Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.” To wit, we recently noticed a small wet spot on our bedroom ceiling. The roofing company discovered that the corresponding section of the roof was too shallow to be shingled and replaced the section with the correct material. That spot dried up and stayed dry, but we walked into our bedroom during the next big storm to find water dripping from a recessed light in a different location under the brand-new section of roof. Nothing’s perfect.
We could go on (trust us). But we will move, with a similar sense of resignation, to today’s case. Vardouniotis v. Pfizer, Inc., 2020 WL 3890928 (N.Y. Sup. July 7, 2020), begins as a rare and lovely example of a court applying the correct standard to dismiss a failure-to-warn claim on federal preemption grounds. In Vardouniotis, the plaintiff took the defendant’s prescription drug to help her quit smoking. She alleged that it caused her to suffer injuries that included a number of symptoms related to pain in her back, neck, abdomen, legs, and hips, along with movement disorders, “difficulty lifting items, persistent exhaustion, labored breathing, depression; and anxiety.” Vardouniotis, 2020 WL 3890928 at *1. She asserted the usual panoply of product liability claims, including a claim that the defendant had not adequately warned of the risks of “movement disorders, serious injury, or death.” Id. In its motion to dismiss, the defendant argued that the warnings claims were preempted by the FDCA.
The court explained that, to “update a label without prior FDA approval, a manufacturer must comply with the ‘changes being effected’ (‘CBE’) regulation, which allows manufacturers to add or strengthen label warnings unilaterally to “reflect newly acquired information.” Id. at *2, citing 21 CFR § 314.70(c)(6)(iii). The only time the FDCA and its implementing regulations do not preempt a state law failure-to-warn claim is when the manufacturer could have changed the label pursuant to the CBE regulation. Under that circumstance, “the burden shifts to the party asserting a preemption defense to demonstrate that there is clear evidence that the FDA would not have approved” the label change. Id. at *2-3 (citation omitted). This is the Levine “clear evidence” rule that has confounded courts – and produced singularly bad decisions – since 2009. Not so here.
The defendant argued that the plaintiff had not alleged that the defendant had “information that . . . revealed risks of a different type or severity or frequency than warned of in the . . . label and [that the defendant] had not previously submitted to the FDA.” Id. at *3. In other words, according to the defendant, the plaintiff had not alleged the existence of “newly acquired information” that would have triggered the defendant’s ability to change the label without prior FDA approval. The plaintiff countered with citations to newspaper articles and journal publications describing risks not listed in the label, and she argued that she didn’t know, before discovery, whether or not those risks were identified to the FDA as part of the defendant’s New Drug Application.
The court commented that, although the plaintiff “cite[d] newspaper articles in her memorandum of law, [the] articles were not annexed to the complaint or her opposition to [the defendant’s] motion to dismiss.” Id. The court also declined to take judicial notice of “materials derived from a Federal Aviation Administration website or a Wall Street Journal article,” because “[j]udicial notice of facts is reserved for matters of common knowledge, well-established and settled.” Moreover, “[judicial notice of a fact may not properly be based upon a factual assertion simply because the assertion is contained in a newspaper article.” Id. (internal punctuation and citations omitted).“ Thus,” the court stated, “the plaintiff has not identified any newly acquired information that could have justified [the defendant’s] revising the . . . label unilaterally through the CBE regulation without FDA approval.” Id. Nor was the court swayed by the plaintiff’s argument that she needed discovery to defeat preemption, commenting that “the mere hope that discovery may reveal facts essential to justify opposition does not warrant denial [of a motion to dismiss].” Id. at *4 (internal punctuation and citation omitted). The court held, “As the plaintiff has failed to make a sufficient showing that such facts could be obtained in discovery, the plaintiff’s failure to warn claims are dismissed.” Id.
We remember the days leading up to the Levine decision and our disappointment when the decision came down. In the ensuing years, we have been frustrated, far more often than not, by courts’ refusal or inability to approach preemption motion-to-dismiss decisions with open-minded rigor. It’s pretty simple: if a plaintiff properly alleges that a manufacturer failed to change a label in the face of “newly acquired information” about a new or heightened risk, she may be able to defeat dismissal on preemption grounds. Otherwise, her failure-to-warn claims should be dismissed as preempted by federal law. So many courts get it wrong, and we were delighted to read a decision that gets it right.
But nothing’s perfect. The court granted the defendant’s motion with respect to some of the plaintiff’s remaining claims and denied it with respect to others. But here is where the decision really went off the rails: the court held that the plaintiff had adequately pled her negligence claim when she alleged that she was injured as a result of the defendant’s “failure to adequately test” its drug. The court also declined to dismiss the plaintiff’s gross negligence and “wanton and malicious conduct” claims based on the same allegations. Here’s the thing: our “duty to test” cheat sheet includes four cases, including a Second Circuit case, holding that there is no such duty under New York law. The Vardouniotis court didn’t even discuss the issue when it allowed these claims to proceed. We are disturbed by this. The concept of “failure to test” intrudes on territory that is framed by FDA’s comprehensive regulatory scheme. Our drug and device clients don’t need common-law “failure to test” claims, especially in jurisdictions that have already rejected them.
Nevertheless, we love the preemption portion of this decision. We will continue to keep you posted on the good, the bad, and the merely imperfect. In the meantime, stay safe out there.