We have decided that 2023 will be a year of new adventures for us. We are dipping our toes into the world of dog shows (our gorgeous poodle puppy is now past five months old and soon to begin his show career with a top poodle handler) and we are running for local elected office. The journey is finite, more road is behind than ahead, and change – simply for change’s sake – strikes us as a good thing.
But not in the law. Much of today’s case struck us as capricious: where the law didn’t fit the narrative, the court changed it. And that’s not the way it works. Let us explain.
In Haddad v. Merck & Co., Inc., 2022 WL 18397392 (C.D. Cal. Dec. 9. 2022), the plaintiffs alleged that the defendant’s asthma medication caused them to suffer neuropsychiatric side effects. The defendants warned of these adverse events over the years, progressively strengthening the warnings and increasing their prominence. In 2009, a detailed warning was added to the “Precautions” section of the label. Additional minor changes were implemented over the next decade until, in 2020, the FDA required the defendant to add a “Black Box Warning,” the strongest category of warning, stating that “serious neuropsychiatric effects” had been reported, providing a long list of such effects, and stating that the benefits of the drug might not outweigh the risks.
The plaintiffs’ claims comprised the typical litany: warnings claims sounding in strict liability and negligence, negligent misrepresentation, and breaches of express and implied warranties. The defendants moved to dismiss the plaintiffs’ claims on the grounds that: 1) the claims as to the Black Box Warning were preempted; 2) the claims were time-barred; and 3) the warnings, negligence, negligent misrepresentation, and warranty claims failed to state claims under Rule 12(b)(6).
The defendants argued that the failure-to-warn claims were preempted by the FDCA for the time period after the Black Box Warning was added to the label. The court noted that defendants could not unilaterally modify the content of the label through the C.B.E. (“Changes Being Effected”) process; thus, claims as to “the content or form of the Black Box Warning” were preempted. Haddad, 2022 WL 18397392 at *3. The court emphasized that preemption did not extend to claims about the “manner or method of publication” of the warning. Id. This is important – stay tuned.
Statute of Limitations
The defendants moved to dismiss the plaintiffs’ claims as barred by California’s two-year product liability statute of limitations. One plaintiff alleged that she started and stopped taking the drug when she was a child and had no memory of taking it. She also developed her neuropsychiatric symptoms when she was a child, more than ten years before she filed suit. She alleged that she learned about the possible causal connection between her symptoms and the drug when her parents saw a television ad after the Black Box Warning was added. Though her claims were time-barred on their face, the court held that California’s discovery rule saved the claims because the plaintiff filed suit within two years of discovering the possible connection between her symptoms and the defendant’s drug. This ruling makes sense to us – not so the next one.
The other two plaintiffs began taking the drug years before the Black Box Warning was added but kept taking it for a year afterwards. The defendants argued that these plaintiffs’ claims were time-barred to the extent that they sought damages for years of injuries they sustained more than two years before they filed suit because they did not adequately plead the discovery rule. The court held that these plaintiffs “[did] not need to plead the discovery rule . . . because they allege a continuous violation, which is an alternate theory of claim accrual.” Id. at *4. The court continued:
The . . . allegations all center around a single, continuing alleged wrong by Defendants: the failure to adequately warn against or disclose information about the known risk of neuropsychiatric injuries from the use of [the drug]. This wrong, as alleged, started from the first time the drug went to market through at least the issuance of the Black Box Warning. This is precisely the type of situation contemplated by the continuing violation doctrine, which is a response to the inequities that would arise if the expiration of the limitations period following a first breach of duty or instance of misconduct were treated as sufficient to bar suit for any subsequent breach or misconduct. Given the allegations that Defendants failed to adequately warn consumers from the inception of the drug through the issuance of the Black Box Warning and maybe even after that, the tort is necessarily continuous and ongoing.
Id. at *5 (internal punctuation and citations omitted). The court continued, “Since the continuous violation doctrine applies, Plaintiffs can recover for any tortious conduct that occurred outside the [limitations] period provided it is ‘sufficiently linked’ to conduct within the . . . period.” Id. Because the alleged tortious conduct was so linked, and because the plaintiffs filed suit within two years of the issuance of the Black Box Warning, the court held that their claims were not time-barred.
But here’s the thing: that’s not the law. In a prescription drug product liability case, a plaintiff’s claim typically accrues when the plaintiff is injured unless an adequately-pled discovery rule alters the accrual date. Even Haddad concedes that the continuous violation doctrine is “most often applied in the employment context.” Id. But that understates the complete absence of precedent for applying it in the context of a prescription drug product liability case. And so the court changed the law, essentially tolling the statute of limitations for the entire time the plaintiffs took the drug and restoring years of damages claims that were time-barred under any honest reading of the applicable law. We shudder at the slippery slope implications of this holding.
Failure to State a Claim
The court granted the defendant’s motion to dismiss the negligent misrepresentation claim, which had once been dismissed without prejudice and not adequately re-pled, and denied the motion as to the warranty claims.
Much more interesting was the discussion of the warnings claims. The court’s preemption ruling barred the plaintiffs’ claims that the content of the Black Box Warning was inadequate. But, Haddad held that the ruling “still leaves room for [the plaintiff] to plead a claim for the adequacy of the manner and distribution of the Black Box Warning.” Id. at *6. (Haddad’s authority for this proposition is a footnote in a 53-year-old Ninth Circuit case about plate glass, not prescription drugs or preemption.) According to Haddad, the complaint adequately explains “how the timing of the Black Box Warning, in April 2020, at the beginning of the COVID-19 pandemic, meant that the FDA needed to take additional steps [dear doctor” letters, for example] to make sure that prescribing physicians received the Black Box Warning.” Id. Again – need we say it? – that’s not the law. A prescription drug manufacturer discharges its duty to warn a prescribing physician (California applies the learned intermediary doctrine) by including adequate warnings in the product’s labeling. Adding additional obligations to compensate for current events isn’t – or shouldn’t be – the province of a trial court judge.
Speaking of the learned intermediary doctrine, Haddad acknowledged that, even if the warnings were “inadequate” because of the way they were propounded, the plaintiffs still bore the burden of proving the causation element of their warnings claims. As regular readers know, we love warnings causation, a doctrine that, for purposes of a 12(b)(6) motion, requires plaintiffs to plead that a different or stronger warning would have altered their doctors’ decisions to prescribe the drug. Ummmm, except in Haddad. Here, the court allowed the plaintiffs to plead warnings causation “on information and belief,” accepting their argument that they tried and failed to get hold of their doctors to ask them for information about the decision to continue prescribing the drug. Given that Haddad had, as already discussed, statute of limitations problems, one wonders how plausible that explanation is.
Way too much “tweaking” of the law, in our view, working backward from a desired result and shoehorning the law to fit. Does a court have latitude to mold the law to respond to current events? We would argue that it does not and that any other conclusion is fraught with peril. We suspect that we will see more examples of litigants “crying COVID” and asking courts to skate past precedent. We’ll keep you posted. In the meantime, stay safe out there.