They say the smartest people are the ones who are always learning something new. Those who are open to new ideas and concepts. People who are eager to acquire new information. That’s a great way to live. Long live enlightenment. However, when it comes to federal preemption of a failure to warn claim involving a prescription pharmaceutical, the only new knowledge that counts is the FDA’s.

That’s essentially what the court told Plaintiff in Roshkovan v. Bristol-Myers Squibb Company, 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022). Plaintiff was prescribed defendant’s drug to treat his chronic myeloid leukemia. He alleged that the drug caused him to suffer a loss of vision in his right eye due to hemorrhaging. Id. at *2. He brought failure to warns claims sounding in both negligence and strict liability.

The first thing defendant asked the court to do was take judicial notice of the drug’s labels from the FDA website. The court granted that request on two grounds. First, courts “regularly take judicial notice of materials prepared by government agencies.” Id. at *5. Second, the court was willing to consider the labels under the “incorporation by reference” doctrine. Because plaintiff’s failure to warn claims were based on the content of the labels, and the labels were referenced and quoted in the complaint, defendant could incorporate them into their motion and the court could consider them in deciding the motion. Id.

The court next considered defendant’s argument that the drug’s warnings were adequate as a matter of law. The labels included warnings about the risk of bleeding and hemorrhagic events and information about adverse events related to the eye and vision. The label did not include the specific risk suffered by plaintiff—loss of vision due to retinal hemorrhage. Id. at *8. And because “California poses a high standard for ambiguous warnings,” the court was unwilling to find the warning adequate as a matter of law. Id. at *9.

That left open the question of the adequacy of plaintiff’s allegations regarding causation. Here plaintiff did not fare as well. Plaintiff alleged only that his physician prescribed the drug and the drug’s label was inadequate. In other words, plaintiff simply alleged that that the inadequate warning caused his injury. Under the learned intermediary rule, however, plaintiff bears the burden of proving that the inadequate warning “would have altered the prescribing physician’s decision to use the product.” Id. Therefore, to satisfy TwIqbal, plaintiff’s complaint must also so allege, and not in a conclusory fashion. On this ground, plaintiff’s claims were dismissed.

But the court went on to consider defendant’s argument that the claims were also preempted. This is where we get to who knew what when. Failure to warn is not preempted if the defendant could have changed the label without FDA approval via the Changes Being Effected (CBE) regulation. That regulation provides that a manufacturer can change its label to reflect “newly acquired information” that adds or strengthens a warning “for which there is evidence of a causal association” without prior FDA approval. Id. at *10.

Newly acquired information can be many things (studies, reports, new analyses), but first and foremost it must be information that was not previously submitted to the FDA. Plaintiff in this case took great pains to set out all the information known to the FDA long before plaintiff ever took the drug – including that both the manufacturer and the FDA knew as far back as 2005 that the drug allegedly caused severe eye-related disorders. Id. So, plaintiff actually alleged “the opposite of what is required to overcome preemption.” The only person plaintiff alleges “belatedly uncovered” this information was plaintiff: “In September 2019, Plaintiff discovered …..” Unless we are talking about the statute of limitations, what the plaintiff knew when doesn’t really matter. And while not addressed in the opinion, it could be plaintiff was trying to plead around the statute of limitations and by doing so pleaded himself right into preemption. Since the complaint, as currently pleaded, demonstrates that the manufacturer and the defendant were aware of the risk of vision loss and the drug’s labels were approved with this knowledge, the claims are preempted. Id. at *11.

Since the pleading deficiencies as to both causation and preemption could potentially be remedied, plaintiff is getting a second bite at the apple. This time to survive plaintiff is going to have to move the focus off himself and onto his prescriber and the FDA.

This article was written by Michelle Yeary  of Dechert LLP.