A potential top-ten case came across our desks the other day, and even better, it comes out of our home state of California. In Amiodarone Cases, No. A161023, 2022 WL 16646728 (Cal. Ct. App. Nov. 3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. Along the way, the Court disabused several harmful misconceptions on California’s learned intermediary doctrine and held that fraud claims based on journal articles and decades-old statements were bunk.
The FDA approved amiodarone in 1985 as a last-resort treatment for ventricular fibrillation, and a few years later—in 1989 and 1992—the agency notified the manufacturer of statements that it considered false and misleading, including purported promotion for an unapproved use. Id. at *1. Fast forward a few decades, and hundreds of plaintiffs in a coordination proceeding in California have alleged that they experienced side effects after their doctors prescribed amiodarone off label. Id. at *2.
You read that correctly. These plaintiffs were reaching back to alleged misstatements made 30 years ago. Moreover, amiodarone has been available in generic forms since 1998, so the plaintiffs ginned up claims against generic manufacturers, too—that all defendants (branded and generic) failed adequately to warn plaintiffs of potential risks because they did not ensure that patients received FDA-approved Medication Guides with their prescriptions.
This is not a new idea. Amiodarone patients in other jurisdictions have made similar Medication Guide/warnings claims, and some have survived challenges to the pleadings, including in Wisconsin and Illinois. You can see our take on these orders here and here. Long story short, we disagreed with those results, especially the short shrift that those orders gave to implied preemption.
The trial court in California saw things more our way and dismissed the plaintiffs’ Medication Guide claims without leave to amend. More importantly, the California Court of Appeal affirmed in a published opinion.
The Court of Appeal held that federal law preempted the plaintiffs’ failure-to-warn claims because the plaintiffs were trying to enforce the federal Food, Drug and Cosmetic Act. Faithful readers know our affinity for 21 U.S.C. section 337(a), which mandates that all enforcement of the FDCA “shall be by and in the name of the United States.” Id. at *5 (citing the statute). There is no private right of action under the FDCA. Here, Medication Guides are a form of FDA-approved labeling for prescription drugs, and drug manufacturers (and distributors) have a duty under federal regulations to ensure that Medication Guides are available for distribution to patients in sufficient numbers. Id. at *4.
By alleging that the defendants did not ensure distribution of Medication Guides, the plaintiffs were attempting to enforce the FDCA, which only the federal government can do. That led to federal preemption under section 337 and the Supreme Court’s Buckman case. Moreover, the Court rejected the plaintiffs’ argument that they were basing their claims only on state law because the drug manufacturers owed the plaintiffs no duty to warn under California law. That is because California’s learned intermediary doctrine holds that a drug manufacturer’s duty to warn runs to physicians—not directly to patients. Id.
This reasoning is sound and straightforward, but perhaps even more interesting is the Court of Appeal’s defense of the learned intermediary doctrine itself. At least it is interesting to us because it directly confronts and rejects specious arguments that we often see and that courts occasionally accept. First, the plaintiffs argued that the learned intermediary doctrine is an affirmative defense that does not appear on the face of the complaint and thus cannot be the basis for a motion to dismiss (or as we Californians still say, a demurrer). The Court of Appeal correctly rejected that argument, as the learned intermediary doctrine is not a defense, but instead is a reflection of the legal limits to the duty to warn, and thus is a plaintiff’s burden to plead. As the Court explained,
We are not aware of any California decision that characterizes the learned intermediary doctrine as an affirmative defense. To the contrary, it has long been the law in California that the learned intermediary doctrine defines the scope of a manufacturer’s duty to warn in the context of prescription drugs. . . .
Because the duty to warn is an essential element of plaintiffs’ claims, and the learned intermediary doctrine sets the scope of the duty with respect to the prescription drug . . . , it is plaintiffs’ burden to plead and prove that defendants failed to adequately warn the prescription physician of the potential risks.
Id. at *6. This correctly describes the learned intermediary doctrine in California and many other places.
Second, the plaintiffs argued that the learned intermediary doctrine did not apply because they alleged that their physicians were not adequately warned. In other words, because the manufacturers allegedly did not adequately warn doctors, they had a duty to warn the patients. Id. at *7. We are always flummoxed when courts seriously entertain this argument because it makes no sense. If a plaintiff could avoid the learned intermediary doctrine merely by alleging that a drug manufacturer did not adequately warn physicians, then the learned intermediary doctrine would never apply—because every plaintiff in a failure-to-warn case necessarily alleges that the warnings were not adequate. The Court of Appeal was not fooled:
Plaintiffs have not demonstrated that the learned intermediary doctrine somehow does not apply when plaintiffs allege that the warnings to physicians are inadequate. Nor that the absence of an adequate warning about a prescription drug to a physician somehow results in a duty to provide warnings to the patient.
Id. As a final salvo against all defendants, the plaintiffs argued that their Medication Guide claim was saved from preemption because it was based on California’s Sherman Act, i.e., the state’s equivalent Food, Drug, and Cosmetics law. Id. at *8. This tack will sound familiar to California food lawyers, because it mimics the California Supreme Court’s jurisprudence on federal preemption (or lack thereof) in food cases, such as the deliciously named Farm Fresh Salmon case. An attempt to “foodify” California drug law did not work in a case on which we wrote two years ago, and it did not work in Amiodarone either: California’s Sherman Act expressly exempts prescription drugs from its labeling requirements. Id. at *8.
These rulings gutted the plaintiffs’ Medication Guide claims against all defendants, and the Court of Appeal’s rulings on federal preemption and the learned intermediary doctrine are what make the case eminently blogworthy.
But what about the age-old misrepresentation claims against the branded manufacturer? The Court of Appeal held that those claims had no merit either. The most recent alleged misrepresentations dated from 1992; the representations did not concern the use of amiodarone to treat anything other than the approved indication; and the plaintiffs did not allege that any of their physicians actually saw the alleged misrepresentations. Id. at *11. Allegations that a physician was “apparently a victim” of a promotional campaign were conclusory and insufficient to state a claim. Id. Statements made by third parties in medical articles were also not sufficient, because the authors were not the branded manufacturer’s agents. Id. at *12-*13.
Look out for this case in our annual top ten.