The last time we looked into Bueno v. Merck, it was anything but bueno.  Taking the position that, “if there is a cause of action, there must be jurisdiction,” a misguided decision had held that a branded drug manufacturer could be haled to court under an innovator liability claim, despite the defendant having never sold anything to the plaintiff in the state.  See Bueno v. Merck & Co., 626 F. Supp.3d 1154 (S.D. Cal. 2022).  That decision made our bottom ten list in in 2022.

Two years later – and who knows how many $$$ spent in the interim – the result on the merits was incomparably better.  All claims dismissed with prejudice for a variety of excellent reasons.  Bueno v. Merck & Co., ___ F. Supp.3d ___, 2024 WL 3974754 (S.D. Cal. Aug. 27, 2024).  Ditto for a companion case decided the same day.  See Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024).

Here’s what happened.

First, the plaintiff in Bueno lost on choice of law.  Since “relevant conduct at issue here occurred entirely in Florida,” rather than in California, again this would seem like a no-brainer.  Bueno, 2024 WL 3974754, at *7.  But since that result would tank the plaintiff’s only viable liability theory – the aforementioned claim for innovator liability – plaintiff unsuccessfully urged the opposite result:

[Plaintiff] asserts that he experienced injury in California.  But the purported situs of the injury does not automatically control which state’s laws apply to a plaintiff’s claims.  Rather, it is merely a relevant consideration.  And, here, Plaintiff’s assertion that he experienced injury in California is only a minor consideration given that he asserts that he experienced injury in Florida as well.  Further, the fact that [plaintiff] may currently be a California resident is not dispositive.

Id. (citations and quotation marks omitted).

Strike one in Bueno.

Next up was the learned intermediary rule, which the decision addressed, assuming that California law applied.  The rule applies to all warning-related claims, including negligence.  Id.  It applies to claims both for warning “inadequacy [and] absence of the warning” altogether.  Id. at *8.  The plaintiff failed with all of negligent warning allegations, those being:  (1) that a label change should have said “are consistent” rather than “appear consistent”; (2) that a plaintiff-bespoke use of the drug (prescription “for allergic rhinitis” after “experienc[ing] suicidality”) should have been contraindicated; and (3) that in addition to adding a boxed warning, the defendant should have followed up with a “Dear doctor” letter touting the new warning.  Id. at *8-9.

These claims failed because they didn’t even mesh with plaintiff’s own expert opinions.  Id. at *9.  We can see why it would be hard for anyone to opine that “are consistent” means anything different than “appear consistent,” but the expert didn’t even try.  Id.  Maybe this expert simply filed the wrong report, since most of the opinions “ha[d] no relevance to [this plaintiff],” id., but we doubt it, because plaintiff made no move to substitute anything else, and a second expert did not do any better.  As to the actually claimed “neuropsychiatric” risks of the drug, the plaintiff’s experts opined only that:

the manufacturer . . . should have anticipated, monitored, and/or warned about neuropsychiatric risks, she does not explain how the neuropsychiatric warnings that existed on the [drug’s] label were inadequate.  The same is true of the report written by Plaintiff’s other expert, . . . [that] does not discuss any specific inadequacies in the [drug’s] label.

Id. at *9-10 (citations and quotation marks omitted).  This lack of any viable expert testimony on the issue of warning inadequacy meant that the defendants were entitled to summary judgment even if the plaintiff had won on choice of law.  Id. at *10

Strike two.

While the bad jurisdictional ruling forced the defendant in Bueno to spend more time and money, it did get a return on this investment – favorable prescriber learned intermediary causation testimony “that at the time he prescribed montelukast to [plaintiff], he was familiar with its risks and benefits.”  Id. at *8.  As in the majority of learned intermediary decisions, causation was also at issue.  Under the recent Himes case:

Where the evidence shows that the physician would have continued to recommend the treatment notwithstanding the stronger warning, a plaintiff can also prove causation by proving that an objectively prudent person in the patient’s position would have declined treatment despite the physician’s assessment that the benefits of the treatment for the patient would still outweigh any risks disclosed by a stronger warning.

Id. (quotation marks omitted).  In learned intermediary cases, the “Plaintiff bears the burden of proving that any inadequacies by Defendants in warning Plaintiff’s physicians of the risks associated with [the drug that] caused his injuries” Id. (citation omitted).

The prescriber in Bueno testified that the plaintiff’s nitpicky distinction between “appear consistent” and “are consistent” was “not really” significant to his prescription.  Id. at *11.  With no other evidence to contradict the prescriber’s testimony, the plaintiff in Bueno could “not meet his burden to prove that changing, ‘appear consistent’ to ‘are consistent’ . . . would materially affect his physician’s prescribing decisions.”  Id. (citation omitted).  As for the purported custom-made contraindication, it failed because “[t]he record . . . does not demonstrate that Plaintiff ever reported suicidality or suicidal ideation to [his prescriber].”  Id.  Nor would a “Dear doctor” have made any difference – because, well, time:

[S]ending [the prescriber] a “Dear doctor” letter following the 2020 addition of the black box warning to the [drug’s] label would not have changed [his] prescribing decisions for [plaintiff] because [he] did not treat [plaintiff] after November 2019.

Id. at *12 (citations omitted).

Strike three.

Finally, and most importantly for its impact on other cases, Bueno also determined that the plaintiff’s warning claims were preempted – because plaintiff did not have the requisite “newly acquired information” to establish that the defendants could have made a unilateral label change under FDA regulations.

• “In general, the FDA must approve any subsequent label change through a supplemental application process.”  Bueno, 2024 WL 3974754, at *12 (citation and quotation marks omitted).
• “[T]he FDA’s CBE regulation permits drug manufacturers to change a label to reflect newly acquired information if the changes add or strengthen a warning for which there is evidence of a causal association, without prior approval from the FDA.”  Id. (citation and quotation marks omitted).
• Thus, preemption requires a “threshold inquiry of whether there is newly acquired information to support a CBE submission.”  Id. at *13 (citations and quotation marks omitted).
• Plaintiff offered no evidence to support his claim that “many adverse event reports . . . were piling up.”  Id. at 14 (citation and quotation marks omitted).
• Adverse event reports that already “were in the FDA database” were, by definition, “previously made available to the FDA,” and thus could not be “newly acquired.”  Id. (citation and quotation marks omitted).
• “Nor does Plaintiff explain how any of the adverse event reports revealed a causal relationship between [the drug] and the adverse event that could justify a CBE change.”  Id. (citations omitted).
• Thus, “Plaintiff’s vague citation to approximately ten thousand reports” already made to the FDA did not establish “newly acquired information” that could “defeat” preemption.  Id.
• Newly acquired information could not be created during after-the-fact “by an expert in preparation for litigation with the benefit of hindsight,” as the plaintiff attempted to do.  Id. at *15 (citation and quotation marks omitted).
• “[A]sserting that a manufacturer could or should have done more studies − i.e., that a manufacturer should have created the newly acquired information” – does not defeat preemption.  Id. (citation and quotation marks omitted).
• Even if otherwise permissible, plaintiff’s expert’s “five to ten minute simple analysis” was not “reasonable evidence” of a “recalculation” that could support a label change.  Id. at *15-16 (citations and quotation marks omitted).
• Those “recalculations . . . cannot constitute newly acquired information because Plaintiff has not demonstrated that her calculations are reliable or based on the generally accepted methodology approved by the FDA.”  Id. at *17.
• Instead, the recalculations were “crude estimates” that “were divorced from the FDA’s requested and generally accepted methodology.”  Id. (citations and quotation marks omitted).
• Further, that expert “came to a faulty mathematical conclusion” by including data “she should not have used.”  Id. (citation and quotation marks omitted).
• “[A]nalyses using incorrect data, unsupported by published research, cannot constitute reasonable or reliable evidence” and thus cannot defeat preemption.  Id. (citations omitted).  Id. (citation omitted).

Strike four.

The companion case, Parker, 2024 WL 3974764, was similar in both result and reasoning, except since the plaintiff was a California citizen, no choice of law analysis was necessary, and that plaintiff’s prescription dates were different, which slightly altered the factual analysis.  In Parker, the boxed warning appeared during the course of that plaintiff’s treatment, and the prescriber immediately stopped the prescription.  Id. at *3.  Even more than the plaintiff in Bueno, the plaintiff in Parker concealed significant information about his medical history from his prescribing physicians.  Id. at *3-4.  He even neglected to tell a subsequent prescriber that his original prescription for the drug had been halted due to the boxed warning.  Id. at *4.

The plaintiff in Parker made the same three warning claims – nitpicking “was” versus “appears,” the plaintiff-customized contraindication, and the redundant “Dear doctor” letter.  Id. at *6-7.  Parker asserted the same insufficient expert evidence from the same experts.  Id. at *7-8.  However, in Parker plaintiff’s counsel never bothered to depose any of six different prescribers, leading to a complete failure of proof on causation.  Id. at *8-9.  The custom contraindication failed for the additional reason that it did not apply to the Parker plaintiff’s medical condition.  Id. at *9.  That’s a problem with bespoke warning claims.  Nor would any “Dear doctor” letter have made a difference, since plaintiff admitted that the only prescriber he mentioned in his opposing papers “was adamant about taking [plaintiff] off [the drug] as soon as she discovered the black box warning.”  Id. (citation and quotation marks omitted).  Nor could the Parker plaintiff take advantage of the “objectively prudent” patient exception created in Hines, since the plaintiff, himself, did just the opposite – he continued taking the drug after the first prescription was stopped.  How?  Here’s how:

After the FDA added the black box warning to the [drug] label, [Prescriber #1] stopped prescribing Plaintiff [the drug].  However, Plaintiff did not follow [that] prescribing recommendation and did not stop taking [the drug].  Following [Prescriber #1’s] decision to stop [plaintiff’s] prescription, [Prescriber #2], who was unaware of [Prescriber #1’s] decision, prescribed [plaintiff the drug] again . . . during their last visit.  It is undisputed that had [plaintiff] told [Prescriber #2] that the [Prescriber #1] stopped [the] prescription . . ., [Prescriber #2] would have discontinued the prescription, but [plaintiff] did not share that information with [Prescriber #2].

Parker, 2024 WL 3974764, at *10 (citations omitted).  This plaintiff himself wanted the purportedly defective drug so badly that he lied to his own doctors to continue getting it after the defendant’s boxed warning.  Where do they get these plaintiffs?

The preemption analysis in Parker was identical.

Thus, while the plaintiffs in these cases were the beneficiaries of very dubious personal jurisdictional rulings, they might be wishing now that their cases had been dismissed at the outset.  The opinions in Bueno and Parker are excellent on both warning-related and preemption, so we commend them to our readers.