Photo of Bexis

A few years ago we did a couple of posts about the learned intermediary decision that arose from the Zimmer Nexgen Knee Implant MDL, and was subsequently affirmed by the Seventh Circuit Court of appeals.  We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation, 218 F. Supp. 3d 700 (N.D. Ill. 2016), “Probably the Best Wisconsin Law Decision We’ve Ever Seen.”  Then we described In re Zimmer, NexGen Knee Implant Products Liability Litigation, 884 F.3d 746 (7th Cir. 2018), as “The Best Wisconsin Law Decision We’ve Ever Seen, Affirmed.”  We did so because Wisconsin was, at the time, one of the few states – and by far the largest – with no appellate precedent adopting the learned intermediary rule.  The Nexgen litigation changed all that.

Fast forward to last year and we invited our readers with focused state-law practices to submit guest posts on how the learned intermediary rule stood in all the states where there was no state court appellate decision adopting the doctrine.  We did that because, while federal precedent is good, the learned intermediary rule is ultimately a proposition of state law so that state court decisions take precedence.  We received responses for Iowa, South Carolina, and Wisconsin (BTW, we’re still looking for guest posts on Idaho, the Dakotas, three of the smaller New England states and Puerto Rico).

The Wisconsin guest post let us know about a pending decision that – we all hoped – would take that state out of the “no state appellate precedent” category altogether:

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.

That was precisely the kind of on-the-ground information we had hoped for from this kind of guest post from local practitioners familiar with the lay of a particular state’s legal landscape.

Well, Rennick has now been decided and, continuing with the football analogy of our guest posters, it turned out to be a meaningless exhibition game that, in some way advanced the ball, but at one critical point fumbled it away out of bounds.  See Rennick v. Teleflex Medical, Inc., 2022 WL 1016686 (Wis. App. April 5, 2022) (per curiam).

The plaintiff in Rennick claimed injury from alleged migration of the defendant’s surgical clip.  Id. at *1.  The warning/learned intermediary issue arose because the defendant’s implanting surgeon “would not have altered his decision to use the clips had [defendant] provided a warning . . . about a risk of clip migration,” to which plaintiff responded “that the learned intermediary doctrine did not apply.”  Id. at *2.  Plaintiff relied upon a variety of materials concerning the risk of clip migration, and his own affidavit that “he would have altered his behavior to avoid his injuries had he known about the risk.”  Id.  The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.”  Id. at *3.  The surgeon’s testimony supported two grounds for non-causation:  lack of reliance, and that a warning would not have changed how the prescription product was used.

[Defendant] point[ed] to deposition testimony from [the prescribing surgeon] that he learned the [relevant medical] technique, not from anything [defendant] provided, but by reading medical literature and learning the technique from other physicians.  [Defendant] further supports its argument saying that [the prescribing surgeon] indicated that he would still have used the clips if he had received a warning about the risk of migration because of the overall positive experience he has had and the inability to perform this type of surgery without the clips.

Id. at *4.

The Wisconsin guest post thought that the applicability of the learned intermediary rule was squarely before the appellate court in Rennick, and given the above description of the case history, we would have thought so, too.  But the Rennick decision stated that it was not deciding this issue.  “We need not address the adoption of this doctrine in Wisconsin because we conclude that it does not apply to the facts of this case.”  Id. at *4.  To carry off that dodge, Rennick created a limitation on the learned intermediary rule that has been adopted exactly nowhere else – that it only applies in cases of inadequate, as opposed to absent, warnings:

[T]he doctrine applies when the manufacturer has “inform[ed] the prescribing physician” of the risks associated with its product.  See [Zimmer Nexgen, 884 F.3d] at 751.  Here, it is undisputed that [defendant] provided no warning of any sort of the risk. . . .  Having provided no warning about this risk of migration, [defendant] has not met the threshold requirement for the application of the learned intermediary doctrine.

Rennick, 2022 WL 1016686, at *4 (no citations omitted).

We included that unusual citation parenthetical because the critical statement – that “no warning” precludes the learned intermediary rule – is completely unsupported in Rennick, and we would add, unprecedented.  Rennick simply made something up to avoid deciding the main issue being presented.  Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. at *3 – which means, as we’ve discussed before, a manufacturer cannot include warnings about such off-label uses absent specific FDA approval.

Even then Rennick’s rationale didn’t do a very good job.

We’ve seen a lot of distinctions/exceptions concerning the learned intermediary rule – Section 2.03 of Bexis’ book goes through just about every learned intermediary rule wrinkle known to man, but not this one (we searched it thoroughly).  One certainly doesn’t find this distinction at the Zimmer Nexgen language that Rennick cited.  The full sentence there reads:  “The [learned intermediary] doctrine holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risks by informing the prescribing physician of those risks.”  884 F.3d at 751.  Nothing about what does or does not “inform” prescribers.

That would-be distinction between no warning and an inadequate warning is as illogical as it is unprecedented because, as Rennick itself stated, the doctrine is “an exception to this general rule” that manufacturers “ha[ve] a duty to warn consumers directly.”  2022 WL 1016686, at *4.  Whether the learned intermediary rule applies turns on “who” rather than “what.”  The doctrine doesn’t depend on what, if anything, the defendant conveyed to the physician – only that an intermediary physician was present to be told whatever information was at issue.  While adequacy what satisfies the defendant’s duty; it has no bearing on whether the duty exists in the first place.  Cases on this point are legion.  Here’s a recent example:

[E]ven when warnings are assumed to be deficient, in the context of prescription products, the analysis always relies on the impact of a hypothetical stronger warning on the physician.  After all, because the adequacy of warnings is always challenged in failure-to-warn claims, if the learned intermediary doctrine became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate. . . .  We thus conclude that the district court correctly relied on the learned intermediary doctrine to analyze the claims.

Himes v. Somatics, LLC, 2022 WL 989469, at *1-2 (9th Cir. April 1, 2022) (applying California law) (emphasis added).

Moreover, the particular distinction Rennick used has no basis in the law.  See Munoz v. American Medical Systems, Inc., 2021 WL 1200038, at *2 (C.D. Cal. March 30, 2021) (“Where the learned intermediary doctrine applies, the plaintiff must prove that . . . no warning was provided or the warning was inadequate”); Ackermann v. Wyeth Pharmaceuticals, 471 F. Supp.2d 739, 747 (E.D. Tex. 2006) (rejecting distinction between “a case of no warning as opposed to an inadequate warning”), aff’d, 526 F.3d 203 (5th Cir. 2008); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *13 (D. Me. March 21, 2003) (learned intermediary rule applied, “[b]ut when an inadequate warning or no warning is provided to the learned intermediary, the manufacturer or seller has not satisfied its duty to the consumers”).  Cf. Crook v. Kaneb Pipe Line Operating Partnership, L.P., 231 F.3d 1098, 1102 (8th Cir. 2000) (“sophisticated user” doctrine may apply “when no warnings or inadequate warnings are given”) (applying Nebraska law); Petty v. United States, 740 F.2d 1428, 1438 (8th Cir. 1984) (heeding presumption case; “distinction between no warning . . . and an inadequate warning is unpersuasive”) (applying Iowa law).

This nonexistent and nonsensical distinction between “none” vs. “inadequate” warnings is where we believe Rennick fumbled the ball out of bounds.  Some advancing of the ball is implied in Rennick in that, at least in cases involving inadequate warnings, it suggests that the learned intermediary rule applies.  Finally, Rennick amounted to a meaningless preseason game because this per curiam decision is unreported, 2022 WL 1016686, at *7 (“This opinion will not be published.”) and thus not only lacks precedential value, but “may not be cited in any court of this state as precedent or authority.”  Wis. Stat. §809.23(3)(a-b).

That’s fine with us.