As always, discussion of the pelvic mesh litigation comes from the non-Reed Smith side of the blog.
This summer we blogged about many pre-trial and in limine rulings in the Pelvic Mesh MDL. Most were quite favorable. One of those decisions that we thought was pretty good was Cisson v. C.R. Bard, Inc., see post, which threw out a duty to test claim and applied a stringent state-of-the-art standard. Back in July, we thought that ruling was helpful to the defendant and would serve it well at trial. Well, we’re clearly not seers. While we sometimes like to look into our crystal ball, our predictions are usually based on nothing more than wishful thinking (we like to think it’s more than that, but usually it’s not). The Cisson case went to trial and the jury returned a verdict against the defendant awarding both compensatory and punitive damages. Defendant moved for judgment as a matter of law during trial and the court deferred until post-verdict. Unfortunately, the court upheld the verdict and in so doing made some not so great rulings.
A quick background of the case. Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain. Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed. Plaintiff alleged that she continue to experience pain and evidence was presented that she suffered extrusion, erosion, excessive scarring, and inflammation. Cisson v. C.R. Bard, Inc., 2013 U.S. Dist. LEXIS 149976 at *3-4 (Oct. 18, 2013). Plaintiff presented two claims to the jury – design defect and failure to warn.
On her design defect claim, plaintiff alleged multiple possible defects in the design: the arms on the device were a design defect, the device’s pore size was inadequate, the device should not have been constructed from polypropylene because pelvic mesh is intended for permanent implantation. Id. at *4-6. In its motion for judgment as a matter of law, defendant did not challenge that the alleged defect related to the device’s arms should go to the jury, but did argue that plaintiff had failed to prove that polypropylene or pore size constituted design defects. The court never gets to the substance of the defense arguments on design defect, but rather employs a strange quasi-res ipsa loquitur rationale — it doesn’t matter what the alleged defect theory is, as long as there is any defect theory to go to the jury. The court based its conclusion on a finding that under Georgia law “it is not necessary for the plaintiff to specify precisely the nature of the defect.” Id. at *13. Closer scrutiny of Georgia law on this issue may be a topic for another day. For now, the unfortunate result is that it appears that presentation of multiple legally insufficient design defect theories is excusable as long any one remaining theory was sufficient.
On failure to warn, the court found that plaintiff had presented sufficient evidence both that defendant’s warnings were inadequate and that the inadequacy was a cause of plaintiff’s injuries. The causation ruling is the result of the implanting surgeon testifying adversely to the defendant. As to each warning plaintiff alleged defendant should have provided, the surgeon testified he was unaware of the risk and that had he known it would have changed his decision to use the device. Id. at *26-32. Not great, but it happens.
The inadequacy ruling is a bit more unusual but not unheard of. It appears to be undisputed that the warnings that accompanied the device included erosion, inflammation, pain during intercourse, scarring and extrusion – the very injuries plaintiff alleged she suffered. Id. at *20. Defendant argued, rightfully we believe, that its warning was therefore adequate as a matter of law and that it discharged its duty by warning surgeons of these risks. The court, however, held that a manufacturer can be liable for not including specific warnings about the rate and severity of the complications. Id. at *21-23. The implication of that ruling – warning of all of the risks themselves is not enough — is problematic. While we’ve seen it before, we’d prefer it didn’t get any further traction.
One other note on causation. On failure to warn of the risks of polypropylene, plaintiff proffered testimony from two experts. Neither, however, testified directly that the material in question actually caused plaintiff’s injuries. Instead of striking the claim, the court allowed the jury to “infer” causation and held that it “must give the plaintiff the benefit of every legitimate inference that can be drawn from the evidence.” Id. at *32. While a different ruling on this one piece of the case wouldn’t have had much effect here, again the concern is future impact.
Finally, the court refused to set aside the award of punitive damages. The important aspect of the ruling here is its evasion of Georgia law that regulatory compliance precludes punitive damages (“A plaintiff ordinarily cannot show by clear and convincing evidence that a defendant who complied with federal and industry standards is culpable under the Georgia punitive damages statute.”).
Id. at *33-34. Despite acknowledging that standard, the court goes on to disregard it and essentially hold that regardless of compliance, punitive damages can be awarded where “there is other evidence of culpable behavior.” Id. at *35. Here, we simply think the court got it wrong.
All in all, both the rationale and the tone of this opinion are problematic. While many aspects of the decision could be limited by the facts of the case, all of us litigators love a good sound bite — and this decision provides some for our opponents.