This has been an important concept in the gadolinium litigation and it delivered another preemption win in Javens v. GE Healthcare Inc., 2020 WL 2783581 (D. Del. May 29, 2020).  The changes being effected (“CBE”) label change process has strict limitations on when it can be used to add or amend warnings without prior FDA approval.  It’s not a magic wand that plaintiffs get to wield to make preemption disappear.  Rather, a drug manufacturer may be able to “add or strengthen” a drug’s warning if it has “newly acquired information of a causal association between the drug and a risk of harm.”  Id. at *3.  If a warning proposed by plaintiff doesn’t meet that criteria, it is not a CBE label change.  In that situation, federal law would prohibit the manufacturer from adding a warning that would satisfy state law.  Id. at *2. That’s conflict preemption.  That’s what happened here.

Before getting to the substance of the ruling, one of plaintiff’s arguments was that preemption, as an affirmative defense, could not be decided on a motion to dismiss.  Plaintiff argued that deciding the issue on the pleadings shifts the burden to plaintiff to affirmatively plead facts justifying the applicability of the CBE label change process.  Id. at *4.  The court, however, found that preemption as a primarily legal issue, could be properly considered at the pleadings stage.  Id.  The court identified numerous cases deciding preemption on a motion to dismiss, including the First and Second Circuits.  Id. at *5 (citations omitted).  As part of this argument, plaintiff also tried to argue that the Second Circuit decision relied on by the court (Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019)) was superseded by Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019) because Albrecht limited preemption to situations where defendant could demonstrate by “clear evidence” that the FDA would not have permitted the proposed label change.  But plaintiff missed that the issue here – whether the proposed label change could be done as a CBE – was not an issue in Albrecht.  In Albrecht, defendant conceded that the proposed change met the CBE requirements.  Id.  The question before the Court was whether defendant had demonstrated that the FDA would have rejected that proposed change.  We don’t get that far in Javens.

As in other gadolinium cases, plaintiff alleges that she suffered complications from gadolinium retention that was unwarned about in patients with normal kidney function.     Plaintiff cited numerous studies in her complaint that address gadolinium retention in animals and humans with normal kidney function.  Missing from any cited study was a causal link between gadolinium retention and any adverse side effect alleged by plaintiff.  Id. at *3.  In fact, plaintiff’s complaint included an allegation that the FDA was currently “working on determining the exact consequences of these new findings of gadolinium retention in patients with normal renal function.”  Id.  To be a CBE label change, defendant has to have new evidence of “a causal association between the drug and a risk of harm.”  Here, plaintiffs actually pleaded that the association is inconclusive, even to the FDA.  Adverse event reports (“AERs”) don’t change the analysis.  AERs may be considered new evidence, but they aren’t causation evidence.  Id.  Without evidence of a causal link, defendant could not have unilaterally changed its label.  The question of whether there is clear evidence the FDA would have rejected the change is never reached.  Plaintiff’s failure to warn claims are preempted.

Plaintiff’s design and manufacturing claims were also preempted based on well-established law that prohibits a manufacturer from making any major changes to a drug’s “qualitative or quantitative formulation” once it has been approved.  Id.  at *6.  Plaintiff argued that defendant manufactured a different product that was a safer alternative.  But, if plaintiff’s contention was that the product she used should have been re-designed to be like defendant’s other product, that’s not allowed without prior FDA approval.  A defendant can’t re-design an approved drug.  If plaintiff’s contention was that defendant should have sold the other product instead, that is the “stop-selling” rationale rejected by the Supreme Court in Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013).  Either way, it doesn’t save her claim.