We like juries. Jurors give us their time and attention, sometimes for weeks or months at a time, and they receive little or nothing in terms of tangible benefit in return. The vast majority take the task seriously and give us their best on topics that are at once human and very complex. We sometimes embrace their results, and sometimes we appeal from them or move to set them aside, but either way we respect the process without reservation.
Not every issue, however, is best left to juror discretion, and juries require guidance, mainly in the form of instructions on the law and rulings on the evidence. The former provides a proper legal referent against which to render a verdict. The latter regulates the information they receive so they consider material that is relevant and helpful, and not information that is misleading, improper, or tends to show nothing of consequence to the issues in the case. And the court should provide a necessary check against jury discretion with its power to decide issues as a matter of law and grant new trials.
Juries operating outside these parameters might not come to fair results, through no fault of their own, and we think that is what went wrong in Cox v. KLS Martin, L.P., 2013 U.S. Dist. LEXIS 114708 (W.D. Mo. Aug. 14, 2013). As with many bloggable cases, the facts provoke sympathy. Cox involved an implanted medical device known as a mechanical intraoral distracter, which was used as intended to treat Pierre Robins Sequence, a rare disorder in which an infant’s lower jaw is underdeveloped. As the court described it, mandibular distraction involves cutting through bones on both sides of the patient’s mandible behind the molars and securing a mechanical intraoral distraction device to both sides of each cut. By then turning an activation mechanism, each distractor slowly separates the bone sections, allowing the formation of new bone. Id. at *1-*2.
Cutting gaps in a baby’s jaw bone and implanting a mechanical stretcher? The Drug and Device Law Parents shudder at the thought, but the alternative of no treatment at all is much worse—the child’s tongue can retract within his or her underdeveloped mandible and cause choking. This weighing of benefits and potential risks is an ever-present theme in virtually every case we deal with, and the Cox case is no exception. Apparently, the implanting surgeon (and the order is a little fuzzy on these facts) bent the device improperly during the procedure, and nine days later, "the distal fixation plate on the right side separated from the distractor body at the post-plate welded connection." Id. at 2. We think that is a long way of saying that the device came apart at the weld while implanted.
The parents sued the product manufacturer stating product liability claims under Missouri law, and a jury returned a verdict in their favor. Like we said before, we like juries. We really do. But based on the court’s order denying the manufacturer’s post-trial motions, the court left far too much to the jury’s discretion, resulting in a judgment that is difficult to understand.
To begin with, the jury was allowed to decide in its unfettered discretion whether the product was "unreasonably dangerous" and, thus, defective in design. Many states define a defective product by one reference or another to the "unreasonably dangerous" language found in Section 402A of the Restatement (Second) of Torts, and most define that term for the jury’s benefit. But not Missouri. Under Missouri’s version of strict product liability, "the concept of unreasonabl[e] danger, which is determinative of whether a product is defective in a design case, is presented to the jury as an ultimate issue[ ] without further discussion. Id. at *4. The jury then "gives this concept [unreasonable danger] content by applying their collective intelligence and experience to the broad evidentiary spectrum of facts and circumstances presented by the parties." Id.
It is entirely unsatisfactory, in a case involving an implanted medical device with known and warned-of risks, for state law to just kick it to the jury to decide, without direction, whether the product is defective. The Cox verdict demonstrates why. The jury found that the mechanical intraoral distracter was "unreasonably dangerous," but what was the evidence to support that finding? The device broke and caused an injury. The court put it this way:
Although there was evidence to support Defendant’s position that the device was not unreasonably dangerous, there was also evidence to the contrary—the device broke, caused a second surgery, and prolonged the lengthy and painful distraction process—and a legitimate factual dispute should not be resolved as a matter law.
Id. at *5.
This kind of reasoning drives us nuts. The mere fact that a product failed and caused an injury should never be sufficient to establish that it was defective. Strict liability is not absolute liability, and product manufacturers are not insurers of their products against known risks, which are inherent in every medical product. Moreover, the "it broke so it must be defective" reasoning highlights the Achilles heel of our tort system: If a medical device is used to treat 10,000 patients, and it fails in one, those are exceptionally good odds. The jury trial, however, revolves around the misfortunes of the one and leaves the jury with an incomplete and skewed view of the product’s benefits and risks. The Cox order refers to a doctor’s testimony without elaborating, so perhaps there is more to the evidence than meets the eye. From our angle, this resembles a design defect claim that should not have gone to the jury.
The Cox order presents a similar story on the parents’ warnings-based claims. As you might expect, it is a known risk that a medical device designed to apply mechanical force can break when bent, and the manufacturer appears to have warned of this risk. The order is a little fuzzy on these facts too, but the manufacturer apparently warned against bending the device, and the risk that it might break. The surgeon even said that he received the warning, testifying that "Yes, they have told us from the very beginning that if you bend a plate excessively, you would break them or snap them off, so we are very aware it." Id. at *10-*11.
The defendants therefore challenged the verdict on the basis that the warnings were adequate, that additional or other warnings would not have altered the physician’s behavior (i.e., no warnings causation), and that plaintiffs introduced no expert opinion otherwise. The court, however, again punted to the jury and explained at some length that expert testimony was not required. The court acknowledged Missouri authority requiring expert testimony to prove a failure-to-warn case, but dismissed that authority as holding only that expert testimony was required in cases involving complex issues outside the common knowledge of jurors. Id. at *6-*7.
We think the result is wrong here, too. Instructions and warnings that accompany implanted medical devices present complex issues, and they are directed to medical professionals, not lay jurors. As we have said before, because warnings must be adequate as to the physician, a plaintiff (who bears the burden of proving a warning is inadequate) must present the testimony of a physician with an opinion that the warning wasn’t good enough, and most courts to address the issue have so held. In Cox, the Court nonetheless ruled that the "jury was capable of determining whether [the] warning was adequate to inform [the surgeon] that the device may be damaged if care was not taken during the manipulation process." Id. at *8. Capable based on what? The jurors’ "collective intelligence and experience" with mechanical intraoral distracters? Their experience using such devices during the "manipulation process," or any other process? Even applying Missouri’s general rule as the court stated it, we cannot see how the adequacy of the warnings was within this jury’s common knowledge such that expert testimony was not required.
On warnings causation—one of our favorite topics—the manufacturer emphasized evidence that the surgeon was aware of the manufacturer’s warning against bending the product and knew not to bend it excessively. Evidence of that nature should sever the chain of causation because an alleged failure to warn cannot cause an injury when the physicians already knew about the risk. The Court, however, managed to uphold the jury’s verdict on this finding too because, although the surgeon knew about the "general danger" that bending the product could result in breaking at the welds, he was not aware of the "specific danger" of bending the device during a particular phase of the procedure, the cutting process.
The court’s explanation splits hairs:
[The surgeon] may have been aware of the general danger to the device—that the welds could break or snap off if the plates were bending excessively during the bending procedure before implantation—but the testimony does not demonstrate that [the surgeon] was clearly aware of the specific danger that the welds could fail after implantation if the plates were inadvertently bent during the cutting procedure.
Id. at 11. Okay. But we still do not see how reference to a "specific" bending danger tends to prove that the surgeon would have made any different treating decision if he had been warned more "specifically" about bending during one part of the procedure. Missouri follows a heeding presumption—another of our favorite topics. But the surgeon testified that he was aware of the warning and knew not to bend the plate excessively. Id. at *10-*11. Whatever the heeding presumption entails, that testimony should have rebutted it. The court, however, saw it differently. Id. at *10. The result was that the jury received a warnings case where the manufacturer warned about the risk and where the implanting surgeon knew about the risk, and seemingly never said he would have acted differently had he been warned more "specifically" in any event. Again, there probably was more to the evidence than disclosed in one short order, but the result still does not sit right with us.
This case strikes us as one where the jury deserved more. Implanted medical devices are not power saws, and the complex issues in Cox called for more instructions and expert testimony to help this jury come to the right result. They received neither.