This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week. In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013). In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here). Things didn’t go as well with the in limine motions. It was more of a mixed bag. Here are a few of the issues addressed by the court.
FDA 510(k) Clearance
This was plaintiffs’ motion. They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process. Id. at *4-6. Seems pretty relevant, doesn’t it? It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market. Yet the court granted plaintiffs’ motion.
Why? Well, the court was concerned that this type of evidence would waste time by creating an unnecessary “mini-trial” on the 510(k) process and on the FDA’s enforcement authority. The jury also might improperly perceive that the FDA’s clearance meant that plaintiffs’ claims should fail. Moreover, if evidence of the FDA’s clearance was admitted through an expert, that expert would “effectively be offering a legal conclusion.” Believing this, the court excluded all evidence related to the FDA 510(k) process and enforcement. But this decision is hard to reconcile with the real world under which the industry operates. The plaintiffs have claimed that the Avaulta products have defects in design, manufacture or labeling, and the 510(k) process addresses all those things. In the real world, the 510(k) process regulates the manner in which medical devices are developed, designed, manufactured and labeled. It’s not everything. But it’s a lot of it. Given that, it’s hard to imagine how the jury is anything but hamstrung by not having evidence as to how that process played out with the Avaulta products. The jury will get an incomplete picture of the standards under the products were developed and whether Avaulta met those standards. Juries hear evidence on industry standards all the time. And they receive instructions from the court all the time on how to weigh that evidence. There seems to be little reason why that wouldn’t have worked well here. Just because 510(k) clearance doesn’t preempt a plaintiff’s claims, it doesn’t mean that evidence of such clearance should disappear from trial. Further, we don’t see how an FDA expert testifying on the 510(k) process and ultimate clearance of the Avaulta products would be offering a legal conclusion. The process and the clearance are facts, not legal conclusions. The expert could give qualified opinions as to whether the defendant met the FDA standards, just as the court allowed plaintiffs’ FDA expert to give similar opinions in its earlier Daubert rulings.
Surgery Consent Forms.
The defense did better here. Id. at *6-8. The plaintiffs asked the court to exclude evidence of plaintiffs’ signing consent forms for the surgeries to implant the mesh. Huh? Evidence of consent related to the very surgery during which the product was implanted seems to be as relevant as relevant gets. It could have a significant bearing, in the least, on proximate causation and assumption of the risk. The court denied plaintiffs’ motion.
Promotional Materials Not Used with Plaintiffs’ Prescribing Physicians
The defense moved to exclude promotional materials that were not identified as having been seen by plaintiffs’ prescribers. Id. at *16-17. Makes sense. If the plaintiffs’ prescribers weren’t exposed to the materials, the materials could have no relevance to the prescribers’ decisions to use the product. The court seemed to implicitly accept this. Yet it didn’t grant the defense’s motion. The reason was punitive damages. That claim is still alive, and the court chose to await trial to determine whether the materials might be relevant to it.
Duty to Warn Plaintiffs Directly and Duty to Train Plaintiffs’ Physicians
The defense also asked the court to exclude argument that it had a duty to (i) warn the plaintiffs directly or (ii) train the implanting doctors. Id. at *13-14. The first argument, of course, rests on the learned intermediary doctrine, which says that the manufacturer’s duty to warn is to the doctor not the patient. This point seems so clear that the plaintiffs conceded it. As to the “training” motion, the court held that its ruling would be too dependent on context, so any decision would be made at trial.
Defendant’s Post-Implant Conduct
In another motion that is sometimes brought in these cases, the defendants sought to exclude evidence of its own conduct after the implant of the devices. Id. at *11-12. The basis for the motion is FRE 407 on Subsequent Remedial Measures. This type of motion often addresses evidence of a subsequent change in the product’s label, a decision to withdraw the product, and other post-injury actions. We mention this motion only to highlight that it’s available. Here, the court didn’t rule, again needing context from trial to determine whether the exceptions to FRE 407 might allow plaintiffs to admit the evidence.
Connection with Cancer
The plaintiffs are seeking to use at trial medical literature that raises a possible connection between the polypropylene used in the Avaulta products and cancer. Id. at *20-21. The defense sought to exclude it. Why? Because none of the plaintiffs claimed that they got cancer from the product. That’s a pretty good reason. The court recognized that, as well as the potential for undue prejudice that can come with the mere mention of cancer. Nonetheless, the court once again deferred its decision until trial when it will have more context. The court made a number of other rulings and deferred even more rulings until trial. Feel free, however, to take a look at the entire opinion. It presents a fair representation of the type of in limine evidentiary issues that ordinarily arise in these types of mass torts.