The MDL court in the pelvic mesh litigation issued in limine rulings for an upcoming trial involving Ethicon’s TVT Secur system. In re Ethicon, Inc., 2014 U.S. Dist. LEXIS 14088 (S.D.W Va. Feb. 5, 2014). There were almost 30 rulings. The motions addressed topics that ranged from the mundane, such as clinical trials and complication rates, to the much more interesting, such as TV ads by plaintiff-lawyers. Most of the topics are familiar to those of you who have been through these types of trials. The good news is that the defense won most of the motions, and here are some highlights:
Conclusions from Clinical Trials. Plaintiffs wanted to prevent Ethicon from testifying or arguing that a certain number of clinical trials supported the safety of the TVT system. Plaintiffs claimed the conclusions of the clinical trials were hearsay. The court didn’t rule, punting on a decision until trial. But the plaintiffs appear to have already lost. The court held that testimony about the conclusions of clinical trials was not hearsay if an Ethicon employee testified that Ethicon relied on the studies, which it no doubt did.
Complication Rates. Plaintiffs moved to exclude complication rates related to the use of TVT system, arguing that such rates couldn’t be reliably calculated because the complications themselves are underreported and the number of the TVT systems that have actually been used is unknown. The court agreed only to the extent that anecdotal evidence would be excluded. The defense is otherwise free to introduce complication rates that are derived from reliable statistical methods and/or peer-reviewed literature.
Gold Standard and Standard of Care. Plaintiffs took a few shots at keeping out evidence that the TVT system was the “standard of care” or the “gold standard” for treating stress urinary incontinence. It didn’t work. First, plaintiffs argued that terms like standard of care and gold standard would confuse the jury and create mini-trials. It’s a design defect case, and those arguments didn’t fly. The court held that this type of testimony is relevant to whether the TVT is unreasonably dangerous or has safer alternative designs. Next, Plaintiffs tried to exclude statements from medical organizations describing the TVT system as the standard of care. The court denied this too. Such statements are admissible in a number of ways, including as learned treatises, as reliance material for experts, and as evidence of Ethicon’s state of mind. Finally, Plaintiffs sought to exclude Ethicon from presenting testimony that alternative treatments to the TVT system were rarely taught in medical schools. That is clearly evidence relevant to whether safer-alternatives were available, and, not surprisingly, the court denied the motion.
Attorney-Driven Litigation. Plaintiffs anticipated – no doubt, correctly – that the defense would argue that the lawsuit was attorney-driven, and so they moved to exclude that type of evidence or argument – to mixed results. The court prohibited Ethicon from presenting evidence that the surgeon who performed the plaintiff’s TVT surgery had been recommended to her by her lawyer because the court saw nothing to suggest that the surgeon acted outside the standard of care. That seems like one of those ironic-type victories, doesn’t it? Stipulation anyone? The court, on the other hand, allowed the defense to present evidence that the plaintiff chose to sue only after seeing a lawyer ad on TV, holding that such evidence is probative of plaintiff’s credibility as to her injuries. That’s a big victory for the defense.
Instructional and Marketing Materials. The court had already dismissed plaintiffs’ warning and warranty claims, leaving only design defect and punitive damages claims. So the defense moved to exclude the TVT system’s Instructions For Use and marketing materials. The court was coy in its ruling. But it sure reads like a defense victory. While the court denied the motion, it said that the motion was, in essence, asking the court to reaffirm the rule that only relevant material is admissible. It then said, “I have already ruled that evidence related to the TVT’s IFU and patient education brochures is not relevant to the plaintiffs’ design defect claim.” That sure reads like a defense victory to us.
Bad Acts. The court excluded many of the types of bad-act evidence that we often see plaintiffs try to introduce at trial, including state AG actions, DOJ settlements, SEC settlements, and governmental investigations. None of these investigations, actions or settlements were related to the TVT system. The court withheld until trial rulings on any other “bad act” evidence that plaintiffs might seek to introduce. But the court also gave the plaintiffs a Heisenberg-like warning: “tread carefully.”
Other TVT System Lawsuits. The court excluded all of this, holding that evidence of other TVT lawsuits is unduly prejudicial and would confuse or mislead the jury.
Financial Support of Articles and Payments to the Inventor of the TVT
System. The defense lost these motions. The court held that, even if Ethicon had no obligation to disclose its financial support of a published article, the jury is still entitled to consider whether it was reasonable for Ethicon to rely on financially-conflicted articles. The court also allowed plaintiffs to introduce evidence that Ethicon paid the professor who invented the TVT system and lead one of its key studies through milestone payments, which the court held could be relevant to negligence and punitive damages.
Referring to Confidential Designation in Front of the Jury. We’ve seen this move. Plaintiffs’ lawyers suggest something nefarious is behind “confidential” designations placed on documents, even when those designations were affixed as part of the litigation. It’s based on guesswork that the only reasons for confidentiality are illicit. The court understood that such suggestions were unduly prejudicial and based on speculation, and it excluded plaintiffs from making them.
Emails with Off-Color Comments.
The court considered two internal Ethicon emails that contained off-color comments, one addressing an adverse event report. The court held that bad-taste does not equal wanton or malicious conduct and excluded the emails.
Material Safety Data Sheets and Complications Unrelated to Plaintiff’s Injury. Plaintiffs intended to use MSDS from suppliers of companies other than Ethicon and/or that reflected complications unrelated to those suffered by plaintiff. For obvious reasons, the court excluded these. It also generally excluded evidence of alleged complications unrelated to plaintiff’s injuries.
There are more rulings, but these give you the gist.
Next comes trial.