One of the few states where there is any doubt about the applicability of the learned intermediary rule is Wisconsin. That’s primarily because the rule has never been addressed (one way or the other) by any Wisconsin state appellate court. The Wisconsin cases applying the rule have been federal district courts applying Wisconsin law. See Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999) (applying Wisconsin law); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999); and Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963 (D. Wis. 1981), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981).
We’ve recently learned that a Wisconsin state trial court followed the learned intermediary rule in a fairly extensive opinion. We’d give a shout out to our source, but then we’d have to complain about how the opinion was kept under wraps for a decade. We, of course, sent that along to Westlaw, so now it has a citation. Straub v. Berg, 2003 WL 26468454 (Wis. Cir. Jan. 6, 2003).
That being accomplished, we pass it along to our readers, in the event they have any litigation under Wisconsin law. Straub is another case alleging that a drug caused the plaintiffs’ decedent to commit
suicide. These are not easy cases for plaintiffs to win, and Straub was no exception. Plaintiffs did manage to stave off summary judgment under the defendant’s first argument, that suicide was an ipso facto superseding cause, due to facts that did not “foreclose the possibility” that the drug could have “create[d] a mental condition capable of resulting in behavior manifested by uncontrollable impulses.” 2003 WL 26468454, at *6. Maybe later, once all the facts are in, this could be ruled on as a matter of law, but not yet. Id.
Yes! Pagination in WL trial orders! At least going forward.
That’s when the learned intermediary rule rode to the rescue. Liability would have to be based on warnings of this alleged inherent drug risk, but such warnings, where the drug is by prescription only, go to prescribing doctors, not patients:
Although Wisconsin courts have not addressed the application of the learned intermediary doctrine, courts of numerous other jurisdictions almost universally hold that in the case of prescription drugs, a manufacturer’s provision of proper warnings to a prescribing physician will satisfy the manufacturer’s duty to warn since the patient cannot obtain the drug except through the physician.
Id. at *6 (citing Lukaszewicz). So there it is.
And in Straub, the rule was dispositive. The label, right on its face, warned of “depression” (in its own paragraph) as well as mood changes and malaise. Discontinuation and seeing one’s doctor were recommended. Id. at *7. That was exactly the condition plaintiffs alleged in the complaint. Id. Plaintiffs responded with a flurry of hearsay documents, most of which were irrelevant to the prevailing state of the art because they post-dated the suicide in the case, and some of which involved foreign regulatory matters. Id. None was admissible evidence:
Plaintiffs’ submissions . . . offer no admissible factual basis to support their argument that [defendant] failed to advise treating physicians of the severity of the risk of depression, that is,
that it could induce a depression so severe that it could lead to suicidal thoughts, attempts and suicide.
Plaintiffs’ final Hail Mary in Straub also failed. Plaintiffs advocated the direct-to-consumer exception to the rule (although how that would have changed anything is unclear). In any rate, the court found no basis for it. “This exception has been addressed by only a few jurisdictions.” Id. at *7. Moreover plaintiffs did “not allege that [the drug] was advertised directly to consumers and their submissions fail to provide any evidence that [it] was directly marketed to consumers.” Id. Summary judgment granted on the basis of the “learned intermediary doctrine defense.”
Now, we know and you know that the learned intermediary rule is not a “defense” in the sense that the defense beard the burden of proof, only in colloquial terms is it a defense in that it provides, as in Straub, a basis for our side to prevail, but with that nit, we’re happy with the decision.
There doesn’t seem to have been any appeal. Anyway, Straub is another piece on the Wisconsin board for the good guys concerning the learned intermediary rule. May there be more.