There are two main issues that make the eyes of your dutiful Drug and Device Law bloggers well up in frustration over In re Taxotere (Docetaxel) Eye Inj. Prods. Liab. Litig., No. 3023, 2025 U.S. Dist. LEXIS 233514, 2025 WL 3442731 (E.D. La. Dec. 1, 2025).

The first is a gut-level, “this is an example of something wrong with our civil justice system” point:

There have been thousands of lawsuits filed in two MDLs (MDL-2740 and MDL-3023) stretching back nearly a decade and involving the chemotherapy drug Taxotere—which is essential for the treatment of certain breast, lung (non-small cell), prostate, stomach (gastric), and head and neck cancers.  The newer MDL involves allegations that the Taxotere label did not provide full and detailed enough warnings about a potential risk that the drug might make patients cry; the earlier Taxotere MDL involved allegations that this chemotherapy drug caused hair loss. 

For the new MDL, the label warned of “excessive tearing which may be attributable to lacrimal duct obstruction,” but in the plaintiffs’ lawyers’ opinion, this warning also should have said that the “excessive tearing” was due to “stenosis” and patients should specifically consult “a lacrimal specialist at the first sign of excessive tearing.”

Got that? The drug label advised oncologists that their cancer patients might have “excessive tearing” due to tear “duct obstruction,” but because the label did not also say that the cause of the excessive tearing was “stenosis” and to immediately consult a “lacrimal specialist,” we have an MDL, thousands of lawsuits, and almost a decade of obscenely expensive litigation grinding on, with only the lawyers involved reaping anything other than minimal benefit.

Is it any wonder why we generally favor a high-regulation/low-litigation model?  (Or, at least we do when the regulators are actual scientists and doctors who follow the standards of those respective professions. Ahem.)

Which brings us to the second issue, preemption.

The Fifth Circuit already has had to correct the Taxotere MDL District Court once regarding preemption, in a case arising from the hair loss MDL, Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024). As Bexis explained about that decision, Taxotere came onto the market through the so-called “paper NDA” process, 21 U.S.C. §355(b)(2). In this earlier Taxotere decision, the Fifth Circuit rejected the District Court’s conclusion otherwise, and held that PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) applied just the same for paper NDA medications as for any other. Thus, because of federal preemption, plaintiffs cannot challenge the sufficiency of a drug’s label warning unless they can show that the manufacturer had “newly acquired” information that “reveal[ed] risks of a different type or greater severity or frequency than previously included in submissions to FDA” such that the manufacturer could have initiated a label change using the changes being effected (or “CBE”) regulation, 21 C.F.R. § 314.70(c)(6)(iii).

In fact, Hickey went further, and reviewed five items of medical literature that supposedly formed the “newly acquired information” that supposedly gave rise to a duty on the part of the Taxotere manufacturer to add the plaintiff-lawyer proposed language about hair loss.

According to the Fifth Circuit, four of the five items of medical literature identified by the plaintiffs could not constitute newly acquired information as a matter of law on the appellate record because they failed to meet the “different type or greater severity or frequency” requirement for the CBE regulation to apply, and because the overall degree of risk was essentially the same.

As to the fifth item of “medical literature”—an “abstract,” not even a full-fledged study—the Fifth Circuit left the door open by only the slimmest of cracks, remanding to the District Court to reconsider this evidence using the proper legal standard.

In this newest In re Taxotere preemption decision, from the excessive tearing MDL, the plaintiffs and District Court plowed through that narrow opening like the door wasn’t even there.

Once again, the manufacturer moved for summary judgment, arguing (similar to the argument in Hickey) that plaintiffs’ claims are preempted because it could not have invoked the CBE regulation—that no “newly acquired information” existed to justify a unilateral label change.

The District Court held that the manufacturer bears the ultimate burden of persuasion on preemption (but deferred whether the plaintiffs bear a limited burden of production to identify evidence of newly acquired information, because the plaintiffs here in fact did that).

The District Court also held that the question of whether information constitutes “newly acquired information” is a matter of law for the judge, not the jury and, as a result, expert testimony on that “ultimate issue” is inadmissible.

Because of this, the District Court’s entire decision—that the manufacturer did have newly acquired information of the necessary import to require a label change—is based entirely on its own assessment of the significance of one small study (the 2003 Esmaeli Cancer Study), without consideration of the affidavit by that study’s author, Dr. Bita Esmaeli, submitted by the manufacturer.

What makes all this troubling is that the District Court makes some pretty dramatic claims about the medical significance of the 2003 Esmaeli Cancer Study, even though that study was really small (it only involved 148 patients), and was duplicative of pre-label approval studies (the 2001 Esmaeli Article and the 2000 Kneuper Hall Abstract) that, as the District Court itself says, “reported on similar injuries and surgical interventions and penned similar warnings regarding the need for referral to an ophthalmologist and/or prompt intervention.”

There is a lot we can say about the significance, or lack thereof, of the conclusions of the 2003 Esmaeli Cancer Study, but the most notable thing the District Court seemed to miss is that, if anything, the study showed that the alleged condition (lacrimal duct obstruction due to stenosis) appears more common in use of Taxotere at a higher, off-label dosage (weekly instead of every three weeks)—in other words, how oncologists would use Taxotere for sicker cancer patients.

Thus, this single, small, repetitive study reflects, at most, new information reflecting a risk of a “different type or greater severity or frequency” regarding excessive tearing for the sickest cancer patients, and nothing about new information for most Taxotere patients receiving the usual treatment doses at the usual pace.  That matters because (at least, perhaps, until further review by the Fifth Circuit), the only Taxotere MDL plaintiffs who should have a non-preempted failure to warn claim are those that received the higher dosage.

And these plaintiffs will still have to prove warnings causation—that their treating oncologists would have declined to prescribe chemotherapy to them as cancer patients, had those oncologists only known about the incrementally different language of the plaintiffs’ lawyers proposed excessive tearing warning. Which, in a non-insane world, should be something very difficult to prove. How many physicians are going to testify, “Correct, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis, and that a lacrimal specialist consult should be considered.”

Which brings us back to our first point—does this litigation make any sense?