The SCOTUS decision in the Wyeth v. Levine case created much mischief in the field of preemption. The Court’s sloppy overstatement of the significance and availability of the Changes Being Effected (CBE) process breathed new life into prescription drug failure to warn cases that should have been safely interred at the pleadings stage. As bad as the Levine decision was, things were made worse when lazy lower courts seized upon the Levine rationale to wave along failure to warn cases with scarcely an ounce of analysis.
But the times they are a-changing. The SCOTUS Albrecht decision restored some rigor and sanity to the doctrine of preemption of prescription drug failure to warn claims. More and more, we seem to be coming closer to a logical decision tree: What exactly should have been warned of that wasn’t? (Many plaintiffs do not want to come clean on that point until closing argument.) When exactly should that warning have been employed? (If the point in time preceded the approved label or postdated the plaintiff’s usage of the product, the case should be a goner.) What exact evidence shows that the manufacturer should have availed itself of the vaunted CBE process? (Is the evidence strong enough? Is it new enough?)
Rayes v. Novartis Pharms. Corp., 2021 U.S. Dist. LEXIS 112216 (C.D. Cal. June 11, 2021), is a recent, favorable prescription drug preemption case emphasizing the importance of “newly acquired information” as a prerequisite that plaintiffs must satisfy to avoid preemption under Albrecht. The plaintiff in Rayes claimed that he suffered serious eye injuries, including vision loss, from the drug Beovu, which is indicated for the treatment of age-related macular degeneration. The First Amended Complaint (FAC) included claims for failure to warn, negligence, fraudulent misrepresentation, and negligent misrepresentation. Despite that multiplicity of causes of action, the claims boiled down to failure to warn and failure to test. The defendant filed a motion to dismiss.
The plaintiff had a couple of things going for him in the Rayes case. There was peer reviewed literature supporting a causal relationship between the drug and the injury, the label had been changed to add a warning, and there seemed to be safer alternative drugs available. But the defendant had something better: preemption. Naturally, the court confronted the Levine question of whether the defendant should have implemented a CBE to add the warnings in question to the Beovu label. Such a CBE must be premised on “newly acquired information,” which is defined as “data, analyses, or other information not previously submitted to the [FDA] which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., metaanalyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” Id. at *12-13 (quoting McGrath v. Bayer Healthcare Pharms. Inc., 393 F.Supp. 3d 161, 167 (E.D.N.Y. 2019).)
The Rayes court concluded that the plaintiff did not meet the “newly acquired information” standard: “Plaintiff’s FAC is full of allegations of newly acquired information that does not help his case.” Id. at *13. Most of the allegations in the complaint (such as the label change) post-dated the plaintiff’s use of the product and thus could not possibly serve as “new” information as to this plaintiff. Only the period between FDA approval and the plaintiff’s use was relevant.
The “only genuinely new information” that the plaintiff alleged was between three to ten individual adverse event reports of retinal vasculitis after use of Beovu. But the Rayes court concluded that such a small number of adverse events would plainly have been insufficient to constitute “newly acquired information” under relevant FDA standards for scientific evidence that could justify a CBE. Id. at *16. We expect fellow defense hacks to cite this holding frequently going forward.
The plaintiff was not quite done yet, though the Rayes court would quickly change that. The plaintiff sought to “circumvent” preemption by claiming that the defendant failed to disclose clinical trial information to the FDA showing the drug’s “propensity” to cause the alleged eye injuries. Id. at *14. But that sort of claim, grounded upon a manufacturer’s alleged misrepresentation to the FDA, is preempted per the SCOTUS Buckman decision. To the extent the plaintiff alleged fraud/misrepresentation to persons other than the FDA, those claims were insufficiently pleaded.
As a nice, gratuitous cherry on top of this judicial treat, the Rayes court also held that the plaintiff’s misrepresentation claims flunked the particularity requirement of Federal Rule of Civil Procedure 9(b): “The only fraud Plaintiff alleges with any particularity is fraud against the FDA, which, as discussed above, is preempted by Buckman.” Id. at *16.
The court dismissed the FAC without leave to amend. The Rayes case presents a clear vision of Levine preemption, as refined by Albrecht, and focused on what is and is not adequate newly acquired information.