Some things were never meant to go together. Oil and water. Ice cream and ketchup. Harry Potter and Lord Voldemort (although fans of the books will quickly point out that Boy Who Lived was actually linked inextricably to his arch enemy). Picnics and honey bees. Elected officials and the power to borrow money. You get the idea. Some things are conceived in such different universes that that they should not be combined, no matter how hard someone tries.
Prescription drugs and class actions. That is another combination that never should be, and for good reason. Because of the nature of prescription drugs and the way they are regulated and dispensed, disputes involving prescription drugs unavoidably present issues that are unique to each patient. Individual issues of warnings, causation, and injury (among other things) overwhelm any attempt to deal with prescription drugs in a collective fashion, which is why class actions in the drug and medical device space are not very common.
Consider for example a recent case from New York where the plaintiff attempted to plead claims that would be certifiable as a class, but wound up having her claims dismissed with prejudice instead. The case is Zottola v. Eisai, Inc., No. 20-cv-02600, 2021 WL 4460563 (S.D.N.Y. Sept. 29, 2021), and the product involved was a prescription weight control product voluntarily withdrawn from the market because of a slight increased occurrence of cancer in a clinical trial. Id. at *7. The plaintiff sued, but not because she experienced cancer. She experience no alleged complication at all, nor does she even appear to allege that the drug was not effective. Instead, she alleged that the defendant’s “labels and disclosures” deceived her and a nationwide class of individuals into purchasing the product. Id.
The plaintiff’s failure to allege an injury and her vague reference to “labels and disclosures” were not oversights. They were intentional efforts to allege claims that she could pursue on a classwide basis. Individual injury and causation issues? Not a problem if you allege no injury at all. Individual issues of reliance? Not a problem if you gloss over the alleged misrepresentations in favor of purportedly uniform “labels and disclosures.”
That is what the plaintiff figured. But in watering down her claim to the lowest common denominators (or more accurately, non-existent denominators), the plaintiff failed to state a cause of action. As in most putative class actions of this kind, the plaintiff’s marquee claim was consumer fraud, which in New York is a statutory claim under New York’s General Business Law (the “NYBGL”). She failed to state a claim, however, for three reasons. First, the plaintiff alleged no cognizable injury, as an allegation that she “would not have purchased the product” but for the manufacturer’s allegedly deceptive conduct is insufficient to establish a cognizable injury under New York law. Id. at *3. Here, the plaintiff seems allegedly to have gotten exactly what she paid for.
Second, the plaintiff did not allege “consumer oriented” conduct. Remember the product was a prescription drug, and under New York’s learned intermediary rule, the manufacturer’s duty to warn ran to the prescribing physician, not the patient. As a result, the alleged deceptive conduct—failing to provide adequate drug warnings—was by definition not “consumer oriented.” The plaintiff urged the district court to create a new exception to the learned intermediary rule for medicines that are “not life saving,” but the court correctly ruled that “the nature of the drug is irrelevant.” Id. at *4.
Third, by referring only to unspecified representations in the “labels and disclosures” and doing so “on information and belief,” the plaintiff did not allege conduct that was “materially misleading.” There simply was no “there” there. The plaintiff again tried to create an exception for herself, this time by arguing that she did not have to alleged fraud with any particularity because she was asserting an “omission-based” claim. But an “omission-based” claim runs headlong (again) into the learned intermediary rule, because the manufacturer owed the plaintiff no duty to disclose. That duty ran to the physician. Id. at *4-*5.
The plaintiff’s other claims—conversion, implied warranty, fraud, and unjust enrichment—all failed for similar reasons. Conversion was a square peg in the plaintiff’s alleged round hole. Id. at *6. All the other claims were based on the allegation that the defendant misled consumers by concealing a risk of cancer, and the court already determined that the plaintiff had failed to allege any materially misleading behavior. Id.
In our view, this order demonstrates the unavoidable tension between class actions and prescription drugs. This plaintiff tried to go general with her allegations, and she tried altogether to avoid alleging an actual injury or deceptive conduct with any specificity. Her design was to ease her own burden on class certification, but she succeeded only in pleading herself out of court. Plaintiff doubled down on this strategy by requesting leave to amend, but in only a cursory manner and without explaining what she could do to cure the deficiencies in her complaint Id. at *11-*12. The district court therefore denied leave to amend and “dismiss[ed] the offending Complaint with prejudice,” which of course clears the way for an appeal.
So there you have it. Two things that just don’t go together. Like Taylor Swift and romantic relationships. Ocean liners and icebergs. Or fried chicken and waffles. Wait, fried chicken and waffles are a thing, and it is delicious. Strike that last one.