We understand the value of branching out and trying new things. Recently, a close companion prevailed upon us to try calamari (thumbs down). We signed up for a Zoom acting class during the pandemic. And we are seriously considering a “new” hair color, to take advantage of the natural phenomenon that has occurred during the past thirteen months. But sometimes it is satisfying to do the same thing over and over again. One year, we returned five times to see a relatively obscure Broadway show. We order green curry every single time we eat Thai food. And we will happily report on every good “warnings causation” decision that comes down the pike. (Witness this post and this post and this post and this post.)
As most of you know, a plaintiff asserting a failure-to-warn claim bears the burden of proving both that the defendant’s warnings were inadequate and that the inadequate warning proximately caused her alleged injuries. In a prescription drug or medical device case, in most jurisdictions governed by the learned intermediary rule, a plaintiff satisfies her burden of proving causation by adducing evidence that a different or stronger warning would have altered her doctor’s decision to prescribe the drug or device. In the absence of such evidence, if the judge applies the standard correctly, the defendant is entitled to summary judgment. (There are wrinkles: some jurisdictions muddy this standard by accepting evidence that the stronger warning would have caused the doctor to warn the plaintiff differently, stopping short of requiring evidence that the warning would have changed the doctor’s decision to prescribe the product.)
The exceptions are jurisdictions that apply a “heeding presumption.” In its strongest form, the heeding presumption creates a rebuttable presumption that a doctor would have read and heeded an adequate warning. Once the plaintiff demonstrates that the warning was inadequate, the presumption kicks in and the burden shifts to the defendant to adduce evidence that rebuts the presumption. Needless to say, we hate heeding presumptions. We think it skates close to a due process violation to shift the burden of proving an essential element of a substantive claim on the strength of a presumption based on sheer speculation. Today’s case, Zember v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 52878 (E.D. Wisc. Mar. 22, 2021), turned on whether or not the plaintiff was entitled to a heeding presumption and on how that affected the “warnings causation” analysis.
In Zember, a pelvic mesh case remanded from the mesh MDL, the plaintiff was implanted with the defendant’s mesh device to treat her stress urinary incontinence. On her master complaint, she checked off eighteen (eighteen!) claims she was pursuing against the defendant, including all manner of product liability, warranty, and fraud-based claims. The defendant moved for summary judgment on many of the claims. The plaintiff responded only to the arguments addressing the strict liability failure-to-warn claim. (The court granted the unopposed portions of the motion.)
With respect to the failure-to-warn claim, the defendant did not argue that the defendant’s warnings were inadequate, skipping to the causation element of the claim. As a threshold matter, the court acknowledged that, while Wisconsin had not formally adopted the learned intermediary doctrine, the Seventh Circuit had predicted that the Wisconsin Supreme Court would adopt the doctrine. “Thus,” the court stated, “[we] will proceed as though the learned intermediary doctrine applies under Wisconsin law.” Zember, 2021 U.S. Dist. LEXIS 52878 at *9 n.4. As the court described the relevant test, a Wisconsin plaintiff must establish causation by proving that a proper warning would have caused the doctor to alter his behavior and would have prevented the plaintiff’s injury. Id. at *11.
The defendant argued that the plaintiff had adduced no evidence that her doctor would not have implanted the mesh device if a stronger warning had accompanied the device. In opposition, the plaintiff first invoked the “neglectful mesh plaintiff’s lament,” arguing that she hadn’t had the “opportunity” to depose her implanting physician because he had “been out of the country.” The court responded with a figurative eye-roll, noting that the case had been pending since 2012 and that it “came from the MDL court with specific instructions that discovery not be permitted to continue.” Id. at *11-12.
Next, the plaintiff argued that the court should apply a heeding presumption; in other words, a presumption that the doctor would have heeded an adequate warning and would have changed his prescribing decision based on the warning. Id. at *12. The court explained that Wisconsin courts had not spoken to the applicability of a heeding presumption to failure-to-warn claims involving medical devices but that the Seventh Circuit had expressed “serious doubt” that Wisconsin would adopt the presumption in this context (and that Wisconsin had rejected the presumption in other contexts). The court concluded,
The Court will not apply a presumption that [the doctor] would have heeded an adequate warning if he had been provided one. Plaintiffs cannot make a showing of causation as they have not procured any testimony from [the doctor] that he either relied on the warning provided or would have acted differently if given an adequate warning. Thus, Plaintiffs have not raised a genuine dispute as to causation, and the Court will award summary judgment to Defendants” on the failure-to-warn claim.
Id. at *13. We love this decision. We are delighted that the court added weight to the “no heeding presumption in Wisconsin” conclusion. And we are pleased that the court understood and applied the correct burden of proof to the causation element of the failure-to-warn claim. We never get enough of courts getting this stuff right, and we hope we can bring you more examples. In the meantime, stay safe out there (and try the green curry).