We acquired our trial chops in the Central District of California, where we were an AUSA. We had a great time. We learned a lot. We have warm feelings for C.D. Cal. But we do not love all the decisions that come out of that jurisdiction.
Burton v. Abbvie, Inc., 2023 U.S. Dist. LEXIS 170907 (C.D. Cal. Sept. 25, 2023), is a not very good decision. It applies California law to prop up a claim that a prescription drug caused the plaintiff to suffer from Stevens Johnson Syndrome/Toxic Epidermal Necrosis (SJS/TEN). SJS/TEN cases are problematic because they usually involve serious, disfiguring injuries to sympathetic plaintiffs. The Burton case is complicated by a regulatory quirk: before the plaintiff’s use of the drug (eye drops for treating conjunctivitis) the manufacturer submitted a label change that specifically warned of SJS, but not TEN. Does that matter? Does that make medical sense? Does that undermine the plaintiff’s claims for failure to warn, negligent misrepresentation, gross negligence, fraud and fraud by concealment?
The plaintiff used a generic version of the eye drops, but sued the brand manufacturer under the theory of innovator liability. That theory is unsound and unfair, but the case is in California, which gave us the doctrinal abomination of T.H. v. Novartis. Thus, the Burton court pauses only very briefly on the innovator liability issue before getting to – and bungling – the other defense arguments.
Let’s frame the first defense arguments as a couple of very basic questions: Where’s the failure to warn? What’s the fraud?
The plaintiff claimed that TEN was “different” from SJS, so the amended warning was still defective. Not citing any case where such a distinction had been recognized, the Burton court held the difference between SJS and TEN, and the significance of such difference, to be questions of fact “that will require medical expert testimony to resolve.” There are plenty of cases out there discussing the relationship between SJS and TEN (it is a difference in degree), but the Burton court felt bound by the allegations of the complaint, and held that there just might be a valid claim that an SJS warning might be inadequate. Grrrr. To paraphrase our favorite police officer character (Bunk) from our favorite TV show (The Wire) criticizing our favorite villain (Omar), it makes us sick to see how far we’ve fallen.
Speaking of peak TV, this is the part of the show where preemption rides in to the rescue, right? Wrong. The defendant argued that the plaintiff’s claim was preempted because she did not sufficiently allege the existence of newly acquired information that would have allowed the defendant to change the drug label without FDA approval. Again, the Burton court stood on procedural ceremony so as to dodge the crucial issue. Here is how the dodge works: (1) Preemption is an affirmative defense, therefore (2) unless a plaintiff does the defense the immense favor of pleading what amounts to Albrecht “clear evidence” that the FDA would have rejected a label change, then (3) a motion to dismiss based on preemption must be denied.
As if to recognize the sophistry of this syllogism, the Burton court also held that the plaintiff sufficiently pleaded newly acquired information to avoid preemption. Since TEN is different than SJS (see above), any literature regarding TEN is newly acquired, regardless of the intervening label change addressing SJS. More sophistry. And then it gets worse. Even if the proposed warning information set forth in the complaint is old stuff, that is “irrelevant” because newly acquired information includes data, analyses, or other information that, according to the Burton court, was not previously submitted to the FDA. Because the defendant did not establish that any information available at the time of the label change was necessarily submitted to the FDA, the preemption argument suffers defenestration. (For those of you unfamiliar with that curiously Central European method of dealing with political or religious opponents, defenestration means thrown out of an upper story window).
We think the Burton court misunderstands what “newly” means, and the only way it can make that misunderstanding work is to violate Buckman preemption. The case ends up becoming focused on whether the defendant hid information from the FDA. That seems utterly wrong. The Burton court protests (too much) that the plaintiff is not alleging a preempted fraud on the FDA claim, but only a failure to submit information to the FDA pertaining to the defendant’s preemption defense. That sounds like classic Buckman to us.
Throw a dart at the Burton opinion and you’ll find something bad. The Burton court smiles upon the plaintiff’s nitpicking of the SJS warning in various ways. For example, the plaintiff insisted that racial and sexual differences in SJS/TEN incidence should have been included. (The plaintiff was African-American). That is a fairly common claim in SJS cases. That sort of thing is hardly free from controversy, and it would probably make more sense for the FDA, rather than a jury, to decide whether to touch that hot stove.
In any event, that label nitpicking permitted the plaintiff to escape Rule 9(b) dismissal for want of specificity. Silly specificity is still specificity, and that’s what counts, apparently.