We are certain that profound revelations – scientific, economic, and political – will arise from the Covid-19 crisis. For now, we comment on bits of knowledge we have gained so far. We have learned, spending 24 hours each day with our dogs, that they bark 20 hours each day. We have learned that the concept of “mealtimes” lacks relevance. We have learned that we must read enough to be equipped to protect ourselves and our loved ones but that we need to stop reading when anxiety overtakes all else. And we have learned to look for the good news.
Regular readers of this blog will recall that we posted, a month or so ago, about a decision from the Taxotere MDL, granting summary judgment to the defendant because the plaintiff could not meet her burden of proving so-called warnings causation; in other words, she had not adduced evidence that a different or stronger warning would have altered her physician’s prescribing decision. With thanks to defense counsel Harley Ratliff for sending it to us, today’s case is another bit of good news in the same vein. In In re Taxotere (Docetaxel) Prods. Liab. Litig (June Phillips), 2020 WL 1819665 (E.D. La. Apr. 7, 2020), the plaintiff, who suffered from an aggressive form of breast cancer, again alleged that the defendant had not adequately warned that its chemotherapy drug could cause permanent hair loss. The defendant moved for summary judgment on the warnings claim.
The court reiterated that, under Louisiana law, the learned intermediary doctrine defines a prescription drug manufacturer’s duty to warn. Under the doctrine, a manufacturer has a duty to warn only the prescribing physician. A manufacturer has no duty to provide warnings to the patient – that is the physician’s job. Against this backdrop, a plaintiff must satisfy a two-pronged test to prevail on a failure-to-warn claim: she must prove both that the manufacturer’s warnings were inadequate and that “this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff’s injury.” Phillips, 2020 WL 1819665 at *2 (citation omitted). As we always emphasize (often for naught) when we brief this issue, because causation is an element of a warnings claim, it is the plaintiff’s burden to prove it – it is not the defendant’s burden to prove the absence of the causal link. To satisfy this burden, as the court explained, “the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that, but for the inadequate warning, the treating physician would not have used or prescribed the product.” Id. (internal punctuation and citation omitted).
In this case, the physician testified that there were no other adequate options for treating plaintiff’s cancer, because the other available drugs were known to be cardio-toxic. The plaintiff suffered from a preexisting cardiac condition, and she was 75 years old, and the risk of cardio toxicity is greater in patients over the age of 65. As such, the physician testified that he would not have administered the other available drugs to the plaintiff even if he had been warned that permanent hair loss was a risk associated with the defendant’s product.
On this record, the court granted summary judgment for the defendant on the failure-to-warn claim, correctly holding that the plaintiff could not satisfy her burden of proving causation. We applaud this result. We should mention that the court did go off on a “frolic and a detour” before signing off, commenting that the plaintiff had not “rebutted” the absence of warnings causation with any “evidence suggesting that she would have looked for another oncologist” had she been warned of the risk of permanent hair loss. Id. There is no room, in a correct analysis, for discussion of such “rebuttal,” because the warnings that were or were not communicated directly to the plaintiff are irrelevant under the learned intermediary doctrine. Any other conclusion would render the doctrine meaningless.
But all’s well that ends well, and this case ends with a well-deserved win for the defendant. Stay safe, and we’ll keep you posted on decisions on both sides of the “warnings causation” scale.