Like most of you, and like our co-bloggers (from whom you will hear similar laments this week) we are in the midst of "social distancing." We have locked down our home, begun an indefinite period of working remotely, ordered a case of boxed macaroni and cheese, and fielded emails cancelling an inordinate number of long-awaited events. The final straw was the not-unexpected cancellation of the Philadelphia stop on Jane Goodall's lecture tour. The tour, entitled "Gombe: 60 Years of Discovery" commemorates Dr. Goodall's 60 years of studying wild chimpanzees at her Gombe Stream Research Center in Tanzania. We have revered Dr. Goodall for many of those years. As an untrained 23-year-old secretary, Jane Goodall telephoned Dr. Louis Leakey and told him she wanted to study great apes. And the rest truly is history. We are – and always have been – in awe. (At one point, we could recite the family trees of the key groups of Gombe chimpanzees.) It would be an understatement to say that we were overjoyed to have tickets to see Dr. Goodall in person for the first time. And now, like everything else, it is cancelled.
This too shall pass, and such disappointments obviously must take a back seat to much larger global health concerns. We look forward to speaking of all of this in the past tense. In the meantime, we will look for glimmers of positivity, in life and in jurisprudence. Today's case is such a glimmer.
Regular readers will recall that our last post bemoaned a dismal warnings causation decision out of the Eastern District of Pennsylvania. Lest you conclude that no one ever gets this right, we give you In re Taxotere (Docetaxel) Prods. Liab. Litig. (Kelly Gahan), 2020 WL 1830851 (E.D. La. March 3, 2020), a case out of the Taxotere MDL. The plaintiff, an emergency room physician, took the defendants' cancer medication when she was diagnosed with breast cancer. She asserted the usual product liability claims, including failure to warn, alleging that the drug caused permanent alopecia (hair loss).
The defendants moved for summary judgment (Colorado law applied to the plaintiff's substantive claims) arguing that, under the learned intermediary doctrine, the plaintiff could not meet her burden of proving that any inadequacy of the defendants' warnings proximately caused her alleged injuries, because her prescribing physician would not have changed her decision to prescribe the drug even if the warning had been different.
In response, the plaintiff argued that the learned intermediary doctrine did not apply in the absence of a finding that the label adequately warned of the adverse event she suffered, and that the drug's label did not warn of permanent alopecia (thought the doctor had independent knowledge of this risk). As we recently have found ourselves arguing over and over, this is backwards. The learned intermediary doctrine informs the entire failure-to-warn analysis by providing that a prescription drug manufacturer has a duty to provide adequate warnings only to the prescribing physician and has no duty to warn the patient directly. Application of the doctrine does not turn on a finding that the warnings were adequate. That comes next.
The Gahan court agreed, emphasizing that it was the plaintiff's burden to prove the causation element of her warnings claims; in other words, that "an adequate warning would have changed her doctor's prescribing decision." 2020 WL 1830851 at *2. In this case, the evidence showed that three of the patients to whom the doctor had previously prescribed the drug suffered permanent hair loss, and that the doctor had read numerous relevant articles, including one that described the risk of permanent alopecia associated with the drug. The doctor shared all of this information with the plaintiff, discussed all of the pros and cons of the drug, provided the plaintiff with an alternate chemotherapy option, and ultimately left the choice up to the plaintiff. The doctor "made her prescribing decision only after several robust discussions with [the plaintiff] about her two options." Id. at *3. "It was [the plaintiff] who made the ultimate decision" to proceed with the defendants' drug "after conducting her own research." Id. Crucially, the doctor testified in her deposition that there was no label change would have changed her prescribing decision.
The court found that it could not "escape the undeniable conclusion that [the doctor] was aware of the risk of permanent hair loss and proceeded" with the drug regimen anyway. As such, the court held, the plaintiff had "failed to create an issue of fact on whether [the doctor's] prescribing decision would have changed if [the defendants] had adequately warned of the alleged risk" of permanent hair loss. Id. a *4. Summary judgment for the defendants on the warnings claims.
We love this decision. It correctly articulates the applicable burden of proof then follows through to dismiss the claim when the plaintiff cannot satisfy her burden. Trust us — this doesn't happen very often. We will continue to bring you best and the worst decisions on this issue. Meanwhile, stay safe out there. We are grateful that we can stay in touch during this time of isolation.
This article is presented for informational purposes only and is not intended to constitute legal advice.