Sometimes, a Magic 8 Ball is just as good as the highest court in the land when it comes to providing answers to difficult questions. In the case of determining whether or not “failure to update labeling” claims are preempted, the United States Supreme Court picked “Better not tell you now”. After the United States Supreme Court denied generic drug manufacturer Pliva’s petition for certiorari in Pliva, Inc. v. Huck (Docket No. 14-544), manufacturers have no resolution on the issue of whether failure-to-update labeling claims against generic drug manufacturers are preempted under the Court’s earlier holding in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Further compounding the confusion, there is a jurisdictional split regarding the reach of Mensing and whether it operates to preempt state-law failure-to-warn claims based on the theory that a generic drug manufacturer has failed to timely update a label with new FDA-approved safety information.
In Huck, just as in Mensing, the plaintiff alleged that she developed tardive dyskinesia after ingesting Pliva’s metoclopramide, the generic form of the prescription drug Reglan. When she began taking the medicine in 2004, the labeling warned that the drug was not was approved for therapy longer than 12 weeks and that tardive dyskinesia, a severe neurological disorder, was a possible side effect of treatment. Approximately 5 months later, the FDA approved an update to the brand name label, which included a bolded warning advising that the medicine should not be used for more than 12 weeks. Ms. Huck continued taking generic metoclopramide for another two years. Pliva never updated its labeling to provide the bolded warning.
Following her use of metoclopramide, Ms. Huck developed tardive dyskinesia, prompting her to sue both the branded and generic manufacturers of Reglan. She raised a number of product liability theories against both sets of defendants, including claims for breach of warranty, negligence, fraud, and misrepresentation. The branded manufacturers were dismissed early the proceedings, successfully arguing that, because Huck never took branded Reglan, she could not prove legal causation under governing Iowa law. As for the generic manufacturer, Pliva, both the Iowa trial court and the appellate court agreed that each of Huck’s claims were preempted under Mensing. Huck v. Trimark Physicians Group, No. 3-129, 12-0596, 2013 Iowa App. LEXIS 435 (Iowa Ct. App. Apr. 24, 2013). Importantly, both courts rejected plaintiff’s attempt to circumvent Mensing by arguing that Pliva’s liability should rest on its failure to update its labeling to include a boldface warning about duration of use, which FDA approved shortly after she started taking metoclopramide in 2004.
Ms. Huck appealed the dismissal of her claims to the Iowa Supreme Court. Although the Court affirmed the lower courts’ orders dismissing the branded defendants, it disagreed that Huck’s failure-to-warn claim against Pliva was preempted. Analyzing Mensing, the Court determined that Huck’s failure-to-warn claim was different. It was not based on an argument that Pliva should have provided a stronger warning than that contained in the branded warning, but rather, that Pliva should have updated its generic drug label to include the FDA-approved bolded warning about use of metoclopramide for longer than 12 weeks. Accordingly, the Court found that, in the absence of a conflict between Pliva’s state law duty to provide adequate warnings and its federal law duty to match its labeling to the branded label, there is no preemption. Huck v. Wyeth, Inc., 850 N.W.2d 353, 364 (Iowa 2014).
Pliva petitioned the United States Supreme Court for certiorari in Huck, arguing that the Iowa Supreme Court’s decision should be evaluated to resolve a jurisdictional split regarding the breadth of preemption in the wake of Mensing. Raising this split and its attendant uncertainty for generic drug manufacturers, Pliva criticized the Iowa Supreme Court’s “form over substance” approach, arguing that plaintiffs may not evade the federal Food Drug and Cosmetic Act (FDCA)’s private enforcement bar by using linguistic liberties to turn an alleged violation of the FDCA – the real issue in Huck – into a state law claim for failure to warn. This, Pliva argued, is still preempted by the explicit provisions of the FDCA.
Unfortunately for generic drug manufacturers, the Supreme Court denied Pliva’s petition for certiorari on March 30, 2015, stating nothing more than that “[t]he petition for writ of certiorari is denied.” Accordingly, generic drug manufacturers – who supply nearly eighty (80) percent of the medicine that is used to fill prescriptions today – are left in a realm of uncertainty as to the reach of Mensing when failure-to-warn claims are raised. Can a clever plaintiff go forward on a failure to warn claim? As Huck and similar cases establish, plaintiffs have become craftier at pleading around Mensing in recent years and, more often than not, lower courts are agreeing that their warnings theories are sufficient to avoid preemption, at least at the pleadings stage.
After Huck, generic drug manufacturers may no longer take comfort in what once was almost a surefire preemption defense, but must take care to craft and develop additional early defenses. One such set of defenses to which particular care should be given are causation defenses based on a lack of proximate causation between any alleged warning defect and the prescribing physician’s decision to prescribe the medicine and/or the patient’s decision to take it. Such defenses often support early dispositive motions, which provide a cleaner dispositive defense than miring through what, in the absence of Supreme Court clarification, has become a messy landscape of preemption.
As to the future reach of Mensing, the Supreme Court and the Magic 8 Ball agree…“Ask again later.”