The recent spate of gadolinium cases brought by patients with normal kidney function are looking like fertile ground for federal preemption, and we are not saying that just because we like the results. Our point is that if you had to come up with an example of a case where federal law ought to preempt state-law product liability claims of all kinds—including both design defect claims and failure-to-warn claims—you might come up with a case like Thomas v. Bracco Diagnostics, Inc., No. 3:19-cv-00493, 2020 WL 1016273 (W.D. La. Feb. 27, 2020). A magistrate judge in Thomas has recommended dismissal of all claims against a gadolinium contrast agent manufacturer on the basis of preemption, and the order is a good example of how preemption under Bartlett and Albrecht should work.
The plaintiff in Thomas allegedly experienced difficulties after being injected with the defendant’s contrast agent, presumably to create sharper images during an MRI. Id. at *1. The problem for the plaintiff though was that his amended complaint (like the complaint before it) ran headlong into federal requirements. His beef was that gadolinium allegedly had toxic effects when retained in the body, which could have been prevented had the manufacturer (1) designed the product using a compound less likely to be retained and/or (2) provided a stronger warning regarding gadolinium retention.
So let’s take the design defect claim first. When federal law prohibits a drug manufacturer from changing the chemical composition of a drug without FDA approval, federal law preempts a lawsuit alleging that state law requires such a change. That’s Mutual Pharmaceutical Co. v. Bartlett, the 2013 Supreme Court case holding that design defect claims against a generic manufacturer were preempted because the manufacturer had no ability under federal law to change the design of its products. We were quick to observe at the time that Bartlett’s rationale applied equally to innovator drugs, and multiple courts have since agreed. The most notable opinion of this kind is probably Yates v. Ortho-McNeil-Janssen, 808 F.3d 281 (6th Cir. 2015), which we discussed here.
The facts of Thomas fall squarely in the Bartlett bucket. The plaintiff’s proposed alternate design using a different compound was a “change to the qualitative formula and thus a major change” requiring FDA pre-approval. As a result, because the defendant manufacturer could not have independently adopted the proposed alternative, any state requirement purporting to compel that alternative was preempted. Thomas, at *9.
The failure-to-warn claim met a similar fate, but under different Supreme Court authority—Wyeth v. Levine and Merck v. Albrecht. Implied preemption of a failure-to-warn claim can be a tough row to hoe for innovator drugs (as opposed to generics), owing mainly to the “clear evidence” standard first announced in Levine. As the standard goes, a failure-to-warn claim is preempted if there is clear evidence that the FDA would not have approved the warning that the plaintiff alleges is required under state tort law. Thomas, at *9.
Two factors led to preemption of the failure-to-warn claim in Thomas. First, as faithful readers of the blog know, Wyeth v. Levine relied heavily on the purported ability of innovator drug manufacturers to unilaterally change their drug labels through the FDA’s Changes Being Effected regulations. The CBE regulations were no help, however, to the plaintiff in Thomas because the plaintiff presented no newly acquired information regarding the product’s risks. As the court explained, “Notably, the studies and reports included in Thomas’s complaint discuss how gadolinium can be retained, but do not demonstrate proof of any adverse effects from gadolinium retention.” Id. at *10. In other words, because there was no newly acquired risk information, the federal CBE regulations would not permit the label change that the plaintiff’s state-law tort claims would compel. That’s implied preemption.
But even more importantly, the manufacturer produced clear evidence that the FDA would not have approved a warning about the purported adverse health consequences of injection with the manufacturer’s product. One month before the plaintiff’s injection, the FDA approved a revised warning specifically about gadolinium retention, which said that retention occurred but that no causal relationship between retained gadolinium and any adverse effect in patients with normal renal function had been established. Id. The FDA therefore considered the exact risk about which the plaintiff was complaining and approved warning language that contradicted the plaintiff’s state-law claim. The court concluded that “[t]he language of the label change, issued very shortly before the Plaintiff’s injection . . ., and specifically stating facts contrary to the warning sought by the Plaintiff, is clear evidence that the FDA would not have approved a label change which warned of such adverse events.” Id. That’s implied preemption, too. Moreover, the defendant met the “clear evidence” standard, even though the defendant did not itself request the label change.
The court dismissed the plaintiff’s claims (brought, by the way, under the Louisiana Product Liability Act) for other reasons, but the main show is preemption. The facts lined up to meet all the applicable legal standards. A perfect storm maybe. Or maybe just a fair result. We like the latter.