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 New York.
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. Bayer Healthcare Pharm, Inc., 2020 WL 705170, *1 (S.D.N.Y. Feb. 12, 2020) underwent a remarkable 23 MRIs between 2007 and 2015, and each time she was injected with a gadolinium contrast agent. As in our other recent gadolinium posts, plaintiff here had normal kidney function. Her lawsuit, therefore, hinges on her contention that defendants should have warned of the risks of gadolinium retention in patients with normal kidney function.
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 New York. Id. at *4, *5. The injections of those defendants’ gadolinium agents occurred in Florida, not New York. Id. at *7. Plaintiff currently resides in New York and it appears she received her other injections in New York. But that wasn’t enough to satisfy New York’s long arm statute because specific jurisdiction requires that plaintiff’s suit “arise out of, or relate to, the defendant’s contacts with the forum.” Id. While plaintiff argued that both defendants marketed and distributed their products in New York, she failed to allege any connection between those activities and the injuries she allegedly incurred in Florida. Id.
As to one of the non-New York defendants, plaintiff made two additional failing arguments. First, defendant owned a facility in New York. But plaintiff failed to connect that facility to her alleged injury. Second, defendant is a wholly-owned subsidiary of a New York company. The court started by noting that it is uncommon to confer personal jurisdiction on a foreign subsidiary based on the actions of its domestic parent. Id. at *8. More importantly, what plaintiff is asking is for the court to exercise general jurisdiction over the parent company. In a post Daimler AG v. Bauman world, imputing general jurisdiction is questionable at best. Id. (quoting Daimler AG). But the court didn’t really need to address that issue head on, because plaintiff failed to allege anything other than that the two entities had a relationship. Without some allegations regarding alter ego, control, or veil piercing – ownership alone is not enough to impute jurisdiction. Id. at *9.
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 FDA’s 2018 finding also included that “gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function” and “in patients with normal kidney function, a causal connection . . . could not be established.” Id. at *12. If the FDA has not found a link between retention and adverse health effects in persons like plaintiff with no renal dysfunction, the court was not persuaded that it should ignore that finding and hold that defendant should have changed its label to the contrary years earlier. Id. Because the FDA’s 2018 notice was attached to the complaint and it contradicted plaintiff’s conclusory allegations, the court did not have to accept those allegations as true. Id. But even without the FDA notice, the court found plaintiff’s allegations wouldn’t pass TwIqbal because they were too vague and did “not draw the crucial causal link between” the cited adverse events and gadolinium retention in patients with normal renal function. Id.
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.