Well, at least that's true when we are blogging about defense wins. And this week, we have another good gadolinium case. This time from
Just a quick reminder - gadolinium is a contrast agent that is injected into a patient before undergoing an MRI. The gadolinium is intended to pass through the body, but there are known risks of retention in patients with impaired kidney function.
Plaintiff in Sabol v.
Before we get to the substance of those allegations, two defendants sought dismissal based on a lack of personal jurisdiction. Neither defendant was headquartered or incorporated in
As to one of the non-
The next issue before the court was the reverse - did plaintiff state a claim against the parent company where it alleged no facts that the parent is liable for the claims against the subsidiary. Same problem. Mere ownership also is not enough to impute liability to the parent. Id. at *10.
That left one remaining defendant who made three substantive arguments - preemption, lack of foreseeability, no legally cognizable injury. The court needed only to address the first issue concluding that all plaintiff's claims were preempted.
This part might sound a little familiar. Plaintiff's argument was that defendant should have and could have revised its labeling to include a warning regarding gadolinium retention in patients with normal kidney function pursuant to the "changes being effected" (CBE) regulations. Those regulations provide that a manufacturer can "add or strengthen" a warning without prior FDA approval if the manufacturer has "newly acquired information" that provides "reasonable evidence of a causal association" of a "clinically significant adverse reaction." Id. at *11. Further, a "clinically significant adverse reaction" is one that is "potentially fatal," "serious," or can "be prevented or mitigated through appropriate use of the drug." Id. So, to avoid impossibility preemption, a plaintiff has to allege not just a labeling deficiency, but "a labeling deficiency that [defendant] could have corrected under [the CBE exception.]" Id. A defendant seeking preemption must either demonstrate that the proposed label change falls outside the CBE process or show clear evidence that the FDA would not have approved the change. Id. This case follows option one.
First, the court looked at the 2018 gadolinium FDA-approved label which includes a reference that patients with normal kidney function may retain gadolinium. But, the
Second, plaintiff cited two studies that were published in 2015 or earlier - the time when plaintiff was injected with the drug. But neither demonstrated "reasonable evidence" of a causal relationship. One study focused on skin plaques which the court could not determine were a "clinically significant adverse event" to allow for a CBE label change. More importantly, it was a case study involving two patients who in fact may have had impaired kidney function. Id. at *13. The second study focused on hyperintense signals in the brain which again the court could not assume were a significant enough event to trigger a CBE label change. It too was a case study with a "tentative, at best, suggestion of a causal relationship." Id.
Overall, plaintiff failed to plead any facts showing defendant had newly acquired information that would have permitted it to change its label unilaterally. Therefore, plaintiff's claims were preempted. The court also found the complaint lacking in plausible allegations of a causal association between the drug and plaintiff's alleged injuries, another fatal flaw. Id. at *14.
This article is presented for informational purposes only and is not intended to constitute legal advice.
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