Photo of Rachel B. Weil

Yesterday afternoon, only a few minutes after we saw the storm warning and cut short our walk with the Drug and Device Law Little Rescue Dogs, a brief but violent thunderstorm crashed through our neighborhood in the western suburbs of Philadelphia. (We note, parenthetically, that the adjective “violent” describes our weather with unprecedented and escalating frequency – not that there is climate change, of course.) Our house was built the same year we were built, and our yard, like the rest of the neighborhood, is dotted with mature and massive trees. And we, unlike some of our neighbors, are lucky: we still can use the present tense in that sentence. Our next-door neighbors have a tree down across their back yard. Three doors down, where the family includes two tiny children, a tree crashed through the roof.   (Thank goodness, everyone is ok.) Thousands (including us, though we have a generator) remain without power a day later.

After the storm passed, we walked around the neighborhood.  Huge limbs littered the ground, many in the path we would have taken on our normal dog walk.  Which plays nicely into the theme of today’s post: in the face of a specific warning, it’s pretty hard to mount a credible claim that you weren’t warned.  A shout-out to Harley Ratliff of Shook Hardy for sending us the decision and for another great result.

We have posted previously about great warnings decisions from the Taxotere MDL, here and here.  As readers of this blog are aware, a plaintiff must satisfy two tests to prevail on a failure-to-warn claim: the plaintiff must prove that the warning was inadequate and then must prove that the inadequacy of the warning proximately caused her injuries.  Both of our recent posts dealt with the second element, “warnings causation,” a pet issue of ours in our practice and in our posts.  Today’s short but very sweet summary judgment decision doesn’t need to go beyond the first element, adequacy of the warning.

As the court explained, a label is adequate as a matter of law when it is “accurate, clear, consistent” and “conveys the unmistakable meaning as to the consequences of ingesting the drug.”  In re: Taxotere (Docetaxel) Prods. Liab. Litig., MDL No. 16-2470, 2020 WL 2747279, at *2 (E.D. La. May 27, 2020) (internal punctuation and citation omitted).  To defeat summary judgment, the court went on, the plaintiffs would need to offer expert evidence creating an issue of fact on the adequacy of the warning.

The plaintiffs in this MDL allege that the defendant’s chemotherapy drug, which they were administered to treat their breast cancer, caused them to suffer permanent alopecia (hair loss).  In 2015, the defendant updated the label to add a specific warning of this risk to the “Adverse Reactions” and “Patient Counseling Information” sections of the label and to the “Patient Leaflet.”  And every one of the 200 plaintiffs addressed by the defendant’s summary judgment motion was treated after the specific “permanent alopecia” warning was added to the label.  Slam-dunk, right?   Mixing sports metaphors, the plaintiffs tried a “Hail Mary” pass: they argued that the warning still was not adequate because it should have been included in the “Warnings and Precautions” section of the label.  As the FDA’s guidance document explains, the Warnings and Precautions section is “intended to identify and describe a discrete set of adverse reactions and other safety hazards that are serious or are otherwise clinically significant. . . .” (Emphasis in original.)

Now here’s the most fun part of the decision: the plaintiffs’ own expert, a ubiquitous plaintiffs’ regulatory mouthpiece, “repeatedly testified” that the risk of permanent alopecia should be addressed in either the ‘Warnings and Precautions’ section or the ‘Adverse Events’ section of the label: “I think in either section, as long as it . . . clearly and prominently warned of permanent hair loss, that’s what I care about.” Taxotere, 2020 WL 2747278 at *1, *3.  And so the plaintiffs attempted to backpedal.  As the court explained, rolling its eyes (as are we), “Unsurprisingly, Plaintiffs now back away from this opinions.  They aver that it [was] case-specific [in cases in which the plaintiffs’ treatment pre-dated the warning] and should not be considered along with the instant Motion.”  Id.  (In other words, the plaintiffs would have paid the expert to say something different if they realized that so many cases involved post-2015 ingestion.) The court wasn’t buying it:

The Court will not allow Plaintiffs to shield these nearly 200 cases from dismissal under this logic.  For months now, the parties and this Court have discussed the filing of this ‘fencepost’ (or omnibus) motion.  The parties agreed on the briefing schedule. Most striking, however, is that Plaintiffs’ expert testimony regarding placement of the alopecia warning is solely in the possession of Plaintiffs.  Plaintiffs had ample time and opportunity to identify and present expert evidence supporting their argument that permanent hair loss should have been addressed in the ‘Warnings and Precautions’ section of the label.  Yet Plaintiffs failed to do so.

Id.   And so the court held that, “because the label clearly and consistently warned of the precise injury Plaintiffs suffered,” it was adequate as a matter of law.  Summary judgment for the defendant. On 200 claims. A great win, and a lovely piece of smash-the-gamesmanship jurisprudence.  We understand that there is a companion decision, and we will tell you about that one next.

Meanwhile, it feels to us like it is getting harder and harder to navigate the land mines that the world is throwing in our path – the violence of this past week and the horrific event that precipitated it, the ongoing Covid-19 crisis, and the capricious and savage changes in weather.  We wish safety for all of you in the face of it all.