Prescription drugs and class actions don’t mix

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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 in fact inextricably linked with his nemesis). Picnics and bees. Elected officials and the power to borrow money. You got the idea. Some things are designed in universes so different that they shouldn’t be combined no matter how hard someone tries.

Prescription Drugs and Class Actions. It’s another combination that should never be, and for good reason. Due to the nature of prescription drugs and the way they are regulated and dispensed, prescription drug disputes inevitably present unique patient issues. Individual issues of warnings, causation, and injury (among others) go beyond any attempt to deal with prescription drugs collectively, which is why class actions in the field of drugs and medical devices are not very common.

Take, for example, a recent case in New York where the complainant attempted to argue claims that would be certifiable as a group, but ended up having her claims dismissed with prejudice. The case is Zottola v. Eisai, Inc., No. 20-cv-02600, 2021 WL 4460563 (SDNY September 29, 2021), and the affected product was a prescription weight control product voluntarily withdrawn from the market due to a slight increase in the frequency of cancer in a clinical test. Identifier. at 7 O’clock. The complainant sued, but not because she suffered from cancer. She has not suffered any suspected complications and does not even appear to claim that the medication was not working. Instead, she alleged that the defendant’s “labels and disclosures” tricked her, and a class of individuals nationwide, into purchasing the product. Identifier.

The plaintiff’s failure to allege prejudice and its vague reference to “labels and disclosures” were not oversights. These were intentional efforts to allege allegations that she could pursue class-wide. Individual injury and causation issues? No problem if you pretend there are no injuries. Individual addiction problems? It’s okay if you ignore the alleged misrepresentation in favor of supposedly uniform “labels and disclosures”.

This is what the complainant thought. But by watering down her claim to the lowest common denominators (or more accurately, to the non-existent denominators), the complainant did not indicate a cause of action. As in most such putative class actions, the plaintiff’s flagship claim was consumer fraud, which in New York is a statutory claim under the General Business Law of New York (the “NYBGL”). However, she did not make a complaint for three reasons. First of all, the plaintiff alleged that there was no identifiable harm, as the claim that it “would not have purchased the product” had it not been for the allegedly deceptive conduct of the manufacturer is insufficient to establish identifiable harm under New York law. Identifier. at 3. Here, the complainant appears to have gotten exactly what she paid for.

Second, the plaintiff did not allege “consumer oriented” conduct. Remember that the product was a prescription drug, and under the New York Scholarly Intermediation Rule, the manufacturer’s duty to warn was with 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 scholarly intermediary rule for drugs that “do not save lives”, but the court correctly ruled that “the nature of the drug is irrelevant” . Identifier. at 4 o’clock.

Third, by referring only to representations not specified in the “labels and disclosures” and doing so “on the basis of information and beliefs”, the plaintiff did not allege conduct that was “substantially deceptive”. There just wasn’t any “there” there. The complainant again attempted to create an exception, this time arguing that she did not have to allege fraud with any particularity because she was making a claim “based on omissions”. But a “omission-based” claim (again) comes up against the learned intermediary rule (again), because the manufacturer owed no disclosure obligation to the claimant. This duty fell to the doctor. Identifier. to * 4- * 5.

Plaintiff’s other claims – conversion, implied warranty, fraud and unjust enrichment – all failed for similar reasons. The conversion was a square dowel in the claimant’s alleged round hole. Identifier. to 6. All other claims were based on the allegation that the defendant had misled consumers by concealing a cancer risk, and the court has already determined that the plaintiff had not alleged materially deceptive behavior. Identifier.

In our view, this order demonstrates the inevitable tension between class actions and prescription drugs. This complainant tried to generalize her allegations, and she simply tried to avoid alleging actual harm or deceptive conduct with any specificity. Her design was to alleviate her own burden on class certification, but she only succeeded in making an amicable plea. The complainant doubled down on this strategy by seeking leave to amend, but superficially and without explaining what she could do to remedy the shortcomings of her complaint. Identifier. to * 11- * 12. The district court therefore refused permission to modify and “reject[ed] the complaint incriminated with prejudice ”, which of course opens the way to an appeal.

So this is it. Two things that don’t go together. Like Taylor Swift and romantic relationships. Cruise ships and icebergs. Or fried chicken and waffles. Wait, fried chicken and waffles are one thing, and it’s delicious. Hit the latter.


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