[Drug and Device Law] Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case
We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post. It is a beautiful fall day where we have a relative lull in our slate of depositions, briefs, and arguments, so we will get right to it. Last month, we had trouble making sense of a long Daubert and summary judgment order in a metal-on-metal hip implant bellwether case. This month, we think that the evidentiary rulings in the same case make more sense. Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 6704750 (N.D. Ga. Nov. 2, 2015). Except for this: neither side filed timely motions in limine, they submitted a joint “Position Statement” on evidentiary issues, and the court issued rulings complete with limiting instructions. That was awfully generous of the court, as most judges will not rule on what evidence can come in absent a timely motion or objection. It may be too simplistic to say that plaintiff lawyers in drug and device product liability cases prefer the rules of evidence to be fast and loose, allowing them to spin a narrative that riles up the baser instincts in the jury, whereas defense counsel in such cases prefer that evidence be focused on the issues that the jury will be asked to decide. In any event, knowing what evidence will be coming in on what issues allows both sides to prepare their respective case so that the jury can hear something coherent. The Federal Rules of Evidence give trial judges a fair amount of latitude to maximum the chance that the jury will understand the evidence presented and how it fits with what they are asked to decide. The Christiansen rulings do a pretty good job of that.
In addition to what she could offer from her ten experts and apparently friendly implanting surgeon, plaintiff wanted to offer “fact” testimony from four other orthopedic surgeons who had not treated her and were not designated as experts. We can think of three basic plausible ways, but maybe objectionable depending on the facts, that these non-treating surgeons could be fact witnesses: 1) they could have something to say about their personal involvement in designing the product at issue; 2) they could have some interaction with the manufacturer before the plaintiff’s implant that allegedly provided notice of the risk of the injury that plaintiff claims (“metallosis” per the prior decision); or 3) they could have done some study on the risks and/or benefits of the product that they will talk about. No, plaintiff wanted them to talk about whether the product was defective under Utah’s consumer expectations test—with an orthopedic surgeon being the consumer for this prescription device—and what the manufacture told them about the device.
Plaintiff apparently knew that these surgeons were critics of the product and would testify their experience told them that it was dangerous beyond their—and, by extension, objective orthopedic surgeons’—expectations. The court permitted them to talk about their expectations from the product in terms of its uses, benefits, and “range of risks,” but not that the failure rates they witnesses were too high. “Testimony from the [non-treating surgeons] about device failures they claim their patients suffered generally is not relevant and, if allowed, would require a mini-trial on each of the failures to determine if the failures occurred for the same alleged reasons that Plaintiff’s device failed.” Id. at *3. So, the failure rate testimony was out under both Rule 402 and Rule 403. This simple ruling implies a number of broader principles at play. First, risks or failures should only be relevant if they are about what the plaintiff claims happened to her. This comes up with warnings claims all the time—plaintiff says the warning was inadequate as to the risk of x but the plaintiff claims her injury was y—but also applies to design defect claims. The overall failure rate does not indicate the relevant failure rate for plaintiff’s claim any more than the overall complication rate indicates the rate of a specific complication. Second, talking about what happened with other patients is much like presenting adverse events. This evidence is ill suited as proof of defect, but may provide notice for a warnings claim depending on the timing and injury/failure. The potential to devolve into a series of mini-trials is real and distracting, as the court here saw, but there is also the issue of whether the defendant will have had sufficient discovery on the patients that these non-treating non-expert surgeons would discuss to allow for meaningful cross-examination. As for the plan to have these surgeons talk about their own interactions with the defendant, the court did not have enough information to rule beyond three broad strokes. First, any interactions they had after the plaintiff’s implant are not relevant to anything. Id. at *3 n.5. Second, any interactions they had are not relevant to the warnings claim, which is rightfully focused on the implanting surgeon. Id. at *3 & n.6. Third, if their testimony is relevant to their permissible testimony about their expectations, then the court will give the jury a limiting instruction so that the testimony is not taken as applying to some other issue. Id. It will be interesting to see whether the surgeons—or the two of them who can be called without exceeding the court’s sua sponte limit—can succeed in smearing the defendant, its product, and its warning within the court’s framework. After all, this is why plaintiff wants to pile on with these witnesses.
Plaintiff also wanted to limit the evidence that the defendant could present in two areas. The first comes up more and more as plaintiffs try to suggest that medical devices are developed out of thin air rather than building on what came before: trying to exclude evidence of testing and experience with the predicate device. Without knowing the details, we can make an educated guess that testing was done in connection with the predicate device on things like materials selection, performance, and biocompatibility that was not repeated for the plaintiff’s device because that is how it is supposed to work for medical devices. So, by making the falsely attractive argument of “we should just be talking about the product at issue in the case, its specific testing and the defendant’s specific experience with it,” the plaintiff hoped to exclude some potentially key evidence. (We know that experience with other products is something drug and device manufacturer defendants often try to exclude, often using the Rule 403 “mini-trial” argument mentioned above, so we recognize there is a potential goose-gander dynamic here.) The court here saw that the “design, testing, and clinical experiences” with the predicate produce was relevant to a number of issues in the case. Experience with metal-on-metal parts in the predicate product “informed” the design and production of the plaintiff’s product, which “is relevant to the design issues in this litigation, including the issue of alleged misrepresentations, to refute Plaintiff’s claim about metal ion release and to refute any claims that Defendants did not have sufficient experience in producing metal-on-metal products.” Id. at *4. Without explanation, the court also noted relevance to punitive damages. This is an important additional consideration, as letting the jury hear that there was a prior marketed product that that the manufacturer thought helped justify the design of the plaintiff’s product does tend to negate the sort of intent require to piggyback punitive damages on finding the design was defective. The second is something we see less often: evidence from surveillance of the plaintiff. There is no doubt that surveillance that the defendant would want to use would be relevant and maybe even highly impactful. The rub, per plaintiff, was that this surveillance evidence was not disclosed until being mentioned on the trial exhibit list. “The Court notes that, by its nature, surveillance evidence to ascertain whether a plaintiff is still suffering from an alleged injury may need to be conducted closed to trial, after discovery deadlines have passed.” Id. at *5. This evidence may be directly admissible, but it certainly can be used to impeach the plaintiff if she claims not to do things she was observed doing during the surveillance. That will be the kind of evidence that the jury will understand, regardless of how many witnesses plaintiff calls to dump on her hip implant.
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Posted By Eric Alexander to Drug and Device Law at 11/12/2015 08:00:00 AM --
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