A few of us are collaborating in beta testing of generative synthetic intelligence (“AI”) for authorized purposes within the legislation agency surroundings.  To this point the decision is – associates can breathe simple, no less than for now.  Nothing we’ve seen is able to replicating authorized analysis even at a first-year degree of high quality.

However that doesn’t imply that AI received’t affect prescription medical product legal responsibility litigation.  Particularly, we’re not stunned to study that AI is getting used within the context of FDA-required hostile occasion reporting, purported issues with which have change into one of many different aspect’s go-to preemption dodges.  Just some examples from a easy Google search:

Adversarial occasion circumstances bear scientific evaluation.  Case analysis contains assessing the potential for a causal relationship between the drug and hostile occasion, in addition to assessing the end result of the case.  An AI mannequin was developed primarily based on related options utilized in causality assessments; it was educated, validated, and examined to categorise circumstances by the likelihood of a causal relationship between the drug and hostile occasion.  AI/ML has additionally been utilized to find out seriousness of the end result of ICSRs [Individual Case Safety Reports], which not solely helps case analysis, but in addition the timeliness of particular person case submissions that require expedited reporting.

FDA, “Utilizing Synthetic Intelligence & Machine Studying within the Improvement of Drug & Organic Merchandise,” at 10 (2022).  “We conclude that AI can usefully be utilized to some points of ICSR processing and analysis, however the efficiency of present AI algorithms requires a ‘human-in-the-loop’ to make sure good high quality.”  Ball & Dal Pan, “Synthetic Intelligence” for Pharmacovigilance: Prepared for Prime Time?,” 45 Drug Security 429, at summary (2022).

Early detection of ADRs and drug-induced toxicity is an important indicator of a drug’s viability and security profile.  The introduction of synthetic intelligence (AI) and machine studying (ML) approaches has resulted in a paradigm shift within the area of early ADR and toxicity detection.  The appliance of those trendy computational strategies permits for the fast, thorough, and exact prediction of possible ADRs and toxicity.

Yang & Kar, “Software of Synthetic Intelligence & Machine Studying in Early Detection of Adversarial Drug Reactions (ADRs) & Drug-Induced Toxicity,” 1 Synthetic Intelligence Chemistry, at summary (2023)

What this tells us, as litigators in MDLs and different mass torts, is that plaintiffs’ efforts at taking “discovery” of AI algorithms employed in FDA-mandated hostile occasion reporting received’t be far behind.  Notably with AI, nevertheless, there’s a fantastic line between what has already been created and what AI can create going ahead. The secret is to restrict such discovery to what “discovery” is meant to be, as outlined by Fed. R. Civ. P. 34.  Within the case of digital data, Rule 34(a)(1) permits a requesting celebration “to examine, copy, check, or pattern . . . electronically saved data” (emphasis added).  Thus, requestors are restricted to discovering “information . . . saved in any medium.”  Id.

The 2006 Advisory Committee notes specify that “Rule 34 applies to data that’s mounted in a tangible type and to data that’s saved in a medium from which it may be retrieved and examined.”  Different key language within the feedback is:

The addition of testing and sampling to Rule 34(a) with regard to paperwork and electronically saved data is just not meant to create a routine proper of direct entry to a celebration’s digital data system, though such entry could be justified in some circumstances.

(Emphasis added).

We emphasize these factors as a result of what we don’t need to occur is for the opposite aspect to transcend entry to “saved” data allowed underneath Rule 34, and as an alternative attempt to manipulate AI packages to create new outputs that – the opposite aspect will contend – exhibit hypothetical inaccuracies or shortcomings which will by no means have occurred within the real-world operation of such AI.

The authorized proposition is just this:  “Plaintiff might not require Defendants to create proof that doesn’t at the moment exist.”  Brown v. Clark, 2013 WL 1087499, at *5 (E.D. Cal. March 14, 2013).  “Defendants haven’t any obligation underneath the invention guidelines to create proof to assist Plaintiff’s claims.”  Warner v. Cate, 2016 WL 7210111, at *9 (E.D. Cal. Dec. 12, 2016).

Whereas Plaintiff is entitled to hunt related proof from the Defendants in discovery and to file a movement to compel if crucial, Plaintiff might solely search proof that already exists.  The foundations of discovery don’t permit Plaintiff to compel Defendants to conduct an investigation to create proof for Plaintiff.

Rider v. Yates, 2010 WL 503061, at *1 (E.D. Cal. Feb. 5, 2010).  Events “should not required to create proof that doesn’t at the moment exist in an effort to adjust to their discovery obligations.”  Bratton v. Shinette, 2018 WL 4929736, at *5 (E.D. Cal. Oct. 11, 2018).  “If no such [evidence] exists, as [the producer] purports, [requestors] can’t depend on Rule 34 to require [them] to create a doc assembly their request.”  Abouelenein v. Kansas Metropolis Kansas Neighborhood Faculty, 2020 WL 1124396, at *4 (D. Kan. March 6, 2020).  A “[p]laintiff is just not entitled to play-by-plays of ever-changing information.”  Moriarty v. American Basic Life Insurance coverage Co., 2021 WL 6197289, at *4 (S.D. Cal. Dec. 31, 2021).

That’s what permitting plaintiffs to control a defendant’s AI reporting system quantities to.  They’d be going past merely accessing “saved” data and as an alternative could be demanding to make one thing new – akin to a intentionally incomplete hostile occasion report – that didn’t exist when such “discovery” was sought.  We have to anticipate plaintiffs trying this interference with our shopper’s AI methods, with hostile occasion reporting representing a very doubtless early stress level.