Last November, we offered well-deserved criticisms of a really bad MDL-wide preemption decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022) (“ASD-ADHD I”). One of its huge gaffes was not citing the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. __, 139 S. Ct. 1668 (2019), which sets out the current standard for evaluating the preemption of drug warnings claims. More generally, ASD-ADHD I seemed not to understand the regulatory scheme applicable to labeling for over-the-counter drugs. Since that decision, the court has entered two orders that would have made more sense before deciding preemption. The optimist would say “better late than never.” The pessimist would say something homey about horses and barn doors. We reserve judgment until we see how this plays out.
To set the background, this MDL is premised on a purported risk that in utero exposure to acetaminophen causes autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD). Maybe there will be established causal relationships at some point in the future, but getting past a vigorous evaluation of Rule 702 motions on expert opinions on general causation based on the current studies will be a challenge. Second Circuit law sets a high bar, as seen with the demise of the Mirena MDL for lack of general causation evidence. (See here, here, and here.) Under the following somewhat simplified and idealized summary, a labeling claim requires there be evidence that the drug’s label was insufficient to warn of the risk of a condition the plaintiff allegedly developed from taking the drug. Insufficiency is measured against the reliable risk evidence at the time of the use. Because of a little thing called preemption, the drug manufacturer must have been able to change the label unilaterally to make it adequate without violating regulatory requirements. That means that a court evaluating preemption for a claim must consider, among other things, the risk information available at the relevant time, what the plaintiff claims was inadequate about the label at that time, and what regulatory requirements applied to the drug at that time.
One thing courts often give plaintiffs a pass on in this context is specifying what they—or their competent testifying experts on the subject—say the label should have said to be adequate. We have seen the MCL courts in New Jersey order plaintiffs to specify what an adequate warning would have looked like. We have also seen some judges hold the lack of a specified warning against plaintiffs. More often, however, not forcing plaintiffs to spell it out makes it easier for them to avoid summary judgment on warnings claims, both on the elements of the claim and on preemption. In short, fuzziness helps provide plaintiffs with wiggle room. Therefore, we were pleasantly surprised to learn in In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2023 WL 3026413 (S.D.N.Y. Apr. 19, 2023) (“ASD-ADHD II”) that the court had ordered the plaintiffs to specify their “proposed labeling change” even before their expert reports were due. This would have been useful information to have had before deciding preemption.
Within two weeks of receiving plaintiff’s proposed labeling, the court asked FDA to weigh in. Well, the plaintiffs’ proposed labeling change was not really that, merely something they said the manufacturers of OTC products containing acetaminophen “could have included on the labels” at some time. Obvious, “could have” is not “should have,” which is the basis for alleged liability, but even “could have” can be wrong. In addition, discussion of labeling changes is not terribly meaningful without the time frame. Before the plaintiffs took the drug? Before the latest FDA monograph that did not include anything beyond the standard “If pregnant or breast-feeding, ask a health professional before use” (which means FDA did not think more was needed at that time)? After the availability of the study or studies that plaintiffs claim shows increased risk of ASD and/or ADHD? A better question to require plaintiffs to answer would have been “what specifically do you contend the labeling should have stated about ASD and ADHD, at what specific times, and based on what specific evidence of risk?”
Nonetheless, asking FDA (through the U.S. Attorney for the Southern District of New York) to weigh in within ten weeks was a good idea and something that courts do not do enough. Again, it would have been better to have sought this input before deciding preemption. The questions posed also are not sufficiently focused on time frames and regulatory requirements for OTC labeling changes, but they are not bad:
1. Should the Plaintiffs’ Proposed Warning be added to acetaminophen labels?
2. As of today, does science warrant the addition to acetaminophen labels of any warning or advice regarding in utero exposure to acetaminophen and the risk of ASD or ADHD?
Id. at *1-2. If FDA chooses to answer, then we would expect those answers to factor into a second bite at the preemption apple. There would be no particular need for expert discovery if the plaintiffs cannot articulate a non-preempted warnings claim. As we have written, there really is no such thing as non-preempted design defect claim for an approved prescription drug. For the OTC drugs at issue here, the result should be the same. This is also not a litigation based on alleged manufacturing defects. And “stop selling” theories are generally not recognized and would be preempted anyway.
So, maybe the dominos will all fall so that the entire MDL, or almost all the claims and plaintiffs in it, will go away based on how FDA answers the questions posed to it. This begs the question why more judges, particularly MDL judges, do not “invite” FDA to give its “views” on basic aspects of preemption that would have major implications to the viability of the asserted claims. Judges are not bound by what FDA says in terms of the ultimate result, but they can certainly consider and credit a response like “No, at any point prior to today, no manufacturer of an acetaminophen-containing over-the-counter drug could have unilaterally added any additional warning related to a risk of teratogenic or mutagenic effects on the offspring of pregnant women and no such warning would have been accepted if proposed.” The impossibility principle from Mensing and Bartlett negates a claim contingent on FDA accepting a labeling change that the manufacturer should have requested. But looking at what FDA has said and done to assess preemption of warnings claims under Levine and now Albrecht is pretty standard.
As we have noted in a few different contexts (like here, here, and here), some courts recently have been pretty critical of FDA and not very inclined to defer to its decisions, or to those of federal agencies in general. While we do not think FDA is infallible, it is in the best position to speak to whether a specific labeling change to an OTC drug with a monograph would comply with its requirements, if not all questions about drug labeling. If the Supreme Court had understood from FDA how the CBE really works, then it might not have done such a poor job in Levine, the odd grandparent of all drug warnings claims preemption decisions.