by pointing to results of other studies presumably as evidence of what the proposed but not conducted studies would have shown. Id. The court found the evidence insufficient both because the referenced studies addressed similar, but not the same, product as that at issue in the case and because plaintiff proffered the studies on their own with no supporting expert testimony. Id. While the court didn’t offer a final ruling on the admissibility of failure to test evidence with regard to failure to warn, it cast serious doubt on plaintiff’s ability to overcome the foundational hurdle. Id. at *4.
Before we reach state-of-the-art, we have to acknowledge the slightly less satisfying portion of this decision – the admissibility of evidence of failure to test with regard to plaintiff’s design defect claim. Here the court found that under Georgia’s risk-utility test, a manufacturer has “a duty to exercise reasonable care in choosing the design” of its product, which duty includes the duty to test the product. Id. at *4. Again, the court was clear that failure to test does not stand alone, but it is one of the factors in the risk-utility analysis.
So, while evidence of lack of testing is admissible on design defect, the court limited it to pre-market studies. And, we’re back on track. We typically think of the state-of-the-art defense in terms of failure to warn — whether it was possible for the defendant to know of the alleged risk given the state of scientific knowledge at the time. But it applies to design defect as well because a defendant is only liable if the product was defective at the time it was “sold by the manufacturer.” Id. at *5 (quoting Georgia law). So, if there is any breach of a defendant’s duty to act reasonably in designing its product, it has to occur before the product reaches the market. Evidence of the failure to conduct post-market studies “simply do[es] not make it any more or less probable that [defendant] breached its duty to test at the time” it sold the product. Id.
In summary, no independent claim for duty to warn, no evidence of lack of post-market testing, and it’s unlikely lack of pre-market testing will be admissible as evidence in plaintiff’s failure to warn case. It will come in as an element of reasonableness on design defect, and we know limiting instructions have their own limitations, but the foundational requirements and acknowledgement of state-of-the-art are enough to make us say defendant is ahead by one heading into the ninth.