We are feeling happy and grateful this week. On Sunday, we were able to hug the Drug and Device Law Dowager Countess for the first time in fourteen months and to share a Mothers’ Day meal with her and our siblings, all fully vaccinated and past the waiting period. The Countess is closer to 90 than 80, and we lived in fear for her all during the past year, so we were overjoyed to reach and celebrate this milestone.
Today’s cases do nothing to dampen our mood. When last we posted, we promised to report on the second half of a group of great Taxotere decisions that came down within a couple-day period in April. As you will recall, Taxotere (in its branded form and in its generic form, docetaxel) is a chemotherapy drug used to treat breast cancer. Plaintiffs allege that the drug caused them to suffer permanent alopecia (hair loss) and that the defendant did not warn of this risk. Today’s two cases, both issued by the Eastern District of Louisiana on April 19, 2021 under the In re: Taxotere (Docetaxel) Prods. Liab. Litig. caption, relate to plaintiffs Wanda Stewart (2021 WL 1534481) and Emma Willie (2021 U.S. Dist. LEXIS 74573). Both are decisions on our favorite issue, warnings causation. Under the learned intermediary doctrine, as readers of this blog are aware, a plaintiff asserting a failure-to-warn claim against the manufacturer of a prescription drug or medical device must prove both that the warnings were inadequate and that the inadequate warning proximately caused her alleged injuries. To defeat summary judgment on proximate causation, a plaintiff must adduce evidence that a different or stronger warning would have altered her doctor’s prescribing decision.
Warnings causation decisions are plagued by minefields, with judges frequently misapplying both the standard and the burden of proof. The Taxotere court historically has added its own layer to these misadventures, routinely chipping away at the learned intermediary doctrine by considering testimony about how being counseled with proper warnings might have altered a patient’s own chemotherapy choice, when the correct analysis should focus only on the doctor’s prescribing decision. As we reported here, in one of the excellent decisions in this Taxotere foursome, the Fifth Circuit gave the back of its hand to the notion that the causation analysis should be different in chemotherapy cases, on the same day the Stewart and Willie decisions were issued. The Stewart court did not have the benefit of the Fifth Circuit’s decision, and reiterated its “chemotherapy decision-making process is unique” thesis, but it still managed to reach the correct conclusion.
Stewart involved the generic version of Taxotere. It was decided under Louisiana law, which recognizes a heeding presumption; in other words, it assumes that the doctor would have read and heeded an adequate warning if one had been provided. But the presumption may be rebutted “with evidence showing that an adequate warning would have been futile under the circumstances.” Stewart, 2021 WL 1534481 at *4. In Stewart, the court held that a “permanent alopecia” warning would have been “futile under the circumstances” for two reasons. First, the doctor testified that, because he was familiar with the branded Taxotere label, he did not remember reviewing the label for the generic version of the drug, though he was “sure [he] looked at it at one point.” He testified that, although the label was changed to include a permanent alopecia warning after Stewart was treated, he had not seen the warning. The court explained, “When a physician does not recall ever reading the label at issue, the learned intermediary doctrine requires summary judgment for the manufacturer,” id., and his assumption that he “looked at it at some point” did not alter this result. (You can read more about this issue here.)
Even leaving aside the failure-to-read issue, the doctor’s testimony established that he would not have changed his prescribing decision in the face of a “permanent alopecia” warning. The doctor testified that he considered the aggressiveness of Stewart’s cancer and that he chose her treatment regimen because it afforded her the best chance to reduce her tumor before surgery and to avoid metastatic disease. He testified that, even if the label had warned of permanent hair loss, his decision would have been the same. Finally, he testified that, “to this day, he counsels patients on hair loss the same way he did” when Stewart was treated. Id. at *4. The plaintiff argued that the doctor would have respected her opinion if she had decided not to use the drug, but she also testified that she would have followed the doctor’s recommendation for the best treatment to save or prolong her life and wouldn’t have chosen a less effective chemotherapy regime for the sake of avoiding permanent hair loss. The court concluded, “Considering this evidence, [the defendant] has demonstrated that, even with a different warning, [the doctor] would have decided on a docetaxel-containing regimen” to treat Stewart’s cancer. Id. at *5. Note that the court was applying an incorrect burden of proof here: presumption or no, the defendant should not have been required to disprove anything, since after being rebutted, heeding presumptions disappear. Instead, it was the plaintiff’s burden to adduce evidence of proximate causation to defeat summary judgment. But notwithstanding some frolics and detours, the court reached the correct result and granted summary judgment for the defendant on the warnings claim.
Willie was decided under Mississippi law, which does not recognize a heeding presumption. Nevertheless, the court’s reasoning was nearly identical to the reasoning of Stewart. The plaintiff argued that, if her doctor had been warned of the risk of permanent hair loss, he would have warned the plaintiff and she would have elected not to take Taxotere. In fact, the doctor testified that he “would probably [have told] patients that there [was] a chance that their hair might not come back.” Willie, 2021 U.S. Dist. LEXIS 74573 at *5. But “he also testified that if Willie came to him today with the same diagnosis, he would still recommend the same . . . regimen that he recommended to her years ago.” Id. at *5-6. With respect to the now-defunct “counseling” point, the court emphasized the plaintiff’s testimony that she was focused on survival and trusted the doctor’s recommendations, which undercut her argument that she would have rejected the doctor’s recommendations in order to preserve her hair. In her deposition, she even testified that she would choose “living,” even in the face of “hair loss.” Id. at *9-10. Again, no evidence of “warnings causation,” a record replete with contrary evidence, and summary judgment for the defendant.
We are hopeful that the Fifth Circuit’s decision on the counseling/“patient choice” point will enable (force?) the MDL court to reach these correct decisions in less tortuous fashion. But we’ll take the results any way we can get them. We’ll keep you posted. In the meantime, stay safe out there.