There has been plenty of press coverage over the wave of lawsuits, in Wisconsin and elsewhere, against manufacturers of opioid pain medications. While the sheer volume of these lawsuits and the attention they have garnered in Congress may result in some type of global settlement and/or legislative changes, the question of whether these cases can ultimately survive the manufacturer’s inevitable legal challenges is currently unanswered. But the manufacturers’ legal position got a proverbial “shot in the arm” when the Seventh Circuit recently affirmed the District Court’s decision in the In re Zimmer Nexgen Knee Implant Products Liability Litigation.
In what was described by the Reed Smith law firm as “the best Wisconsin law decision we have ever seen,”1 the District Judge in the Zimmer Nexgen multi-district litigation issued a summary judgment order in October 2016 that found the learned intermediary doctrine is the law in Wisconsin. A copy of that decision can be found here. Under this rule, the manufacturer or supplier of a prescription drug – or, as in Zimmer Nexgen, a medical device designed for surgical implantation – has no duty to warn the patient receiving the drug or device as long as the manufacturer provides adequate warnings to the prescribing physician. No Wisconsin appellate court has directly addressed this issue, making it one of only two states (the other being South Dakota) where the highest court or the intermediate appellate courts have not adopted the doctrine in some form. On March 8, 2018, the Seventh Circuit affirmed that order, causing Reed Smith to proclaim that its opinion “now inherits the mantle of ‘Best Wisconsin Law Decision We’ve Ever Seen’."2 A copy of that decision can be found here.
On appeal, the plaintiff in Zimmer Nexgen raised warnings claims and argued that the manufacturer failed to adequately warn both the plaintiff and his surgeon. The Seventh Circuit agreed with the District Court and dismissed the plaintiff’s failure to warn claim based on the learned intermediary rule:
In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so. Accordingly, to the extent that [the plaintiff’s] defective-warnings claim is based on [the manufacturer’s] duty to warn him, it is foreclosed by the learned-intermediary doctrine.
The Seventh Circuit also rejected plaintiff’s argument that the manufacturer failed to adequately warn the surgeon, because this surgeon testified he relied exclusively on his education and training, not on any materials from the manufacturer, when he decided what device he would implant into the plaintiff and how he would do it.
And as if that weren’t enough good news for the manufacturer, the Seventh Circuit also rejected the plaintiff’s warnings claims on causation. Because the surgeon did not read the instructions for use and therefore could not have been affected by a different warning, the plaintiff urged the Seventh Circuit to apply a “heeding presumption.” This is another doctrine that creates a presumption in the absence of proof that the doctor would have read and heeded a proper warning. Again, Wisconsin appellate courts have not addressed the heeding presumption but the Seventh Circuit concluded: “We seriously doubt that they would adopt it in this context.”
We fully expect the learned intermediary doctrine and the heeding presumption to play important roles in the opioid litigation. The decisions in the Zimmer Nexgen litigation suggest it will be much more difficult for plaintiffs to ultimately prevail on their claims, at least those that are premised on a failure to warn.
Questions about this client alert, and about the Zimmer Nexgen case, should be directed to Paul Benson.
 http://www.jdsupra.com/legalnews/probably-the-best-wisconsin-law-14966/ (November 1, 2016).
 http://www.jdsupra.com/lgealnews/the-best-wisconsin-law-decision-we-ve-71714/ (March 21, 2018).