Regular readers know that, after receiving a useful guest post on Iowa learned intermediary law, we asked our readers if they would like to prepare similar detailed arguments in favor of the LIR for other states in which there was no state-court appellate law. Here is one for Wisconsin. It’s authored by three attorneys from Maslon LLP, Stephanie Laws, Katie Maechler, and Jeremy Krahn. Anybody planning to assert the LIR in Wisconsin should definitely study this post. There is material that only local Wisconsin lawyers likely know about. As always our guest posters deserve 100% of the credit (and any blame) for their work.
Despite being Minneapolis-based product liability litigators, we know Wisconsin. Our grandparents, aunts and uncles, and sisters-in-law are from Wisconsin. We’ve seen its cheeseheads, eaten its cheese curds, and observed its countless cow-covered hills on our treks to and from the University of Wisconsin-Madison, from where one of our authors graduated. We have jumped off its docks and eaten its Friday night fish fries. We know State Street and Mifflin Street. We once attended a Lambeau Field tailgate so cold that we thawed our beers on the grill to drink them—true story.
To know is not entirely to love. As steadfast, hopeless Minnesota Vikings fans, we often find ourselves rooting against Wisconsin, if for no other reason than to quiet the green jerseys we encounter in the office, at the grocery store—everywhere. We hope the Packers become immunized against another Superbowl run. We do not like Aaron Rodgers, although we wish him well.
Notwithstanding this rivalry, as product liability defense attorneys, we can’t help but cheer for Wisconsin when it comes to its potential adoption of the learned intermediary doctrine. Wisconsin is one of ten remaining jurisdictions without state-court appellate authority recognizing the learned intermediary rule in prescription medical product cases. Yet Wisconsin has recently made it to the red zone, and may soon cross the goal line, with the Wisconsin Court of Appeals’ forthcoming decision in Rennick v. Teleflex Med. Inc., fully briefed in early 2021, which will hopefully—and finally—make clear that Wisconsin adopts the doctrine, as consistently predicted by Wisconsin federal courts since 2016. But until and unless it does, this blogpost provides a playbook for navigating the doctrine before a Wisconsin court.
Until recently, Wisconsin’s recognition of the learned intermediary doctrine was hotly contested, with courts applying the doctrine, holding Wisconsin explicitly did not adopt the doctrine, or declining to apply it in the absence of a clear mandate. Compare Monson v. Acromed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999) (applying the doctrine), with Maynard v. Abbott Labs., 2013 WL 695817, at *5 (E.D. Wis. Feb. 26, 2013) (“Wisconsin does not apply the learned intermediary doctrine.”), and Forst v. SmithKline Beecham Corp., 602 F. Supp. 2d 960, 968 (E.D. Wis. 2009) (declining to apply doctrine absent adoption by the Wisconsin Supreme Court).
That changed in October 2016, when the Northern District of Illinois issued the Zimmer opinion—recognized by loyal readers of this blog as “the best Wisconsin law decision ever”—which carefully parsed Wisconsin case law regarding the doctrine in the context of plaintiffs’ failure-to-warn claims against the manufacturer of a prosthetic knee implant, and unequivocally predicted the Wisconsin Supreme Court would adopt the rule. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., 218 F. Supp. 3d 700, 727–28 (N.D. Ill. 2016). In doing so, the Court explained the crucial role of a knowledgeable intermediary in a patient’s decision to use an implantable medical device:
[A] patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks—based on the patient’s particular circumstances and physiology—that accompany the selected implant or [knee-replacement] surgery in general.
Id. at 727. The Zimmer court distinguished caselaw declining to apply the learned intermediary doctrine under Wisconsin law, noting it involved “prescription drugs, not medical devices.” Id.
Unable to leave bad enough alone, the plaintiffs appealed their summary judgment loss and challenged the district court’s application of the doctrine. The Seventh Circuit affirmed in March 2018, issuing the new Best Wisconsin Law Decision Ever. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., 884 F.3d 746 (7th Cir. 2018). The Seventh Circuit pointed to the doctrine’s “broad support in other jurisdictions” in both the medical device and prescription drug contexts, and noted “[t]he justification for adopting the learned-intermediary doctrine in cases involving prescription drugs applies even more forcefully in cases involving surgical implants” where physicians generally play a larger role in facilitating access. Id. at 751–52.
Since the Zimmer opinions, every Wisconsin federal court to consider the learned intermediary doctrine has adopted their well-reasoned analysis. See, e.g., Reynolds v. C.R. Bard, Inc., 2021 WL 4193199, at *9 (W.D. Wis. Sept. 15, 2021); Johnson v. C.R. Bard Inc., 2021 WL 1784661, at *7 (W.D. Wis. May 5, 2021); Zember v. Ethicon, Inc., 2021 WL 1087041, at *4 n.4 (E.D. Wis. Mar. 22, 2021); Tzakis v. Wright Med. Tech., Inc., 2020 WL 955016, at *5 (W.D. Wis. Feb. 27, 2020); Karnes v. C.R. Bard, Inc., 2019 WL 1639807, at *7 (W.D. Wis. Apr. 16, 2019). Interestingly, every one of these involved a prescription medical device.
Despite this abundant federal case law, no Wisconsin appellate court yet has addressed whether Wisconsin will adopt the learned intermediary doctrine. See Tzakis, 2020 WL 955016 at *5 n.3 (“Wisconsin appellate courts have still not considered the doctrine’s application, which leaves this court with no guidance beyond Zimmer.”). That wait may soon be over.
Wisconsin’s adoption of the learned intermediary defense is presently teed up before the Wisconsin Court of Appeals in Rennick v. Teleflex Med. Inc. In Rennick, a patient and physician, sued Teleflex Medical, Inc., a manufacturer of surgical clips, alleging the clips used in his kidney surgery migrated, causing post-surgical complications and injuries. Tr. of Oral Decision Granting Def.’s Mot. for Summ. J. at 5–9, Rennick v. Teleflex Med. Inc., Case No. 2018-CV-003317 (Wis. Cir. Ct. Oct. 13, 2020) (Doc. 129). Teleflex moved for summary judgment on all claims, including failure-to-warn theories, arguing in part that, because it was only required to warn plaintiff’s implanting physician, and given the implanting physician’s testimony that he would have used the clips even if warned of the migration risk, plaintiff could not establish causation. Id. at 12–24.
The trial court extensively analyzed the Seventh Circuit’s holding in Zimmer, agreed with its prediction that the “[Wisconsin] Supreme Court itself would indeed adopt the doctrine,” and determined “that the doctrine is applicable and therefore should be applied in this case.” Id. at 14–24. Despite the lack of warnings regarding migration, the trial court concluded there was no evidence in the record that the implanting physician would have altered his prescribing decision or use of the clips had such warnings been provided. Id. 30–31. It also rejected the plaintiff’s argument for a heeding presumption, concluding “there’s no factual basis . . . in the record for the Court to find that [the implanting physician] would have heeded any warning had it been provided and had he reviewed it.” Id. at 30. Much like Zimmer, the trial court found the implanting physician did not rely on the instructions for use, but rather on his own experience and training in prescribing and utilizing the device. Id. at 24; see Zimmer, 884 F.3d at 753–54. It then granted Teleflex’s motion for summary judgment on each of plaintiff’s claims, reasoning that plaintiff could not establish causation. Tr. of Oral Decision Granting Def.’s Mot. for Summ. J. at 33.
Plaintiff appealed, as plaintiffs do. In his briefing, the plaintiff-appellant noted that Wisconsin had not adopted the learned intermediary doctrine, and argued it would not adopt the doctrine in the way the trial court had applied it—claiming the doctrine could only apply where the manufacturer had actually provided adequate warnings to the implanting physician, which appellant characterized as a “factual prerequisite” to the defense. Br. of Pl.-Appellant at 25–28, Rennick v. Teleflex Med. Inc., Case No. 2020-AP-001454 (Wis. Ct. App. Dec. 11, 2020), 2020 WL 7672906, at *25–28. For its part, the defendant-respondent characterized the appellant’s argument as not challenging the doctrine’s adoption, and argued the doctrine should apply given the implanting physician’s testimony that he would have used the clips even if provided with different warnings. Br. Def.-Resp’t at 15–21, Rennick v. Teleflex Med. Inc., Case No. 2020-AP-001454 (Wis. Ct. App. Jan. 11, 2021), 2021 WL 248621, at *15–21. The full appellate briefing, which was completed early in 2021 and discusses the trial court’s oral opinion at length, is available on Westlaw. See Br. of Pl.-Appellant, 2020 WL 7672906; Br. of Def.-Resp’t, 2021 WL 248621; Reply Br. of Pl.-Appellant, Rennick v. Teleflex Med. Inc., Case No. 2020-AP-001454 (Wis. Ct. App. Jan. 26, 2021), 2021 WL 413945.
In addition to the Zimmer opinions and Rennick, which rely on the physician’s gatekeeper role in prescription medical product cases, there are additional compelling reasons for Wisconsin to adopt the learned intermediary defense. Most notably, its adoption is consistent with Wisconsin’s well-established sophisticated user defense, which “impos[es] no duty to warn if the user knows or should know of the potential danger, especially when the user is a professional who should be aware of the characteristics of the product.” Haase v. Badger Mining Corp., 669 N.W.2d 737, 743 (Wis. Ct. App. 2003) (internal quotations omitted), aff’d, 682 N.W.2d 389 (Wis. 2004). The premise underlying the sophisticated user doctrine is similar to that underlying the learned intermediary doctrine—it contemplates a level of knowledge by the purchaser (i.e., the prescribing physician) who can adequately warn any end user (i.e., the patient) about the product’s risks.
Although the sophisticated user doctrine is often applied in a workplace scenario, the policies underpinning its adoption apply in equal if not greater force in the learned intermediary context: it places the duty to warn on the party in the best position to ensure safety and to communicate safety information to the ultimate user. Haase, 669 N.W. 2d at 743–44; see also Mohr v. St. Paul Fire & Marine Ins. Co., 674 N.W.2d 576, 585–85 (Wis. Ct. App. 2003) (holding the sophisticated user doctrine applies outside of workplace scenarios and applying it to a student’s claims against the manufacturer of his high school’s diving platform, reasoning the defense was “embodied” in the Restatement (Second) of Torts § 388, which Wisconsin had adopted), rev. denied (Wis. Mar. 23, 2004).
These policies are particularly applicable given Wisconsin physicians’ statutory obligation to apprise patients of the risks inherent in a proposed treatment, which both emphasizes the gatekeeper nature of the physician/patient relationship and makes further, additional warnings unnecessary. See Wis. Stat. § 448.30 (“Any physician who treats a patient shall inform the patient about the availability of reasonable alternative medical modes of treatment and about the benefits and risk of these treatments.”).
We’re Minnesotans, but we know Wisconsin. And though we’ll never back the Packers, due to Zimmer, the skilled defense counsel in Rennick, and Wisconsin’s sophisticated user doctrine, we bet the forthcoming Rennick opinion becomes the new “Best Wisconsin Law Decision Ever.”