Long ago, it seemed that large-scale drug or device litigation was usually spurred on by a recall, market withdrawal, or major labeling change describing a new risk or limiting the scope of product use. The plaintiff lawyers these days seem to be more willing to put their energy into attacking currently marketed products without triggering events along these lines. However, back when the rules on implied preemption for claims about prescription drugs were less settled—generally before the implications of Bartlett and Mensing for branded drugs had been recognized—some courts struggled with how a subsequent voluntary withdrawal from the market affected preemption and, more generally, product liability. We detailed some of this in a long post about the Yates decision from the Sixth Circuit on the preemption of design defect claims as to a branded prescription drug. Regardless of any recall, the temporal focus for whether failure to warn and design defect claims are preempted is not at some point in time after plaintiff stopped using the prescription drug. Yet, there has been a tendency for some courts to get squeamish about the idea that a manufacturer can be “immune to” or “insulated from” liability if the drug is off the market by the time the motions are being decided.
Cosey v. Global Blood Therapeutics, Inc., No. 1:25-CV-09400, 2026 WL 2150348 (N.D. Ill. July 27, 2026), is a case where the court did the right thing on preemption despite a short time between plaintiff’s alleged injury from the drug and the decision by the manufacturer to withdraw it from the market. The drug at issue in Cosey was, at the time of the use, one of the few approved medications (including gene therapy) available to treat sickle cell disease, a serious and potentially fatal genetic disorder. One of the known significant complications of the disease is a vaso-occlusive crisis (“VOCs”) where blood flow is blocked by the accumulation of deformed hemoglobin molecules. Plaintiff’s minor was first prescribed defendant’s medication for her sickle cell disease in January 2022, not very long after the medication was approved and had its indication expanded to cover use by younger children. Id. at *1-2. After more than two years of apparently safe and effective use, plaintiff’s minor allegedly suffered a VOC. Within four months, on September 25, 2024, the manufacturer voluntarily withdrew the drug based on a possible increased risk of VOCs. The Cosey decision identifies the basis of this decision as “the totality of the clinical data that indicated the overall benefit of [the drug] did not outweigh the risk in the approved sickle cell patient population [and the] data suggested occurrence of VOCs and fatal events that required further assessment.” Id. at *1. FDA’s website from which the court’s language appears to have been drawn adds that an increased risk of VOCs had been reported in postmarketing clinical trials. Despite her VOC, plaintiff’s minor apparently kept taking the medication until the market withdrawal. Relying in part on the tight timing, plaintiff sued the manufacturer and another entity and asserted the predictable product liability claims. Predictably, the defendants moved to dismiss based on implied preemption and TwIqbal.
On the design defect claim, plaintiff argued that the manufacturer could have come up with a hypothetical safer drug and tried to get it approved instead of the drug it actually developed and got approved. Citing only Bartlett, Cosey found this claim impliedly preempted. Whether pre-approval or post-approval, “altering its composition” would not have resulted in a marketable drug without FDA approving the new drug. So, there was no unilateral action that the defendants could take to sell a non-defective drug. Id. at *3. As far as we can tell, plaintiff did not argue explicitly that the recall negated preemption of the design defect claim, but the design defect allegations were not much more than the manufacturer’s statements in connection with the withdrawal. Either way, this claim was dismissed with prejudice.
On failure to warn, which the court addressed along with express and implied warranty, Cosey took a deeper dive, citing the CBE regulations, Albrecht, Dolin, and some other decisions explaining that plaintiff has to do more than just say “CBE” to avoid implied preemption (as Levine misunderstood). The complaint did not identify “‘newly acquired information’ that would have permitted unilateral modification to [the drug’s] label under the CBE regulation.” Id. at *5. The court was not fooled by plaintiff’s citation of the evidence the manufacturer said was new a few months after plaintiff’s alleged injury when it decided to withdraw the drug. Nor were general allegations that there must have been something earlier sufficient.
Plaintiff’s conclusory allegations that Defendants possessed “newly acquired information” about risks of [the drug], without identifying what that “newly acquired information” was or how it demonstrated a risk of a different type or greater severity than what the FDA already considered, does not suffice to undermine preemption. Since Plaintiff failed to identify any newly acquired information that shows Defendants were aware of an increased VOC risk, with sufficient time to initiate a label change before they withdrew the product, Plaintiff’s failure-to-warn claims fail.
Id. (emphasis added). We pause on the italicized language to flag an issue that matters more in individual cases than in litigation-wide preemption motions. Even where a CBE actually can be used to make a label change unilaterally, albeit temporarily, it still takes time. We have seen cases where the allegedly newly acquired information that a plaintiff says should have led to a new warning was acquired a day or two before the last pre-injury prescription of the medication. Under Cosey’s reasoning, the plaintiff would have to show the labeling change could have been effectuated in time for the prescribing physician to see it while it still could have affected the outcome alleged in the case.
Plaintiff also included the sort of generalized negligence claim that is common in product liability cases, but typically does not implicate recognized duties to do more than design, manufacture, and warn about the product. It appears that plaintiff did not actually contend there was some manufacturing issue specific to the pills that his minor took. Instead, this was just a rehash of design and warnings claims the court already addressed. Citing the Seventh Circuit’s Wagner decision we discussed here and here, the court found these repackaged claims preempted for the same reasons.
“For purposes of completeness,” Cosey also addressed what it called defendants’ argument that the warnings claims “are also preempted based on the learned intermediary doctrine.” Id. This, of course, is not a thing. In Illinois, as in almost all states, the learned intermediary doctrine defines the duty to warn for the manufacturer of a prescription medical product. The court’s conclusion that “Plaintiff cannot argue that, if properly warned, her physician would have altered her prescription, where her allegations make no mention of her physician at all” describes a failure to plead the elements of a state law claim consistent with TwIqbal. Id. at *6. In that context, it makes a bit more sense to give plaintiff another chance to plead a cognizable, non-preempted warnings claim. Even if plaintiff uses the extra time the court gave him to amend to mention the prescribing physician by name, we doubt he can come up with factual allegations of newly acquired evidence from the right time period to avoid preemption of his warnings claims.
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