One slushy morning this week, we found ourselves searching for our favorite black duck boots. We found one and put in on, then, after much rummaging in the dark recesses of our closet, found a second. At this point, we were on the edge of missing our train, so we put on the second shoe and rushed out the door. A little later, sitting on the train and conscious of a little too much seatmate attention on our feet, we were amused to discover that we had, in fact, grabbed two very different boots. In other words, we almost got it right, but not quite. The same could be said about today's case, an otherwise nice decision encompassing a post-BMS personal jurisdiction holding and a post-Levine implied preemption holding, both correct, but stopping just short of the finish line.
In Klein v. Bayer Healthcare Pharms., Inc., et al., 2019 WL 3945652 (D. Nev. Aug. 21, 2019), a several-months-old decision that just appeared in our search results, the plaintiff was injected with the defendants' gadolinium-based contrast agents ("GBCAs") before she underwent MRIs. She alleged that the GBCAs were retained in her body and caused her to suffer injuries, including fibrosis in her "organs, skin, and bones." Klein, 2019 WL 3945652 at *1. Her federal lawsuit asserted claims sounding in strict liability and negligence for failure to warn her of the "risks of gadolinium retention." The defendants moved to dismiss, arguing, inter alia, that the plaintiff had not adequately pled personal jurisdiction and that her claims were preempted by federal law.
The defendants argued that the plaintiff "failed to plead . . . specific personal jurisdiction because she include[d] only conclusory allegations of [the defendants'] contacts with Nevada and [did] not allege facts showing how these contact relate[d] to her claims." Id. at *2. As the court explained, specific personal jurisdiction exists only when the defendants has "performed some act . . . by which it personally availed itself of the privilege of conducting business in the forum state" and "the plaintiff's claims . . . arise out of or result from [those] forum-related activities." Id.
The court emphasized that a defendant does not "purposefully avail itself of the privilege of doing business in a forum state . . . by merely placing products into the stream of commerce." Id. at *3. With respect to this prong, the plaintiff's complaint included only conclusory allegations that were "not plausible absent facts showing that [the defendant] conducted activities in Nevada” that satisfied the test. Similarly, the plaintiff included only a conclusory allegation that her claim arose out of the defendants' forum-related activities. Accordingly, the court held, she "fail[ed] to plead that she would [not] have sustained her alleged injury but for [the defendants' forum state activities, and thus fail[ed] to plead that her claim [arose] out of [the defendants'] contacts with Nevada.” Id.
As such, the court dismissed the claim for lack of personal jurisdiction and denied the plaintiff's request for jurisdictional discovery "because [the plaintiff had] not articulated a basis" for it. Id. at *4. But the court stopped short of dismissing with prejudice, granting leave to amend "because it [was] not clear that amendment would be futile" and allowing the plaintiff to reassert her request for jurisdictional discovery "if she [had] a basis to support it." We don't agree with the "without prejudice" dismissal, but it is less troublesome to us than the same course charted with respect to the defendants’ preemption argument.
By way of background, the labels of GBCAs include a black box warning advising users that gadolinium retention in patients with abnormal kidney function can result in Nephrogenic Systemic Fibrosis. This boxed warning did not apply in Klein because the plaintiff had normal kidney function. While the FDA issued a safety announcement warning of gadolinium retention in patients with normal kidney function, it stated that "gadolinium retention [had] not been directly linked to adverse health effects in patients with normal kidney function." Id. (citation omitted). The following year, the defendants issued a warning to patients with normal kidney function stating that gadolinium could be retained after a GBCA injection. The plaintiff's complaint alleged that the defendants should have added a warning that gadolinium retention could cause fibrosis in patients with normal kidney function.
The defendants argued "impossibility preemption" – that they could not have added the warning the plaintiff sought without violating federal law. In response, the plaintiff argued that the CBE ("Changes Being Effected") regulation allowed the defendants to add the warning unilaterally if there were newly-discovered evidence of a causal link between GBCAs and fibrosis in patients with normal kidney function. The court emphasized that, to prevail under Levine, the defendants were required to "present clear evidence that the FDA would not have approved" such a unilateral change. Id. at *4. The court held that the defendants had satisfied their burden, because the plaintiff "[did] not allege facts showing that gadolinium retention [was] in itself a clinically significant adverse reaction" or that the defendant "had reasonable evidence of a causal association between [its GBCAs] and a clinically significant adverse reaction in patients with normal kidney function." Id. at *5. Moreover, the FDA had already found that gadolinium retention was not associated with adverse health effects in people with normal kidney function when it considered the appropriate warning for that population. And there were no facts suggesting that the defendants had or should have had newly-acquired information that would have triggered their ability to add the warning under the CBE regulation. So the court correctly found that the warnings claims were preempted, under Levine.
But here's the part that drives us nuts. The court again dismissed without prejudice, holding that it was "not clear that amendment would be futile," granting the plaintiff leave to amend "if she [could] plausibly allege facts showing that [the defendant] had or should have had" the requisite newly-acquired information. Id. To recap, the FDA had already found that the causal connection plaintiff posited did not exist and had already declined to require the warning the plaintiff sought. The plaintiff had pled no "newly acquired evidence" that changed any of this. The Levine test was satisfied in all respects, and nothing in the law or the record should have entitled plaintiff to a second bite of this particular apple. The court ended up with the correct shoes on the correct feet, and it should have continued down the logical path to dismissal with prejudice. That said, "without prejudice" was better than nothing.
Post-script: Since this was an August decision, we were curious about what had happened in the intervening months. Seems the plaintiff agreed with our assessment. Less than a week after the decision was issued, a Stipulation of Dismissal with Prejudice appeared on the docket. Score one in the "correct" and "sensible" column.
This article is presented for informational purposes only and is not intended to constitute legal advice.